FDA’s recent IRB guidance more style than substance

The U.S. Food and Drug Administration (FDA) recently issued a final guidance document for Institutional Review Boards (IRBs), clinical investigators and sponsors regarding “Considerations When Transferring Clinical Investigation Oversight to Another IRB.” The recommendations address regulatory requirements and potential operational approaches when an approved and ongoing clinical investigation that falls under the FDA’s oversight is transferred from one IRB to another, either from one institution to another or within the same institution.

{mosads}The guidance provides useful operational issues to consider, such as the identification of “those studies for which IRB oversight is being transferred” and the establishment of “an effective date for transfer of oversight, including records, for the clinical investigation(s).” However, the guidance fails to provide solid recommendations regarding the level (e.g., full board vs. expedited review) for the receiving IRB or institution. Such an omission could result in the lack of an adequate review by a receiving IRB and carries the potential for undue risk to research participants.

Institutional Review Boards are committees that provide ethical oversight of research activities involving human subjects. They are typically comprised of content experts, ancillary staff and unaffiliated community members. Institutional Review Boards are complex socio-technical systems that derive power from regulatory oversight bodies such as the FDA and the National Institutes of Health’s Office for Human Research Protections (OHRP). Institutional Review Boards assume and maintain their validity through in-depth reviews of proposed and ongoing research activities, robust group discussions, and, oftentimes, a lack of consensus among committee members. They operate independently and frequently maintain divergent thresholds for risk from one committee to another as it relates to investigational studies.

In the case of FDA-regulated products, such as investigational drugs, significant-risk medical devices, and biologics, IRBs represent ethical extensions of the agency. Within this framework, they are charged with reviewing and approving scientific proposals from investigational sponsors and clinical investigators seeking to evaluate the safety and efficacy of applicable test articles for certain medical conditions, while concurrently attempting to minimize risk for research participants. The overreliance of an IRB on the review and approval of another originating IRB, in the context of transferring a study from one IRB to another, serves only to undercut the IRB process itself.

While the recent guidance provides some structural components for IRBs and institutions to consider, its ultimate contribution is likely that of a good start rather than a final outcome.

Seabrooke is a Ph.D. student in Human and Social Dimensions of Science and Technology at Arizona State University and has a background in clinical and translational research, specializing in regulatory science and ethics.

Tags FDA Food and Drug Administration Institutional review board IRB
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