| 45:1.0.1.1.26.1 | SUBPART A
| Subpart A - Basic HHS Policy for Protection of Human Research Subjects | |
| 45:1.0.1.1.26.1.1.1 | SECTION 46.101
| 46.101 To what does this policy apply | |
| 45:1.0.1.1.26.1.1.2 | SECTION 46.102
| 46.102 Definitions for purposes of this policy. | |
| 45:1.0.1.1.26.1.1.3 | SECTION 46.103
| 46.103 Assuring compliance with this policy - research conducted or supported by any Federal department or agency. | |
| 45:1.0.1.1.26.1.1.4 | SECTION 46.104
| 46.104 Exempt research. | |
| 45:1.0.1.1.26.1.1.5 | SECTION 46.105-46.106
| 46.105-46.106 [Reserved] | |
| 45:1.0.1.1.26.1.1.6 | SECTION 46.107
| 46.107 IRB membership. | |
| 45:1.0.1.1.26.1.1.7 | SECTION 46.108
| 46.108 IRB functions and operations. | |
| 45:1.0.1.1.26.1.1.8 | SECTION 46.109
| 46.109 IRB review of research. | |
| 45:1.0.1.1.26.1.1.9 | SECTION 46.110
| 46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. | |
| 45:1.0.1.1.26.1.1.10 | SECTION 46.111
| 46.111 Criteria for IRB approval of research. | |
| 45:1.0.1.1.26.1.1.11 | SECTION 46.112
| 46.112 Review by institution. | |
| 45:1.0.1.1.26.1.1.12 | SECTION 46.113
| 46.113 Suspension or termination of IRB approval of research. | |
| 45:1.0.1.1.26.1.1.13 | SECTION 46.114
| 46.114 Cooperative research. | |
| 45:1.0.1.1.26.1.1.14 | SECTION 46.115
| 46.115 IRB records. | |
| 45:1.0.1.1.26.1.1.15 | SECTION 46.116
| 46.116 General requirements for informed consent. | |
| 45:1.0.1.1.26.1.1.16 | SECTION 46.117
| 46.117 Documentation of informed consent. | |
| 45:1.0.1.1.26.1.1.17 | SECTION 46.118
| 46.118 Applications and proposals lacking definite plans for involvement of human subjects. | |
| 45:1.0.1.1.26.1.1.18 | SECTION 46.119
| 46.119 Research undertaken without the intention of involving human subjects. | |
| 45:1.0.1.1.26.1.1.19 | SECTION 46.120
| 46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency. | |
| 45:1.0.1.1.26.1.1.20 | SECTION 46.121
| 46.121 [Reserved] | |
| 45:1.0.1.1.26.1.1.21 | SECTION 46.122
| 46.122 Use of Federal funds. | |
| 45:1.0.1.1.26.1.1.22 | SECTION 46.123
| 46.123 Early termination of research support: Evaluation of applications and proposals. | |
| 45:1.0.1.1.26.1.1.23 | SECTION 46.124
| 46.124 Conditions. | |
| 45:1.0.1.1.26.2 | SUBPART B
| Subpart B - Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research | |
| 45:1.0.1.1.26.2.1.1 | SECTION 46.201
| 46.201 To what do these regulations apply | |
| 45:1.0.1.1.26.2.1.2 | SECTION 46.202
| 46.202 Definitions. | |
| 45:1.0.1.1.26.2.1.3 | SECTION 46.203
| 46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates. | |
| 45:1.0.1.1.26.2.1.4 | SECTION 46.204
| 46.204 Research involving pregnant women or fetuses. | |
| 45:1.0.1.1.26.2.1.5 | SECTION 46.205
| 46.205 Research involving neonates. | |
| 45:1.0.1.1.26.2.1.6 | SECTION 46.206
| 46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material. | |
| 45:1.0.1.1.26.2.1.7 | SECTION 46.207
| 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. | |
| 45:1.0.1.1.26.3 | SUBPART C
| Subpart C - Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects | |
| 45:1.0.1.1.26.3.1.1 | SECTION 46.301
| 46.301 Applicability. | |
| 45:1.0.1.1.26.3.1.2 | SECTION 46.302
| 46.302 Purpose. | |
| 45:1.0.1.1.26.3.1.3 | SECTION 46.303
| 46.303 Definitions. | |
| 45:1.0.1.1.26.3.1.4 | SECTION 46.304
| 46.304 Composition of Institutional Review Boards where prisoners are involved. | |
| 45:1.0.1.1.26.3.1.5 | SECTION 46.305
| 46.305 Additional duties of the Institutional Review Boards where prisoners are involved. | |
| 45:1.0.1.1.26.3.1.6 | SECTION 46.306
| 46.306 Permitted research involving prisoners. | |
| 45:1.0.1.1.26.4 | SUBPART D
| Subpart D - Additional Protections for Children Involved as Subjects in Research | |
| 45:1.0.1.1.26.4.1.1 | SECTION 46.401
| 46.401 To what do these regulations apply | |
| 45:1.0.1.1.26.4.1.2 | SECTION 46.402
| 46.402 Definitions. | |
| 45:1.0.1.1.26.4.1.3 | SECTION 46.403
| 46.403 IRB duties. | |
| 45:1.0.1.1.26.4.1.4 | SECTION 46.404
| 46.404 Research not involving greater than minimal risk. | |
| 45:1.0.1.1.26.4.1.5 | SECTION 46.405
| 46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. | |
| 45:1.0.1.1.26.4.1.6 | SECTION 46.406
| 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. | |
| 45:1.0.1.1.26.4.1.7 | SECTION 46.407
| 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. | |
| 45:1.0.1.1.26.4.1.8 | SECTION 46.408
| 46.408 Requirements for permission by parents or guardians and for assent by children. | |
| 45:1.0.1.1.26.4.1.9 | SECTION 46.409
| 46.409 Wards. | |
| 45:1.0.1.1.26.5 | SUBPART E
| Subpart E - Registration of Institutional Review Boards | |
| 45:1.0.1.1.26.5.1.1 | SECTION 46.501
| 46.501 What IRBs must be registered | |
| 45:1.0.1.1.26.5.1.2 | SECTION 46.502
| 46.502 What information must be provided when registering an IRB | |
| 45:1.0.1.1.26.5.1.3 | SECTION 46.503
| 46.503 When must an IRB be registered | |
| 45:1.0.1.1.26.5.1.4 | SECTION 46.504
| 46.504 How must an IRB be registered | |
| 45:1.0.1.1.26.5.1.5 | SECTION 46.505
| 46.505 When must IRB registration information be renewed or updated | |