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FDA Proposes Revisions to Rules on the Protection of Human Subjects and Cooperative Research

The U.S. Food and Drug Administration (FDA) proposed two new rules that would update regulations 21 CFR 50 (Protection of Human Subjects) and 21 CFR 56 (Institutional Review Boards). The proposed revisions do not address all of the differences between the revised Common Rule and FDA regulations, but they aim to harmonize to the “extent practicable and consistent with statutory provisions.”

Informed Consent

The first proposed rule would harmonize certain requirements of FDA regulations with the revised Common Rule in accordance with the 21st Century Cures Act. The revised requirements are meant to reduce regulatory burden and clarify certain requirements. The proposed changes add new requirements for informed consent and update the regulations at both 21 CFR 50 and 56.

Cooperative Research and IRB Recordkeeping

In a second proposed rule, the FDA is also proposing revisions to current requirements for cooperative research and IRB recordkeeping. These changes aim to streamline IRB review process, reduce administrative burden, and harmonize with the revised Common Rule.

Comment Period

The comment period was recently extended until December 28, 2022. See the notice for more information.

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Institutional Review Boards; Cooperative Research View Proposed Rule
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Protection of Human Subjects and Institutional Review Boards View Proposed Rule