2022-21088: Protection of Human Subjects and Institutional Review Boards
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The Food and Drug Administration (FDA or Agency) is proposing to amend its regulations to modernize, simplify, and enhance the current system for oversight of FDA-regulated human subject research. This proposed rule, if finalized, would harmonize certain sections of FDA's regulations on human subject protection and institutional review boards (IRBs), to the extent practicable and consistent with other statutory provisions, with the revised Federal Policy for the Protection of Human Subjects (the revised Common Rule), in accordance with the 21st Century Cures Act (Cures Act). We believe the proposed changes, if finalized, will reduce regulatory burden on IRBs, sponsors, and investigators. In addition, we propose related changes to the investigational device exemption (IDE) regulations to clarify and update the requirements for the submission of progress reports.
The agency’s own summary, as published.
What this changes
Amends 3 parts of the Code of Federal Regulations — the standing rules this notice rewrites.
Rulemaking docket
We haven’t pulled this rulemaking’s full docket yet. View docket FDA-2021-N-0286 on Regulations.gov →
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