Title 45--Public Welfare
SUBTITLE A--DEPARTMENT OF HEALTH
AND HUMAN SERVICES
PART 46--PROTECTION OF HUMAN SUBJECTS
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| 46.101 |
To what does this policy apply? |
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| 46.102 |
Definitions. |
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| 46.103 |
Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency. |
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| 46.107 |
IRB membership. |
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| 46.108 |
IRB functions and operations. |
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| 46.109 |
IRB review of research. |
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| 46.110 |
Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. |
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| 46.111 |
Criteria for IRB approval of research. |
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| 46.112 |
Review by institution. |
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| 46.113 |
Suspension or termination of IRB approval of research. |
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| 46.114 |
Cooperative research. |
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| 46.115 |
IRB records. |
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| 46.116 |
General requirements for informed consent. |
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| 46.117 |
Documentation of informed consent. |
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| 46.118 |
Applications and proposals lacking definite plans for involvement of human subjects. |
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| 46.119 |
Research undertaken without the intention of involving human subjects. |
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| 46.120 |
Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency. |
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| 46.122 |
Use of Federal funds. |
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| 46.123 |
Early termination of research support: Evaluation of applications and proposals. |
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| 46.124 |
Conditions. |
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| 46.201 |
Applicability. |
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| 46.202 |
Purpose. |
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| 46.203 |
Definitions. |
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| 46.204 |
Ethical Advisory Boards. |
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| 46.205 |
Additional duties of the Institutional Review Boards in connection with activities involving fetuses, pregnant women, or human in vitro fertilization. |
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| 46.206 |
General limitations. |
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| 46.207 |
Activities directed toward pregnant women as subjects. |
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| 46.208 |
Activities directed toward fetuses in utero as subjects. |
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| 46.209 |
Activities directed toward fetuses ex utero, including nonviable fetuses, as subjects. |
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| 46.210 |
Activities involving the dead fetus, fetal material, or the placenta. |
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| 46.211 |
Modification or waiver of specific requirements. |
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| 46.201 |
To what do these regulations apply? |
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| 46.202 |
Definitions. |
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| 46.203 |
Duties of IRBs in connection with research involving pregnant women, fetuses, and human in vitro fertilization. |
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| 46.204 |
Research involving pregnant women or fetuses prior to delivery. |
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| 46.205 |
Research involving fetuses after delivery. |
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| 46.206 |
Research involving, after delivery, the placenta, the dead fetus, or fetal material. |
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| 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 or fetuses. |
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| 46.301 |
Applicability. |
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| 46.302 |
Purpose. |
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| 46.303 |
Definitions. |
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| 46.304 |
Composition of Institutional Review Boards where prisoners are involved. |
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| 46.305 |
Additional duties of the Institutional Review Boards where prisoners are involved. |
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| 46.306 |
Permitted research involving prisoners. |
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| 46.401 |
To what do these regulations apply? |
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| 46.402 |
Definitions. |
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| 46.403 |
IRB duties. |
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| 46.404 |
Research not involving greater than minimal risk. |
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| 46.405 |
Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. |
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| 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. |
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| 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. |
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| 46.408 |
Requirements for permission by parents or guardians and for assent by children. |
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| 46.409 |
Wards. |