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Part 50
FEDERAL · 21 CFR
Part 50 — Protection of Human Subjects
15 sections · Title 21: Food and Drugs
§ 50.1
Scope.
§ 50.3
Definitions.
§ 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.
§ 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.