Research Involving Animals PowerPoint Presentation

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected

Slide 26 -

NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected

Slide 27 -

NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification.

Slide 28 -

NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf

Slide 29 -

NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review

Slide 30 -

NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs.

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy

Slide 39 -

NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application.

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011

Slide 45 -

NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2%

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7%

Slide 48 -

NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15%

Slide 49 -

NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1%

Slide 50 -

NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011

Slide 51 -

NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011

Slide 52 -

NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011

Slide 53 -

NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011

Slide 54 -

NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011 Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation March 3, 2011

Slide 55 -

NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011 Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation March 3, 2011 Implications of Noncompliance Corrective actions and improved systems Restrict/withdraw approval of Assurance Special terms/conditions of awards Enhanced reporting requirements Cost disallowance Suspension/termination of award Criminal prosecution

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011 Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation March 3, 2011 Implications of Noncompliance Corrective actions and improved systems Restrict/withdraw approval of Assurance Special terms/conditions of awards Enhanced reporting requirements Cost disallowance Suspension/termination of award Criminal prosecution Other Possible Ramifications Negative publicity for the institution- media Inquiries from Congress, other Federal regulators Damage to reputation, assessment of peers Institutional standing with alumni Impact from journals- retractions, article withdrawal Institutional loss of personnel, inability to attract new staff

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011 Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation March 3, 2011 Implications of Noncompliance Corrective actions and improved systems Restrict/withdraw approval of Assurance Special terms/conditions of awards Enhanced reporting requirements Cost disallowance Suspension/termination of award Criminal prosecution Other Possible Ramifications Negative publicity for the institution- media Inquiries from Congress, other Federal regulators Damage to reputation, assessment of peers Institutional standing with alumni Impact from journals- retractions, article withdrawal Institutional loss of personnel, inability to attract new staff Collaborative relationship exists between NIH and grantee Institution The partners share a mutual need to assure compliance Each partner has responsibilities and obligations as stewards of public funds Institutional self-governance is the foundation of PHS Policy NIH-Supported Research is a Partnership

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011 Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation March 3, 2011 Implications of Noncompliance Corrective actions and improved systems Restrict/withdraw approval of Assurance Special terms/conditions of awards Enhanced reporting requirements Cost disallowance Suspension/termination of award Criminal prosecution Other Possible Ramifications Negative publicity for the institution- media Inquiries from Congress, other Federal regulators Damage to reputation, assessment of peers Institutional standing with alumni Impact from journals- retractions, article withdrawal Institutional loss of personnel, inability to attract new staff Collaborative relationship exists between NIH and grantee Institution The partners share a mutual need to assure compliance Each partner has responsibilities and obligations as stewards of public funds Institutional self-governance is the foundation of PHS Policy NIH-Supported Research is a Partnership Guidance to Grantees – Guide Notices Instructions for Completion and Peer Review of the Vertebrate Animal Section in NIH Grant Applications and Cooperative Agreements Notice NOT-OD-10-027 Posted April 2010 Grant Application VAS Worksheet located at OLAW main webpage under Guidance section

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011 Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation March 3, 2011 Implications of Noncompliance Corrective actions and improved systems Restrict/withdraw approval of Assurance Special terms/conditions of awards Enhanced reporting requirements Cost disallowance Suspension/termination of award Criminal prosecution Other Possible Ramifications Negative publicity for the institution- media Inquiries from Congress, other Federal regulators Damage to reputation, assessment of peers Institutional standing with alumni Impact from journals- retractions, article withdrawal Institutional loss of personnel, inability to attract new staff Collaborative relationship exists between NIH and grantee Institution The partners share a mutual need to assure compliance Each partner has responsibilities and obligations as stewards of public funds Institutional self-governance is the foundation of PHS Policy NIH-Supported Research is a Partnership Guidance to Grantees – Guide Notices Instructions for Completion and Peer Review of the Vertebrate Animal Section in NIH Grant Applications and Cooperative Agreements Notice NOT-OD-10-027 Posted April 2010 Grant Application VAS Worksheet located at OLAW main webpage under Guidance section Guidance to Grantees – Guide Notices Update of Sample Animal Welfare Assurance for Foreign Institutions Notice NOT-OD-10-083 Posted April 2010 Instructions and downloadable form at OLAW web site under Sample Documents

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011 Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation March 3, 2011 Implications of Noncompliance Corrective actions and improved systems Restrict/withdraw approval of Assurance Special terms/conditions of awards Enhanced reporting requirements Cost disallowance Suspension/termination of award Criminal prosecution Other Possible Ramifications Negative publicity for the institution- media Inquiries from Congress, other Federal regulators Damage to reputation, assessment of peers Institutional standing with alumni Impact from journals- retractions, article withdrawal Institutional loss of personnel, inability to attract new staff Collaborative relationship exists between NIH and grantee Institution The partners share a mutual need to assure compliance Each partner has responsibilities and obligations as stewards of public funds Institutional self-governance is the foundation of PHS Policy NIH-Supported Research is a Partnership Guidance to Grantees – Guide Notices Instructions for Completion and Peer Review of the Vertebrate Animal Section in NIH Grant Applications and Cooperative Agreements Notice NOT-OD-10-027 Posted April 2010 Grant Application VAS Worksheet located at OLAW main webpage under Guidance section Guidance to Grantees – Guide Notices Update of Sample Animal Welfare Assurance for Foreign Institutions Notice NOT-OD-10-083 Posted April 2010 Instructions and downloadable form at OLAW web site under Sample Documents Guidance to Grantees – Guide Notices Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section in NIH Contract Proposals Notice NOT-OD-10-049 Posted April 2010

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011 Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation March 3, 2011 Implications of Noncompliance Corrective actions and improved systems Restrict/withdraw approval of Assurance Special terms/conditions of awards Enhanced reporting requirements Cost disallowance Suspension/termination of award Criminal prosecution Other Possible Ramifications Negative publicity for the institution- media Inquiries from Congress, other Federal regulators Damage to reputation, assessment of peers Institutional standing with alumni Impact from journals- retractions, article withdrawal Institutional loss of personnel, inability to attract new staff Collaborative relationship exists between NIH and grantee Institution The partners share a mutual need to assure compliance Each partner has responsibilities and obligations as stewards of public funds Institutional self-governance is the foundation of PHS Policy NIH-Supported Research is a Partnership Guidance to Grantees – Guide Notices Instructions for Completion and Peer Review of the Vertebrate Animal Section in NIH Grant Applications and Cooperative Agreements Notice NOT-OD-10-027 Posted April 2010 Grant Application VAS Worksheet located at OLAW main webpage under Guidance section Guidance to Grantees – Guide Notices Update of Sample Animal Welfare Assurance for Foreign Institutions Notice NOT-OD-10-083 Posted April 2010 Instructions and downloadable form at OLAW web site under Sample Documents Guidance to Grantees – Guide Notices Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section in NIH Contract Proposals Notice NOT-OD-10-049 Posted April 2010 Workshops and Conferences IACUC 101 or 101/201 Plus Workshops August 11, Des Moines, IA September 14-15, Houston, TX SCAW IACUC Workshops & Conferences July 15, St. Louis, MO Dec. 5-6, San Antonio, TX AWIC Workshops October 19-20, Beltsville, MD

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011 Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation March 3, 2011 Implications of Noncompliance Corrective actions and improved systems Restrict/withdraw approval of Assurance Special terms/conditions of awards Enhanced reporting requirements Cost disallowance Suspension/termination of award Criminal prosecution Other Possible Ramifications Negative publicity for the institution- media Inquiries from Congress, other Federal regulators Damage to reputation, assessment of peers Institutional standing with alumni Impact from journals- retractions, article withdrawal Institutional loss of personnel, inability to attract new staff Collaborative relationship exists between NIH and grantee Institution The partners share a mutual need to assure compliance Each partner has responsibilities and obligations as stewards of public funds Institutional self-governance is the foundation of PHS Policy NIH-Supported Research is a Partnership Guidance to Grantees – Guide Notices Instructions for Completion and Peer Review of the Vertebrate Animal Section in NIH Grant Applications and Cooperative Agreements Notice NOT-OD-10-027 Posted April 2010 Grant Application VAS Worksheet located at OLAW main webpage under Guidance section Guidance to Grantees – Guide Notices Update of Sample Animal Welfare Assurance for Foreign Institutions Notice NOT-OD-10-083 Posted April 2010 Instructions and downloadable form at OLAW web site under Sample Documents Guidance to Grantees – Guide Notices Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section in NIH Contract Proposals Notice NOT-OD-10-049 Posted April 2010 Workshops and Conferences IACUC 101 or 101/201 Plus Workshops August 11, Des Moines, IA September 14-15, Houston, TX SCAW IACUC Workshops & Conferences July 15, St. Louis, MO Dec. 5-6, San Antonio, TX AWIC Workshops October 19-20, Beltsville, MD Upcoming Online Seminars September 2011 Occupational Health and Safety Programs December 2011 Grants Policy and Congruence

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011 Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation March 3, 2011 Implications of Noncompliance Corrective actions and improved systems Restrict/withdraw approval of Assurance Special terms/conditions of awards Enhanced reporting requirements Cost disallowance Suspension/termination of award Criminal prosecution Other Possible Ramifications Negative publicity for the institution- media Inquiries from Congress, other Federal regulators Damage to reputation, assessment of peers Institutional standing with alumni Impact from journals- retractions, article withdrawal Institutional loss of personnel, inability to attract new staff Collaborative relationship exists between NIH and grantee Institution The partners share a mutual need to assure compliance Each partner has responsibilities and obligations as stewards of public funds Institutional self-governance is the foundation of PHS Policy NIH-Supported Research is a Partnership Guidance to Grantees – Guide Notices Instructions for Completion and Peer Review of the Vertebrate Animal Section in NIH Grant Applications and Cooperative Agreements Notice NOT-OD-10-027 Posted April 2010 Grant Application VAS Worksheet located at OLAW main webpage under Guidance section Guidance to Grantees – Guide Notices Update of Sample Animal Welfare Assurance for Foreign Institutions Notice NOT-OD-10-083 Posted April 2010 Instructions and downloadable form at OLAW web site under Sample Documents Guidance to Grantees – Guide Notices Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section in NIH Contract Proposals Notice NOT-OD-10-049 Posted April 2010 Workshops and Conferences IACUC 101 or 101/201 Plus Workshops August 11, Des Moines, IA September 14-15, Houston, TX SCAW IACUC Workshops & Conferences July 15, St. Louis, MO Dec. 5-6, San Antonio, TX AWIC Workshops October 19-20, Beltsville, MD Upcoming Online Seminars September 2011 Occupational Health and Safety Programs December 2011 Grants Policy and Congruence Guidance for Grantees Frequently Asked Questions: Is social housing required for nonhuman primates when housed in a research setting? Requirement of USDA regulations (9CFR Ch.1, Part 3, Subpart D, 3.81 (a) Single housing is the exception Exemptions based on strong scientific justification, specific veterinary or behavioral reason Lack of caging not acceptable

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011 Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation March 3, 2011 Implications of Noncompliance Corrective actions and improved systems Restrict/withdraw approval of Assurance Special terms/conditions of awards Enhanced reporting requirements Cost disallowance Suspension/termination of award Criminal prosecution Other Possible Ramifications Negative publicity for the institution- media Inquiries from Congress, other Federal regulators Damage to reputation, assessment of peers Institutional standing with alumni Impact from journals- retractions, article withdrawal Institutional loss of personnel, inability to attract new staff Collaborative relationship exists between NIH and grantee Institution The partners share a mutual need to assure compliance Each partner has responsibilities and obligations as stewards of public funds Institutional self-governance is the foundation of PHS Policy NIH-Supported Research is a Partnership Guidance to Grantees – Guide Notices Instructions for Completion and Peer Review of the Vertebrate Animal Section in NIH Grant Applications and Cooperative Agreements Notice NOT-OD-10-027 Posted April 2010 Grant Application VAS Worksheet located at OLAW main webpage under Guidance section Guidance to Grantees – Guide Notices Update of Sample Animal Welfare Assurance for Foreign Institutions Notice NOT-OD-10-083 Posted April 2010 Instructions and downloadable form at OLAW web site under Sample Documents Guidance to Grantees – Guide Notices Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section in NIH Contract Proposals Notice NOT-OD-10-049 Posted April 2010 Workshops and Conferences IACUC 101 or 101/201 Plus Workshops August 11, Des Moines, IA September 14-15, Houston, TX SCAW IACUC Workshops & Conferences July 15, St. Louis, MO Dec. 5-6, San Antonio, TX AWIC Workshops October 19-20, Beltsville, MD Upcoming Online Seminars September 2011 Occupational Health and Safety Programs December 2011 Grants Policy and Congruence Guidance for Grantees Frequently Asked Questions: Is social housing required for nonhuman primates when housed in a research setting? Requirement of USDA regulations (9CFR Ch.1, Part 3, Subpart D, 3.81 (a) Single housing is the exception Exemptions based on strong scientific justification, specific veterinary or behavioral reason Lack of caging not acceptable Guidance for Grantees (con’t) Frequently Asked Questions: Should positive reinforcement training be used for nonhuman primates? Use when safe and feasible Aids in cooperative activities of research or husbandry Reduces stress Reduces need for chemical restraint

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011 Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation March 3, 2011 Implications of Noncompliance Corrective actions and improved systems Restrict/withdraw approval of Assurance Special terms/conditions of awards Enhanced reporting requirements Cost disallowance Suspension/termination of award Criminal prosecution Other Possible Ramifications Negative publicity for the institution- media Inquiries from Congress, other Federal regulators Damage to reputation, assessment of peers Institutional standing with alumni Impact from journals- retractions, article withdrawal Institutional loss of personnel, inability to attract new staff Collaborative relationship exists between NIH and grantee Institution The partners share a mutual need to assure compliance Each partner has responsibilities and obligations as stewards of public funds Institutional self-governance is the foundation of PHS Policy NIH-Supported Research is a Partnership Guidance to Grantees – Guide Notices Instructions for Completion and Peer Review of the Vertebrate Animal Section in NIH Grant Applications and Cooperative Agreements Notice NOT-OD-10-027 Posted April 2010 Grant Application VAS Worksheet located at OLAW main webpage under Guidance section Guidance to Grantees – Guide Notices Update of Sample Animal Welfare Assurance for Foreign Institutions Notice NOT-OD-10-083 Posted April 2010 Instructions and downloadable form at OLAW web site under Sample Documents Guidance to Grantees – Guide Notices Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section in NIH Contract Proposals Notice NOT-OD-10-049 Posted April 2010 Workshops and Conferences IACUC 101 or 101/201 Plus Workshops August 11, Des Moines, IA September 14-15, Houston, TX SCAW IACUC Workshops & Conferences July 15, St. Louis, MO Dec. 5-6, San Antonio, TX AWIC Workshops October 19-20, Beltsville, MD Upcoming Online Seminars September 2011 Occupational Health and Safety Programs December 2011 Grants Policy and Congruence Guidance for Grantees Frequently Asked Questions: Is social housing required for nonhuman primates when housed in a research setting? Requirement of USDA regulations (9CFR Ch.1, Part 3, Subpart D, 3.81 (a) Single housing is the exception Exemptions based on strong scientific justification, specific veterinary or behavioral reason Lack of caging not acceptable Guidance for Grantees (con’t) Frequently Asked Questions: Should positive reinforcement training be used for nonhuman primates? Use when safe and feasible Aids in cooperative activities of research or husbandry Reduces stress Reduces need for chemical restraint SCENARIO: What Would You Do ?? Anywhere University will be subcontracting some of its proposed animal activities to a foreign performance site at May-Oui Institute. What are the requirements for the grant application and just-in-time approval to allow the animal activities to proceed?

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011 Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation March 3, 2011 Implications of Noncompliance Corrective actions and improved systems Restrict/withdraw approval of Assurance Special terms/conditions of awards Enhanced reporting requirements Cost disallowance Suspension/termination of award Criminal prosecution Other Possible Ramifications Negative publicity for the institution- media Inquiries from Congress, other Federal regulators Damage to reputation, assessment of peers Institutional standing with alumni Impact from journals- retractions, article withdrawal Institutional loss of personnel, inability to attract new staff Collaborative relationship exists between NIH and grantee Institution The partners share a mutual need to assure compliance Each partner has responsibilities and obligations as stewards of public funds Institutional self-governance is the foundation of PHS Policy NIH-Supported Research is a Partnership Guidance to Grantees – Guide Notices Instructions for Completion and Peer Review of the Vertebrate Animal Section in NIH Grant Applications and Cooperative Agreements Notice NOT-OD-10-027 Posted April 2010 Grant Application VAS Worksheet located at OLAW main webpage under Guidance section Guidance to Grantees – Guide Notices Update of Sample Animal Welfare Assurance for Foreign Institutions Notice NOT-OD-10-083 Posted April 2010 Instructions and downloadable form at OLAW web site under Sample Documents Guidance to Grantees – Guide Notices Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section in NIH Contract Proposals Notice NOT-OD-10-049 Posted April 2010 Workshops and Conferences IACUC 101 or 101/201 Plus Workshops August 11, Des Moines, IA September 14-15, Houston, TX SCAW IACUC Workshops & Conferences July 15, St. Louis, MO Dec. 5-6, San Antonio, TX AWIC Workshops October 19-20, Beltsville, MD Upcoming Online Seminars September 2011 Occupational Health and Safety Programs December 2011 Grants Policy and Congruence Guidance for Grantees Frequently Asked Questions: Is social housing required for nonhuman primates when housed in a research setting? Requirement of USDA regulations (9CFR Ch.1, Part 3, Subpart D, 3.81 (a) Single housing is the exception Exemptions based on strong scientific justification, specific veterinary or behavioral reason Lack of caging not acceptable Guidance for Grantees (con’t) Frequently Asked Questions: Should positive reinforcement training be used for nonhuman primates? Use when safe and feasible Aids in cooperative activities of research or husbandry Reduces stress Reduces need for chemical restraint SCENARIO: What Would You Do ?? Anywhere University will be subcontracting some of its proposed animal activities to a foreign performance site at May-Oui Institute. What are the requirements for the grant application and just-in-time approval to allow the animal activities to proceed? The PI at Research University indicates that he will not be performing any animal activities but in his grant application, indicates he will be obtaining custom rabbit antibodies from Alpha Omega Enterprises. What are the requirements for the grant application and just-in-time approval to allow the animal activities to proceed? SCENARIO: What Would You Do ??

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011 Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation March 3, 2011 Implications of Noncompliance Corrective actions and improved systems Restrict/withdraw approval of Assurance Special terms/conditions of awards Enhanced reporting requirements Cost disallowance Suspension/termination of award Criminal prosecution Other Possible Ramifications Negative publicity for the institution- media Inquiries from Congress, other Federal regulators Damage to reputation, assessment of peers Institutional standing with alumni Impact from journals- retractions, article withdrawal Institutional loss of personnel, inability to attract new staff Collaborative relationship exists between NIH and grantee Institution The partners share a mutual need to assure compliance Each partner has responsibilities and obligations as stewards of public funds Institutional self-governance is the foundation of PHS Policy NIH-Supported Research is a Partnership Guidance to Grantees – Guide Notices Instructions for Completion and Peer Review of the Vertebrate Animal Section in NIH Grant Applications and Cooperative Agreements Notice NOT-OD-10-027 Posted April 2010 Grant Application VAS Worksheet located at OLAW main webpage under Guidance section Guidance to Grantees – Guide Notices Update of Sample Animal Welfare Assurance for Foreign Institutions Notice NOT-OD-10-083 Posted April 2010 Instructions and downloadable form at OLAW web site under Sample Documents Guidance to Grantees – Guide Notices Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section in NIH Contract Proposals Notice NOT-OD-10-049 Posted April 2010 Workshops and Conferences IACUC 101 or 101/201 Plus Workshops August 11, Des Moines, IA September 14-15, Houston, TX SCAW IACUC Workshops & Conferences July 15, St. Louis, MO Dec. 5-6, San Antonio, TX AWIC Workshops October 19-20, Beltsville, MD Upcoming Online Seminars September 2011 Occupational Health and Safety Programs December 2011 Grants Policy and Congruence Guidance for Grantees Frequently Asked Questions: Is social housing required for nonhuman primates when housed in a research setting? Requirement of USDA regulations (9CFR Ch.1, Part 3, Subpart D, 3.81 (a) Single housing is the exception Exemptions based on strong scientific justification, specific veterinary or behavioral reason Lack of caging not acceptable Guidance for Grantees (con’t) Frequently Asked Questions: Should positive reinforcement training be used for nonhuman primates? Use when safe and feasible Aids in cooperative activities of research or husbandry Reduces stress Reduces need for chemical restraint SCENARIO: What Would You Do ?? Anywhere University will be subcontracting some of its proposed animal activities to a foreign performance site at May-Oui Institute. What are the requirements for the grant application and just-in-time approval to allow the animal activities to proceed? The PI at Research University indicates that he will not be performing any animal activities but in his grant application, indicates he will be obtaining custom rabbit antibodies from Alpha Omega Enterprises. What are the requirements for the grant application and just-in-time approval to allow the animal activities to proceed? SCENARIO: What Would You Do ?? SCENARIO: What Would You Do ?? Bob’s Biotech (BB) will be the prime grantee on an award involving animal research. BB does not have their own animal facility but has made preliminary plans with Citywide University to conduct the animal studies in Citywide’s facility. What are the requirements for the grant application and just-in-time approval to allow the animal activities to proceed?

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NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Eileen M. Morgan Director, Division of Assurances NIH/OER/OLAW June 24-25, 2011 OLAW provides guidance and interpretation of PHS Policy, supports educational programs, and monitors compliance with the Policy by Assured institutions and PHS funding components to ensure the humane care and use of animals in PHS-supported research, testing, and training and thereby contributing to the quality of research. OLAW Mission Statement OLAW Responsibilities Oversee implementation of PHS Policy Provide interpretation and guidance Negotiate Animal Welfare Assurances Evaluate compliance Institutional self reporting Third party allegations Educational activities Workshops Resources Training sessions Webinars OLAW Educational Programs Partnerships with organizations and institutions Workshops, meetings, conferences Webinars IACUC 101 / 201-Plus training programs IACUC Guidebook, 2nd edition Web-based tutorial, resources Published articles, FAQs, commentary Policy interpretations published in NIH Guide for Grants and Contracts Authorizing Legislation - Public Law 99-158 (11/20/85) Health Research Extension Act NIH Director to establish guidelines for research funded by NIH and other PHS agencies Animal Welfare Assurance mechanism Institutional Animal Care and Use Committee (IACUC) with oversight authority Institutional opportunity to correct deficiencies “It is far preferable to place primary responsibility for assuring compliance with NIH guidelines on committees within institutions rather than relying on intrusive Federal inspections.” Congressional committee report accompanying the 1985 Health Research Extension Act OLAW’s Philosophy PHS Policy All vertebrate animals Animal Welfare Assurance Institutional program of animal care and use Institutional Animal Care and Use Committee Self-regulation by institution Requirements Record keeping – program and IACUC records Reporting – annual and non-compliance PHS Policy Applicability Applicable to all PHS-conducted or supported activities involving animals Animal- any live vertebrate animal used or intended for use in research, training, experimentation, biological testing PHS agencies- CDC, FDA, NIH PHS Policy: Standards for Animal Care and Use AVMA Guidelines on Euthanasia (Formerly Report of the AVMA Panel on Euthanasia) _________________________________ June 2007 Guide for the Care and Use of Laboratory Animals 8th Edition Update of the Guide for the Care and Use of Laboratory Animals Notice NOT-OD-11-XX Publication January 2011 Notice on Guide Eighth edition released January 2011 PDF file available for download at OLAW web site Comment period Educational Efforts and the Guide Present at future workshops Online Seminars for IACUC Staff, IOs Update website tutorial Update Semiannual Program and Facility Checklists Update Sample Animal Study Proposal Update FAQs Provide interpretation as needed Limited distribution of print version Animal Welfare Assurance Contract with Federal Government Documents institutional commitment Description of institutional programs, procedures Principle method for compliance oversight Animal Welfare Assurance No activity involving animals may be conducted or supported until an Assurance is in place Assurance sets forth compliance with Policy Animal program must be based on Guide No Assurance= No PHS support for animal work Types of Animal Welfare Assurances Domestic Assurance Inter-Institutional Assurance Foreign Assurance Domestic Animal Welfare Assurance Control their own animal facilities Have a complete animal care and use program Institutional Official (IO) IACUC Veterinarian Remain in effect for up to 4 years Assurance signed by IO Can be renewed PHS funding Requested by grant management personnel Domestic Animal Welfare Assurance Describes animal care and use program Lines of authority and responsibility Institutional Animal Care and Use Committee Procedures to implement the PHS Policy Program of veterinary care Occupational safety and health program for personnel Training of personnel (investigators, technicians, IACUC) Facilities Species Inter-institutional Assurance Grantee organization does not have animal care and use program Animal work conducted at Assured Institution Good for life of grant (project specific) Requested by grants management personnel Foreign Animal Welfare Assurance Negotiated when Prime grantee is foreign institute Domestic grantee conducting animal work at foreign site Domestic grantee’s IACUC approves animal activities performed at foreign site Guided by International Guiding Principles for Biomedical Research Involving Animals (developed by CIOMS) Requires list of titles of governing laws, regulations and policies from the country of origin (in English) 5 year approval period Requires 1 signature from a representative from the foreign organization plus 2 additional points of contact Prime grantee is accountable to NIH and must confirm: Assurance IACUC approval (dated within 3 years) Only required from one Assured entity Animal welfare requirements apply to all consortium participants and sub-projects For more information see NIH GPS, Part II, Terms and Conditions of NIH Grant Awards, Consortium Agreements Consortium Agreements: Sub-awards Grants Policy Requirements Animal Welfare Assurance for the applicant organization and all performance sites. Verification that the IACUC has reviewed and approved those sections of the application that involve the use of vertebrate animals. Completed Vertebrate Animal Section, VAS Grant Applicant to Address Vertebrate Animal Use (electronic submission) SF 424 ~ Research & Related Application Project / Performance Site Location(s) Other Project Information (Section 2 & 2a) PHS 398 ~ Research Plan Research Plan Attachments Other Research Plan Sections (11. Vertebrate Animals) PDF format Five Points of Vertebrate Animal Section (VAS) addressed SF424 SF SF Grantee Information needs to be reflected Grant Applicant to Address Five Points Describe proposed use and list species, strains, ages, sex, and numbers of animals to be used Justify: use, species, and numbers Veterinary care to include Performance site (separate VAS required for each Performance site) Procedures to minimize pain and distress Pain and distress will be limited to that which is unavoidable Describe use of analgesics, anesthetics, etc. Describe method of euthanasia Reasons for selection of method If not consistent with AVMA Guidelines - provide justification. Worksheet for Review of VAS Five bulleted items to match with 5 Elements Single page checklist Covers all required elements Highlights critical aspects of the VAS 5 points Readily see when item is incomplete Aid in review by reviewers Prompt discussion by SROs of problems they may see with VAS http://grants.nih.gov/grants/olaw/VASchecklist.pdf VAS Worksheet Purpose Help applicant to include needed information to address animal welfare Help reviewer determine if the applicant has appropriately addressed the required five points Ensure weaknesses identified during review are included in the summary statement and addressed prior to award Encourage consistency in review Funding Component (IC) and Peer Review Responsibilities Consideration of animal welfare during peer review (may affect score of application) If reviewers express concerns about animal care and use, the concerns must be resolved prior to funding (Animal Welfare Concerns) Ensure that institution has an Assurance If no Assurance, the IC requests that OLAW negotiate Assurance Verify IACUC approval – valid date for 3 yrs. NIH Regional Seminar on Program Funding and Grants AdministrationResearch Involving. . . Animals (OLAW) Axel Wolff, DVM Director, Division of Compliance Oversight NIH/OER/OLAW Enforced Self-regulation Performance standards Flexibility Self-monitoring Self-correcting Self-reporting OLAW oversight PHS Policy IV.F.3. The IACUC, through the IO, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: Any serious or continuing noncompliance with PHS Policy Any serious deviation from the Guide Any suspension of an activity by the IACUC Health Research Extension Act If the Director of NIH determines that: Animal care conditions at PHS funded site do not meet applicable guidelines The entity has been informed of this and given a reasonable opportunity to take corrective action, and If no corrective action has been taken NIH shall suspend or revoke the grant or contract OLAW’s authority May request, negotiate, approve or disapprove Assurance May limit the effective period of approval May restrict, condition, or withdraw approval May review, approve, disapprove waivers to the PHS Policy OLAW is responsible for administration and coordination of PHS Policy IACUC Authority The IACUC may suspend an activity that it previously approved if not in accordance with Animal Welfare Act, Guide, Assurance, PHS Policy IACUC must review matter at convened meeting of quorum, suspension vote of majority of quorum present Suspension cannot be overturned by IO or other officials Institutional Accountability The institution is accountable for: Financial, administrative aspects of award The animal care and use program, IACUC The investigator is accountable for: The research Compliance with animal care and use program The IACUC, together with IO, exercises oversight over institutional animal care and use Institutional Official Designated representative of grantee organization in matters related to the award and administration of PHS grants Accountable for appropriate use of funds and performance of activities resulting from application Signs Assurance- commits institution to meet requirements of PHS Policy Principal Investigator Designated by grantee as responsible for scientific and technical aspects of project Member of grantee team responsible for ensuring compliance with financial and administrative aspects of award Language from face page of 398/SF 424 Signature and Assurance of Principal Investigator/Program Director Assurance: I certify that the statements herein are true, complete and accurate to the best of my knowledge. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to criminal, civil, or administrative penalties. I agree to accept responsibility for the scientific conduct of the project and to provide the required progress reports if a grant is awarded as a result of this application. Office of Management and Budget Cost Principles and NIH Grants Policy Statement do not permit charges to grant awards for animal activities during periods of time that terms and conditions are not upheld If work is conducted under noncompliant conditions, the expended grant funds may need to be refunded Policy on Allowable Costs for Grants Activity Involving Animals Institutions are not permitted to charge for animal activities when terms and conditions are not upheld Absence of a valid Assurance on file with OLAW Absence of valid IACUC approval Failure to obtain IACUC approval for animal activity Failure to obtain IACUC approval for significant changes prior to implementing Continuing animal activities after IACUC approval has expired Continuing animal activities after suspension of IACUC approval  Policy on Allowable Costs for Grants Activity Involving Animals Institutions are required to report noncompliant situations OLAW (olawdco@mail.nih.gov or 301-594-2061) Institute/Center (IC) supporting the award NIH expects grantees to continue to maintain and care for animals during periods of noncompliance Funding components may allow expenditure of NIH grant funds for maintenance and care of animals on a case-by-case basis NIH Policy on Allowable Costs for Activities with Animals when Terms and Conditions are not Upheld [http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-044.html] Policy on Allowable Costs for Grants Activity Involving Animals Reportable Issues Data Analysis OLAW opened 4,694 cases from 2000 – 2010 Institutional self-reports Allegations from employees Reports from other oversight agencies OLAW review of Assurance, Annual Report Reports from funding components Allegations from other sources OLAW opened 769 cases in 2010 March 3, 2011 Reportable Issues by Institution Type Government 14% Institution of Higher Learning 73% Commercial 4% Other 9% March 3, 2011 Types of Reportable Issues Animal Study Protocol Issues 30% Animal Husbandry 14% Clinical Issues 13% Other Issues 15% Failure to Follow Institutional Policies 13% Investigator & Research Team 7% IACUC Responsibility 2% No Violation Found 1% Physical Plant 4% Institutional Responsibility 2% Reportable Issues 1 Animal Study Protocol Issues 43% Failure to follow protocol 19% Unapproved significant change 16% Work before protocol approval 10% Inadequate oversight 08% Work on expired protocol March 3, 2011 30% Investigator & Research Team Issues Unauthorized laboratory or animal housing Unauthorized or unqualified personnel Food and water restriction issues 7% Reportable Issues 2 March 3, 2011 14% Other Human error, accident Natural disaster Equipment failure Training failure Crime, neglect, abuse Animal Husbandry Issues 32% Food and water issues 27% Inadequate records or ID 21% Other husbandry 7% Sanitation failure 7% Space issue 04% Escaped animal(s) 2% Enrichment or social issue 15% Reportable Issues 3 March 3, 2011 Physical Plant 4% 55% HVAC 24% Other 15% Construction & maintenance 6% Emergency power & light IACUC Issues 2% Institutional Issues 2% 59% OHS issues 38% Failure to report to OLAW 3% Other No Violation Found 1% Types of Animals Involved Rodents 52% All Other Species 6% Ungulates 5% NHPs 6% Not Specified by Institution 24% Carnivores 4% Fish 4% March 3, 2011 Individual Responsible for Reportable Issue PI and Research Team 69% None 7% Institution 3% Animal Care Staff 11% IACUC 5% Other 3% Vet Staff 2% March 3, 2011 Institutional Corrective Action Retrain personnel Counsel, reprimand, terminate employment Modify institutional policies Repair or modify facility Enhance PI and study oversight, probation Modify, suspend, or terminate animal study protocol March 3, 2011 Contact OLAW for Advice or Help Not sure if an issue is reportable? It is better to ask or report than not. Division of Compliance Oversight 301-594-2061 or 301-594-2921 olawdco@mail.nih.gov Consequences are less desirable if reportable issue is withheld and discovered later OLAW needs information on serious reportable issues to represent institution to PHS, Congress, and the media March 3, 2011 Reporting is a Cooperative Process OLAW will provide assistance and guidance Institution must demonstrate that corrective actions are being implemented OLAW will evaluate appropriateness of the actions in correcting and preventing the reportable issue Self-reporting is part of enforced self-regulation March 3, 2011 Implications of Noncompliance Corrective actions and improved systems Restrict/withdraw approval of Assurance Special terms/conditions of awards Enhanced reporting requirements Cost disallowance Suspension/termination of award Criminal prosecution Other Possible Ramifications Negative publicity for the institution- media Inquiries from Congress, other Federal regulators Damage to reputation, assessment of peers Institutional standing with alumni Impact from journals- retractions, article withdrawal Institutional loss of personnel, inability to attract new staff Collaborative relationship exists between NIH and grantee Institution The partners share a mutual need to assure compliance Each partner has responsibilities and obligations as stewards of public funds Institutional self-governance is the foundation of PHS Policy NIH-Supported Research is a Partnership Guidance to Grantees – Guide Notices Instructions for Completion and Peer Review of the Vertebrate Animal Section in NIH Grant Applications and Cooperative Agreements Notice NOT-OD-10-027 Posted April 2010 Grant Application VAS Worksheet located at OLAW main webpage under Guidance section Guidance to Grantees – Guide Notices Update of Sample Animal Welfare Assurance for Foreign Institutions Notice NOT-OD-10-083 Posted April 2010 Instructions and downloadable form at OLAW web site under Sample Documents Guidance to Grantees – Guide Notices Instructions for Completion and Technical Evaluation of the Vertebrate Animal Section in NIH Contract Proposals Notice NOT-OD-10-049 Posted April 2010 Workshops and Conferences IACUC 101 or 101/201 Plus Workshops August 11, Des Moines, IA September 14-15, Houston, TX SCAW IACUC Workshops & Conferences July 15, St. Louis, MO Dec. 5-6, San Antonio, TX AWIC Workshops October 19-20, Beltsville, MD Upcoming Online Seminars September 2011 Occupational Health and Safety Programs December 2011 Grants Policy and Congruence Guidance for Grantees Frequently Asked Questions: Is social housing required for nonhuman primates when housed in a research setting? Requirement of USDA regulations (9CFR Ch.1, Part 3, Subpart D, 3.81 (a) Single housing is the exception Exemptions based on strong scientific justification, specific veterinary or behavioral reason Lack of caging not acceptable Guidance for Grantees (con’t) Frequently Asked Questions: Should positive reinforcement training be used for nonhuman primates? Use when safe and feasible Aids in cooperative activities of research or husbandry Reduces stress Reduces need for chemical restraint SCENARIO: What Would You Do ?? Anywhere University will be subcontracting some of its proposed animal activities to a foreign performance site at May-Oui Institute. What are the requirements for the grant application and just-in-time approval to allow the animal activities to proceed? The PI at Research University indicates that he will not be performing any animal activities but in his grant application, indicates he will be obtaining custom rabbit antibodies from Alpha Omega Enterprises. What are the requirements for the grant application and just-in-time approval to allow the animal activities to proceed? SCENARIO: What Would You Do ?? SCENARIO: What Would You Do ?? Bob’s Biotech (BB) will be the prime grantee on an award involving animal research. BB does not have their own animal facility but has made preliminary plans with Citywide University to conduct the animal studies in Citywide’s facility. What are the requirements for the grant application and just-in-time approval to allow the animal activities to proceed? Questions? Please Ask! OLAW: 301-496-7163 olaw@mail.nih.gov OLAW Website: http://olaw.nih.gov OLAW LISTSERV: http://grants.nih.gov/grants/olaw/references/list.htm Division of Assurances olawdoa@mail.nih.gov Division of Compliance Oversight olawdco@mail.nih.gov Division of Policy and Education olawdpe@mail.nih.gov