White Paper

Single IRB Review For Multicenter Research: A Guide For Institutions

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Single IRB review for multicenter research is now the norm in the US. Initiatives like the NIH Single IRB (sIRB) policy, the revised Common Rule regulations, and the 21st Century Cures Act requiring harmonization between the FDA regulations and the Common Rule have made it clear that the federal agencies favor centralized review by a single IRB for multicenter research.

In this guide, we discuss these requirements and issues to consider as the research community evolves into this new landscape of mandated centralized IRB review. Also, please note that the terms “single IRB” and “central IRB” are used interchangeably throughout the document to refer to the IRB of record overseeing research for all participating sites in a multisite study. The single or central IRB could be an independent IRB or an institutional IRB that has agreed to serve as the IRB of record for research conducted at other institutions.

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