Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 50--PROTECTION OF HUMAN SUBJECTS


TEXT PDF50.1 Scope.
TEXT PDF50.3 Definitions.
TEXT PDF50.20 General requirements for informed consent.
TEXT PDF50.23 Exception from general requirements.
TEXT PDF50.24 Exception from informed consent requirements for emergency research.
TEXT PDF50.25 Elements of informed consent.
TEXT PDF50.27 Documentation of informed consent.
TEXT PDF50.50 IRB duties.
TEXT PDF50.51 Clinical investigations not involving greater than minimal risk.
TEXT PDF50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
TEXT PDF50.53 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.
TEXT PDF50.54 Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
TEXT PDF50.55 Requirements for permission by parents or guardians and for assent by children.
TEXT PDF50.56 Wards.


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