21 CFR Part 50
PART 50—PROTECTION OF HUMAN SUBJECTS
- PART 50—PROTECTION OF HUMAN SUBJECTS
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter A—General
- Subpart A—General Provisions
- § 50.1 Scope.
- § 50.3 Definitions.
- 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 C [Reserved]
- 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.
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