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e-CFR Data is current as of December 5,
2007
TITLE 40--Protection of Environment
CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY
SUBCHAPTER A--GENERAL
PART
26--PROTECTION OF HUMAN SUBJECTS 
Subpart
A--BASIC EPA POLICY FOR PROTECTION OF SUBJECTS IN HUMAN RESEARCH CONDUCTED
OR SUPPORTED BY EPA
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| To what does this policy
apply? | |
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| Assuring compliance with this policy--research conducted
or supported by any Federal Department or
Agency. | |
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| IRB functions and
operations. | |
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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. | |
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| Criteria for IRB approval of
research. | |
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| Suspension or termination of IRB approval of
research. | |
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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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| Early termination of research support: Evaluation of
applications and
proposals. | |
Subpart
B--PROHIBITION OF RESEARCH CONDUCTED OR SUPPORTED BY EPA INVOLVING
INTENTIONAL EXPOSURE OF HUMAN SUBJECTS WHO ARE CHILDREN OR PREGNANT OR
NURSING WOMEN
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| To what does this subpart
apply? | |
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| 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. | |
Subpart
C--OBSERVATIONAL RESEARCH: ADDITIONAL PROTECTIONS FOR PREGNANT WOMEN AND
FETUSES INVOLVED AS SUBJECTS IN OBSERVATIONAL RESEARCH CONDUCTED OR
SUPPORTED BY EPA
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| To what does this subpart
apply? | |
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| Duties of IRBs in connection with observational research
involving pregnant women and
fetuses. | |
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| Additional protections for pregnant women and fetuses
involved in observational
research. | |
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| Protections applicable, after delivery, to the placenta,
the dead fetus, or fetal
material. | |
Subpart
D--OBSERVATIONAL RESEARCH: ADDITIONAL PROTECTIONS FOR CHILDREN INVOLVED AS
SUBJECTS IN OBSERVATIONAL RESEARCH CONDUCTED OR SUPPORTED BY EPA
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|
| To what does this subpart
apply? | |
|
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| Observational research not involving greater than minimal
risk. | |
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| Observational research involving greater than minimal risk
but presenting the prospect of direct benefit to the
individual subjects. | |
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| Requirements for permission by parents or guardians and
for assent by
children. | |
Subparts
E-J--[RESERVED]
Subpart
K--BASIC ETHICAL REQUIREMENTS FOR THIRD-PARTY HUMAN RESEARCH FOR
PESTICIDES INVOLVING INTENTIONAL EXPOSURE OF NON-PREGNANT, NON-NURSING
ADULTS
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|
| To what does this subpart
apply? | |
|
|
| IRB functions and
operations. | |
|
|
| Expedited review procedures for certain kinds of research
involving no more than minimal risk, and for minor changes in
approved research. | |
|
|
| Criteria for IRB approval of
research. | |
|
|
| Suspension or termination of IRB approval of
research. | |
|
|
| General requirements for informed
consent. | |
|
|
| Documentation of informed
consent. | |
|
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| Early termination of
research. | |
|
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| Prior submission of proposed human research for EPA
review. | |
Subpart
L--PROHIBITION OF THIRD-PARTY RESEARCH FOR PESTICIDES INVOLVING
INTENTIONAL EXPOSURE OF HUMAN SUBJECTS WHO ARE CHILDREN OR PREGNANT OR
NURSING WOMEN
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|
| To what does this subpart
apply? | |
|
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| 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. | |
Subpart
M--REQUIREMENTS FOR SUBMISSION OF INFORMATION ON THE ETHICAL CONDUCT OF
COMPLETED HUMAN RESEARCH
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| To what does this subpart
apply? | |
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| Submission of information pertaining to ethical conduct of
completed human
research. | |
Subpart
N--[RESERVED]
Subpart
O--ADMINISTRATIVE ACTIONS FOR NONCOMPLIANCE
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| To what does this subpart
apply? | |
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| Lesser administrative
actions. | |
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| Disqualification of an IRB or an
institution. | |
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| Public disclosure of information regarding
revocation. | |
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| Reinstatement of an IRB or an
institution. | |
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| Actions alternative or additional to
disqualification. | |
Subpart
P--REVIEW OF PROPOSED AND COMPLETED HUMAN RESEARCH
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| EPA review of proposed human
research. | |
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| EPA review of completed human
research. | |
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| Operation of the Human Studies Review
Board. | |
Subpart
Q--ETHICAL STANDARDS FOR ASSESSING WHETHER TO RELY ON THE RESULTS OF HUMAN
RESEARCH IN EPA ACTIONS
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| To what does this subpart
apply? | |
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| Prohibition of reliance on research involving intentional
exposure of human subjects who are pregnant women (and
therefore their fetuses), nursing women, or
children. | |
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| Prohibition of reliance on unethical human research with
non-pregnant, non-nursing adults conducted before April 7,
2006. | |
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| Prohibition of reliance on unethical human research with
non-pregnant, non-nursing adults conducted after April 7,
2006. | |
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| Criteria and procedure for decisions to protect public
health by relying on otherwise unacceptable
research. | |
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