Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=50&amp;showFR=1
Timestamp: 2019-04-19 15:14:40+00:00

Document:
§ 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.
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.

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