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Regulations last checked for updates: May 22, 2025
Title 21 - Food and Drugs last revised: May 19, 2025
All Titles
Title 21
Chapter I
Part 50
Subpart D - Subpart D—Additional Safeguards for Children in Clinical Investigations
§ 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.
§ 50.56 - Wards.
authority:
21 U.S.C. 321
,
343
,
346
,
346
a,
348
,
350a
,
350b
,
352
,
353
,
355
,
360
,
360
c-360f,
360
h-360j,
371
,
379e
,
381
;
42 U.S.C. 216
,
241
,
262
source:
45 FR 36390, May 30, 1980, unless otherwise noted.
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