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

Title 21: Food and Drugs
PART 50—PROTECTION OF HUMAN SUBJECTS
Subpart D—Additional Safeguards for Children in Clinical Investigations

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

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 and documents 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.