Back to Explorer

21CFR50.52

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

1 citation

Regulation 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 .

Authority

21 U.S.C. 321,343,346,346a,348,350a,350b,352,353,355,360,360c-360f,360h-360j,371,379e,381;42 U.S.C. 216,241,262.

View in Graph Explorer

Related Warning Letters (1)

  • Clinical Investigator

    Americo F. Padilla, M.D.

    2025-03-25

Related Guidelines (10)