---
kind: "unit"
title: "6"
title_heading: "Domestic Security"
key: "chI/part46"
level: "part"
label: "Part 46"
heading: "Protection of Human Subjects"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/6/chI-part46"
sections_count: 23
---

# Part 46 — Protection of Human Subjects

Title 6 C.F.R. — Domestic Security › Chapter I — Department of Homeland Security, Office of the Secretary

## Sections

- [§46.101. To what does this policy apply?](/cfr/6/46.101.md)
- [§46.102. Definitions for purposes of this policy.](/cfr/6/46.102.md)
- [§46.103. Assuring compliance with this policy—research conducted or supported by any Federal department or agency.](/cfr/6/46.103.md)
- [§46.104. Exempt research.](/cfr/6/46.104.md)
- [§46.105-46.106. Reserved](/cfr/6/46.105-46.106.md)
- [§46.107. IRB membership.](/cfr/6/46.107.md)
- [§46.108. IRB functions and operations.](/cfr/6/46.108.md)
- [§46.109. IRB review of research.](/cfr/6/46.109.md)
- [§46.110. Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.](/cfr/6/46.110.md)
- [§46.111. Criteria for IRB approval of research.](/cfr/6/46.111.md)
- [§46.112. Review by institution](/cfr/6/46.112.md)
- [§46.113. Suspension or termination of IRB approval of research.](/cfr/6/46.113.md)
- [§46.114. Cooperative research.](/cfr/6/46.114.md)
- [§46.115. IRB records.](/cfr/6/46.115.md)
- [§46.116. General requirements for informed consent.](/cfr/6/46.116.md)
- [§46.117. Documentation of informed consent.](/cfr/6/46.117.md)
- [§46.118. Applications and proposals lacking definite plans for involvement of human subjects.](/cfr/6/46.118.md)
- [§46.119. Research undertaken without the intention of involving human subjects.](/cfr/6/46.119.md)
- [§46.120. Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.](/cfr/6/46.120.md)
- [§46.121. Reserved](/cfr/6/46.121.md)
- [§46.122. Use of Federal funds.](/cfr/6/46.122.md)
- [§46.123. Early termination of research support: Evaluation of applications and proposals.](/cfr/6/46.123.md)
- [§46.124. Conditions.](/cfr/6/46.124.md)