REVISED POLICY FOR IRB REVIEW OF HUMAN SUBJECTS PROTOCOLS IN GRANT APPLICATIONS

Release Date:  May 1, 2000

NOTICE:  OD-00-031

National Institutes of Health

It has been NIH grants policy that applications submitted to NIH, which 
include research involving human participants, are required to have IRB 
approval at the time of submission or within 60 days after application 
receipt date.  Since fewer than half of all applications submitted to 
NIH are funded, and in order to reduce burden on applicants and IRBs, 
the NIH is modifying this policy.

Beginning with applications submitted for the January 2001 Council 
round (generally, those applications submitted for the June/July 2000 
receipt dates), IRB approval is not required prior to NIH peer review 
of an application.  As part of the peer review process, the peer review 
group carefully considers whether the application includes the 
necessary safeguards to protect the rights and welfare of research 
participants.  

This change in policy is intended to provide flexibility at the 
institutional level.  The institution may still determine that certain 
lines of research (e.g., scientifically or ethically controversial 
research) or mechanisms of research (e.g., multicenter clinical trials) 
should receive IRB review prior to submission of the application.

No grant award can be made without IRB approval.  Therefore, following 
NIH peer review and notification of priority score/percentile, 
institutions should proceed with IRB review for those applications that 
have not yet received IRB approval and that appear to be in a fundable 
range.  The term  fundable range  does not signify a certainty of 
funding.  Guidance is currently being developed that will assist 
applicants in determining their status related to a particular 
Institute or Center’s fundable range.

This change in NIH policy is intended to provide institutions with the 
flexibility to reduce the workload burdens that many IRBs are currently 
facing.  This change is consistent with the requirements of 45 CFR 46 
(The Common Rule).  At this time, this flexibility is being provided 
only to IRBs.  Due to PHS Policy language, applications including 
research with animals will continue to require review by the 
Institutional Animal Care and Use Committee (IACUC) at the time of 
submission or within 60 days thereafter.

Following are frequently asked questions to assist you in understanding 
the revised policy:

1. WHAT IS AN INSTITUTE’s  FUNDABLE RANGE? 

A  fundable range  is not to be confused with an Institute’s pay line.  
The  fundable range  will include all applications that fall within an 
Institute’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 round to round.  The intent of widening the 
range of applications beyond the nominal pay line to proceed with IRB 
review is to provide Institutes the discretion to select applications 
beyond the pay line for special consideration, particular program 
relevance, etc.

2. HOW WILL THE INVESTIGATOR AND INSTITUTION KNOW THAT AN APPLICATION 
IS IN THE FUNDABLE RANGE AND THEREAFTER THAT IRB REVIEW SHOULD PROCEED?

With notification of an application’s rating, the investigator will 
also be notified if the application is in the fundable range.  
Notification that an application is in the fundable range will also be 
provided to the institutional business official who signed the 
application.  At that same time, other information may be requested, 
such as updated Other Support in the case of modular applications.

3. WILL THERE BE TIMES WHEN NIH MIGHT EXPECT/REQUEST THAT IRB APPROVAL 
BE OBTAINED EARLIER THAN PERMISSIBLE?

At times, IRB approval may be necessary before submission of an 
application.  This could occur, for example, with a particularly tight 
time line for an RFA, or for certain instances when end-of-fiscal-year 
funding requirements might demand earlier IRB review and approval.

4. WILL THIS CHANGE IN POLICY AFFECT SUBSEQUENT NONCOMPETING AWARDS?

If an institution chooses to wait until after peer review to conduct 
IRB reviews for competing applications, it should be sure to schedule 
subsequent  annual  IRB reviews so that they occur prior to the 
submission of noncompeting continuation applications, which are due two 
months prior to the budget period start date.

5. WHAT DEGREES OF FLEXIBILITY ARE INSTITUTIONS GIVEN IN DETERMINING 
WHEN, WHAT, AND WHY SOME APPLICATIONS MIGHT BE GIVEN IRB REVIEW EARLIER 
THAN PERMISSIBLE?

Institutions have extensive flexibilities in determining when an 
application receives IRB review prior to funding.  The official NIH 
announcement refers to examples such as particular mechanisms (e.g., 
cooperative clinical trials) and sensitive lines of research (e.g., HIV 
research) which an institution might feel should be subjected to IRB 
review prior to application submission.  However, institutions may also 
determine other cases or instances in which they feel more comfortable 
requiring IRB review prior to application submission.

6. WILL NIH PEER REVIEWERS BE EXPECTED TO DO ANYTHING DIFFERENTLY IN 
THEIR REVIEW OF APPLICATIONS INVOLVING HUMAN SUBJECTS RESEARCH THAT 
HAVE NOT YET RECEIVED IRB APPROVAL?

Peer reviewers have always paid careful attention to the review of 
human subjects protocols regardless of the fact they have already 
undergone IRB review.  It is expected that peer reviewers will continue 
with that practice. The NIH expects nothing more nor less from its peer 
reviewers in this regard.

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