45 CFR Part 46
PART 46—PROTECTION OF HUMAN SUBJECTS
- PART 46—PROTECTION OF HUMAN SUBJECTS
- Subtitle A—Department of Health and Human Services › Subchapter A—General Administration
- Subpart A—Basic HHS Policy for Protection of Human Research Subjects
- § 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.
- Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
- § 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.
- Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
- § 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.
- Subpart D—Additional Protections for Children Involved as Subjects in Research
- § 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.
- Subpart E—Registration of Institutional Review Boards
- § 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?
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