21 CFR 50.51
§ 50.51 Clinical investigations not involving greater than minimal risk.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 50.51, § 50.51 Clinical investigations not involving greater than minimal risk, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83458
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Full text
Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which no greater than minimal risk to children is presented may involve children as subjects only if the IRB finds that:
(a) No greater than minimal risk to children is presented; and
(b) Adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians as set forth in § 50.55.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.