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Title 21

Displaying title 21, up to date as of 10/02/2026. Title 21 was last amended 9/30/2026.
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Title 21Food and DrugsPart / Section
Chapter IFood and Drug Administration, Department of Health and Human Services1 – 1299
Subchapter AGeneral1 – 99
Part 50Protection of Human Subjects50.1 – 50.56
Subpart AGeneral Provisions50.1 – 50.3
§ 50.1Scope.
§ 50.3Definitions.
Subpart BInformed Consent of Human Subjects50.20 – 50.27
§ 50.20General requirements for informed consent.
§ 50.22Exception from informed consent requirements for minimal risk clinical investigations.
§ 50.23Exception from general requirements.
§ 50.24Exception from informed consent requirements for emergency research.
§ 50.25Elements of informed consent.
§ 50.27Documentation of informed consent.
Subpart C [Reserved]
Subpart DAdditional Safeguards for Children in Clinical Investigations50.50 – 50.56
§ 50.50IRB duties.
§ 50.51Clinical investigations not involving greater than minimal risk.
§ 50.52Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
§ 50.53Clinical 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.
§ 50.54Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
§ 50.55Requirements for permission by parents or guardians and for assent by children.
§ 50.56Wards.