Institutional Review Boards (IRBs) play a crucial role in safeguarding the rights and welfare of human research subjects. To enhance transparency, accountability, and compliance, the U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have jointly issued final guidance titled Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs (February 2025).
An Institutional Review Board (IRB) is an independent ethics committee responsible for reviewing, approving, and monitoring clinical research involving human participants. IRBs ensure that research complies with ethical principles and federal regulations, protecting study participants' rights, safety, and welfare.
IRBs operate under the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) regulations, including:
21 CFR Part 56 (IRBs for FDA-regulated studies)
45 CFR Part 46 (Common Rule for federally funded research)
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). OHRP and FDA have been working to harmonize the Agencies' regulatory requirements and guidance for human subject research to enhance human subject protection and reduce regulatory burden. This guidance aims to standardize IRB procedures, streamline regulatory requirements, and ensure harmonization across research institutions.
The purpose of this guidance is to assist staff at institutions and IRBs 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.
The IRB Written Procedures Guidance is structured to assist institutions in developing comprehensive protocols. Under 45 CFR 46.103(b)(4) and (5) and 21 CFR 56.108(a) and (b), IRBs must document processes for:
Initial and ongoing review of research studies.
Ensuring compliance with FDA and HHS regulations.
Managing protocol deviations and non-compliance.
Reporting adverse events and unanticipated risks to relevant authorities.
A lack of detailed procedures can lead to inconsistencies, regulatory violations, and risks to patient safety. The FDA and OHRP emphasize that IRBs should go beyond merely restating regulations; they must develop operationally feasible written procedures.
The FDA and OHRP have taken a proactive step in harmonizing regulations for IRB governance. Institutions should carefully evaluate their IRB policies, incorporate the Written Procedures Checklist, and ensure ongoing training for IRB members. For a complete reference, download the official guidance from the FDA website:📄 Institutional Review Board (IRB) Written Procedures Guidance
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