40 CFR Part 26
PART 26—PROTECTION OF HUMAN SUBJECTS
- PART 26—PROTECTION OF HUMAN SUBJECTS
- Chapter I—Environmental Protection Agency › Subchapter A—General
- 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 for purposes of this policy.
- § 26.103 Assuring compliance with this policy—research conducted or supported by any Federal department or agency.
- § 26.104 Exempt research.
- §§ 26.105-26.106 [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.
- 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.
- 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.
- 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.
- 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
- § 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.
- 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.
- 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.
- Subpart N [Reserved]
- 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.
- 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.
- 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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