Subpart D—Additional Safeguards for Children in Clinical Investigations

Sections

• 50.50
  § 50.50 IRB duties.
• 50.51
  § 50.51 Clinical investigations not involving greater than minimal risk.
• 50.52
  § 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
• 50.53
  § 50.53 Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.
• 50.54
  § 50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
• 50.55
  § 50.55 Requirements for permission by parents or guardians and for assent by children.
• 50.56
  § 50.56 Wards.