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 155 × 483
- § 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 10 × 483
- § 50.25 Elements of informed consent 322 × 483
- § 50.27 Documentation of informed consent 237 × 483
Subpart D - Additional Safeguards for Children in Clinical Investigations
- § 50.50 IRB duties
- § 50.51 Clinical investigations not involving greater than minimal risk 2 × 483
- § 50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects 14 × 483
- § 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 1 × 483
- § 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 25 × 483
- § 50.56 Wards