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.
Title 21 published on 2013-04-01
no entries appear in the Federal Register after this date.