Title 21

PART 50 SUBPART D

Subpart D - Additional Safeguards for Children in Clinical Investigations Source:66 FR 20598, Apr. 24, 2001, unless otherwise noted.

• 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.

21:1.0.1.1.21.4.63.1	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.

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