GroundRules
21 CFR 56.113: Suspension or termination of IRB approval of research.
Where this section sits in the code
- Title 21—Food and Drugs
- 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
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON