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.
§ 26.105 - [Reserved]
§ 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.
§§ 26.104--26.106 - [Reserved]
§§ 26.105--26.106 - [Reserved]
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 - XXX
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.
§ 26.1124 - [Reserved]
§ 26.1125 - Prior submission of proposed human research for EPA review.
§§ 26.1103--26.1106 - [Reserved]
§§ 26.1118--26.1122 - [Reserved]
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 - XXX
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.