21 CFR 50.52
§ 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 50.52, § 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83459
- Permanent ID
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Full text
Any clinical investigation within the scope described in §§ 50.1 and 56.101 of this chapter in which more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, may involve children as subjects only if the IRB finds that:
(a) The risk is justified by the anticipated benefit to the subjects;
(b) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and
(c) Adequate provisions are made for soliciting the assent of the children and 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.