Comment Letter on "Just
in Time" IACUC Approval
April 2, 2002
Anthony Demsey, Ph.D.
Senior Advisor for Policy
Office of Extramural Research
National Institutes of Health
Building 1, Room 154
Bethesda, MD 20892
Dear Dr. Demsey:
The Association of American Medical Colleges (AAMC) appreciates
the opportunity to comment on the NIH's March 28 Federal Register
(67
FR 14956) notice proposing to amend the Public Health
Service (PHS) Policy on Humane Care and Use of Laboratory
Animals 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.
The AAMC represents the nation's 125 accredited medical schools,
nearly 400 major teaching hospitals, more than 100,000 faculty
in 98 professional and scientific societies, and the nation's
67,000 medical students and 102,000 residents. More than half
of the extramural research funding awarded by the National
Institutes of Health goes to medical schools and their affiliated
teaching hospitals. Much of this research involves the use
of laboratory animals. As such, the Association has a long
history of involvement in legislative and regulatory issues
concerning the use of animals in research and has a strong
commitment to the humane care and treatment of laboratory
animals.
The AAMC strongly supports this proposed policy change. The
change would reduce the burden on applicants and IACUCs, allowing
resources to be focused on the substantive review of proposals
likely to be funded. Extending "just in time" provisions
to IACUC approval will result in significantly reducing the
regulatory burden and will provide opportunity for more thorough
reviews of those research protocols likely to be funded by
the NIH.
As you know, two years ago the NIH announced a similar policy
change concerning IRB approval for submission of grant applications
involving human subjects. Under that change, IRB approval
is no longer required prior to the NIH peer review of such
applications, allowing IRBs to focus their attention and resources
on applications that are likely to be funded. The extension
of "just in time" IACUC reviews is likely to achieve
a similar result.
The proposed change will enhance institutional flexibility.
Nothing in the proposed policy change would prohibit an institution
from requiring applications to undergo review prior to submission.
Some institutions may continue to require IACUC review and
approval for some or all applications prior to their submission
to NIH. In addition, in certain circumstances individual investigators
may wish to summit their proposals for review prior to submission
in order to avail themselves of the expertise of the IACUC
to strengthen their application.
Appropriately, the NIH has made no change to the current
requirement that modifications required by the IACUC must
be submitted to the NIH with the verification of IACUC approval.
We would like to express our appreciation to the NIH for
addressing this issue. We thank you for this opportunity to
provide our input and invite you to contact Tony Mazzaschi,
AAMC Division of Biomedical and Health Sciences Research,
202-828-0059 if we may be of further assistance.
Sincerely,
Jordan J. Cohen, M.D.
|
