Title 40

PART 26

Part 26 - Protection Of Human Subjects

PART 26 - PROTECTION OF HUMAN SUBJECTS Authority:5 U.S.C. 301; 7 U.S.C. 136a(a) and 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec. 201, Pub. L. 109-54, 119 Stat. 531; and 42 U.S.C. 300v-1(b). Source:56 FR 28012, 28022, June 18, 1991, unless otherwise noted.

40:1.0.1.1.25.1SUBPART A
Subpart A - Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA
40:1.0.1.1.25.1.1.1SECTION 26.101
   26.101 To what does this policy apply
40:1.0.1.1.25.1.1.2SECTION 26.102
   26.102 Definitions for purposes of this policy.
40:1.0.1.1.25.1.1.3SECTION 26.103
   26.103 Assuring compliance with this policy - research conducted or supported by any Federal department or agency.
40:1.0.1.1.25.1.1.4SECTION 26.104
   26.104 Exempt research.
40:1.0.1.1.25.1.1.5SECTION 26.105-26.106
   26.105-26.106 [Reserved]
40:1.0.1.1.25.1.1.6SECTION 26.107
   26.107 IRB membership.
40:1.0.1.1.25.1.1.7SECTION 26.108
   26.108 IRB functions and operations.
40:1.0.1.1.25.1.1.8SECTION 26.109
   26.109 IRB review of research.
40:1.0.1.1.25.1.1.9SECTION 26.110
   26.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
40:1.0.1.1.25.1.1.10SECTION 26.111
   26.111 Criteria for IRB approval of research.
40:1.0.1.1.25.1.1.11SECTION 26.112
   26.112 Review by Institution
40:1.0.1.1.25.1.1.12SECTION 26.113
   26.113 Suspension or Termination of IRB Approval of Research.
40:1.0.1.1.25.1.1.13SECTION 26.114
   26.114 Cooperative Research.
40:1.0.1.1.25.1.1.14SECTION 26.115
   26.115 IRB Records.
40:1.0.1.1.25.1.1.15SECTION 26.116
   26.116 General Requirements for Informed Consent.
40:1.0.1.1.25.1.1.16SECTION 26.117
   26.117 Documentation of informed consent.
40:1.0.1.1.25.1.1.17SECTION 26.118
   26.118 Applications and proposals lacking definite plans for involvement of human subjects.
40:1.0.1.1.25.1.1.18SECTION 26.119
   26.119 Research undertaken without the intention of involving human subjects.
40:1.0.1.1.25.1.1.19SECTION 26.120
   26.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.
40:1.0.1.1.25.1.1.20SECTION 26.121
   26.121 [Reserved]
40:1.0.1.1.25.1.1.21SECTION 26.122
   26.122 Use of Federal funds.
40:1.0.1.1.25.1.1.22SECTION 26.123
   26.123 Early termination of research support: Evaluation of applications and proposals.
40:1.0.1.1.25.1.1.23SECTION 26.124
   26.124 Conditions.
40:1.0.1.1.25.2SUBPART B
Subpart B - Prohibition of Research Conducted or Supported by EPA Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nursing Women
40:1.0.1.1.25.2.1.1SECTION 26.201
   26.201 To what does this subpart apply
40:1.0.1.1.25.2.1.2SECTION 26.202
   26.202 Definitions.
40:1.0.1.1.25.2.1.3SECTION 26.203
   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.
40:1.0.1.1.25.3SUBPART C
Subpart C - Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA
40:1.0.1.1.25.3.1.1SECTION 26.301
   26.301 To what does this subpart apply
40:1.0.1.1.25.3.1.2SECTION 26.302
   26.302 Definitions.
40:1.0.1.1.25.3.1.3SECTION 26.303
   26.303 Duties of IRBs in connection with observational research involving pregnant women and fetuses.
40:1.0.1.1.25.3.1.4SECTION 26.304
   26.304 Additional protections for pregnant women and fetuses involved in observational research.
40:1.0.1.1.25.3.1.5SECTION 26.305
   26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material.
40:1.0.1.1.25.4SUBPART D
Subpart D - Observational Research: Additional Protections for Children Involved as Subjects in Observational Research Conducted or Supported by EPA
40:1.0.1.1.25.4.1.1SECTION 26.401
   26.401 To what does this subpart apply
40:1.0.1.1.25.4.1.2SECTION 26.402
   26.402 Definitions.
40:1.0.1.1.25.4.1.3SECTION 26.403
   26.403 IRB duties.
40:1.0.1.1.25.4.1.4SECTION 26.404
   26.404 Observational research not involving greater than minimal risk.
40:1.0.1.1.25.4.1.5SECTION 26.405
   26.405 Observational research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
40:1.0.1.1.25.4.1.6SECTION 26.406
   26.406 Requirements for permission by parents or guardians and for assent by children.
40:1.0.1.1.25.5SUBPART E
Subparts E-J [Reserved]
40:1.0.1.1.25.6SUBPART K
Subpart K - Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults
40:1.0.1.1.25.6.1.1SECTION 26.1101
   26.1101 To what does this subpart apply
40:1.0.1.1.25.6.1.2SECTION 26.1102
   26.1102 Definitions.
40:1.0.1.1.25.6.1.3SECTION 26.1103-26.1106
   26.1103-26.1106 [Reserved]
40:1.0.1.1.25.6.1.4SECTION 26.1107
   26.1107 IRB membership.
40:1.0.1.1.25.6.1.5SECTION 26.1108
   26.1108 IRB functions and operations.
40:1.0.1.1.25.6.1.6SECTION 26.1109
   26.1109 IRB review of research.
40:1.0.1.1.25.6.1.7SECTION 26.1110
   26.1110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
40:1.0.1.1.25.6.1.8SECTION 26.1111
   26.1111 Criteria for IRB approval of research.
40:1.0.1.1.25.6.1.9SECTION 26.1112
   26.1112 Review by institution.
40:1.0.1.1.25.6.1.10SECTION 26.1113
   26.1113 Suspension or termination of IRB approval of research.
40:1.0.1.1.25.6.1.11SECTION 26.1114
   26.1114 Cooperative research.
40:1.0.1.1.25.6.1.12SECTION 26.1115
   26.1115 IRB records.
40:1.0.1.1.25.6.1.13SECTION 26.1116
   26.1116 General requirements for informed consent.
40:1.0.1.1.25.6.1.14SECTION 26.1117
   26.1117 Documentation of informed consent.
40:1.0.1.1.25.6.1.15SECTION 26.1118-26.1122
   26.1118-26.1122 [Reserved]
40:1.0.1.1.25.6.1.16SECTION 26.1123
   26.1123 Early termination of research.
40:1.0.1.1.25.6.1.17SECTION 26.1124
   26.1124 [Reserved]
40:1.0.1.1.25.6.1.18SECTION 26.1125
   26.1125 Prior submission of proposed human research for EPA review.
40:1.0.1.1.25.7SUBPART L
Subpart L - Prohibition of Third-Party Research involving Intentional Exposure to a Pesticide of Human Subjects who are Children or Pregnant or Nursing Women
40:1.0.1.1.25.7.1.1SECTION 26.1201
   26.1201 To what does this subpart apply
40:1.0.1.1.25.7.1.2SECTION 26.1202
   26.1202 Definitions.
40:1.0.1.1.25.7.1.3SECTION 26.1203
   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.
40:1.0.1.1.25.8SUBPART M
Subpart M - Requirements for Submission of Information on the Ethical Conduct of Completed Human Research
40:1.0.1.1.25.8.1.1SECTION 26.1301
   26.1301 To what does this subpart apply
40:1.0.1.1.25.8.1.2SECTION 26.1302
   26.1302 Definitions.
40:1.0.1.1.25.8.1.3SECTION 26.1303
   26.1303 Submission of information pertaining to ethical conduct of completed human research.
40:1.0.1.1.25.9SUBPART N
Subpart N [Reserved]
40:1.0.1.1.25.10SUBPART O
Subpart O - Administrative Actions for Noncompliance
40:1.0.1.1.25.10.1.1SECTION 26.1501
   26.1501 To what does this subpart apply
40:1.0.1.1.25.10.1.2SECTION 26.1502
   26.1502 Lesser administrative actions.
40:1.0.1.1.25.10.1.3SECTION 26.1503
   26.1503 Disqualification of an IRB or an institution.
40:1.0.1.1.25.10.1.4SECTION 26.1504
   26.1504 Public disclosure of information regarding revocation.
40:1.0.1.1.25.10.1.5SECTION 26.1505
   26.1505 Reinstatement of an IRB or an institution.
40:1.0.1.1.25.10.1.6SECTION 26.1506
   26.1506 Debarment.
40:1.0.1.1.25.10.1.7SECTION 26.1507
   26.1507 Actions alternative or additional to disqualification.
40:1.0.1.1.25.11SUBPART P
Subpart P - Review of Proposed and Completed Human Research
40:1.0.1.1.25.11.1.1SECTION 26.1601
   26.1601 To what does this subpart apply
40:1.0.1.1.25.11.1.2SECTION 26.1602
   26.1602 Definitions.
40:1.0.1.1.25.11.1.3SECTION 26.1603
   26.1603 EPA review of proposed human research.
40:1.0.1.1.25.11.1.4SECTION 26.1604
   26.1604 EPA review of completed human research.
40:1.0.1.1.25.11.1.5SECTION 26.1605
   26.1605 Operation of the Human Studies Review Board.
40:1.0.1.1.25.11.1.6SECTION 26.1606
   26.1606 Human Studies Review Board review of proposed human research.
40:1.0.1.1.25.11.1.7SECTION 26.1607
   26.1607 Human Studies Review Board review of completed human research.
40:1.0.1.1.25.12SUBPART Q
Subpart Q - Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions
40:1.0.1.1.25.12.1.1SECTION 26.1701
   26.1701 To what does this subpart apply
40:1.0.1.1.25.12.1.2SECTION 26.1702
   26.1702 Definitions.
40:1.0.1.1.25.12.1.3SECTION 26.1703
   26.1703 Prohibitions applying to all research subject to this subpart.
40:1.0.1.1.25.12.1.4SECTION 26.1704
   26.1704 Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults.
40:1.0.1.1.25.12.1.5SECTION 26.1705
   26.1705 Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults initiated after April 7, 2006.
40:1.0.1.1.25.12.1.6SECTION 26.1706
   26.1706 Criteria and procedure for decisions to protect public health by relying on otherwise unacceptable research.