GroundRules
21 CFR 50.51: Clinical investigations not involving greater than minimal risk.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER A—GENERAL
- PART 50—PROTECTION OF HUMAN SUBJECTS
- Subpart D—Additional Safeguards for Children in Clinical Investigations
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON