FDA issues joint guidance on Institutional Review Board (IRB) written procedures
The Department of Health and Human Services Office for Human Research Protections and the FDA have issued a final guidance on IRB Written Procedures to enhance human subject protection and reduce regulatory burden. This is part of efforts to harmonise the agencies’ regulatory requirements and guidance for human subject research. This guidance aims to assist staff at institutions and IRBs who are responsible for preparing and maintaining written procedures to ultimately protect the rights and welfare of human subjects.
News reported on the 2nd of April 2025 in Catapult’s regulatory round-up, read the entire report here.
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adelage (20 mai 2025). FDA issues joint guidance on Institutional Review Board (IRB) written procedures. ELSIBI. Consulté le 19 janvier 2026 à l’adresse https://doi.org/10.58079/13yk1





