LABORATORY ANIMAL WELFARE: PROPOSED CHANGE IN PHS POLICY ON HUMANE CARE AND USE OF LABORATORY ANIMALS Release Date: April 1, 2002 NOTICE: NOT-OD-02-041 National Institutes of Health (NIH) Current PHS Policy on Humane Care and Use of Laboratory Animals (PHS Policy), applicable to all PHS-conducted or supported activities involving live, vertebrate animals, provides institutions with a PHS approved Animal Welfare Assurance the option of submitting Institutional Animal Care and Use Committee (IACUC) approval for competing applications or proposals, subsequent to the submission of the application or proposal, but within 60 days from the receipt date. NIH grants policy mandates that applications lacking IACUC approval are considered incomplete; thus IACUC approval is presently required prior to initial NIH peer review. The NIH is proposing to revise the requirement that IACUC verification be submitted prior to NIH peer review. This revision would permit Assured institutions to submit IACUC verification for competing applications subsequent to peer review but prior to award. This concept is often referred to as "just-in-time." This proposed change would enhance the flexibility of institutions and reduce the burden on applicants and IACUCs, allowing resources to be focused on substantive review of proposals likely to be funded. On May 1, 2000, the NIH announced that Institutional Review Board (IRB) approval would no longer be required prior to NIH peer review of an application that involves human subjects. Because of the different bases for these policies, the NIH did not extend this permission to IACUC approval at that time. However, the NIH is now inviting comments from the community on proceeding with a revision of PHS Policy to permit IACUC approval for competing applications to be submitted subsequent to peer review but prior to award. If such a change were adopted it would be optional (i.e., as a matter of institutional policy, institutions could require IACUC review and approval prior to submission of applications or prior to NIH peer review). The current requirement that modifications required by the IACUC must be submitted to NIH with the verification of IACUC approval would remain in effect. Public comment on this proposed revision is requested. The NIH has also requested public comment through a notice in the Federal Register published on March 28, 2002, and posted at: http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002_register &docid=fr28mr02-89 Comments should be sent to the contact person below on or before May 28, 2002. INQUIRIES For additional information, questions, or comments, contact: Anthony Demsey, Ph.D. Senior Advisor for Policy Office of Extramural Research National Institutes of Health Building 1, Room 154 Bethesda, MD 20892 Phone: (301) 496-5127 Fax: (301) 402-3469 E-mail: demseya@od.nih.gov
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Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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