FDA Proposes Revised IRB Regulations, Including Required sIRB for Multisite Trials

On September 28, 2022, the Food and Drug Administration (FDA) released two proposed rules, or Notices of Proposed Rule Making (NPRM), intended to partially harmonize its current regulations with the revised Common Rule.

One NPRM identifies specific provisions relating to IRB review and research informed consent, while the second NPRM focuses on cooperative research and single institutional review board (sIRB) oversight.

These suggested changes seek to “modernize, simplify, and enhance” FDA’s human subject research oversight system, as well as harmonize certain FDA requirements with the revised Common Rule in accordance with the 21st Century Cures Act. It also intends to clarify certain requirements regarding clinical investigations involving devices. Additionally, FDA declined to harmonize with certain other provisions in the Common Rule, suggesting the possibility that FDA regulations may not be compatible with those particular provisions.

Both rules are currently “proposed,” meaning they are not yet effective.

FDA is requesting comments on the provisions in the two NPRMs and has extended the comment period until 11:59 p.m. ET on December 28, 2022, giving the research community 90 days to respond. Following this comment period, FDA will assess feedback and determine how best to proceed with these proposals.

Proposed rule “Institutional Review Boards; Cooperative Research” recommends requiring any U.S.-located institution conducting cooperative research to rely on sIRB oversight for the research being conducted in the U.S. (with certain exceptions). This would harmonize FDA regulations with the revised Common Rule’s sIRB requirements, as well as similar sIRB policies enacted by the National Institutes of Health (NIH).

Proposed rule “Protection of Human Subjects and Institutional Review Boards” seeks to make several changes, including:

• Revise the required information included in the informed consent form (ICF) and how it is presented and organized, including new basic and additional elements of informed consent
• Allow IRBs to waive continuing review in certain circumstances and change certain IRB recordkeeping requirements
• Revise part of 21 CFR 812 regarding progress reports to the IRB for consistency with other proposed continuing review revisions

For more information, review the published proposals in the Federal Register.

Advarra will monitor the rulemaking process and continue to keep the research community informed of relevant developments as they occur.

Advarra can assist the research community in understanding and responding to these proposed changes. The organization is also prepared to support compliance with these requirements should they be implemented. Research professionals can submit questions via Ask Advarra or request assistance via the Contact Us form.

Note: This article was originally published September 28, 2022, and has been updated to include new and clarifying information.

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