21 CFR Part 50, Subpart D - Additional Safeguards for Children in Clinical Investigations
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- § 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.
66 FR 20598, Apr. 24, 2001, unless otherwise noted.