21 CFR 50.51 - Clinical investigations not involving greater than minimal risk.

Regulations last checked for updates: Apr 30, 2025

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

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

§ 50.51 - Clinical investigations not involving greater than minimal risk.

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.

[78 FR 12951, Feb. 26, 2013]

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 50.51