Subpart D. Subpart D—Additional Safeguards for Children in Clinical Investigations

• § 50.50 - IRB duties.
• § 50.51 - Clinical investigations not involving greater than minimal risk.
• § 50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
• § 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 - 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 - Requirements for permission by parents or guardians and for assent by children.
• § 50.56 - Wards.