21 CFR 56.113 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (§ 1.1 To § 99.501) — Food And Drug Administration, Department Of Health And Human Services (§ 1.1 To § 99.501) — General (§ 1.1 To § 99.501) — Institutional Review Boards (§ 56.101 To § 56.124) — Irb Functions And Operations (§ 56.108 To § 56.114) — Suspension or termination of IRB approval of research.

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.