Title 40--Protection of Environment
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY
PART 26--PROTECTION OF HUMAN SUBJECTS
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![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
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To what does this policy apply? |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
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Definitions. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.103 |
Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.107 |
IRB membership. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.108 |
IRB functions and operations.
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![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.109 |
IRB review of research. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.110 |
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/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.111 |
Criteria for IRB approval of research.
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![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.112 |
Review by institution. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.113 |
Suspension or termination of IRB approval of research. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.114 |
Cooperative research. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.115 |
IRB records. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.116 |
General requirements for informed consent. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.117 |
Documentation of informed consent. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.118 |
Applications and proposals lacking definite plans for involvement of human subjects. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.119 |
Research undertaken without the intention of involving human subjects. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.120 |
Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.122 |
Use of Federal funds. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.123 |
Early termination of research support: Evaluation of applications and proposals. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.124 |
Conditions.
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![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
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To what does this subpart apply? |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.202 |
Definitions. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.203 |
Prohibition of research conducted or supported by EPA involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or child. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.301 |
To what does this subpart apply? |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.302 |
Definitions. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.303 |
Duties of IRBs in connection with observational research involving pregnant women and fetuses. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.304 |
Additional protections for pregnant women and fetuses involved in observational research. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.305 |
Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.401 |
To what does this subpart apply? |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.402 |
Definitions. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.403 |
IRB duties. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.404 |
Observational research not involving greater than minimal risk. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.405 |
Observational research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.406 |
Requirements for permission by parents or guardians and for assent by children. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1101
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To what does this subpart apply? |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1102 |
Definitions. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1107 |
IRB membership.
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![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1108 |
IRB functions and operations. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1109 |
IRB review of research. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1110 |
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/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1111 |
Criteria for IRB approval of research. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1112 |
Review by institution.
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![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1113 |
Suspension or termination of IRB approval of research. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1114 |
Cooperative research. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1115 |
IRB records. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1116 |
General requirements for informed consent. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1117 |
Documentation of informed consent. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1123 |
Early termination of research. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1125 |
Prior submission of proposed human research for EPA review. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1201
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To what does this subpart apply? |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1202 |
Definitions. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1203 |
Prohibition of research involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child.
|
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1301 |
To what does this subpart apply? |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1302 |
Definitions. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1303 |
Submission of information pertaining to ethical conduct of completed human research. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1501 |
To what does this subpart apply? |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1502 |
Lesser administrative actions. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1503 |
Disqualification of an IRB or an institution. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1504 |
Public disclosure of information regarding revocation. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1505 |
Reinstatement of an IRB or an institution. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1506 |
Debarment.
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![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1507 |
Actions alternative or additional to disqualification. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1601
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EPA review of proposed human research.
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![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1602 |
EPA review of completed human research. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1603 |
Operation of the Human Studies Review Board. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1701 |
To what does this subpart apply?
|
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1702 |
Definitions.
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![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1703 |
Prohibition of reliance on research involving intentional exposure of human subjects who are pregnant women (and therefore their fetuses), nursing women, or children. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1704 |
Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults conducted before April 7, 2006. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1705 |
Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults conducted after April 7, 2006. |
![TEXT](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/TEXT.gif) |
![PDF](https://webarchive.library.unt.edu/eot2008/20090510123947im_/http://www.access.gpo.gov/images/PDF.gif) | 26.1706 |
Criteria and procedure for decisions to protect public health by relying on otherwise unacceptable research. |