[Federal Register: August 7, 2002 (Volume 67, Number 152)]
[Notices]
[Page 51289-51290]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07au02-108]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Laboratory Animal Welfare: Change in PHS Policy on Humane Care
and Use of Laboratory Animals
AGENCY: National Institutes of Health, DHHS.
ACTION: Amended Policy Statement.
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SUMMARY: The NIH is changing the PHS Policy on Humane Care and Use of
Laboratory Animals (PHS Policy) to permit institutions with PHS Animal
Welfare Assurances to submit verification of Institutional Animal Care
and Use Committee (IACUC) approval for competing applications
subsequent to peer review but prior to award.
DATES: This change in PHS Policy is effective as of September 1, 2002
(i.e., for all applications submitted for the May-June 2003 Advisory
Council dates).
[[Page 51290]]
FOR FURTHER INFORMATION CONTACT: Anthony Demsey, Ph.D., Senior Advisor
for Policy, Office of Extramural Research, National Institutes of
Health, 301-496-5127, email: demseya@od.nih.gov.
SUPPLEMENTARY INFORMATION: In the March 28, 2002, Federal Register (67
FR 14956), the NIH proposed to change the PHS Policy to allow
institutions to provide IACUC approval for competing applications
subsequent to peer review but prior to award. This change would modify
the PHS Policy, applicable to all PHS-conducted or -supported
activities involving live, vertebrate animals, which currently provides
institutions with a PHS-approved Animal Welfare Assurance the option of
submitting verification of IACUC approval for competing applications
(1) at the time of submission, or (2) subsequent to submission but
within 60 days from the receipt date and in any case prior to peer
review. Now, with this change in the PHS Policy, IACUC verification is
no longer required to be submitted prior to NIH peer review, but
instead is simply required prior to award. This process, already
adopted as of May 1, 2000, for Institutional Review Board approval of
applications involving human subjects, is often referred to as ``just-
in-time.'' The purpose of the change is to enhance the flexibility of
institutions and reduce the burden on applicants and IACUCs, allowing
resources to be focused on substantive review of applications likely to
be funded. The change, however, permits funding components to require
verification of IACUC approval at an earlier date if necessary.
Over 200 comments from the research community and institutional
officials were received in response to the March 28, 2002, Federal
Register solicitation for public comment on the proposed change. The
comments were overwhelmingly in favor of the change; some included
suggestions for NIH in its implementation of the change. Consequently,
NIH emphasizes the following principles and expectations:
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.
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.
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.
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.
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.
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.
For the reasons stated above, the NIH amends the PHS Policy on
Humane Care and Use of Laboratory Animals as set forth below:
Amend the second sentence of Section IV.D.2. of the PHS Policy to
delete the words ``a time not to exceed 60 days after the receipt
deadline date'' and replace them with the words ``any time prior to
award unless specifically required earlier by the funding component''
so that the sentence states: ``For competing applications or proposals
only, such verification may be filed at any time prior to award unless
specifically required earlier by the funding component.''
The NIH will modify the NIH Grants Policy Statement and
instructions for the 398 Grant Application Form accordingly.
Dated: July 29, 2002.
Elias A. Zerhouni,
Director, National Institutes or Health.
[FR Doc. 02-19867 Filed 8-6-02; 8:45 am]
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