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

Sections

• 97.401
  § 97.401 To what do these regulations apply?
• 97.402
  § 97.402 Definitions.
• 97.403
  § 97.403 IRB duties.
• 97.404
  § 97.404 Research not involving greater than minimal risk.
• 97.405
  § 97.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
• 97.406
  § 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
  § 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
  § 97.408 Requirements for permission by parents or guardians and for assent by children.
• 97.409
  § 97.409 Wards.