Subpart D—Additional Protections for Children Involved as Subjects in Research

Sections

• § 46.401
  § 46.401 To what does this subpart apply?
• § 46.402
  § 46.402 Definitions.
• § 46.403
  § 46.403 IRB duties.
• § 46.404
  § 46.404 Research not involving greater than minimal risk.
• § 46.405
  § 46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
• § 46.406
  § 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
  § 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
  § 46.408 Requirements for permission by parents or guardians and for assent by children.
• § 46.409
  § 46.409 Wards.