21 CFR 312.66
§ 312.66 Assurance of IRB review.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 312.66, § 312.66 Assurance of IRB review, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/86297
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Full text
An investigator shall assure that an IRB that complies with the requirements set forth in part 56 will be responsible for the initial and continuing review and approval of the proposed clinical study. The investigator shall also assure that he or she will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risk to human subjects or others, and that he or she will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.