45 CFR 46.113

§ 46.113 Suspension or termination of IRB approval of research.

United States · 45 CFR — Public Welfare · Status: effective

Cite this

Citation: 45 CFR 46.113, § 46.113 Suspension or termination of IRB approval of research, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/216334
Permanent ID: ys:prov:216334@1
SHA-256: bf5be635386fb31fcc0cefc870df55dc63ca3efaa04a3b9dbf3d2e37b195628f

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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 department or agency head.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.