GroundRules
21 CFR 50.50: IRB duties.
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
In addition to other responsibilities assigned to IRBs under this part and part 56 of this chapter, each IRB must review clinical investigations involving children as subjects covered by this subpart D and approve only those clinical investigations that satisfy the criteria described in § 50.51, § 50.52, or § 50.53 and the conditions of all other applicable sections of this subpart D.
Collected 2026-08-27T02:24:47Z. Source file · JSON