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