Subpart D. Subpart D—Additional ED Protections for Children Who Are Subjects in Research

• § 97.401 - To what do these regulations apply?
• § 97.402 - Definitions.
• § 97.403 - IRB duties.
• § 97.404 - Research not involving greater than minimal risk.
• § 97.405 - Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
• § 97.406 - 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.
• § 97.407 - Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
• § 97.408 - Requirements for permission by parents or guardians and for assent by children.
• § 97.409 - Wards.