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U.S. Code of Federal Regula...
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Title 21-Food and Drugs
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CHAPTER I—FOOD AND DRUG ADM...
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PART 50—PROTECTION OF HUMAN SUBJECTS
PART 50—PROTECTION OF HUMAN SUBJECTS
§ 50.1 - Scope.
§ 50.3 - Definitions.
§ 50.20 - General requirements for informed consent.
§ 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.
§ 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.