Introduction
The Office for Human Research Protections (OHRP) and the U.S. Food and Drug Administration (FDA) have released the final version of their guidance, “Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs.” This document is essential for institutions and IRBs responsible for overseeing human subjects research under the U.S. Department of Health and Human Services (HHS) and FDA regulations. Here is what you need to know about this important guidance.
Why This Guidance Matters
IRBs play a critical role in protecting human research subjects. The new guidance aims to help institutions develop and maintain robust written procedures that align with regulatory requirements. These procedures ensure IRBs function effectively, maintain compliance, and uphold ethical research standards. This guidance finalizes the draft version from August 2016 and incorporates updates based on public comments and the evolving regulatory landscape.
Key Highlights of the Guidance
- Comprehensive Written Procedures – The guidance emphasizes the importance of institutions and IRBs having clear, well-documented written procedures to guide their operations.
- Written Procedures Checklist – The checklist helps institutions evaluate their procedures and ensure they comply with 45 CFR 46.103(b)(4) and (5) and 21 CFR 56.108(a) and (b).
- Distinguishing Required vs. Recommended Procedures – The document clarifies legally required procedures under HHS and FDA regulations, which recommend best practices for optimal functionality.
- Regulatory Harmonization – This guidance aligns with the 21st Century Cures Act, which mandates harmonization between HHS and FDA human subjects research regulations. This effort helps reduce regulatory burden while maintaining high ethical standards.
- Superseding Previous Guidance – The new guidance supersedes the 2011 OHRP “Guidance on Written IRB Procedures” and the 1998 FDA “Appendix H: A Self-Evaluation Checklist for IRBs.”
Final Thoughts
This updated guidance clarifies expectations for IRB written procedures and promotes greater regulatory consistency across institutions. By adopting these procedures, IRBs can ensure compliance, enhance human subject protection, and improve the overall effectiveness of research oversight. For research institutions, now is the perfect time to review and update IRB written procedures to align with this latest guidance.
How to Access the Guidance
