Source: https://www.ecfr.gov/cgi-bin/text-idx?mc=true&node=pt49.1.11&rgn=div5
Timestamp: 2019-12-14 19:53:33
Document Index: 356195369

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Title 49 → Subtitle A → Part 11
§11.101 To what does this policy apply?
§11.102 Definitions for purposes of this policy.
§11.103 Assuring compliance with this policy—research conducted or supported by any Federal department or agency.
§11.104 Exempt research.
§§11.105-11.106 [Reserved]
§11.107 IRB membership.
§11.108 IRB functions and operations.
§11.109 IRB review of research.
§11.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
§11.111 Criteria for IRB approval of research.
§11.112 Review by Institution
§11.113 Suspension or Termination of IRB Approval of Research.
§11.114 Cooperative Research.
§11.115 IRB Records.
§11.116 General Requirements for Informed Consent.
§11.117 Documentation of informed consent.
§11.118 Applications and proposals lacking definite plans for involvement of human subjects.
§11.119 Research undertaken without the intention of involving human subjects.
§11.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.
§11.121 [Reserved]
§11.122 Use of Federal funds.
§11.123 Early termination of research support: Evaluation of applications and proposals.
§11.124 Conditions.
Source: 82 FR 7274, Jan. 19, 2017, unless otherwise noted.
(a) Except as detailed in §11.104, 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.
(2) 2018 Requirements. For purposes of this section, the 2018 Requirements means the Federal Policy for the Protection of Human Subjects requirements contained in this part. The general compliance date for the 2018 Requirements is January 21, 2019. The compliance date for §11.114(b) (cooperative research) of the 2018 Requirements is January 20, 2020.
(ii) Research for which IRB review was waived pursuant to §11.101(i) of the pre-2018 Requirements before January 21, 2019; and
(iii) Research for which a determination was made that the research was exempt under §11.101(b) of the pre-2018 Requirements before January 21, 2019.
(1) Section 11.102(l) of the 2018 Requirements (definition of research) (instead of §11.102(d) of the pre-2018 Requirements);
(2) Section 11.103(d) of the 2018 Requirements (revised certification requirement that eliminates IRB review of application or proposal) (instead of §11.103(f) of the pre-2018 Requirements); and
(3) Section 11.109(f)(1)(i) and (iii) of the 2018 Requirements (exceptions to mandated continuing review) (instead of §11.103(b), as related to the requirement for continuing review, and in addition to §11.109, of the pre-2018 Requirements); and
[82 FR 7274, Jan. 19, 2017, as amended at 83 FR 2894, Jan. 22, 2018; 83 FR 28519, June 19, 2018]
(a) Each institution engaged in research that is covered by this policy, with the exception of research eligible for exemption under §11.104, 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 §11.103(d)).
(d) Certification is required when the research is supported by a Federal department or agency and not otherwise waived under §11.101(i) or exempted under §11.104. For such research, institutions shall certify that each proposed research study covered by the assurance and this section has been reviewed and approved by the IRB. Such certification must be submitted as prescribed by the Federal department or agency component supporting the research. Under no condition shall research covered by this section be initiated prior to receipt of the certification that the research has been reviewed and approved by the IRB.
(e) For nonexempt research involving human subjects covered by this policy (or exempt research for which limited IRB review takes place pursuant to §11.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8)) that takes place at an institution in which IRB oversight is conducted by an IRB that is not operated by the institution, the institution and the organization operating the IRB shall document the institution's reliance on the IRB for oversight of the research and the responsibilities that each entity will undertake to ensure compliance with the requirements of this policy (e.g., in a written agreement between the institution and the IRB, by implementation of an institution-wide policy directive providing the allocation of responsibilities between the institution and an IRB that is not affiliated with the institution, or as set forth in a research protocol).
(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §11.111(a)(7).
(C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §11.111(a)(7).
(7) Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §11.111(a)(8).
(i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained in accordance with §11.116(a)(1) through (4), (a)(6), and (d);
(ii) Documentation of informed consent or waiver of documentation of consent was obtained in accordance with §11.117;
(iii) An IRB conducts a limited IRB review and makes the determination required by §11.111(a)(7) and makes the determination that the research to be conducted is within the scope of the broad consent referenced in paragraph (d)(8)(i) of this section; and (iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.
(b) Except when an expedited review procedure is used (as described in §11.110), an IRB must review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting.
(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 §11.104 for which limited IRB review is a condition of exemption (under §11.104(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 §11.116. The IRB may require that information, in addition to that specifically mentioned in §11.116, 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 §11.117.
(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 §11.109(f).
(i) Research eligible for expedited review in accordance with §11.110;
(ii) Research reviewed by the IRB in accordance with the limited IRB review described in §11.104(d)(2)(iii), (d)(3)(i)(C), or (d)(7) or (8);
(iii) Research for which limited IRB review is a condition of exemption under §11.104(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 §11.108(b).
(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, §11.116.
(5) Informed consent will be appropriately documented or appropriately waived in accordance with §11.117.
(8) For purposes of conducting the limited IRB review required by §11.104(d)(7)), the IRB need not make the determinations at paragraphs (a)(1) through (7) of this section, and shall make the following determinations:
(i) Broad consent for storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens is obtained in accordance with the requirements of §11.116(a)(1)-(4), (a)(6), and (d);
(ii) Broad consent is appropriately documented or waiver of documentation is appropriate, in accordance with §11.117; and
(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 §11.109(f)(1).
(5) A list of IRB members in the same detail as described in §11.108(a)(2).
(6) Written procedures for the IRB in the same detail as described in §11.108(a)(3) and (4).
(7) Statements of significant new findings provided to subjects, as required by §11.116(c)(5).
(8) The rationale for an expedited reviewer's determination under §11.110(b)(1)(i) that research appearing on the expedited review list described in §11.110(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 §11.103(e).
(1) A written informed consent form that meets the requirements of §11.116. 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 §11.116 have been presented orally to the subject or the subject's legally authorized representative, and that the key information required by §11.116(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.
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 §11.101(i) or exempted under §11.104, 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.
Except for research waived under §11.101(i) or exempted under §11.104, 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.