cfr_sections
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81 rows where part_number = 26 and title_number = 40 sorted by section_id
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| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
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| 40:40:1.0.1.1.25.1.1.1 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | 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? | EPA | [82 FR 7273, Jan. 19, 2017, as amended at 83 FR 2893, Jan. 22, 2018] | (a) Except as detailed in § 26.104, this policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any Federal department or agency that takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by Federal civilian employees or military personnel, except that each department or agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States. Institutions that are engaged in research described in this paragraph and institutional review boards (IRBs) reviewing research that is subject to this policy must comply with this policy. (b) [Reserved] (c) Department or agency heads retain final judgment as to whether a particular activity is covered by this policy and this judgment shall be exercised consistent with the ethical principles of the Belmont Report. 62 62 The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.- Belmont Report. Washington, DC: U.S. Department of Health and Human Services. 1979. (d) Department or agency heads may require that specific research activities or classes of research activities conducted, supported, or otherwise subject to regulation by the Federal department or agency but not otherwise covered by this policy comply with some or all of the requirements of this policy. (e) Compliance with this policy requires compliance with pertinent federal laws or regulations that provide additional protections for human subjects. (f) This policy does not affect any state or local laws or regulations (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe) that may otherwise be applicable and that provide additional protections for human subjects. (g) This policy does not affect any foreign laws or regulat… | |||
| 40:40:1.0.1.1.25.1.1.10 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.111 Criteria for IRB approval of research. | EPA | (a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied: (1) Risks to subjects are minimized: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research ( e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. (4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, § 26.116. (5) Informed consent will be appropriately documented or appropriately waived in accordance with § 26.117. (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate p… | ||||
| 40:40:1.0.1.1.25.1.1.11 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.112 Review by Institution | EPA | Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB. | ||||
| 40:40:1.0.1.1.25.1.1.12 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.113 Suspension or Termination of IRB Approval of Research. | EPA | An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the department or agency head. | ||||
| 40:40:1.0.1.1.25.1.1.13 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.114 Cooperative Research. | EPA | (a) Cooperative research projects are those projects covered by this policy that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. (b)(1) Any institution located in the United States that is engaged in cooperative research must rely upon approval by a single IRB for that portion of the research that is conducted in the United States. The reviewing IRB will be identified by the Federal department or agency supporting or conducting the research or proposed by the lead institution subject to the acceptance of the Federal department or agency supporting the research. (2) The following research is not subject to this provision: (i) Cooperative research for which more than single IRB review is required by law (including tribal law passed by the official governing body of an American Indian or Alaska Native tribe); or (ii) Research for which any Federal department or agency supporting or conducting the research determines and documents that the use of a single IRB is not appropriate for the particular context. (c) For research not subject to paragraph (b) of this section, an institution participating in a cooperative project may enter into a joint review arrangement, rely on the review of another IRB, or make similar arrangements for avoiding duplication of effort. | ||||
| 40:40:1.0.1.1.25.1.1.14 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.115 IRB Records. | EPA | (a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent forms, progress reports submitted by investigators, and reports of injuries to subjects. (2) Minutes of IRB meetings, which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. (3) Records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review as described in § 26.109(f)(1). (4) Copies of all correspondence between the IRB and the investigators. (5) A list of IRB members in the same detail as described in § 26.108(a)(2). (6) Written procedures for the IRB in the same detail as described in § 26.108(a)(3) and (4). (7) Statements of significant new findings provided to subjects, as required by § 26.116(c)(5). (8) The rationale for an expedited reviewer's determination under § 26.110(b)(1)(i) that research appearing on the expedited review list described in § 26.110(a) is more than minimal risk. (9) Documentation specifying the responsibilities that an institution and an organization operating an IRB each will undertake to ensure compliance with the requirements of this policy, as described in § 26.103(e). (b) The records required by this policy shall be retained for at least 3 years, and records relating to research that is conducted shall be retained for at least 3 years after completion of the research. The institution or IRB may maintain the records in printed form, or electronically. All records shall be accessible for inspection and copying by authorized repre… | ||||
| 40:40:1.0.1.1.25.1.1.15 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.116 General Requirements for Informed Consent. | EPA | (a) General. General requirements for informed consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in accordance with the requirements set forth in paragraphs (b) through (d) of this section. Broad consent may be obtained in lieu of informed consent obtained in accordance with paragraphs (b) and (c) of this section only with respect to the storage, maintenance, and secondary research uses of identifiable private information and identifiable biospecimens. Waiver or alteration of consent in research involving public benefit and service programs conducted by or subject to the approval of state or local officials is described in paragraph (e) of this section. General waiver or alteration of informed consent is described in paragraph (f) of this section. Except as provided elsewhere in this policy: (1) Before involving a human subject in research covered by this policy, an investigator shall obtain the legally effective informed consent of the subject or the subject's legally authorized representative. (2) An investigator shall seek informed consent only under circumstances that provide the prospective subject or the legally authorized representative sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence. (3) The information that is given to the subject or the legally authorized representative shall be in language understandable to the subject or the legally authorized representative. (4) The prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. (5) Except for broad consent obtained in accordance with paragraph (d) of this section: (i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or l… | ||||
| 40:40:1.0.1.1.25.1.1.16 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.117 Documentation of informed consent. | EPA | (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject's legally authorized representative. A written copy shall be given to the person signing the informed consent form. (b) Except as provided in paragraph (c) of this section, the informed consent form may be either of the following: (1) A written informed consent form that meets the requirements of § 26.116. The investigator shall give either the subject or the subject's legally authorized representative adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject or the subject's legally authorized representative. (2) A short form written informed consent form stating that the elements of informed consent required by § 26.116 have been presented orally to the subject or the subject's legally authorized representative, and that the key information required by § 26.116(a)(5)(i) was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject or the legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject or the subject's legally authorized representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the subject's legally authorized representative, in addition to a copy of the short form. (c)(1) An IRB may waive the requirement for the investigator to obtain a signed informed consent form for some or all subjects if it finds any of the following: (i) That the only record linking the subject and the research would be the informed consent form and t… | ||||
| 40:40:1.0.1.1.25.1.1.17 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.118 Applications and proposals lacking definite plans for involvement of human subjects. | EPA | Certain types of applications for grants, cooperative agreements, or contracts are submitted to Federal departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. Except for research waived under § 26.101(i) or exempted under § 26.104, no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the Federal department or agency component supporting the research. | ||||
| 40:40:1.0.1.1.25.1.1.18 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.119 Research undertaken without the intention of involving human subjects. | EPA | Except for research waived under § 26.101(i) or exempted under § 26.104, in the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification submitted by the institution to the Federal department or agency component supporting the research, and final approval given to the proposed change by the Federal department or agency component. | ||||
| 40:40:1.0.1.1.25.1.1.19 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency. | EPA | (a) The department or agency head will evaluate all applications and proposals involving human subjects submitted to the Federal department or agency through such officers and employees of the Federal department or agency and such experts and consultants as the department or agency head determines to be appropriate. This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained. (b) On the basis of this evaluation, the department or agency head may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one. | ||||
| 40:40:1.0.1.1.25.1.1.2 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.102 Definitions for purposes of this policy. | EPA | (a) Certification means the official notification by the institution to the supporting Federal department or agency component, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance. (b) Clinical trial means a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. (c) Department or agency head means the head of any Federal department or agency, for example, the Secretary of HHS, and any other officer or employee of any Federal department or agency to whom the authority provided by these regulations to the department or agency head has been delegated. (d) Federal department or agency refers to a federal department or agency (the department or agency itself rather than its bureaus, offices or divisions) that takes appropriate administrative action to make this policy applicable to the research involving human subjects it conducts, supports, or otherwise regulates ( e.g., the U.S. Department of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency). (e)(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (2) Intervention includes both physical procedures by which information or biospecimens are gathered ( e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. (3) Interaction includes communication or interpersona… | ||||
| 40:40:1.0.1.1.25.1.1.20 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.121 [Reserved] | EPA | |||||
| 40:40:1.0.1.1.25.1.1.21 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.122 Use of Federal funds. | EPA | Federal funds administered by a Federal department or agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied. | ||||
| 40:40:1.0.1.1.25.1.1.22 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.123 Early termination of research support: Evaluation of applications and proposals. | EPA | (a) The department or agency head may require that Federal department or agency support for any project be terminated or suspended in the manner prescribed in applicable program requirements, when the department or agency head finds an institution has materially failed to comply with the terms of this policy. (b) In making decisions about supporting or approving applications or proposals covered by this policy the department or agency head may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension under paragraph (a) of this section and whether the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the department or agency head, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to federal regulation). | ||||
| 40:40:1.0.1.1.25.1.1.23 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.124 Conditions. | EPA | With respect to any research project or any class of research projects the department or agency head of either the conducting or the supporting Federal department or agency may impose additional conditions prior to or at the time of approval when in the judgment of the department or agency head additional conditions are necessary for the protection of human subjects. | ||||
| 40:40:1.0.1.1.25.1.1.3 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.103 Assuring compliance with this policy—research conducted or supported by any Federal department or agency. | EPA | (a) Each institution engaged in research that is covered by this policy, with the exception of research eligible for exemption under § 26.104, and that is conducted or supported by a Federal department or agency, shall provide written assurance satisfactory to the department or agency head that it will comply with the requirements of this policy. In lieu of requiring submission of an assurance, individual department or agency heads shall accept the existence of a current assurance, appropriate for the research in question, on file with the Office for Human Research Protections, HHS, or any successor office, and approved for Federal-wide use by that office. When the existence of an HHS-approved assurance is accepted in lieu of requiring submission of an assurance, reports (except certification) required by this policy to be made to department and agency heads shall also be made to the Office for Human Research Protections, HHS, or any successor office. Federal departments and agencies will conduct or support research covered by this policy only if the institution has provided an assurance that it will comply with the requirements of this policy, as provided in this section, and only if the institution has certified to the department or agency head that the research has been reviewed and approved by an IRB (if such certification is required by § 26.103(d)). (b) The assurance shall be executed by an individual authorized to act for the institution and to assume on behalf of the institution the obligations imposed by this policy and shall be filed in such form and manner as the department or agency head prescribes. (c) The department or agency head may limit the period during which any assurance shall remain effective or otherwise condition or restrict the assurance. (d) Certification is required when the research is supported by a Federal department or agency and not otherwise waived under § 26.101(i) or exempted under § 26.104. For such research, institutions shall certify that each proposed research study cover… | ||||
| 40:40:1.0.1.1.25.1.1.4 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.104 Exempt research. | EPA | (a) Unless otherwise required by law or by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the categories in paragraph (d) of this section are exempt from the requirements of this policy, except that such activities must comply with the requirements of this section and as specified in each category. (b) Use of the exemption categories for research subject to the requirements of subparts B, C, and D: Application of the exemption categories to research subject to the requirements of 45 CFR part 46, subparts B, C, and D, is as follows: (1) Subpart B. Each of the exemptions at this section may be applied to research subject to subpart B if the conditions of the exemption are met. (2) Subpart C. The exemptions at this section do not apply to research subject to subpart C, except for research aimed at involving a broader subject population that only incidentally includes prisoners. (3) Subpart D. The exemptions at paragraphs (d)(1), (4), (5), (6), (7), and (8) of this section may be applied to research subject to subpart D if the conditions of the exemption are met. Paragraphs (d)(2)(i) and (ii) of this section only may apply to research subject to subpart D involving educational tests or the observation of public behavior when the investigator(s) do not participate in the activities being observed. Paragraph (d)(2)(iii) of this section may not be applied to research subject to subpart D. (c) [Reserved] (d) Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy: (1) Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the … | ||||
| 40:40:1.0.1.1.25.1.1.5 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | §§ 26.105-26.106 [Reserved] | EPA | |||||
| 40:40:1.0.1.1.25.1.1.6 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.107 IRB membership. | EPA | (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of its members, including race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects. (b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. (c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. (d) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. (e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may n… | ||||
| 40:40:1.0.1.1.25.1.1.7 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.108 IRB functions and operations. | EPA | (a) In order to fulfill the requirements of this policy each IRB shall: (1) Have access to meeting space and sufficient staff to support the IRB's review and recordkeeping duties; (2) Prepare and maintain a current list of the IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications or licenses sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution, for example, full-time employee, part-time employee, member of governing panel or board, stockholder, paid or unpaid consultant; (3) Establish and follow written procedures for: (i) Conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (ii) Determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; and (iii) Ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject. (4) Establish and follow written procedures for ensuring prompt reporting to the IRB; appropriate institutional officials; the department or agency head; and the Office for Human Research Protections, HHS, or any successor office, or the equivalent office within the appropriate Federal department or agency of (i) Any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and (ii) Any suspension or termination of IRB approval. (b) Except when an expedited review procedure is use… | ||||
| 40:40:1.0.1.1.25.1.1.8 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.109 IRB review of research. | EPA | (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy, including exempt research activities under § 26.104 for which limited IRB review is a condition of exemption (under § 26.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7), and (8)). (b) An IRB shall require that information given to subjects (or legally authorized representatives, when appropriate) as part of informed consent is in accordance with § 26.116. The IRB may require that information, in addition to that specifically mentioned in § 26.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects. (c) An IRB shall require documentation of informed consent or may waive documentation in accordance with § 26.117. (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. (e) An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year, except as described in § 26.109(f). (f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances: (i) Research eligible for expedited review in accordance with § 26.110; (ii) Research reviewed by the IRB in accordance with the limited IRB review described in § 26.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8); (iii) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: (A) Data analysis, including analysis of iden… | ||||
| 40:40:1.0.1.1.25.1.1.9 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Basic EPA Policy for Protection of Subjects in Human Research Conducted or Supported by EPA | § 26.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. | EPA | (a) The Secretary of HHS has established, and published as a Notice in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The Secretary will evaluate the list at least every 8 years and amend it, as appropriate, after consultation with other federal departments and agencies and after publication in the Federal Register for public comment. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor office. (b)(1) An IRB may use the expedited review procedure to review the following: (i) Some or all of the research appearing on the list described in paragraph (a) of this section, unless the reviewer determines that the study involves more than minimal risk; (ii) Minor changes in previously approved research during the period for which approval is authorized; or (iii) Research for which limited IRB review is a condition of exemption under § 26.104(d)(2)(iii), (d)(3)(i)(C), and (d)(7) and (8). (2) Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the nonexpedited procedure set forth in § 26.108(b). (c) Each IRB that uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals that have been approved under the procedure. (d) The department or agency head may restrict, suspend, terminate, or choose not to authorize an institution's or IRB's use of the expedited review procedure. | ||||
| 40:40:1.0.1.1.25.10.1.1 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | O | Subpart O—Administrative Actions for Noncompliance | § 26.1501 To what does this subpart apply? | EPA | This subpart applies to any human research subject to subparts A through L of this part. References to State or local laws in this subpart are intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments. | ||||
| 40:40:1.0.1.1.25.10.1.2 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | O | Subpart O—Administrative Actions for Noncompliance | § 26.1502 Lesser administrative actions. | EPA | [71 FR 6168, Feb. 6, 2006, as amended at 78 FR 10544, Feb. 14, 2013] | (a) If apparent noncompliance with the applicable regulations in subparts A through L of this part concerning the operation of an IRB is observed by an officer or employee of EPA or of any State duly designated by the Administrator during an inspection, EPA may send a letter describing the noncompliance to the IRB and to the parent institution. EPA will require that the IRB or the parent institution respond to this letter within a reasonable time period specified by EPA and describe the corrective actions that will be taken by the IRB, the institution, or both to achieve compliance with these regulations. (b) On the basis of the IRB's or the institution's response, EPA may schedule a reinspection to confirm the adequacy of corrective actions. In addition, until the IRB or the parent institution takes appropriate corrective action, EPA may: (1) Withhold approval of new studies subject to the requirements of this part that are conducted at the institution or reviewed by the IRB; (2) Direct that no new subjects be added to ongoing studies subject to this part; (3) Terminate ongoing studies subject to this part when doing so would not endanger the subjects; or (4) When the apparent noncompliance creates a significant threat to the rights and welfare of human subjects, notify relevant State and Federal regulatory agencies and other parties with a direct interest of the deficiencies in the operation of the IRB. (c) The parent institution is presumed to be responsible for the operation of an IRB, and EPA will ordinarily direct any administrative action under this subpart against the institution. However, depending on the evidence of responsibility for deficiencies, determined during the investigation, EPA may restrict its administrative actions to the IRB or to a component of the parent institution determined to be responsible for formal designation of the IRB. | |||
| 40:40:1.0.1.1.25.10.1.3 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | O | Subpart O—Administrative Actions for Noncompliance | § 26.1503 Disqualification of an IRB or an institution. | EPA | (a) Whenever the IRB or the institution has failed to take adequate steps to correct the noncompliance stated in the letter sent by the Agency under § 26.1502(a) and the EPA Administrator determines that this noncompliance may justify the disqualification of the IRB or of the parent institution, the Administrator may institute appropriate proceedings. (b) The Administrator may disqualify an IRB or the parent institution from studies subject to this part if the Administrator determines that: (1) The IRB has refused or repeatedly failed to comply with any of the regulations set forth in this part, and (2) The noncompliance adversely affects the rights or welfare of the human subjects of research. (c) If the Administrator determines that disqualification is appropriate, the Administrator will issue an order that explains the basis for the determination and that prescribes any actions to be taken with regard to ongoing human research, covered by subparts A through L of this part, conducted under the review of the IRB. EPA will send notice of the disqualification to the IRB and the parent institution. Other parties with a direct interest, such as sponsors and investigators, may also be sent a notice of the disqualification. In addition, the agency may elect to publish a notice of its action in the Federal Register. (d) EPA may refuse to consider in support of a regulatory decision the data from human research, covered by subparts A through L of this part, that was reviewed by an IRB or conducted at an institution during the period of disqualification, unless the IRB or the parent institution is reinstated as provided in § 26.1505, or unless such research is deemed scientifically sound and crucial to the protection of public health, under the procedure defined in § 26.1706. | ||||
| 40:40:1.0.1.1.25.10.1.4 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | O | Subpart O—Administrative Actions for Noncompliance | § 26.1504 Public disclosure of information regarding revocation. | EPA | A determination that EPA has disqualified an institution from studies subject to this part and the administrative record regarding that determination are disclosable to the public under 40 CFR part 2. | ||||
| 40:40:1.0.1.1.25.10.1.5 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | O | Subpart O—Administrative Actions for Noncompliance | § 26.1505 Reinstatement of an IRB or an institution. | EPA | [71 FR 6168, Feb. 6, 2006, as amended at 78 FR 10544, Feb. 14, 2013] | An IRB or an institution may be reinstated to conduct studies subject to this part if the Administrator determines, upon an evaluation of a written submission from the IRB or institution that explains the corrective action that the institution or IRB has taken or plans to take, that the IRB or institution has provided adequate assurance that it will operate in compliance with the standards set forth in this part. Notification of reinstatement shall be provided to all persons notified under § 26.1502(b)(4). | |||
| 40:40:1.0.1.1.25.10.1.6 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | O | Subpart O—Administrative Actions for Noncompliance | § 26.1506 Debarment. | EPA | [71 FR 6168, Feb. 6, 2006, as amended at 72 FR 2427, Jan. 19, 2007] | If EPA determines that an institution or investigator repeatedly has not complied with or has committed an egregious violation of the applicable regulations in subparts A through L of this part, EPA may recommend that institution or investigator be declared ineligible to participate in EPA-supported research (debarment). Debarment will be initiated in accordance with procedures specified at 2 CFR part 1532. | |||
| 40:40:1.0.1.1.25.10.1.7 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | O | Subpart O—Administrative Actions for Noncompliance | § 26.1507 Actions alternative or additional to disqualification. | EPA | [71 FR 6168, Feb. 6, 2006, as amended at 78 FR 10544, Feb. 14, 2013] | Disqualification of an IRB or of an institution is independent of, and neither in lieu of nor a precondition to, other statutorily authorized proceedings or actions. EPA may, at any time, on its own initiative or through the Department of Justice, institute any appropriate judicial proceedings (civil or criminal) and any other appropriate regulatory action, in addition to or in lieu of, and before, at the time of, or after, disqualification. EPA may also refer pertinent matters to another Federal, State, or local government agency for any action that that agency determines to be appropriate. | |||
| 40:40:1.0.1.1.25.11.1.1 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | P | Subpart P—Review of Proposed and Completed Human Research | § 26.1601 To what does this subpart apply? | EPA | [78 FR 10544, Feb. 14, 2013] | This subpart applies to both of the following: (a) Reviews by EPA and by the Human Studies Review Board of proposals to conduct new research subject to § 26.1125. (b) Reviews by EPA on or after April 15, 2013 and, to the extent required by § 26.1604, by the Human Studies Review Board of reports of completed research subject to § 26.1701. | |||
| 40:40:1.0.1.1.25.11.1.2 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | P | Subpart P—Review of Proposed and Completed Human Research | § 26.1602 Definitions. | EPA | [78 FR 10544, Feb. 14, 2013] | The definitions in § 26.1102 also apply to this subpart. | |||
| 40:40:1.0.1.1.25.11.1.3 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | P | Subpart P—Review of Proposed and Completed Human Research | § 26.1603 EPA review of proposed human research. | EPA | [71 FR 6168, Feb. 6, 2006. Redesignated at 78 FR 10544, Feb. 14, 2013 and amended at 78 FR 10544, Feb. 14, 2013] | (a) EPA must review all proposals for new human research submitted under § 26.1125 in a timely manner. (b) In reviewing proposals for new human research submitted under § 26.1125, the EPA Administrator must consider and make determinations regarding the scientific validity and reliability of the proposed research, including: (1) Whether the research would be likely to produce data that address an important scientific or policy question that cannot be resolved on the basis of animal data or human observational research. (2) Whether the proposed research is designed in accordance with current scientific standards and practices to: (i) Address the research question. (ii) Include representative study populations for the endpoint in question. (iii) Have adequate statistical power to detect appropriate effects. (3) Whether the investigator proposes to conduct the research in accordance with recognized good research practices, including, when appropriate, good clinical practice guidelines and monitoring for the safety of subjects. (c) In reviewing proposals for new research submitted under § 26.1125, the EPA Administrator must consider and make determinations regarding ethical aspects of the proposed research, including: (1) Whether adequate information is available from prior animal studies or from other sources to assess the potential risks to subjects in the proposed research. (2) Whether the research proposal adequately identifies anticipated risks to human subjects and their likelihood of occurrence, minimizes identified risks to human subjects, and identifies likely benefits of the research and their distribution. (3) Whether the proposed research presents an acceptable balance of risks and benefits. In making this determination for research intended to reduce the interspecies uncertainty factor in a pesticide risk assessment, the EPA Administrator will also consider the process laid out and the attendant discussion for evaluating that type of study as provided in Recommendation 4-1 of the 2004 Report f… | |||
| 40:40:1.0.1.1.25.11.1.4 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | P | Subpart P—Review of Proposed and Completed Human Research | § 26.1604 EPA review of completed human research. | EPA | [71 FR 6168, Feb. 6, 2006. Redesignated at 78 FR 10544, Feb. 14, 2013 and amended at 78 FR 10545, Feb. 14, 2013] | (a) When considering, under any regulatory statute it administers, data from completed research involving intentional exposure of humans to a pesticide, EPA must thoroughly review the material submitted under § 26.1303, if any, and other available, relevant information and document its conclusions regarding the scientific and ethical conduct of the research. (b) EPA shall submit its review of data from human research covered by subpart Q, together with the available supporting materials, to the Human Studies Review Board if EPA decides to rely on the data and: (1) The data are derived from research initiated after April 7, 2006, or (2) The data are derived from research initiated before April 7, 2006, and the research was conducted for the purpose of identifying or measuring a toxic effect. (c) In its discretion, EPA may submit data from research not covered by paragraph (b) of this section to the Human Studies Review Board for their review. (d) EPA shall notify the submitter of the research of the results of the EPA and Human Studies Review Board reviews. | |||
| 40:40:1.0.1.1.25.11.1.5 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | P | Subpart P—Review of Proposed and Completed Human Research | § 26.1605 Operation of the Human Studies Review Board. | EPA | [71 FR 6168, Feb. 6, 2006. Redesignated at 78 FR 10544, Feb. 14, 2013] | EPA shall establish and operate a Human Studies Review Board as follows: (a) Membership. The Human Studies Review Board shall consist of members who are not employed by EPA, who meet the ethics and other requirements for special government employees, and who have expertise in fields appropriate for the scientific and ethical review of human research, including research ethics, biostatistics, and human toxicology. (b) Responsibilities. The Human Studies Review Board shall comment on the scientific and ethical aspects of research proposals and reports of completed research with human subjects submitted by EPA for its review and, on request, advise EPA on ways to strengthen its programs for protection of human subjects of research. | |||
| 40:40:1.0.1.1.25.11.1.6 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | P | Subpart P—Review of Proposed and Completed Human Research | § 26.1606 Human Studies Review Board review of proposed human research. | EPA | [78 FR 10545, Feb. 14, 2013] | In commenting on proposals for new research submitted to it by EPA, the Human Studies Review Board must consider the scientific merits and ethical aspects of the proposed research, including all elements required in § 26.1603(b) and (c) and any additional conditions recommended pursuant to § 26.1603(d). | |||
| 40:40:1.0.1.1.25.11.1.7 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | P | Subpart P—Review of Proposed and Completed Human Research | § 26.1607 Human Studies Review Board review of completed human research. | EPA | [78 FR 10545, Feb. 14, 2013] | In commenting on reports of completed research submitted to it by EPA, the Human Studies Review Board must consider the scientific merits and ethical aspects of the completed research, and must apply the appropriate standards in subpart Q of this part. | |||
| 40:40:1.0.1.1.25.12.1.1 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | Q | 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? | EPA | [78 FR 10545, Feb. 14, 2013] | (a) For decisions under FIFRA (7 U.S.C. 136-136y) or section 408 of FFDCA (21 U.S.C. 346a), this subpart applies to research involving intentional exposure of human subjects to any substance. (b) For decisions under any regulatory statute administered by EPA other than those statutes designated in paragraph (a) of this section, this subpart applies to research involving intentional exposure of human subjects to a pesticide. | |||
| 40:40:1.0.1.1.25.12.1.2 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | Q | Subpart Q—Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions | § 26.1702 Definitions. | EPA | [78 FR 10545, Feb. 14, 2013] | The definitions in § 26.1102 and § 26.1202 also apply to this subpart. | |||
| 40:40:1.0.1.1.25.12.1.3 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | Q | Subpart Q—Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions | § 26.1703 Prohibitions applying to all research subject to this subpart. | EPA | [78 FR 10545, Feb. 14, 2013] | (a) Prohibition of reliance on scientifically invalid research. EPA must not rely on data from research subject to this subpart unless EPA determines that the data are relevant to a scientific or policy question important for EPA decisionmaking, that the data were derived in a manner that makes them scientifically valid and reliable, and that it is appropriate to use the data for the purpose proposed by EPA. In making such determinations, EPA must consider: (1) Whether the research was designed and conducted in accordance with appropriate scientific standards and practices prevailing at the time the research was conducted. (2) The extent to which the research subjects are representative of the populations for the endpoint or endpoints in question. (3) The statistical power of the data to support the scientific conclusion EPA intends to draw from the data. (4) In a study that reports only a No Observed Effect Level (NOEL) or a No Observed Adverse Effect Level (NOAEL), whether a dose level in the study gave rise to a biological effect, thereby demonstrating that the study had adequate sensitivity to detect an effect of interest. (b) Prohibition of reliance on research subject to this subpart involving intentional exposure of human subjects who are pregnant women (and therefore their fetuses), nursing women, or children. Except as provided in § 26.1706, EPA must not rely on data from any research subject to this subpart involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child. | |||
| 40:40:1.0.1.1.25.12.1.4 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | Q | Subpart Q—Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions | § 26.1704 Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults. | EPA | [78 FR 10545, Feb. 14, 2013] | (a) This section applies to research subject to this subpart that is not subject to § 26.1705. (b) Except as provided in § 26.1706, EPA must not rely on data from any research subject to this section if there is clear and convincing evidence that: (1) The conduct of the research was fundamentally unethical ( e.g., the research was intended to seriously harm participants or failed to obtain informed consent); or (2) The conduct of the research was deficient relative to the ethical standards prevailing at the time the research was conducted in a way that placed participants at increased risk of harm (based on knowledge available at the time the study was conducted) or impaired their informed consent. (c) The prohibition in this section is in addition to the prohibitions in § 26.1703. | |||
| 40:40:1.0.1.1.25.12.1.5 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | Q | Subpart Q—Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions | § 26.1705 Prohibition of reliance on unethical human research with non-pregnant, non-nursing adults initiated after April 7, 2006. | EPA | [78 FR 10545, Feb. 14, 2013] | (a) This section applies to research subject to this subpart, that: (1) Was initiated after April 7, 2006. (2) Was subject, at the time it was conducted, either to subparts A through L of this part, or to the codification of the Common Rule by another Federal department or agency. (b) Except as provided in § 26.1706, EPA must not rely on data from any research subject to this section unless EPA determines that the research was conducted in substantial compliance with either: (1) All applicable provisions of subparts A through L of this part, or the codification of the Common Rule by another Federal department or agency; or (2) If the research was conducted outside the United States, with procedures at least as protective of subjects as those in subparts A through L of this part, or the codification of the Common Rule by another Federal department or agency. (c) Except as provided in § 26.1706, EPA must not rely on data from any research subject to this section unless EPA determines that the research was conducted in substantial compliance with either: (1) A proposal that was found to be acceptable under § 26.1603(c), and no amendments to or deviations from that proposal placed participants at increased risk of harm (based on knowledge available at the time the study was conducted) or impaired their informed consent. If EPA discovers that the submitter of the proposal materially misrepresented or knowingly omitted information that would have altered the outcome of EPA's evaluation of the proposal under § 26.1603(c), EPA must not rely on that data. (2) A proposal that would have been found to be acceptable under § 26.1603(c), if it had been subject to review under that section, and no amendments to or deviations from that proposal placed participants at increased risk of harm (based on knowledge available at the time the study was conducted) or impaired their informed consent. (d) The prohibition in this section is in addition to the prohibitions in § 26.1703. | |||
| 40:40:1.0.1.1.25.12.1.6 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | Q | Subpart Q—Standards for Assessing Whether To Rely on the Results of Human Research in EPA Actions | § 26.1706 Criteria and procedure for decisions to protect public health by relying on otherwise unacceptable research. | EPA | [71 FR 6168, Feb. 6, 2006, as amended at 78 FR 10546, Feb. 14, 2013] | This section establishes the exclusive criteria and procedure by which EPA may decide to rely on data from research that is not acceptable under the standards in §§ 26.1703 through 26.1705. EPA may rely on such data only if all the conditions in paragraphs (a) through (d) of this section are satisfied: (a) EPA has obtained the views of the Human Studies Review Board concerning the proposal to rely on the otherwise unacceptable data, (b) EPA has provided an opportunity for public comment on the proposal to rely on the otherwise unacceptable data, (c) EPA has determined that relying on the data is crucial to a decision that would impose a more stringent regulatory restriction that would improve protection of public health, such as a limitation on the use of a pesticide, than could be justified without relying on the data, and (d) EPA has published a full explanation of its decision to rely on the otherwise unacceptable data, including a thorough discussion of the ethical deficiencies of the underlying research and the full rationale for finding that the standard in paragraph (c) of this section was met. | |||
| 40:40:1.0.1.1.25.2.1.1 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | 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 | § 26.201 To what does this subpart apply? | EPA | (a) This subpart applies to all research involving intentional exposure of any human subject who is a pregnant woman (and her fetus) or a child conducted or supported by the Environmental Protection Agency (EPA). This includes research conducted in EPA facilities by any person and research conducted in any facility by EPA employees. (b) The requirements of this subpart are in addition to those imposed under the other subparts of this part. | ||||
| 40:40:1.0.1.1.25.2.1.2 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | 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 | § 26.202 Definitions. | EPA | The definitions in § 26.102 shall be applicable to this subpart as well. In addition, the definitions at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are applicable to this subpart. (a) Research involving intentional exposure of a human subject means a study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject's participation in the study. (b) A child is a person who has not attained the age of 18 years. | ||||
| 40:40:1.0.1.1.25.2.1.3 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | 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 | § 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. | EPA | [71 FR 36175, June 23, 2006] | Notwithstanding any other provision of this part, under no circumstances shall EPA conduct or support research involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child. | |||
| 40:40:1.0.1.1.25.3.1.1 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | C | 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? | EPA | [71 FR 6168, Feb. 6, 2006, as amended at 84 FR 35318, July 23, 2019] | (a) Except as provided in paragraph (b) of this section, this subpart applies to all observational research involving human subjects who are pregnant women (and therefore their fetuses) conducted or supported by the Environmental Protection Agency (EPA). This includes research conducted in EPA facilities by any person and research conducted in any facility by EPA employees. (b) The exemptions at § 26.104(d) are applicable to this subpart. (c) The provisions of § 26.101(c) through (m) are applicable to this subpart. (d) The requirements of this subpart are in addition to those imposed under the other subparts of this part. | |||
| 40:40:1.0.1.1.25.3.1.2 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | C | Subpart C—Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA | § 26.302 Definitions. | EPA | The definitions in §§ 26.102 and 26.202 shall be applicable to this subpart as well. In addition, observational research means any human research that does not meet the definition of research involving intentional exposure of a human subject in § 26.202(a). | ||||
| 40:40:1.0.1.1.25.3.1.3 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | C | Subpart C—Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA | § 26.303 Duties of IRBs in connection with observational research involving pregnant women and fetuses. | EPA | The provisions of 45 CFR 46.203 are applicable to this section. | ||||
| 40:40:1.0.1.1.25.3.1.4 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | C | Subpart C—Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA | § 26.304 Additional protections for pregnant women and fetuses involved in observational research. | EPA | The provisions of 45 CFR 46.204 are applicable to this section. | ||||
| 40:40:1.0.1.1.25.3.1.5 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | C | Subpart C—Observational Research: Additional Protections for Pregnant Women and Fetuses Involved as Subjects in Observational Research Conducted or Supported by EPA | § 26.305 Protections applicable, after delivery, to the placenta, the dead fetus, or fetal material. | EPA | The provisions of 45 CFR 46.206 are applicable to this section. | ||||
| 40:40:1.0.1.1.25.4.1.1 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | D | 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? | EPA | [71 FR 6168, Feb. 6, 2006, as amended at 84 FR 35318, July 23, 2019] | (a) This subpart applies to all observational research involving children as subjects, conducted or supported by EPA. This includes research conducted in EPA facilities by any person and research conducted in any facility by EPA employees. (b) Exemptions at § 26.104(d)(1) and (d)(3) through (8) are applicable to this subpart. The exemption at § 26.104(d)(2) regarding educational tests is also applicable to this subpart. However, the exemption at § 26.104(d)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this subpart, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed. (c) The exceptions, additions, and provisions for waiver as they appear in § 26.101(c) through (i) are applicable to this subpart. | |||
| 40:40:1.0.1.1.25.4.1.2 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | D | Subpart D—Observational Research: Additional Protections for Children Involved as Subjects in Observational Research Conducted or Supported by EPA | § 26.402 Definitions. | EPA | [71 FR 6168, Feb. 6, 2006, as amended at 84 FR 35318, July 23, 2019] | The definitions in § 26.102 shall be applicable to this subpart as well. In addition, the following terms are defined: (a) For purposes of this subpart, Administrator means the Administrator of the Environmental Protection Agency and any other officer or employee of the Environmental Protection Agency to whom authority has been delegated by the Administrator. (b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. (c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research. (d) Parent means a child's biological or adoptive parent. (e) Guardian means an individual who is authorized under applicable State, Tribal, or local law to consent on behalf of a child to general medical care. (f) Observational research means any research with human subjects that does not meet the definition of research involving intentional exposure of a human subject in § 26.202(a). | |||
| 40:40:1.0.1.1.25.4.1.3 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | D | Subpart D—Observational Research: Additional Protections for Children Involved as Subjects in Observational Research Conducted or Supported by EPA | § 26.403 IRB duties. | EPA | In addition to other responsibilities assigned to IRBs under this part, each IRB shall review observational research covered by this subpart and approve only research that satisfies the conditions of all applicable sections of this subpart. | ||||
| 40:40:1.0.1.1.25.4.1.4 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | D | Subpart D—Observational Research: Additional Protections for Children Involved as Subjects in Observational Research Conducted or Supported by EPA | § 26.404 Observational research not involving greater than minimal risk. | EPA | EPA will conduct or fund observational research in which the IRB finds that no greater than minimal risk to children is presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in § 26.406. | ||||
| 40:40:1.0.1.1.25.4.1.5 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | D | Subpart D—Observational Research: Additional Protections for Children Involved as Subjects in Observational Research Conducted or Supported by EPA | § 26.405 Observational research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. | EPA | If the IRB finds that an intervention or procedure presents more than minimal risk to children, EPA will not conduct or fund observational research that includes such an intervention or procedure unless the IRB finds and documents that: (a) The intervention or procedure holds out the prospect of direct benefit to the individual subject or is likely to contribute to the subject's well-being; (b) The risk is justified by the anticipated benefit to the subjects; (c) The relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and (d) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in § 26.406. | ||||
| 40:40:1.0.1.1.25.4.1.6 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | D | Subpart D—Observational Research: Additional Protections for Children Involved as Subjects in Observational Research Conducted or Supported by EPA | § 26.406 Requirements for permission by parents or guardians and for assent by children. | EPA | [71 FR 6168, Feb. 6, 2006, as amended at 84 FR 35318, July 23, 2019] | (a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the observational research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the observational research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with § 26.116(e). (b) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine, in accordance with and to the extent that consent is required by § 26.116, that adequate provisions are made for soliciting the permission of each child's parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under § 26.404 or § 26.405. (c) In addition to the provisions for waiver contained in § 26.116, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may replace the con… | |||
| 40:40:1.0.1.1.25.6.1.1 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | 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? | EPA | (a) Except as provided in paragraph (c) of this section, this subpart applies to all research initiated on or after September 23, 2019 involving intentional exposure of a human subject to: (1) Any substance if, at any time prior to initiating such research, any person who conducted or supported such research intended either to submit results of the research to EPA for consideration in connection with any action that may be performed by EPA under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136-136y) or section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a), or to hold the results of the research for later inspection by EPA under FIFRA or section 408 of FFDCA; or (2) A pesticide if, at any time prior to initiating such research, any person who conducted or supported such research intended either to submit results of the research to EPA for consideration in connection with any action that may be performed by EPA under any regulatory statute administered by EPA other than those statutes designated in paragraph (a)(1) of this section, or to hold the results of the research for later inspection by EPA under any regulatory statute administered by EPA other than those statutes designated in paragraph (a)(1) of this section. (b) For purposes of determining a person's intent under paragraph (a) of this section, EPA may consider any available and relevant information. EPA must rebuttably presume the existence of intent if: (1) The person or the person's agent has submitted or made available for inspection the results of such research to EPA; or (2) The person is a member of a class of people who, or whose products or activities, are regulated by EPA and, at the time the research was initiated, the results of such research would be relevant to EPA's exercise of its regulatory authority with respect to that class of people, products, or activities. (c) Unless otherwise required by the Administrator, research is exempt from this subpart if it involves only the colle… | ||||
| 40:40:1.0.1.1.25.6.1.10 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | § 26.1113 Suspension or termination of IRB approval of research. | EPA | An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the Administrator of EPA. | ||||
| 40:40:1.0.1.1.25.6.1.11 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | § 26.1114 Cooperative research. | EPA | In complying with this subpart, sponsors, investigators, or institutions involved in multi-institutional studies may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort. | ||||
| 40:40:1.0.1.1.25.6.1.12 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | § 26.1115 IRB records. | EPA | (a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following: (1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects. (2) Minutes of IRB meetings, which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution. (3) Records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review as described in § 26.1109(f)(1). (4) Copies of all correspondence between the IRB and the investigators. (5) A list of IRB members in the same detail as described in § 26.1108(a)(2). (6) Written procedures for the IRB in the same detail as described in § 26.1108(a)(3) and (4). (7) Statements of significant new findings provided to subjects, as required by § 26.1116(c)(5). (8) The rationale for an expedited reviewer's determination under § 26.1110(b)(1)(i) that research appearing on the expedited review list described in § 26.1110(a) is more than minimal risk. (9) Documentation specifying the responsibilities that an institution and an organization operating an IRB each will undertake to ensure compliance with the requirements of this subpart. (b) The records required by this subpart shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. The institution or IRB may maintain the records in printed form or electronically. All records shall be accessible for inspection and copying by authorized representatives of EPA… | ||||
| 40:40:1.0.1.1.25.6.1.13 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | § 26.1116 General requirements for informed consent. | EPA | (a) General. General requirements for informed consent, whether written or oral, are set forth in this paragraph and apply to consent obtained in accordance with the requirements set forth in paragraphs (b) and (c) of this section. Except as provided elsewhere in this subpart: (1) Before involving a human subject in research covered by this subpart, an investigator shall obtain the legally effective informed consent of the subject. (2) An investigator shall seek informed consent only under circumstances that provide the prospective subject sufficient opportunity to discuss and consider whether or not to participate and that minimize the possibility of coercion or undue influence. (3) The information that is given to the subject shall be in language understandable to the subject. (4) The prospective subject must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information. (5)(i) Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. (ii) Informed consent as a whole must present information in sufficient detail relating to the research and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's understanding of the reasons why one might or might not want to participate. (6) No informed consent may include any exculpatory language through which the subject is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. (b) Basic elements of informed consent. In seeking infor… | ||||
| 40:40:1.0.1.1.25.6.1.14 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | § 26.1117 Documentation of informed consent. | EPA | (a) Informed consent shall be documented by the use of a written consent form approved by the IRB and signed (including in an electronic format) by the subject. A written copy shall be given to the subject. (b) The informed consent form may be either of the following: (1) A written informed consent form that meets the requirements of § 26.1116. The investigator shall give the subject adequate opportunity to read the informed consent form before it is signed; alternatively, this form may be read to the subject. (2) A short form written informed consent form stating that the elements of informed consent required by § 26.1116 have been presented orally to the subject, and that the key information required by § 26.1116(a)(5)(i) was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary must be given to the subject, in addition to a copy of the short form. | ||||
| 40:40:1.0.1.1.25.6.1.15 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | §§ 26.1118-26.1122 [Reserved] | EPA | |||||
| 40:40:1.0.1.1.25.6.1.16 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | § 26.1123 Early termination of research. | EPA | The Administrator may require that any project covered by this subpart be terminated or suspended when the Administrator finds that an IRB, investigator, sponsor, or institution has materially failed to comply with the terms of this subpart. | ||||
| 40:40:1.0.1.1.25.6.1.17 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | § 26.1124 [Reserved] | EPA | |||||
| 40:40:1.0.1.1.25.6.1.18 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | § 26.1125 Prior submission of proposed human research for EPA review. | EPA | Any person or institution who intends to conduct or sponsor human research covered by § 26.1101(a) shall, after receiving approval from all appropriate IRBs, submit to EPA prior to initiating such research all information relevant to the proposed research specified by § 26.1115(a), and the following additional information, to the extent not already included: (a) A discussion of: (1) The potential risks to human subjects; (2) The measures proposed to minimize risks to the human subjects; (3) The nature and magnitude of all expected benefits of such research, and to whom they would accrue; (4) Alternative means of obtaining information comparable to what would be collected through the proposed research; and (5) The balance of risks and benefits of the proposed research. (b) All information for subjects and written informed consent agreements as originally provided to the IRB, and as approved by the IRB. (c) Information about how subjects will be recruited, including any advertisements proposed to be used. (d) A description of the circumstances and methods proposed for presenting information to potential human subjects for the purpose of obtaining their informed consent. (e) All correspondence between the IRB and the investigators or sponsors. (f) Official notification to the sponsor or investigator, in accordance with the requirements of this subpart, that research involving human subjects has been reviewed and approved by an IRB. | ||||
| 40:40:1.0.1.1.25.6.1.2 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | § 26.1102 Definitions. | EPA | (a) Administrator means the Administrator of the Environmental Protection Agency (EPA) and any other officer or employee of EPA to whom authority has been delegated. (b) Common Rule refers to the Federal Policy for the Protection of Human Subjects as established in 1991 and codified by EPA and 14 other Federal departments and agencies (see the Federal Register issue of June 18, 1991 (56 FR 28003)) and its subsequent revisions as adopted by EPA and other federal departments and agencies (see the Federal Register issue of January 19, 2017 (82 FR 7149)). The Common Rule contains a widely accepted set of standards for conducting ethical research with human subjects, together with a set of procedures designed to ensure that the standards are met. Once codified or adopted by a Federal department or agency, the requirements of the Common Rule apply to research conducted or sponsored by that Federal department or agency. EPA's codification of the Common Rule appears in 40 CFR part 26, subpart A. (c) Federal department or agency refers to a federal department or agency (the department or agency itself rather than its bureaus, offices or divisions) that takes appropriate administrative action to make the Common Rule applicable to the research involving human subjects it conducts, supports, or otherwise regulates ( e.g., the U.S. Department of Health and Human Services, the U.S. Department of Defense, or the Central Intelligence Agency). (d)(1) Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens, or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. (2) Intervention includes both physical procedures by which information or biospecimens are gathered ( e.g., venipuncture) and manipulations of the subject or the subj… | ||||
| 40:40:1.0.1.1.25.6.1.3 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | §§ 26.1103-26.1106 [Reserved] | EPA | |||||
| 40:40:1.0.1.1.25.6.1.4 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | § 26.1107 IRB membership. | EPA | (a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities that are presented for its approval. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a category of subjects vulnerable to coercion or undue influence, such as prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects. (b) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. (c) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. (d) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. (e) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not … | ||||
| 40:40:1.0.1.1.25.6.1.5 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | § 26.1108 IRB functions and operations. | EPA | (a) In order to fulfill the requirements of this subpart each IRB shall: (1) Have access to meeting space and sufficient staff to support the IRB's review and recordkeeping duties; (2) Prepare and maintain a current list of the IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications or licenses sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution, for example, full-time employee, part-time employee, member of governing panel or board, stockholder, paid or unpaid consultant; (3) Establish and follow written procedures for: (i) Conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (ii) Determining which projects require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since previous IRB review; (iii) Ensuring prompt reporting to the IRB of proposed changes in research activity, and for ensuring that investigators will conduct the research activity in accordance with the terms of the IRB approval until any proposed changes have been reviewed and approved by the IRB, except when necessary to eliminate apparent immediate hazards to the subject. (4) Establish and follow written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Environmental Protection Agency of: (i) Any unanticipated problems involving risks to human subjects or others or any instance of serious or continuing noncompliance with this subpart or the requirements or determinations of the IRB; and (ii) Any suspension or termination of IRB approval. (b) Except when an expedited review procedure is used (see § 26.1110), an IRB must review proposed research at convened meetings at which a majority of the members of the IRB are pres… | ||||
| 40:40:1.0.1.1.25.6.1.6 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | § 26.1109 IRB review of research. | EPA | (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this subpart. (b) An IRB shall require that information given to subjects as part of informed consent is in accordance with § 26.1116. The IRB may require that information, in addition to that specifically mentioned in § 26.1116, be given to the subjects when, in the IRB's judgment, the information would meaningfully add to the protection of the rights and welfare of subjects. (c) An IRB shall require documentation of informed consent in accordance with § 26.1117. (d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing. (e) An IRB shall conduct continuing review of research requiring review by the convened IRB at intervals appropriate to the degree of risk, not less than once per year, except as described in paragraph (f) of this section. (f)(1) Unless an IRB determines otherwise, continuing review of research is not required in the following circumstances: (i) Research eligible for expedited review in accordance with § 26.1110; (ii) Research that has progressed to the point that it involves only one or both of the following, which are part of the IRB-approved study: (A) Data analysis, including analysis of identifiable private information or identifiable biospecimens, or (B) Accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care. (2) [Reserved] (g) An IRB shall have authority to observe or have a third party observe the consent process and the research. | ||||
| 40:40:1.0.1.1.25.6.1.7 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | § 26.1110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. | EPA | (a) The Secretary of HHS, has established, and published as a notice in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The Secretary will evaluate the list at least every 8 years and amend it, as appropriate after consultation with other federal departments and agencies and after publication in the Federal Register for public comment. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor office. (b)(1) An IRB may use the expedited review procedure to review the following: (i) Some or all of the research appearing on the list described in paragraph (a) of this section, unless the reviewer finds that the study involves more than minimal risk. (ii) Minor changes in previously approved research during the period for which approval is authorized. (2) Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in § 26.1108(b). (c) Each IRB that uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals that have been approved under the procedure. (d) The Administrator may restrict, suspend, terminate, or choose not to authorize an institution's or IRB's use of the expedited review procedure for research covered by this subpart. | ||||
| 40:40:1.0.1.1.25.6.1.8 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | § 26.1111 Criteria for IRB approval of research. | EPA | (a) In order to approve research covered by this subpart the IRB shall determine that all of the following requirements are satisfied: (1) Risks to subjects are minimized: (i) By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and (ii) Whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes. (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research ( e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons. (4) Informed consent will be sought from each prospective subject, in accordance with, and to the extent required by § 26.1116. (5) Informed consent will be appropriately documented in accordance with § 26.1117. (6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of… | ||||
| 40:40:1.0.1.1.25.6.1.9 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | K | Subpart K—Basic Ethical Requirements for Third-Party Human Research for Pesticides Involving Intentional Exposure of Non-Pregnant, Non-Nursing Adults | § 26.1112 Review by institution. | EPA | Research covered by this subpart that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB. | ||||
| 40:40:1.0.1.1.25.7.1.1 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | 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 | § 26.1201 To what does this subpart apply? | EPA | [78 FR 10544, Feb. 14, 2013] | This subpart applies to any research subject to subpart K of this part. | |||
| 40:40:1.0.1.1.25.7.1.2 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | 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 | § 26.1202 Definitions. | EPA | The definitions in § 26.1102 shall be applicable to this subpart as well. In addition, the definitions at 45 CFR 46.202(a) through (f) and at 45 CFR 46.202(h) are applicable to this subpart. In addition, a child is a person who has not attained the age of 18 years. | ||||
| 40:40:1.0.1.1.25.7.1.3 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | 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 | § 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. | EPA | [71 FR 36175, June 23, 2006] | Notwithstanding any other provision of this part, under no circumstances shall a person conduct or support research covered by § 26.1201 that involves intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child. | |||
| 40:40:1.0.1.1.25.8.1.1 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | M | Subpart M—Requirements for Submission of Information on the Ethical Conduct of Completed Human Research | § 26.1301 To what does this subpart apply? | EPA | [78 FR 10544, Feb. 14, 2013] | This subpart applies to any person who submits to EPA on or after April 15, 2013 either of the following: (a) A report containing the results of any human research for consideration in connection with an action that may be performed by EPA under FIFRA (7 U.S.C. 136-136y) or section 408 of FFDCA (21 U.S.C. 346a). (b) A report containing the results of any human research on or with a pesticide for consideration in connection with any action that may be performed by EPA under any regulatory statute administered by EPA. | |||
| 40:40:1.0.1.1.25.8.1.2 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | M | Subpart M—Requirements for Submission of Information on the Ethical Conduct of Completed Human Research | § 26.1302 Definitions. | EPA | [84 FR 35324, July 23, 2019] | The definitions in § 26.1102 apply to this subpart as well. | |||
| 40:40:1.0.1.1.25.8.1.3 | 40 | Protection of Environment | I | A | 26 | PART 26—PROTECTION OF HUMAN SUBJECTS | M | Subpart M—Requirements for Submission of Information on the Ethical Conduct of Completed Human Research | § 26.1303 Submission of information pertaining to ethical conduct of completed human research. | EPA | Any person who submits to EPA data derived from human research covered by this subpart shall provide at the time of submission information concerning the ethical conduct of such research. To the extent available to the submitter and not previously provided to EPA, such information should include: (a) Copies of all of the records relevant to the research specified by § 26.1115(a) to be prepared and maintained by an IRB. (b) Copies of all of the records relevant to the information identified in § 26.1125(a) through (f). (c) Copies of sample records used to document informed consent as specified by § 26.1117, but not identifying any subjects of the research. (d) If any of the information listed in paragraphs (a) through (c) of this section is not provided, the person shall describe the efforts made to obtain the information. |
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chapter TEXT,
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