Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs
February 2025
This guidance has been prepared jointly by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). To enhance human subject protection and reduce regulatory burden, OHRP and FDA have been actively working to harmonize the Agencies’ regulatory requirements and guidance for human subject research. This guidance is intended for institutions and institutional review boards (IRBs) responsible for review and oversight of human subject research under the HHS and FDA regulations.
The purpose of this guidance is to assist staff at institutions and IRBs who are responsible for preparing and maintaining written procedures. The guidance includes a Written Procedures Checklist (also referred to in this guidance as the Checklist) that incorporates the HHS and FDA regulatory requirements for written procedures for the IRB and recommendations on the type of operational details to include to support each of these requirements.
Categories Federal