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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