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Electronic Code of Federal Regulations

e-CFR data is current as of May 28, 2020

Title 16Chapter IISubchapter APart 1028 → §1028.113


Title 16: Commercial Practices
PART 1028—PROTECTION OF HUMAN SUBJECTS


§1028.113   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 department or agency head.

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