NIH Finalizes Single Institutional Review Board Policy for Multiple-Site Studies

On June 20, 2016, the National Institutes of Health (NIH) finalized a policy that permits a single Institutional Review Board (IRB) to review human subject protections at all locations of a multi-center study.

The “Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research” implements a draft version of the policy issued in December 2014. The new rule is “intended to enhance and streamline the process of IRB review and reduce inefficiencies so that research can proceed as expeditiously as possible without compromising ethical principles and protections for human research participants,” according to the NIH news release about the policy change.

“We were seeing delays and complications in moving research forward in a way that wasn’t providing commensurate protections for human research participants,” Carrie D. Wolinetz, associate director for science policy at NIH, explained to Bloomberg BNA. “If we thought that having multiple IRBs review the research resulted in a stronger fabric of protection for participants, we would be all for it. But there’s no evidence that that is the case.”

Under the new policy, NIH grant applications must include a plan describing the use of a single IRB that will serve as the IRB of record for all study sites. The policy will take effect on May 25, 2017, and will apply to all domestic sites of NIH-funded studies. The NIH plans to issue guidance and resources before that date to help institutions adjust to the changes.

Sources: National Institutes of Health news release, June 21, 2016; Federal Register, June 21, 2016.

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