21 CFR § 50.51
Clinical investigations not involving greater than minimal risk
June 25, 2020
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.
[78 FR 12951, Feb. 26, 2013]