21 CFR 56.105
§ 56.105 Waiver of IRB requirement.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 56.105, § 56.105 Waiver of IRB requirement, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83477
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Full text
On the application of a sponsor or sponsor-investigator, the Food and Drug Administration may waive any of the requirements contained in these regulations, including the requirements for IRB review, for specific research activities or for classes of research activities, otherwise covered by these regulations.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.