45 CFR 46.404 - Research not involving greater than minimal risk.

Regulations last checked for updates: Feb 08, 2026

Title 45 - Public Welfare last revised: Jan 28, 2026

View all text of Subpart D [§ 46.401 - § 46.409]

§ 46.404 - Research not involving greater than minimal risk.

HHS will conduct or fund research in which the IRB finds that no greater than minimal risk to children is presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in § 46.408.

authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b)

cite as: 45 CFR 46.404