Ralston Hall

Institutional Review Board

Federal Guidelines for the Institutional Review Board

Excerpts from federal regulations regarding the protection of human participants are included here. Content is organized under the following headings:

  1. § 46.107 Membership of the IRB
  2. § 46.109 IRB review of research
  3. § 46.101 IRB-exempt research
  4. § 46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research
  5. § 46.111 Criteria for IRB approval of research
  6. § 46.113 Suspension or termination of IRB approval for research
  7. § 46.115 IRB records
  8. § 46.116 General requirements for informed consent
  9. § 46.117 Documentation of informed consent

Human Participants Requirements
Categories of Research Expedited

The content that follows is excerpted from “Title 28 Judicial Administration – Part 46: Protection of Human Subjects”, Electronic Code of Federal Regulations. Accessed September 9, 2008 from: http://ecfr.gpoaccess.gov

1. § 46.107 IRB Membership

  1. 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, 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. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments 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 vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
  2. Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
  3. 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.
  4. 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.
  5. 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.
  6. An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB

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2. § 46.109 IRB Review of Research

  1. An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy.
  2. An IRB shall require that information given to subjects as part of informed consent is in accordance with §46.116. The IRB may require that information, in addition to that specifically mentioned in §46.116, 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.
  3. An IRB shall require documentation of informed consent or may waive documentation in accordance with §46.117.
  4. 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.
  5. An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.

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3. § 46.101 IRB-exempt Research

Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as
    1. research on regular and special education instructional strategies, or
    2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
  2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
    1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
    2. any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
  3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
    1. the human subjects are elected or appointed public officials or candidates for public office; or
    2. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
  4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
  5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
    1. Public benefit or service programs;
    2. procedures for obtaining benefits or services under those programs;
    3. possible changes in or alternatives to those programs or procedures; or
    4. possible changes in methods or levels of payment for benefits or services under those programs.
  6. Taste and food quality evaluation and consumer acceptance studies,
    1. if wholesome foods without additives are consumed or
    2. if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

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4. § 46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

  1. The Secretary, 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 list will be amended, as appropriate after consultation with other departments and agencies, through periodic republication by the Secretary, HHS, in the Federal Register. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor office.
  2. An IRB may use the expedited review procedure to review either or both of the following:
    1. Some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk,
    2. Minor changes in previously approved research during the period (of one year or less) for which approval is authorized. 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 §46.108(b).
  3. Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals which have been approved under the procedure.
  4. 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.

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5. § 46.111 Criteria for IRB approval of research.

  1. 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:
      1. By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and
      2. 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 (for example, 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 and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, 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 §46.116.
    5. Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.
    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 provisions to protect the privacy of subjects and to maintain the confidentiality of data.
  2. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

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6. § 46.113 Suspension or termination of IRB approval of research.

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.

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7. § 46.115 IRB records.

  1. 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.
    4. Copies of all correspondence between the IRB and the investigators.
    5. A list of IRB members in the same detail as described is §46.103(b)(3). (Please see Belmont Report)
    6. Written procedures for the IRB in the same detail as described in §46.103(b)(4) and §46.103(b)(5). (Please see Belmont Report)
    7. Statements of significant new findings provided to subjects, as required by §46.116(b)(5).
  2. The records required by this policy 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. All records shall be accessible for inspection and copying by authorized representatives of the department or agency at reasonable times and in a reasonable manner.

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8. § 46.116 General requirements for informed consent.

Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative 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.

  1. Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:
    1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
    2. A description of any reasonably foreseeable risks or discomforts to the subject;
    3. A description of any benefits to the subject or to others which may reasonably be expected from the research;
    4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
    5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
    6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
    7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
    8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
  2. Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
    1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
    2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
    3. Any additional costs to the subject that may result from participation in the research;
    4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
    5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
    6. The approximate number of subjects involved in the study.
  3. An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:
    1. The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:
      1. Public benefit of service programs;
      2. Procedures for obtaining benefits or services under those programs;
      3. Possible changes in or alternatives to those programs or procedures; or
      4. Possible changes in methods or levels of payment for benefits or services under those programs; and
    2. The research could not practicably be carried out without the waiver or alteration.
    3. An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:
    4. The research involves no more than minimal risk to the subjects;
    5. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
    6. The research could not practicably be carried out without the waiver or alteration; and
    7. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
  4. The informed consent requirements in this policy are not intended to preempt any applicable federal, state, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.
  5. Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law.

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9. § 46.117 Documentation of informed consent.

  1. Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.
  2. Except as provided in paragraph (c) of this section, the consent form may be either of the following:
    1. written consent document that embodies the elements of informed consent required by §46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or
    2. A short form written consent document stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the 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 representative, in addition to a copy of the short form.
  3. An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
    1. That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
    2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

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