21 CFR §50.51

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗

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.