Electronic Code of Federal Regulations

We invite you to try out our new beta eCFR site at https://ecfr.federalregister.gov. We’ve made big changes to make the eCFR easier to use. Be sure to leave feedback using the Help button on the bottom right of each page!

e-CFR data is current as of August 12, 2020

Title 21 → Chapter I → Subchapter A → Part 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

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.

Need assistance?