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Search for FDA Guidance Documents > Institutional Review Board (IRB) Written Procedures





FDA and OHRP Issue Final Joint Guidance on IRB Written Procedures

The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have issued final joint guidance titled, “Institutional Review Board (IRB) Written Procedures:  Guidance for Institutions and IRBs”.  This final guidance was prepared jointly by FDA and OHRP and is intended for institutions and IRBs responsible for review and oversight of human subject research under the FDA and HHS regulations.  This joint guidance is now available on FDA's website at https://www.fda.gov/RegulatoryInformation/Guidances/ucm512760.htm, and OHRP’s website at https://www.hhs.gov/ohrp/regulations-and-policy/guidance/institutional-issues/institutional-review-board-written-procedures/index.html.

This guidance is intended to assist staff at institutions and IRBs who are responsible for preparing and maintaining written procedures.