Code of Federal Regulations > Title 38 > Chapter I > Part 16 - PART 16—PROTECTION OF HUMAN SUBJECTS

U.S. Code of Federal Regulations

Regulations most recently checked for updates: Oct 31, 2025

§ 16.101 - To what does this policy apply?

§ 16.102 - Definitions for purposes of this policy.

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

§ 16.104 - Exempt research.

§§ 16.105-16.106 - §[Reserved]

§ 16.107 - IRB membership.

§ 16.108 - IRB functions and operations.

§ 16.109 - IRB review of research.

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

§ 16.111 - Criteria for IRB approval of research.

§ 16.112 - Review by Institution

§ 16.113 - Suspension or Termination of IRB Approval of Research.

§ 16.114 - Cooperative Research.

§ 16.115 - IRB Records.

§ 16.116 - General Requirements for Informed Consent.

§ 16.117 - Documentation of informed consent.

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

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

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

§ 16.121 - [Reserved]

§ 16.122 - Use of Federal funds.

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

§ 16.124 - Conditions.