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Human Subjects Protocols in Grant Applications

Human Subjects Protocols in Grant Applications

Agency for Healthcare Research and Quality (AHRQ-formerly AHCPR) Revised Policy for IRB Review of Human Subjects Protocols in Grant Applications


The Agency for Healthcare Research and Quality (AHRQ) announced 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 core/percentile points beyond. This range will vary from year to year and often from one review cycle to another.