US strengthens registration requirements for institutional review boards
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration and the Office for Human Research Protections have strengthened the registration requirements for institutional review boards that oversee clinical investigations of FDA-regulated products and federally supported research, respectively1,2. The new measures, which come into effect on 14 July, aim to create a first-ever comprehensive database of IRBs that will make it easier for the FDA and the OHRP to inspect IRBs and to convey information to them.
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