NIH Issues Final Rule on
Peer Review Committees
January 9, 2004 - After several years in process,
the Department of Health and Human Services (DHHS) and NIH
have finalized revised regulations on the conduct of scientific
peer review of NIH research grants and R&D contracts (69
Federal Register 272). When first proposed in September
2000, the regulations were needed to clarify the status and
requirements for peer review study sections, which differ
from NIH advisory councils or similar bodies that are subject
to the Federal Advisory Committees Act.
Notable revisions in the new regulations pertain to reviewers'
Conflicts of Interest, and establish wide-ranging criteria
for determining "real" and "apparent"
conflicts. A real conflict of interest, for example,
includes a non-salary financial benefit of $10,000 or more
that a reviewer (or reviewer's close family or colleagues)
receives from an organization or individual submitting a research
proposal. The rule requires disclosure of such conflicts and
recusal of reviewers as necessary, and allows for reconsideration
of conflicts by the NIH director. In its comment letter of
Nov. 20, 2000, the AAMC encouraged NIH's revision of these
regulations, but argued that the distinction between real
and apparent conflicts is artificial and misleading: all
conflicts of interest involve questions of perception as to
potential for bias or partiality, and should be addressed
accordingly. The AAMC had also recommended that the threshold
for determining financial benefit be made consistent with
other federal regulations, which the new rule does accomplish.
Information:
Stephen Heinig, Lead Science Policy Analyst
AAMC Biomedical Health Sciences Research
sheinig@aamc.org
(202) 828-0488
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