e-CFR data is current as of January 19, 2017
TITLE 40—Protection of Environment
CHAPTER I—ENVIRONMENTAL PROTECTION AGENCY SUBCHAPTER A—GENERAL PART 26—PROTECTION OF HUMAN SUBJECTS
Subpart A—BASIC EPA POLICY FOR PROTECTION OF SUBJECTS IN HUMAN RESEARCH CONDUCTED OR SUPPORTED BY EPA
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| To what does this policy apply? |
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| Definitions for purposes of this policy. |
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| Assuring compliance with this policy—research conducted or supported by any Federal department or agency. |
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| IRB functions and operations. |
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| Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. |
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| Criteria for IRB approval of research. |
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| Suspension or Termination of IRB Approval of Research. |
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| General Requirements for Informed Consent. |
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| Documentation of informed consent. |
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| Applications and proposals lacking definite plans for involvement of human subjects. |
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| Research undertaken without the intention of involving human subjects. |
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| Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency. |
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| Early termination of research support: Evaluation of applications and proposals. |
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Subpart B—PROHIBITION OF RESEARCH CONDUCTED OR SUPPORTED BY EPA INVOLVING INTENTIONAL EXPOSURE OF HUMAN SUBJECTS WHO ARE CHILDREN OR PREGNANT OR NURSING WOMEN
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| To what does this subpart apply? |
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| 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. |
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Subpart C—OBSERVATIONAL RESEARCH: ADDITIONAL PROTECTIONS FOR PREGNANT WOMEN AND FETUSES INVOLVED AS SUBJECTS IN OBSERVATIONAL RESEARCH CONDUCTED OR SUPPORTED BY EPA
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| To what does this subpart apply? |
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| Duties of IRBs in connection with observational research involving pregnant women and fetuses. |
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| Additional protections for pregnant women and fetuses involved in observational research. |
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| Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material. |
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Subpart D—OBSERVATIONAL RESEARCH: ADDITIONAL PROTECTIONS FOR CHILDREN INVOLVED AS SUBJECTS IN OBSERVATIONAL RESEARCH CONDUCTED OR SUPPORTED BY EPA
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| To what does this subpart apply? |
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| Observational research not involving greater than minimal risk. |
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| Observational research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. |
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| Requirements for permission by parents or guardians and for assent by children. |
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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
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| To what does this subpart apply? |
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| IRB functions and operations. |
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| Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. |
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| Criteria for IRB approval of research. |
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| Suspension or termination of IRB approval of research. |
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| General requirements for informed consent. |
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| Documentation of informed consent. |
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| Early termination of research. |
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| Prior submission of proposed human research for EPA review. |
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Subpart L—PROHIBITION OF THIRD-PARTY RESEARCH INVOLVING INTENTIONAL EXPOSURE TO A PESTICIDE OF HUMAN SUBJECTS WHO ARE CHILDREN OR PREGNANT OR NURSING WOMEN
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| To what does this subpart apply? |
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| 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. |
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Subpart M—REQUIREMENTS FOR SUBMISSION OF INFORMATION ON THE ETHICAL CONDUCT OF COMPLETED HUMAN RESEARCH
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| To what does this subpart apply? |
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| Submission of information pertaining to ethical conduct of completed human research. |
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Subpart N—[RESERVED]
Subpart O—ADMINISTRATIVE ACTIONS FOR NONCOMPLIANCE
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| To what does this subpart apply? |
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| Lesser administrative actions. |
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| Disqualification of an IRB or an institution. |
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| Public disclosure of information regarding revocation. |
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| Reinstatement of an IRB or an institution. |
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| Actions alternative or additional to disqualification. |
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Subpart P—REVIEW OF PROPOSED AND COMPLETED HUMAN RESEARCH
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| To what does this subpart apply? |
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| EPA review of proposed human research. |
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| EPA review of completed human research. |
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| Operation of the Human Studies Review Board. |
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| Human Studies Review Board review of proposed human research. |
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| Human Studies Review Board review of completed human research. |
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Subpart Q—STANDARDS FOR ASSESSING WHETHER TO RELY ON THE RESULTS OF HUMAN RESEARCH IN EPA ACTIONS
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| To what does this subpart apply? |
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| Prohibitions applying to all research subject to this subpart. |
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| Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults. |
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| Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults initiated after April 7, 2006. |
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| Criteria and procedure for decisions to protect public health by relying on otherwise unacceptable research. |
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