21 C.F.R. § 50.51 Clinical investigations not involving greater than minimal risk.
Title 21 - Food and Drugs
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 and documents that 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.
Title 21: Food and Drugs
PART 50—PROTECTION OF HUMAN SUBJECTS
Subpart D—Additional Safeguards for Children in Clinical Investigations
§ 50.51 Clinical investigations not involving greater than minimal risk.
