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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