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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 45 - Public Welfare |
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Subtitle A - Department of Health and Human Services |
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SubChapter A - General Administration |
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Part 46 - Protection of Human Subjects |
| 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. |
| § 46.107 - 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. |
| §§ 46.104--46.106 - [Reserved] |
| §§ 46.105--46.106 - [Reserved] |
| 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. |
| § 46.208 - Activities directed toward fetuses in utero as subjects. |
| § 46.209 - Activities directed toward fetuses ex utero, including nonviable fetuses, as subjects. |
| § 46.210 - Activities involving the dead fetus, fetal material, or the placenta. |
| § 46.211 - Modification or waiver of specific requirements. |
| 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 do these regulations 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. |
| § 46.407 - 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? |