AHRQ REVISED POLICY FOR IRB REVIEW OF HUMAN SUBJECTS PROTOCOLS IN
GRANT APPLICATIONS
Release Date: September 27, 2000
NOTICE: HS-00-003
Agency for Healthcare Research and Quality (formerly AHCPR)
The Agency for Healthcare Research and Quality (AHRQ) announces that it is
revising its policy on Institutional Review Board (IRB) approval of human
subjects protocols in grant applications.
It has been AHRQ grants policy that applications submitted to AHRQ, which
include research involving human subjects, are required to have IRB approval
at the time of submission or within 60 days after an application receipt date.
In order to reduce burdens on applicants and IRBs, the AHRQ is modifying this
policy. Beginning with applications submitted for the February 1, 2001
receipt date, IRB approval of human subjects is not required prior to peer
review of an application. This revised policy covers all research grant
applications submitted to AHRQ. As part of the peer review process, the peer
review groups will continue to carefully consider whether the application
includes the necessary safeguards to protect the rights and welfare of
research participants.
This change in policy is intended to be consistent with the NIH Revised Policy
for IRB Approval of Human Subjects Protocols in Grant Applications, published
in the NIH Guide to Grants and Contracts (NIH Guide) on May 1, 2000. This
change is consistent with the requirements of 45 CFR 46 (The Common Rule).
The policy is intended to provide flexibility at the institutional level to
reduce the workload burden that many IRBs are currently facing. Institutions
may still determine that certain lines of research (e.g., scientifically or
ethically controversial research) or mechanisms of research (e.g., multi-
center clinical trials) should receive IRB review and approval prior to
submission of the application. At times, AHRQ may require IRB approval at the
time of submission of an application, and will provide adequate advance notice
of this exception to the general policy. This could occur, for example, with
a particularly tight time line for an RFA or in certain instances when end-of-
fiscal-year funding requirements might demand earlier IRB review and approval.
As with the NIH revised policy, no grant award can be made without IRB
approval. Therefore, following peer review the investigator will be notified
of the application’s score and if the application is in the fundable range.
At that time, the institutions should proceed with IRB review for those
applications that have not yet received IRB approval and that are in the
fundable range. Notification that an application is in the fundable range
will also be provided to the institutional business official whose signature
appears on the face page of the application. AHRQ will establish the fundable
range for each peer review meeting. The term fundable range does not
signify a certainty of funding. It will include all applications that fall
within the Agency’s pay line and also applications that extend a number of
priority score/percentile points beyond. This range will vary from year to
year and often from one review cycle to another.
For questions on this policy, please contact Dr. Francis Chesley, M.D., at
301-594-6410.
Weekly TOC for this Announcement
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