21 CFR Part 50 — Protection of Human Subjects
Subpart A — General Provisions
Subpart B — Informed Consent of Human Subjects
- § 50.20— General requirements for informed consent.
- § 50.22— Exception from informed consent requirements for minimal risk clinical investigations.
- § 50.23— Exception from general requirements.
- § 50.24— Exception from informed consent requirements for emergency research.
- § 50.25— Elements of informed consent.
- § 50.27— Documentation of informed consent.
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.