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Title 45

Displaying title 45, up to date as of 6/05/2026. Title 45 was last amended 6/04/2026.
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Title 45Public WelfarePart / Section
Subtitle ADepartment of Health and Human Services1 – 199
Subchapter AGeneral Administration1 – 102
Part 46Protection of Human Subjects46.101 – 46.505
Subpart ABasic HHS Policy for Protection of Human Research Subjects46.101 – 46.124
§ 46.101To what does this policy apply?
§ 46.102Definitions for purposes of this policy.
§ 46.103Assuring compliance with this policy—research conducted or supported by any Federal department or agency.
§ 46.104Exempt research.
§ 46.105-46.106 [Reserved]
§ 46.107IRB membership.
§ 46.108IRB functions and operations.
§ 46.109IRB review of research.
§ 46.110Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
§ 46.111Criteria for IRB approval of research.
§ 46.112Review by institution.
§ 46.113Suspension or termination of IRB approval of research.
§ 46.114Cooperative research.
§ 46.115IRB records.
§ 46.116General requirements for informed consent.
§ 46.117Documentation of informed consent.
§ 46.118Applications and proposals lacking definite plans for involvement of human subjects.
§ 46.119Research undertaken without the intention of involving human subjects.
§ 46.120Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.
§ 46.121 [Reserved]
§ 46.122Use of Federal funds.
§ 46.123Early termination of research support: Evaluation of applications and proposals.
§ 46.124Conditions.