Single IRBs in Multisite Trials: Questions Posed by the New NIH Policy

Klitzman, Robert L.; Pivovarova, Ekaterina; Lidz, Charles W.

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. On January 19, 2017, final amendments to the federal human research participant protection regulations (the Common Rule) were also published, requiring use of a single IRB, although implementation will be delayed until January 20, 2020. The NIH directive seems straightforward, but effective implementation will require that institutions, researchers, and policy makers decide how to address a number of critical issues. The Common Rule amendments explicitly recognize that further guidance will need to be developed, necessitating that these stakeholders confront several dilemmas.


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Journal of the American Medical Association

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July 27, 2020