On May 17, HHS’s Office for Human Research Protections (OHRP) and FDA issued a joint, final guidance on written procedures for institutional review boards (IRBs). The agencies are both responsible for issuing and enforcing federal regulations designed to protect human subjects in research, and have been working together to harmonize federal regulatory requirements and guidance in this area. This finalizes draft guidance issued in August 2016, which we summarized here.

This guidance does not establish legally enforceable responsibilities, but merely offers recommendations for compliance. It supersedes two previously issued guidance documents: FDA’s Appendix H: A Self Evaluation Checklist for IRBs (1998) and OHRP’s Guidance on Written IRB Procedures (2011). FDA said the checklist is designed “to prompt a thorough and more efficient evaluation of written procedures that are needed to help ensure the protection of human research subjects.”

Analysis:

The guidance indicates that IRBs’ written procedures that simply restate the regulations at 45 CFR 46.103(b)(4) and (5), and at 21 CFR 56.108(a) and (b) provide insufficient detail about the IRB’s operations to ensure that the IRB’s operations meet the applicable regulatory requirements. Emphasizing the need for greater detail in IRBs’ written procedures, the guidance urges IRBs to review past OHRP and FDA guidances in preparing their written procedures. The guidance further recommends IRBs make their written procedures publicly available to facilitate compliance.

The heart of the guidance is its 9-page, 59-section “IRB Written Procedures Checklist,” which is offered as “a tool to assist in determining what information should be covered in written procedures rather than a tool for assessing compliance.” This checklist should prove useful to IRBs, as “inadequate written procedures” was the second-most common noncompliance finding in an OHRP analysis of letters it produces after investigating allegations of noncompliance or auditing an institution’s human research protection program. Compared to the regulations, the checklist provides both a more comprehensive framework and a detailed set of recommended operational procedures for IRBs.