NIH Releases Final Policy on Use of Single IRBs for Multi-site Studies

By | June 30, 2016

On June 21, the National Institutes of Health (NIH) issued its final policy on the use of single Institutional Review Boards (IRBs) for multi-site research studies and clinical trials. The policy “establish(es) the expectation that a single IRB of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States.” The new policy will go into effect on May 25, 2017.

The NIH Notice provides information on how the final policy will be implemented. Of note: the policy only applies to multi-site studies in which the same protocol is conducted at each site, not to studies in which multiple sites carry out different roles; exceptions can be granted in cases where federal, state, or tribal policy prohibits single IRB use or if a “compelling justification” is provided; and the policy will not apply to multi-site studies with ongoing, non-competing awards until a competing renewal application is submitted. Finally, costs associated with single IRB review may be charged to grants/contracts as direct or indirect costs. Guidance on how to do this was released concurrently with the final policy.

Most of the Notice was devoted to summarizing public comments received on the draft policy. NIH noted that, in general, individual researchers, professional societies, and patient advocacy groups supported the proposed policy and agreed that it would streamline the IRB review process without hurting human subjects protections. Academic institutions, on the other hand, generally took issue with the scope of the policy—that ALL multi-site studies, even those performed at just two institutions, must utilize a single IRB of record—and raised concerns that issues of local context could not be adequately addressed by a single IRB.

The final policy is largely unchanged from the draft policy released for comment in December 2014 and supported by FASEB in January 2015.