21 C.F.R. PART 50--PROTECTION OF HUMAN SUBJECTS
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
PART 50--PROTECTION OF HUMAN SUBJECTS
Subpart A--GENERAL PROVISIONS
Subpart B--INFORMED CONSENT OF HUMAN SUBJECTS
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| General requirements for informed consent.
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| Exception from general requirements.
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| Exception from informed consent requirements for emergency research.
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| Elements of informed consent.
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| Documentation of informed consent.
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Subpart C--[RESERVED]
Subpart D--ADDITIONAL SAFEGUARDS FOR CHILDREN IN CLINICAL INVESTIGATIONS
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| Clinical investigations not involving greater than minimal risk.
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| Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
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| 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.
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| Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
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| Requirements for permission by parents or guardians and for assent by children.
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