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Electronic Code of Federal Regulations

e-CFR data is current as of October 16, 2019

Title 21Chapter ISubchapter APart 50


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER A—GENERAL

PART 50—PROTECTION OF HUMAN SUBJECTS

rule

Subpart A—GENERAL PROVISIONS

§50.1
Scope.
§50.3
Definitions.
rule

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.
rule

Subpart C—[RESERVED]

rule

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.

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