LABORATORY ANIMAL WELFARE: CHANGE IN PHS POLICY ON HUMANE CARE AND USE 
OF LABORATORY ANIMALS

Release Date:  August 8, 2002 (supercedes NOT-OD-01-008)

NOTICE NUMBER: NOT-OD-02-064

National Institutes of Health (NIH)

In the March 28, 2002, Federal Register (and the April 5, 2002, NIH 
Guide for Grants and Contracts), the NIH announced that it was 
considering a change in the PHS Policy on Humane Care and Use of 
Laboratory Animals to allow institutions to provide IACUC approval in a 
"just-in-time" fashion prior to award, as is now permitted for IRB 
approval.  The comment period ended on May 28, 2002, and responses from 
the research community and institutional officials were overwhelmingly 
in favor of this change.  Consequently, the NIH now announces that 
beginning with applications submitted for the October 1, 2002, receipt 
date (and any other receipt dates that result in applications being 
reviewed for May/June 2003 Councils), IACUC "just-in-time" will be in 
effect.  That is, institutions will be permitted flexibility in the 
timing of IACUC review relative to submission of an application.

The NIH wants to emphasize certain principles and expectations of the 
"just-in-time" process for IACUC review and approval.

o  The fundamental PHS Policy requirement that no award may be made 
without an approved Assurance and without verification of IACUC 
approval remains in effect.  This change only affects the timing of the 
submission of the verification of that review.

o  This change is intended to permit flexibility and discretion on the 
part of the institution.  It is not a requirement that IACUC approval 
be deferred.  Institutional officials retain the discretion to require 
IACUC approval prior to peer review in certain circumstances of their 
choosing if they so desire.

o  Under no circumstances may an IACUC be pressured to approve a 
protocol, or be overruled on its decision to withhold approval.  NIH 
peer review groups will continue to address the adequacy of animal 
usage and protections in their review of an application, and will 
continue to raise concerns about animal welfare issues.  However, in no 
way is peer review intended to supersede or serve as a replacement for 
IACUC approval.  An institution that elects to use IACUC "just-in-time" 
bears the responsibility for supporting the role of the IACUC.

o  It remains incumbent upon investigators to be totally forthcoming 
and timely in conveying to their IACUCs any modifications related to 
project scope and animal usage that may result from the NIH review and 
award process.   Should an institution find that one of its 
investigators disregards his/her responsibilities, the institution may, 
for example, determine that all animal protocols from that investigator 
be subject to IACUC approval before it will permit submission of an 
application from that investigator.

o  The existing PHS Policy requirement that modifications required by 
the IACUC be submitted to the NIH with the verification of IACUC 
approval remains in effect, and it remains the responsibility of 
institutions to communicate any IACUC-imposed changes to NIH staff. 

o  The NIH understands its responsibility to ensure that institutions 
are given adequate notice to allow for timely IACUC review prior to 
award, and will take appropriate internal measures to fulfill its 
responsibility to establish timely feedback.

An announcement is published in the Federal Register (67 FR 51289), 
giving the precise language change and citation in the PHS Policy.

To see the Federal Register Notice in HTML format, go to:
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002
_register&docid=fr07au02-108.

To see the Federal Register Notice in PDF format, go to:
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002
_register&docid=fr07au02-108.pdf.

INQUIRIES  (Updated: 8/11/2004)

For questions or further information, contact:

Denis Doyle
Office of Laboratory Animal Welfare (OLAW) 
National Institutes of Health
RKL1, Suite 360, MSC 7982
6705 Rockledge Drive
Bethesda, MD 20892-7982 
Phone: 301-594-2289
Fax: 301-402-7065
E-Mail: olaw@od.nih.gov

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