Title 21: Food and Drugs
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/ PART 56 - INSTITUTIONAL REVIEW BOARDS
/ Subpart C - IRB Functions and Operations / § 56.113 Suspension or termination of IRB approval of research.
§ 56.113 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.