Title 45--Public Welfare
SUBTITLE A--DEPARTMENT OF HEALTH
AND HUMAN SERVICES
PART 46--PROTECTION OF HUMAN SUBJECTS
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To what does this policy apply? |
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Definitions. |
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Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
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IRB membership. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
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IRB functions and operations. |
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IRB review of research. |
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Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
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Criteria for IRB approval of research. |
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Review by institution. |
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Suspension or termination of IRB approval of research. |
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Cooperative research. |
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IRB records. |
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General requirements for informed consent. |
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Documentation of informed consent. |
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Applications and proposals lacking definite plans for involvement of human subjects. |
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Research undertaken without the intention of involving human subjects. |
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Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency. |
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Use of Federal funds. |
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Early termination of research support: Evaluation of applications and proposals. |
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Conditions. |
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Applicability. |
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Purpose. |
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Definitions. |
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Ethical Advisory Boards. |
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Additional duties of the Institutional Review Boards in connection with activities involving fetuses, pregnant women, or human in vitro fertilization. |
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General limitations. |
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Activities directed toward pregnant women as subjects. |
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Activities directed toward fetuses in utero as subjects. |
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Activities directed toward fetuses ex utero, including nonviable fetuses, as subjects. |
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![PDF](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/PDF.gif) | 46.210 |
Activities involving the dead fetus, fetal material, or the placenta. |
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Modification or waiver of specific requirements. |
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To what do these regulations apply? |
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Definitions. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
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Duties of IRBs in connection with research involving pregnant women, fetuses, and human in vitro fertilization. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
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Research involving pregnant women or fetuses prior to delivery. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
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Research involving fetuses after delivery. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/PDF.gif) | 46.206 |
Research involving, after delivery, the placenta, the dead fetus, or fetal material. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/PDF.gif) | 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. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/PDF.gif) | 46.301 |
Applicability. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
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Purpose. |
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Definitions. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
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Composition of Institutional Review Boards where prisoners are involved. |
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![PDF](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/PDF.gif) | 46.305 |
Additional duties of the Institutional Review Boards where prisoners are involved. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/PDF.gif) | 46.306 |
Permitted research involving prisoners. |
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To what do these regulations apply? |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/PDF.gif) | 46.402 |
Definitions. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/PDF.gif) | 46.403 |
IRB duties. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/PDF.gif) | 46.404 |
Research not involving greater than minimal risk. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/PDF.gif) | 46.405 |
Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/PDF.gif) | 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. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/PDF.gif) | 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. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090113130200im_/http://www.access.gpo.gov/images/PDF.gif) | 46.408 |
Requirements for permission by parents or guardians and for assent by children. |
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Wards. |