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21 CFR Part 50 · Protection of Human Subjects

§ 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects

Subpart D - Additional Safeguards for Children in Clinical Investigations Official text on eCFR Amendment history

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 .

Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.

What FDA inspectors cite under § 50.52

Form FDA 483 observations citing this section, fiscal years 2009–2023 (Bioresearch Monitoring).

  • Factors required for approval 14

Warning letters citing § 50.52

1 FDA warning letters since 2017 cite this section :

FDA guidance that cites § 50.52

and 20 more.

Amendment history

Federal Register documents that created or amended this section.