Part 46 — Protection of Human Subjects
Current through Aug 10, 2026
Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); 42 U.S.C. 300v-1(b).
Editorial Note: The Department of Health and Human Services issued a notice of waiver regarding the requirements set forth in part 46, relating to protection of human subjects, as they pertain to demonstration projects, approved under section 1115 of the Social Security Act, which test the use of cost—sharing, such as deductibles, copayment and coinsurance, in the Medicaid program. For further information see 47 FR 9208, Mar. 4, 1982.
Sections
- § 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.
- § 46.201 To what do these regulations apply?
- § 46.202 Definitions.
- § 46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
- § 46.204 Research involving pregnant women or fetuses.
- § 46.205 Research involving neonates.
- § 46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.
- § 46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
- § 46.301 Applicability.
- § 46.302 Purpose.
- § 46.303 Definitions.
- § 46.304 Composition of Institutional Review Boards where prisoners are involved.
- § 46.305 Additional duties of the Institutional Review Boards where prisoners are involved.
- § 46.306 Permitted research involving prisoners.
- § 46.401 To what does this subpart apply?
- § 46.402 Definitions.
- § 46.403 IRB duties.
- § 46.404 Research not involving greater than minimal risk.
- § 46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
- § 46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.
- § 46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
- § 46.408 Requirements for permission by parents or guardians and for assent by children.
- § 46.409 Wards.
- § 46.501 What IRBs must be registered?
- § 46.502 What information must be provided when registering an IRB?
- § 46.503 When must an IRB be registered?
- § 46.504 How must an IRB be registered?
- § 46.505 When must IRB registration information be renewed or updated?