21 CFR § 50.50 - Irb Duties.

---
identifier: "/us/cfr/t21/s50.50"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 50.50 - IRB duties."
title_number: 21
title_name: "Food and Drugs"
section_number: "50.50"
section_name: "IRB duties."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "A"
subchapter_name: "GENERAL"
part_number: "50"
part_name: "PROTECTION OF HUMAN SUBJECTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262."
regulatory_source: "45 FR 36390, May 30, 1980, unless otherwise noted."
cfr_part: "50"
---


# 50.50 IRB duties.

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.