NOT-HS-00-003: AHRQ REVISED POLICY FOR IRB REVIEW OF HUMAN SUBJECTS PROTOCOLS IN GRANT APPLICATIONS

Department of Health
and Human Services (HHS)
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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.
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