New NIH policy to streamline review of multi-site clinical studies

The National Institutes of Health announced today in a press release a new policy that “sets the expectation that multi-site studies conducting the same protocol use a single (institutional review board) to carry out the ethical review of the proposed research.”

The release explained:

IRBs play a critical role in reviewing and approving studies involving human research participants. IRBs evaluate the potential benefits of research and risks to participants. In the past, most clinical research studies were carried out at single institutions. Now studies are increasingly conducted at multiple sites to help increase the number and diversity of the participants, improve operational efficiencies, and accelerate the generation of research results. However, for the majority of multi-site studies, the IRB at each participating site continues to conduct an independent review. This review adds time, but generally does not meaningfully enhance protections for the participants.  This new NIH policy seeks to end duplicative reviews that slow down the start of the research.

The new policy “applies to all competing grant applications (new, renewal, revision, or resubmission) with receipt dates on or after May 25, 2017. Ongoing, non-competing awards will not be expected to comply with this policy until the grantee submits a competing renewal application.”

See the NIH blog Under the Poliscope for more information.

And here’s a press release from December 2014, when the agency first publicized the draft policy.

Categories: Announcements, Uncategorized

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