Part 50 — Protection of Human Subjects
Current through Sep 8, 2026
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.
Source: 45 FR 36390, May 30, 1980, unless otherwise noted.
Sections
- § 50.1 Scope.
- § 50.3 Definitions.
- § 50.20 General requirements for informed consent.
- § 50.22 Exception from informed consent requirements for minimal risk clinical investigations.
- § 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.
- § 50.56 Wards.