On June 21, 2016, the US government announced changes that are arguably the most significant of the last quarter century concerning the protection of human research participants – a requirement for use of central or single institutional review boards (IRBs) in multisite National Institutes of Health (NIH) – funded research. Specifically, the NIH announced a new policy (effective September 25, 2017) to mandate that nonexempt multisite research with humans funded by the NIH be reviewed by a single IRB.

Although the NIH single-IRB policy is designed to improve IRB review of multisite studies by accelerating the review process, given the number of public comments that were generated prior to the policy being finalized and the fact that the policy has been developed in the absence of the systematic collection of data, significant issues remain unresolved.

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