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Title 21 - Title 21
Part 50 - PROTECTION OF HUMAN SUBJECTS
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Description
GENERAL - PROTECTION OF HUMAN SUBJECTS
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14 sections
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§50.1 - Scope.
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§50.20 - General requirements for informed consent.
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§50.23 - Exception from general requirements.
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§50.24 - Exception from informed consent requirements for emergency research.
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§50.25 - Elements of informed consent.
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§50.27 - Documentation of informed consent.
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§50.3 - Definitions.
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§50.50 - IRB duties.
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§50.51 - Clinical investigations not involving greater than minimal risk.
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§50.52 - Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
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§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.
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§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.
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§50.55 - Requirements for permission by parents or guardians and for assent by children.
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§50.56 - Wards.
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