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.
Weekly TOC for this Announcement
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