Release Date:  December 6, 2000 (superceded by NOT-OD-02-064)

NOTICE:  OD-01-008

National Institutes of Health

On May 1, 2000, the NIH announced that beginning with applications 
submitted for the January 2001 Council round, IRB approval is no longer 
required prior to NIH peer review of an application which involves 
human participants.  
This change in policy is intended to provide flexibility at the institutional 
level to reduce the workload burdens that many IRBs are currently facing, while 
still ensuring full protection of participants in human studies.

At this time, however, there is no change in the NIH policy for 
submission of IACUC approval when animal studies are involved.  IACUC 
approval is still required of all such applications either when the 
application is submitted, or within 60 days thereafter; otherwise, the 
application cannot be peer reviewed.  Applicants are reminded that if 
IACUC approval does not accompany the application, they should wait 
until notified of the scientific review group assignment and then 
forward the documentation to the designated Scientific Review 

Because of the different bases for IRB and IACUC review requirements, 
rulemaking would be required to allow similar flexibility for IACUC 
review.  Over the next year, the NIH will closely monitor 
implementation of the revised policy on the timing of IRB approval.  If 
as expected, this change in policy continues to provide the necessary 
safeguards but with enhanced institutional flexibility, the NIH will 
consider proceeding with rulemaking to permit similar flexibility in 
the timing of IACUC approvals.

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