21 CFR 56.113
§ 56.113 Suspension or termination of IRB approval of research.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 56.113, § 56.113 Suspension or termination of IRB approval of research, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83487
- Permanent ID
ys:prov:83487@1- SHA-256
6c87cafe7b777e188a285873c31131bb93e54804be29dd4cd6d13bb09f79344f
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Full text
An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the Food and Drug Administration.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.