21 CFR 50.50 - IRB duties.

Regulations last checked for updates: May 01, 2025

Title 21 - Food and Drugs last revised: Apr 28, 2025

View all text of Subpart D [§ 50.50 - § 50.56]

§ 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.

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

source: 45 FR 36390, May 30, 1980, unless otherwise noted.

cite as: 21 CFR 50.50