12.0 Public Health Service Policy Change Affecting National Institutes
of Health (NIH) Grant Applications, Awards, and IACUC Review
AMENDED PUBLIC HEALTH SERVICE POLICY1
The National Institutes of Health has amended
the PHS Policy on Humane Care and Use of 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.
12.2.0 EFFECTIVE DATE
OF POLICY AMENDMENT
September 1, 2002 (i.e., for all applications
submitted for the May-June 2003 Advisory Council dates).
12.3.0 SCOPE AND PURPOSE
- IACUC verification is no longer required
to be submitted prior to NIH peer review, but instead is required
prior to award.
- The purpose of the change is to enhance
flexibility of institutions and reduce burden on applicants
and IACUCs, allowing resources to be focused on substantive
review of applications likely to be funded. The change permits
funding components to require verification of IACUC approval
at an earlier date if necessary.
12.4.0 NIH PRINCIPLES
- The fundamental PHS Policy requirement
that no award may be made without an approved Assurance and
without verification of IACUC approval remains unchanged. The
amended policy affects only the time of the submission of the
verification of the IACUC review.
- The Policy change is intended to permit
flexibility and discretion on the part of the institutions.
It is not a requirement that the IACUC approval be deferred.
Institutional officials retain the discretion to require IACUC
approval prior to peer review in certain circumstances.
- Under no circumstances may the IACUC be
pressured to approve a protocol or be overruled on its decision
to withhold approval. Peer review is not a replacement for IACUC
review. An institution that elects to use this policy bears
the responsibility for supporting the role of the IACUC.
- It is incumbent upon the investigators
to be forthcoming and timely in conveying to the IACUC any modifications
related to the project and animal usage that may result from
the NIH review and award process. Should the IACUC find that
an investigator has disregarded his/her responsibilities, the
IACUC may determine that all animal protocols from that investigator
become subject to review and approval before it will permit
submission of an application to the agency from that investigator.
- The existing PHS Policy requirement that
modifications required by the IACUC be submitted to NIH with
verification of IACUC approval remains in place, and it remains
the responsibility of the University to communicate any IACUC-imposed
changes to the NIH staff.
- The NIH will ensure that the University
is 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.
more information Contact the University of Hawaii Compliance Officer:
2538 McCarthy Mall
Snyder Hall 410
Honolulu, HI 96822
Phone: (808) 956-4552,
Fax: (808) 956-5785
Mr. Norman Magno at email@example.com
Ms. Denise Yee at firstname.lastname@example.org
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Last modified: [10-7-02]