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Electronic Code of Federal Regulations

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e-CFR Data is current as of October 17, 2014

Title 40Chapter ISubchapter APart 26


TITLE 40—Protection of Environment

CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY

SUBCHAPTER A—GENERAL

PART 26—PROTECTION OF HUMAN SUBJECTS

rule

Subpart A—BASIC EPA POLICY FOR PROTECTION OF SUBJECTS IN HUMAN RESEARCH CONDUCTED OR SUPPORTED BY EPA

§26.101
To what does this policy apply?
§26.102
Definitions.
§26.103
Assuring compliance with this policy—research conducted or supported by any Federal Department or Agency.
§§26.104-26.106
[Reserved]
§26.107
IRB membership.
§26.108
IRB functions and operations.
§26.109
IRB review of research.
§26.110
Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
§26.111
Criteria for IRB approval of research.
§26.112
Review by institution.
§26.113
Suspension or termination of IRB approval of research.
§26.114
Cooperative research.
§26.115
IRB records.
§26.116
General requirements for informed consent.
§26.117
Documentation of informed consent.
§26.118
Applications and proposals lacking definite plans for involvement of human subjects.
§26.119
Research undertaken without the intention of involving human subjects.
§26.120
Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.
§26.121
[Reserved]
§26.122
Use of Federal funds.
§26.123
Early termination of research support: Evaluation of applications and proposals.
§26.124
Conditions.
rule

Subpart B—PROHIBITION OF RESEARCH CONDUCTED OR SUPPORTED BY EPA INVOLVING INTENTIONAL EXPOSURE OF HUMAN SUBJECTS WHO ARE CHILDREN OR PREGNANT OR NURSING WOMEN

§26.201
To what does this subpart apply?
§26.202
Definitions.
§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.
rule

Subpart C—OBSERVATIONAL RESEARCH: ADDITIONAL PROTECTIONS FOR PREGNANT WOMEN AND FETUSES INVOLVED AS SUBJECTS IN OBSERVATIONAL RESEARCH CONDUCTED OR SUPPORTED BY EPA

§26.301
To what does this subpart apply?
§26.302
Definitions.
§26.303
Duties of IRBs in connection with observational research involving pregnant women and fetuses.
§26.304
Additional protections for pregnant women and fetuses involved in observational research.
§26.305
Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
rule

Subpart D—OBSERVATIONAL RESEARCH: ADDITIONAL PROTECTIONS FOR CHILDREN INVOLVED AS SUBJECTS IN OBSERVATIONAL RESEARCH CONDUCTED OR SUPPORTED BY EPA

§26.401
To what does this subpart apply?
§26.402
Definitions.
§26.403
IRB duties.
§26.404
Observational research not involving greater than minimal risk.
§26.405
Observational research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
§26.406
Requirements for permission by parents or guardians and for assent by children.
rule

Subparts E-J [Reserved]

rule

Subpart K—BASIC ETHICAL REQUIREMENTS FOR THIRD-PARTY HUMAN RESEARCH FOR PESTICIDES INVOLVING INTENTIONAL EXPOSURE OF NON-PREGNANT, NON-NURSING ADULTS

§26.1101
To what does this subpart apply?
§26.1102
Definitions.
§§26.1103-26.1106
[Reserved]
§26.1107
IRB membership.
§26.1108
IRB functions and operations.
§26.1109
IRB review of research.
§26.1110
Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
§26.1111
Criteria for IRB approval of research.
§26.1112
Review by institution.
§26.1113
Suspension or termination of IRB approval of research.
§26.1114
Cooperative research.
§26.1115
IRB records.
§26.1116
General requirements for informed consent.
§26.1117
Documentation of informed consent.
§§26.1118-26.1122
[Reserved]
§26.1123
Early termination of research.
§26.1124
[Reserved]
§26.1125
Prior submission of proposed human research for EPA review.
rule

Subpart L—PROHIBITION OF THIRD-PARTY RESEARCH INVOLVING INTENTIONAL EXPOSURE TO A PESTICIDE OF HUMAN SUBJECTS WHO ARE CHILDREN OR PREGNANT OR NURSING WOMEN

§26.1201
To what does this subpart apply?
§26.1202
Definitions.
§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.
rule

Subpart M—REQUIREMENTS FOR SUBMISSION OF INFORMATION ON THE ETHICAL CONDUCT OF COMPLETED HUMAN RESEARCH

§26.1301
To what does this subpart apply?
§26.1302
Definitions.
§26.1303
Submission of information pertaining to ethical conduct of completed human research.
rule

Subpart N—[RESERVED]

rule

Subpart O—ADMINISTRATIVE ACTIONS FOR NONCOMPLIANCE

§26.1501
To what does this subpart apply?
§26.1502
Lesser administrative actions.
§26.1503
Disqualification of an IRB or an institution.
§26.1504
Public disclosure of information regarding revocation.
§26.1505
Reinstatement of an IRB or an institution.
§26.1506
Debarment.
§26.1507
Actions alternative or additional to disqualification.
rule

Subpart P—REVIEW OF PROPOSED AND COMPLETED HUMAN RESEARCH

§26.1601
To what does this subpart apply?
§26.1602
Definitions.
§26.1603
EPA review of proposed human research.
§26.1604
EPA review of completed human research.
§26.1605
Operation of the Human Studies Review Board.
§26.1606
Human Studies Review Board review of proposed human research.
§26.1607
Human Studies Review Board review of completed human research.
rule

Subpart Q—STANDARDS FOR ASSESSING WHETHER TO RELY ON THE RESULTS OF HUMAN RESEARCH IN EPA ACTIONS

§26.1701
To what does this subpart apply?
§26.1702
Definitions.
§26.1703
Prohibitions applying to all research subject to this subpart.
§26.1704
Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults.
§26.1705
Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults initiated after April 7, 2006.
§26.1706
Criteria and procedure for decisions to protect public health by relying on otherwise unacceptable research.


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