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.

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.

21:1.0.1.1.21.1	SUBPART A	Subpart A - General Provisions
21:1.0.1.1.21.1.63.1	SECTION 50.1	50.1 Scope.
21:1.0.1.1.21.1.63.2	SECTION 50.3	50.3 Definitions.
21:1.0.1.1.21.2	SUBPART B	Subpart B - Informed Consent of Human Subjects
21:1.0.1.1.21.2.63.1	SECTION 50.20	50.20 General requirements for informed consent.
21:1.0.1.1.21.2.63.2	SECTION 50.23	50.23 Exception from general requirements.
21:1.0.1.1.21.2.63.3	SECTION 50.24	50.24 Exception from informed consent requirements for emergency research.
21:1.0.1.1.21.2.63.4	SECTION 50.25	50.25 Elements of informed consent.
21:1.0.1.1.21.2.63.5	SECTION 50.27	50.27 Documentation of informed consent.
21:1.0.1.1.21.3	SUBPART C	Subpart C [Reserved]
21:1.0.1.1.21.4	SUBPART D	Subpart D - Additional Safeguards for Children in Clinical Investigations
21:1.0.1.1.21.4.63.1	SECTION 50.50	50.50 IRB duties.
21:1.0.1.1.21.4.63.2	SECTION 50.51	50.51 Clinical investigations not involving greater than minimal risk.
21:1.0.1.1.21.4.63.3	SECTION 50.52	50.52 Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
21:1.0.1.1.21.4.63.4	SECTION 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.
21:1.0.1.1.21.4.63.5	SECTION 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.
21:1.0.1.1.21.4.63.6	SECTION 50.55	50.55 Requirements for permission by parents or guardians and for assent by children.
21:1.0.1.1.21.4.63.7	SECTION 50.56	50.56 Wards.