United States: Draft Guidance Issued For IRB Written Procedures

The Department of Health and Human Services ("HHS") Office for Human Research Protections ("OHRP") and FDA recently released draft guidance for the written procedures of Institutional Review Boards ("IRBs"), which is intended to assist IRBs and institutional officials responsible for review and oversight of human subject research. The draft guidance, when finalized, will supersede FDA's 1998 "Appendix H: A Self-Evaluation Checklist for IRBs" and OHRP's 2011 "Guidance on Written IRB Procedures." The issuance of joint draft guidance reflects OHRP's and FDA's ongoing efforts to harmonize the agencies' regulatory requirements and guidance for human subject research.

The draft guidance strongly encourages IRBs to focus on specific operational details and to provide written procedures sufficient for investigators and regulators to understand precisely how the IRB is managing and satisfying its regulatory obligations. The agencies noted an observation that the written procedures of some IRBs simply reiterate the regulations, providing insufficient detail about the actual operations of the IRB. To prompt a critical assessment of IRB operations and organizational structure, the majority of the draft guidance is presented as a checklist identifying the agencies' regulatory requirements and recommendations for IRB written procedures. While HHS and FDA regulations require IRBs to have written procedures for certain functions (45 C.F.R. § 46.103(b)(4) and (5), 21 C.F.R. § 56.108(a) and (b)), such as the initial and continuing review of research and ensuring prompt reporting to the IRB of proposed changes in research activity, the agencies encourage IRBs to consider developing written procedures not required by the regulations, such as procedures for activities required by the regulations but for which written procedures are not required. For example, the checklist includes recommendations for written procedures regarding IRB membership and managing conflicts of interest of IRB members. The goal, according to OHRP and FDA, is for IRB written procedures to be sufficiently detailed to ensure that IRB members and administrative staff are carrying out their duties consistently and effectively, and that the rights and welfare of human subjects are protected.

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