§50.50. IRB duties.
21 C.F.R. § 50.50
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.
Notes, amendments, and revision history
Source
Source: 66 FR 20598, Apr. 24, 2001, unless otherwise noted.
Authority
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
Source: 45 FR 36390, May 30, 1980, unless otherwise noted.