Code of Federal Regulations > Title 45 > Chapter A > Part 46 > Subpart A - Subpart A—Basic HHS Policy for Protection of Human Research Subjects

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Oct 06, 2025

§ 46.101 - To what does this policy apply?

§ 46.102 - Definitions for purposes of this policy.

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

§ 46.104 - Exempt research.

§ 46.105-46.106 - [Reserved]

§ 46.107 - IRB membership.

§ 46.108 - IRB functions and operations.

§ 46.109 - IRB review of research.

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

§ 46.111 - Criteria for IRB approval of research.

§ 46.112 - Review by institution.

§ 46.113 - Suspension or termination of IRB approval of research.

§ 46.114 - Cooperative research.

§ 46.115 - IRB records.

§ 46.116 - General requirements for informed consent.

§ 46.117 - Documentation of informed consent.

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

§ 46.119 - Research undertaken without the intention of involving human subjects.

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

§ 46.121 - [Reserved]

§ 46.122 - Use of Federal funds.

§ 46.123 - Early termination of research support: Evaluation of applications and proposals.

§ 46.124 - Conditions.