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# FDA Proposes New Regs for Non-compliant IRBs
- URL: https://www.fdaweb.com/fda-proposes-new-regs-for-non-compliant-irbs/
- Published: 2016-04-04T12:00:00.000Z
- Updated: 2026-09-14T20:52:33.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5135266

*Federal Register* Proposed rule: FDA is proposing to amend the regulation describing lesser administrative actions that may be imposed on an Institutional Review Board (IRB) that has failed to comply with FDA’s IRB regulations. It is clarifying that FDA may require the IRB to withhold approval of new FDA-regulated studies, stop the enrollment of new subjects in ongoing studies, and terminate ongoing studies, or any combination of these actions, until the noncompliance with regulations is corrected. To view this proposed rule, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-04-04/pdf/2016-07524.pdf?ref=fdaweb.com)