Title 21

PART 50

Part 50 - Protection Of Human Subjects

PART 50 - PROTECTION OF HUMAN SUBJECTS Authority:21 U.S.C 321, 343, 346, 346a, 348, 350a, 350b, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-263n. Source:45 FR 36390, May 30, 1980, unless otherwise noted.

21:1.0.1.1.20.1SUBPART A
Subpart A - General Provisions
21:1.0.1.1.20.1.63.1SECTION 50.1
   50.1 Scope.
21:1.0.1.1.20.1.63.2SECTION 50.3
   50.3 Definitions.
21:1.0.1.1.20.2SUBPART B
Subpart B - Informed Consent of Human Subjects
21:1.0.1.1.20.2.63.1SECTION 50.20
   50.20 General requirements for informed consent.
21:1.0.1.1.20.2.63.2SECTION 50.23
   50.23 Exception from general requirements.
21:1.0.1.1.20.2.63.3SECTION 50.24
   50.24 Exception from informed consent requirements for emergency research.
21:1.0.1.1.20.2.63.4SECTION 50.25
   50.25 Elements of informed consent.
21:1.0.1.1.20.2.63.5SECTION 50.27
   50.27 Documentation of informed consent.
21:1.0.1.1.20.3SUBPART C
Subpart C [Reserved]
21:1.0.1.1.20.4SUBPART D
Subpart D - Additional Safeguards for Children in Clinical Investigations
21:1.0.1.1.20.4.63.1SECTION 50.50
   50.50 IRB duties.
21:1.0.1.1.20.4.63.2SECTION 50.51
   50.51 Clinical investigations not involving greater than minimal risk.
21:1.0.1.1.20.4.63.3SECTION 50.52
   50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
21:1.0.1.1.20.4.63.4SECTION 50.53
   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.
21:1.0.1.1.20.4.63.5SECTION 50.54
   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.
21:1.0.1.1.20.4.63.6SECTION 50.55
   50.55 Requirements for permission by parents or guardians and for assent by children.
21:1.0.1.1.20.4.63.7SECTION 50.56
   50.56 Wards.