SUBPART D—Additional Safeguards for Children in Clinical Investigations (§50.50 to §50.56)
- 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' disor
- 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.