HHS advisory committee addresses institutional review board rules

By | November 3, 2016

The fall meeting of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) on October 25–26 focused in large part on clarifying new rules affecting institutional review boards (IRB). The committee advises the Secretary of Health and Human Services on human subjects research matters and offers recommendations to researchers and institutions conducting studies with human participants.

In April, the National Institutes of Health (NIH) revised rules for reviewing human gene transfer protocols. Previously, all protocols were reviewed by the Recombinant DNA Advisory Committee (RAC) before implementation. Under new regulations, IRBs and Institutional Biosafety Committees (IBCs) will review protocols first, and the RAC will step in to review if the review board or biosafety committee thinks the study is sufficiently novel or risky. SACHRP recommended that NIH clarify the new rules by allowing IRBs and IBCs to co-sign requests for review and by being transparent with the rationale for accepting or rejecting requests for RAC review.

Earlier this summer, NIH released new rules requiring multi-site studies to use a single IRB to conduct the necessary ethical review. The committee offered recommendations on adapting to the new regulations but urged institutions to consider the impact that ceding institutional board review would have on the rest of its Human Research Protection Program. The rules are set to take effect at the end of May.

In August, the Office of Human Research Protections and the Food and Drug Administration (FDA) released draft guidance on written procedures for IRBs. SACHRP generally approved of the guidance, but had concerns about the effect the checklist may have on how review boards develop written procedures. In particular, the committee noted that there was little differentiation between functions that IRBs are required to do and those that could be completed by other institutional groups. The committee was concerned that the guidelines could lead the boards to take on unnecessary responsibilities, distracting from their core mission of protecting human subjects.

SACHRP also finalized recommendations on issues of informed consent as well as on the review and classification of benchmarking and cluster randomized trials. In addition, SACHRP discussed draft guidance from FDA on the use of real-world data to evaluate medical devices, but was not ready to release any specific recommendations.

The next SACHRP meeting will be held March 15–16 and is expected to focus on updates to the Common Rule.