Part 26 — Protection of Human Subjects
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.
- § 26.107— 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.
- § 26.122— 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
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.
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.
- § 26.1107— 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.
- § 26.1123— Early termination of research.
- § 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
Subpart M — Requirements for Submission of Information on the Ethical Conduct of Completed Human Research
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.