cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
32 rows where part_number = 97 and title_number = 34 sorted by section_id
This data as json, CSV (advanced)
Suggested facets: subpart, subpart_name, amendment_citations
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 34:34:1.1.1.1.30.1.113.1 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.101 To what does this policy apply? | ED | [82 FR 7272, Jan. 19, 2017, as amended at 83 FR 28516, June 19, 2018] | (a) Except as detailed in § 97.104, 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… | |||||
| 34:34:1.1.1.1.30.1.113.10 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.111 Criteria for IRB approval of research. | ED | (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, § 97.116. (5) Informed consent will be appropriately documented or appropriately waived in accordance with § 97.117. (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… | ||||||
| 34:34:1.1.1.1.30.1.113.11 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.112 Review by Institution | ED | 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. | ||||||
| 34:34:1.1.1.1.30.1.113.12 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.113 Suspension or Termination of IRB Approval of Research. | ED | 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. | ||||||
| 34:34:1.1.1.1.30.1.113.13 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.114 Cooperative Research. | ED | (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. | ||||||
| 34:34:1.1.1.1.30.1.113.14 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.115 IRB Records. | ED | (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 § 97.109(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 § 97.108(a)(2). (6) Written procedures for the IRB in the same detail as described in § 97.108(a)(3) and (4). (7) Statements of significant new findings provided to subjects, as required by § 97.116(c)(5). (8) The rationale for an expedited reviewer's determination under § 97.110(b)(1)(i) that research appearing on the expedited review list described in § 97.110(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 § 97.103(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… | ||||||
| 34:34:1.1.1.1.30.1.113.15 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.116 General Requirements for Informed Consent. | ED | (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… | ||||||
| 34:34:1.1.1.1.30.1.113.16 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.117 Documentation of informed consent. | ED | (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 § 97.116. 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 § 97.116 have been presented orally to the subject or the subject's legally authorized representative, and that the key information required by § 97.116(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… | ||||||
| 34:34:1.1.1.1.30.1.113.17 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.118 Applications and proposals lacking definite plans for involvement of human subjects. | ED | 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 § 97.101(i) or exempted under § 97.104, 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. | ||||||
| 34:34:1.1.1.1.30.1.113.18 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.119 Research undertaken without the intention of involving human subjects. | ED | Except for research waived under § 97.101(i) or exempted under § 97.104, 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. | ||||||
| 34:34:1.1.1.1.30.1.113.19 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency. | ED | (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. | ||||||
| 34:34:1.1.1.1.30.1.113.2 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.102 Definitions for purposes of this policy. | ED | (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… | ||||||
| 34:34:1.1.1.1.30.1.113.20 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.121 [Reserved] | ED | |||||||
| 34:34:1.1.1.1.30.1.113.21 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.122 Use of Federal funds. | ED | 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. | ||||||
| 34:34:1.1.1.1.30.1.113.22 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.123 Early termination of research support: Evaluation of applications and proposals. | ED | (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). | ||||||
| 34:34:1.1.1.1.30.1.113.23 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.124 Conditions. | ED | 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. | ||||||
| 34:34:1.1.1.1.30.1.113.3 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.103 Assuring compliance with this policy—research conducted or supported by any Federal department or agency. | ED | (a) Each institution engaged in research that is covered by this policy, with the exception of research eligible for exemption under § 97.104, 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 § 97.103(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 § 97.101(i) or exempted under § 97.104. For such research, institutions shall certify that each proposed research study cover… | ||||||
| 34:34:1.1.1.1.30.1.113.4 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.104 Exempt research. | ED | (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 … | ||||||
| 34:34:1.1.1.1.30.1.113.5 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | §§ 97-97.106 [Reserved] | ED | |||||||
| 34:34:1.1.1.1.30.1.113.6 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.107 IRB membership. | ED | (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… | ||||||
| 34:34:1.1.1.1.30.1.113.7 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.108 IRB functions and operations. | ED | (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… | ||||||
| 34:34:1.1.1.1.30.1.113.8 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.109 IRB review of research. | ED | (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 § 97.104 for which limited IRB review is a condition of exemption (under § 97.104(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 § 97.116. The IRB may require that information, in addition to that specifically mentioned in § 97.116, 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 § 97.117. (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 § 97.109(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 § 97.110; (ii) Research reviewed by the IRB in accordance with the limited IRB review described in § 97.104(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… | ||||||
| 34:34:1.1.1.1.30.1.113.9 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | A | Subpart A—Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) | § 97.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. | ED | (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 § 97.104(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 § 97.108(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. | ||||||
| 34:34:1.1.1.1.30.3.113.1 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | D | Subpart D—Additional ED Protections for Children Who Are Subjects in Research | § 97.401 To what do these regulations apply? | ED | (a) This subpart applies to all research involving children as subjects conducted or supported by the Department of Education. (1) This subpart applies to research conducted by Department employees. (2) This subpart applies to research conducted or supported by the Department of Education outside the United States, but in appropriate circumstances the Secretary may, under § 97.101(i), waive the applicability of some or all of the requirements of the regulations in this subpart for that research. (b) Exemptions in § 97.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The exemption in § 97.101(b)(2) regarding educational tests is also applicable to this subpart. The exemption in § 97.101(b)(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 or investigators do not participate in the activities being observed. (c) The exceptions, additions, and provisions for waiver as they appear in § 97.101(c) through (i) are applicable to this subpart. | ||||||
| 34:34:1.1.1.1.30.3.113.2 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | D | Subpart D—Additional ED Protections for Children Who Are Subjects in Research | § 97.402 Definitions. | ED | The definitions in § 97.102 apply to this subpart. In addition, the following definitions also apply to this subpart: (a) Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. (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 or local law to consent on behalf of a child to general medical care. | ||||||
| 34:34:1.1.1.1.30.3.113.3 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | D | Subpart D—Additional ED Protections for Children Who Are Subjects in Research | § 97.403 IRB duties. | ED | In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered by this subpart and approve only research that satisfies the conditions of all applicable sections of this subpart. | ||||||
| 34:34:1.1.1.1.30.3.113.4 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | D | Subpart D—Additional ED Protections for Children Who Are Subjects in Research | § 97.404 Research not involving greater than minimal risk. | ED | ED conducts or funds 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 § 97.408. | ||||||
| 34:34:1.1.1.1.30.3.113.5 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | D | Subpart D—Additional ED Protections for Children Who Are Subjects in Research | § 97.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. | ED | ED conducts or funds research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the IRB finds that— (a) The risk is justified by the anticipated benefit to the subjects; (b) 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 (c) Adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in § 97.408. | ||||||
| 34:34:1.1.1.1.30.3.113.6 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | D | Subpart D—Additional ED Protections for Children Who Are Subjects in Research | § 97.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. | ED | ED conducts or funds research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if the IRB finds that— (a) The risk represents a minor increase over minimal risk; (b) The intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; (c) The intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition that is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and (d) Adequate provisions are made for soliciting assent of the children and permission of their parents or guardians, as set forth in § 97.408. | ||||||
| 34:34:1.1.1.1.30.3.113.7 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | D | Subpart D—Additional ED Protections for Children Who Are Subjects in Research | § 97.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. | ED | ED conducts or funds research that the IRB does not believe meets the requirements of § 97.404, § 97.405, or § 97.406 only if— (a) The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and (b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either that— (1) The research in fact satisfies the conditions of § 97.404, § 97.405, or § 97.406, as applicable; or (2)(i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; (ii) The research will be conducted in accordance with sound ethical principles; and (iii) Adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in § 97.408. | ||||||
| 34:34:1.1.1.1.30.3.113.8 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | D | Subpart D—Additional ED Protections for Children Who Are Subjects in Research | § 97.408 Requirements for permission by parents or guardians and for assent by children. | ED | (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, if 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 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 research. Even if 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 § 97.116. (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 § 97.116, that adequate provisions are made for soliciting the permission of each child's parent(s) or guardian(s). If parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under § 97.404 or § 97.405. If research is covered by §§ 97.406 and 97.407 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or if only one parent has legal responsibility for the care and custody of the child. (c) In addition to the provisions for waiver contained in § 97.116,… | ||||||
| 34:34:1.1.1.1.30.3.113.9 | 34 | Education | 97 | PART 97—PROTECTION OF HUMAN SUBJECTS | D | Subpart D—Additional ED Protections for Children Who Are Subjects in Research | § 97.409 Wards. | ED | (a) Children who are wards of the State or any other agency, institution, or entity may be included in research approved under § 97.406 or § 97.407 only if that research is— (1) Related to their status as wards; or (2) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards. (b) If research is approved under paragraph (a) of this section, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate must be an individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator or investigators, or the guardian organization. |
Advanced export
JSON shape: default, array, newline-delimited, object
CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);