Code of Federal Regulations > Title 45 > Chapter A > Part 46 > Subpart D - Subpart D—Additional Protections for Children Involved as Subjects in Research

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Apr 25, 2025

§ 46.401 - To what does this subpart apply?

§ 46.402 - Definitions.

§ 46.403 - IRB duties.

§ 46.404 - Research not involving greater than minimal risk.

§ 46.405 - Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.

§ 46.406 - Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.

§ 46.407 - Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

§ 46.408 - Requirements for permission by parents or guardians and for assent by children.

§ 46.409 - Wards.