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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER A--GENERAL
 
PART 50PROTECTION OF HUMAN SUBJECTS
 

Subpart A--General Provisions
   § 50.1 - Scope.
   § 50.3 - Definitions.

Subpart B--Informed Consent of Human Subjects
   § 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.

Subpart C [Reserved]

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, 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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