Title 6, Part 46 — Protection of Human Subjects

To what does this policy apply?

Definitions for purposes of this policy.

Assuring compliance with this policy—research conducted or supported by any Federal department or agency.

Exempt research.

§§ 46.105-46.106 [Reserved]

IRB membership.

IRB functions and operations.

IRB review of research.

Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

Criteria for IRB approval of research.

Review by institution

Suspension or termination of IRB approval of research.

Cooperative research.

IRB records.

General requirements for informed consent.

Documentation of informed consent.

Applications and proposals lacking definite plans for involvement of human subjects.

Research undertaken without the intention of involving human subjects.

Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.

[Reserved]

Use of Federal funds.

Early termination of research support: Evaluation of applications and proposals.

Conditions.