C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER A—GENERAL › PART 56—INSTITUTIONAL REVIEW BOARDS › Subpart C—IRB Functions and Operations

21 C.F.R. § 56.113

Suspension or termination of IRB approval of research

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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.

Notes of Decisions
Cited in 1 case, 1994–1994 · leading case: Halikas v. Univ. of Minnesota, 856 F. Supp. 1331 (D. Minnesota 1994).
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Halikas v. Univ. of Minnesota, 856 F. Supp. 1331 (D. Minnesota 1994). · cites it 2× “Federal regulations require that an IRB report any suspension or termination of IRB research approval.”
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