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OHRP Institutional Review Board (IRB)

Guidelines from the Office for Human Research Protections (OHRP)

 
Office for Human Research Protections (OHRP)


REGISTRATION OF AN INSTITUTIONAL REVIEW BOARD (IRB)
OR INDEPENDENT ETHICS COMMITTEE (IEC)

    NOTE: All research that is conducted, supported, or regulated by any US Government Agency under the Federal Policy (or Common Rule) for the Protection of Human Subjects is subject to certain uniform requirements regarding IRB membership, IRB review and approval criteria, IRB operations and recordkeeping, and informed consent.


    1. RESPONSIBILITIES OF DOMESTIC IRBs AND INTERNATIONAL IECs PROVIDING REVIEW AND OVERSIGHT OF FDA-REGULATED RESEARCH

    1. The IRB should ensure that all human subject research that is regulated by the Food and Drug Administration (FDA), and for which the IRB provides review and oversight, complies with FDA regulations at Title 21 Code of Federal Regulations Parts 50 and 56 (21 CFR 50 and 56). FDA-regulated research in this case includes (a) clinical investigations overseen by domestic IRBs and regulated by FDA under sections 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act; (b) clinical investigations overseen by domestic IRBs that support applications for research or marketing permits for FDA-regulated products (such as drugs, biological products, devices, food additives, and color additives); and (c) clinical investigations overseen by foreign IRBs that are required to comply with 21 CFR Part 56.

    2. Except for research exempted or waived under Sections 56.104 or 56.105 of the FDA regulations, all research for which the IRB is responsible should be reviewed, prospectively approved, and subject to continuing oversight by the IRB. The IRB should have the authority to approve, require modifications in, or disapprove the research for which it is responsible.

    3. Except where specifically waived or altered by the IRB under sections 50.23, 50.24, or 56.109(c) of the FDA regulations, all research for which the IRB is responsible should require written informed consent, in nonexculpatory language understandable to the subject (or the subjectís legally authorized representative), including the following basic elements per section 50.25(a) and (b) of the FDA regulations: (a) Identification as research; purposes, duration, and procedures; procedures which are experimental; (b) Reasonably foreseeable risks or discomforts; (c) Reasonably expected benefits to the subject or others; (d) Alternative procedures or treatments, if any, that might be advantageous to the subject; (e) Extent of confidentiality to be maintained; (f) Whether compensation or medical treatment are available if injury occurs (if more than minimal risk); (g) Whom to contact for answers to questions about the research, subjectsí rights, and research-related injury; (h) Participation is voluntary; refusal to participate, or discontinuation of participation, will involve no penalty or loss of benefits to which subject is entitled; and (i) When appropriate, additional elements per Section 50.25(b) of the FDA regulations.

    4. The IRB should establish written procedures for (a) conducting IRB initial and continuing review, approving research, and reporting IRB findings to the investigator and the institution; (b) 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; (c) ensuring that changes in approved research are reported promptly to the IRB and are not initiated without IRB approval, except when necessary to eliminate apparent immediate hazards to the subject; and (d) ensuring prompt reporting to the IRB, institutional officials, and the FDA, of any (i) unanticipated problems involving risks to subjects or others in any covered research; (ii) serious or continuing noncompliance with Federal, institutional, or IRB requirements; and (iii) suspension or termination of IRB approval for FDA-regulated research.

    5. Information provided under this registration should be updated at least every 36 months in order to maintain active registration. Failure to update this information may result in termination of the IRBís registration with HHS.

    6. Food and Drug Administration (FDA) regulations at 21 CFR 56.107 specify IRB membership requirements as follows:

    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 entity. 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.

    1. RESPONSIBILITIES OF IRBs PROVIDING REVIEW AND OVERSIGHT OF FEDERALLY-SUPPORTED RESEARCH: IRBs LOCATED IN THE UNITED STATES

    a. All IRB activities related to human subject research should be guided by the ethical principles in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

    b. The IRB should ensure that all Federally-supported human subject research for which the IRB provides review and oversight complies with the Federal Policy* (Common Rule) for the Protection of Human Subjects. All human subject research supported by the Department of Health and Human Services (HHS) should comply with all Subparts of HHS regulations at Title 45 Code of Federal Regulations Part 46 (45 CFR 46). All Federally-supported human subject research should also comply with any additional human subject regulations and policies of the supporting Department or Agency. All Federally-supported human subject research should comply with any human subject regulations and policies of any relevant regulatory Department or Agency. In reviewing research that is both Federally-supported and FDA-regulated, the IRB should satisfy all of the responsibilities applicable to each.

    * 7 CFR 1c Department of Agriculture
    10 CFR 745 Department of Energy
    14 CFR 1230 National Aeronautics and Space Administration
    15 CFR 27 Department of Commerce
    16 CFR 1028 Consumer Product Safety Commission
    22 CFR 225 Agency for International Development
    24 CFR 60 Department of Housing and Urban Development
    28 CFR 46 Department of Justice
    32 CFR 219 Department of Defense
    34 CFR 97 Department of Education
    38 CFR 16 Department of Veterans Affairs
    40 CFR 26 Environmental Protection Agency
    45 CFR 46 Department of Health and Human Services
    45 CFR 690 National Science Foundation
    49 CFR 11 Department of Transportation
    By Executive Order Central Intelligence Agency
    By Statute Department of Agriculture

  1. Except for research exempted or waived under Sections 101(b) or 101(i) of the Federal Policy, all research for which the IRB is responsible should be reviewed, prospectively approved, and subject to continuing oversight by the IRB. The IRB should have the authority to approve, require modifications in, or disapprove the research for which it is responsible.

  2. Except where specifically waived or altered by the IRB under Sections 101(i), 116(c) and (d), or 117(c) of the Federal Policy all research for which the IRB is responsible should require written informed consent, in nonexculpatory language understandable to the subject (or the subjectís legally authorized representative), including the following basic elements per Section 116(a) and (b) of the Federal Policy: (a) Identification as research; purposes, duration, and procedures; procedures which are experimental; (b) Reasonably foreseeable risks or discomforts; (c) Reasonably expected benefits to the subject or others; (d) Alternative procedures or treatments, if any, that might be advantageous to the subject; (e) Extent of confidentiality to be maintained; (f) Whether compensation or medical treatment are available if injury occurs (if more than minimal risk); (g) Whom to contact for answers to questions about the research, subjectsí rights, and research-related injury; (h) Participation is voluntary; refusal to participate, or discontinuation of participation, will involve no penalty or loss of benefits to which subject is entitled; and (i) When appropriate, additional elements per Section 116(b) of the Federal Policy.

  3. The IRB should establish written procedures for (a) conducting IRB initial and continuing review, approving research, and reporting IRB findings to the investigator and the institution; (b) 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; (c) ensuring that changes in approved research are reported promptly and are not initiated without IRB approval, except when necessary to eliminate apparent immediate hazards to the subject; and (d) ) ensuring prompt reporting to the IRB, institutional officials, the relevant Department or Agency Head, any applicable regulatory body, and OHRP of any of any (i) unanticipated problems involving risks to subjects or others in any covered research; (ii) serious or continuing noncompliance with Federal, institutional, or IRB requirements; and (iii) suspension or termination of IRB approval for Federally-supported research.

  4. The IRB should ensure that it has appropriate knowledge of the local context in which research for which it is responsible will be conducted.

  5. The IRB Chairperson, IRB members, IRB staff, and human subject research investigators should complete appropriate education related to the protection of human subjects before reviewing or conducting human subject research.

  6. The IRB should ensure the existence of adequate education and oversight mechanisms (appropriate to the nature and volume of the research being conducted) to verify that research investigators, IRB members and staff, and other relevant personnel maintain continuing knowledge of, and comply with, relevant Federal regulations, OHRP guidance, other applicable guidance, State and local law, and IRB determinations and policies for the protection of human subjects. The IRB should require documentation of such training from research investigators as a condition for conducting Federally-supported human subject research.

  7. The IRB should endeavor to ensure that it is provided with resources, professional staff, and support staff appropriate to the nature and volume of the research for which it is responsible.

  8. Information provided under this registration should be updated at least every 36 months in order to maintain active registration. Failure to update this information may result in termination of the IRBís registration with HHS.

  9. The Federal Policy (Common Rule) for the Protection of Human Subjects and Department of Health and Human Services (HHS) regulations at 45 CFR 46.107 specify IRB membership requirements as follows:

  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 entity. 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.






  1. RESPONSIBILITIES OF IECs and IRBs PROVIDING REVIEW AND OVERSIGHT OF FEDERALLY-SUPPORTED RESEARCH: OVERSIGHT OF FEDERALLY-SUPPORTED RESEARCH: IECs and IRBs LOCATED OUTSIDE THE UNITED STATES
  1. All IEC/IRB activities related to human subject research should be guided either by the ethical principles in the World Medical Associationís Declaration of Helsinki (as adopted in 1996 or 2000), or by the ethical principles in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the US National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, or by other internationally recognized ethical standards.

  2. The IEC/IRB should ensure that all US-supported human subject research for which the IEC/IRB provides review and oversight complies with the requirements of any applicable Federal regulatory agency as well as one of the following: (i) the US Federal Policy (Common Rule) for the Protection of Human Subjects and/or the US Department of Health and Human Services (HHS) regulations at 45 CFR 46; (ii) the May 1, 1996 International Conference on Harmonization E-6 Guidelines for Good Clinical Practice (ICH-GCP-E6) Sections 1 through 4; (iii) the 1993 Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines for Biomedical Research Involving Human Subjects; (iv) the 1998 Medical Research Council of Canada Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans; (v) the 2000 Indian Council of Medical Research Ethical Guidelines for Research Involving Humans; or (vi) other internationally recognized standards for the protection of human subjects. In reviewing research that is both Federally-supported and FDA-regulated, the IRB should satisfy all of the responsibilities applicable to each.

  3. All US-supported research for which the IEC/IRB is responsible should be reviewed, prospectively approved, and subject to continuing oversight and review at least annually by the IEC/IRB. The convened IEC/IRB, with a majority of its members present, should have authority to approve, require modifications in, or disapprove the research for which the IEC/IRB is responsible.

  4. Unless authorized by the supporting US Agency, all US-supported research for which the IEC/IRB is responsible should require written informed consent, in nonexculpatory language understandable to the subject (or the subjectís legally authorized representative), including the following basic elements: (a) Identification as research; purposes, duration, and procedures; procedures which are experimental; (b) Reasonably foreseeable risks or discomforts; (c) Expected benefits to the subject or others; (d) Alternative procedures or treatments; (e) Extent of confidentiality to be maintained; (f) Whether compensation or medical treatment are available if injury occurs (if more than minimal risk); (g) Whom to contact for answers to questions about the research, subjectsí rights, and research-related injury; (h) Participation is voluntary; refusal to participate, or discontinuation of participation, will involve no penalty or loss of benefits to which subject is entitled; and (i) When appropriate, additional elements as determined by the IEC/IRB.

  5. The IEC/IRB should establish written procedures for (a) verifying whether proposed activities qualify for exemption from, or waiver of, IEC/IRB review; (b) conducting initial and continuing IEC/IRB review, approving research, and reporting IEC/IRB findings to the investigator and the institution conducting the research; (c) determining appropriate continuing review intervals and oversight mechanisms for all approved research; (d) ensuring that changes in approved research are not initiated without IEC/IRB approval, except when necessary to eliminate apparent immediate hazards to the subject; and (e) ensuring prompt reporting to the IEC/IRB, institutional officials, the relevant US Agency Head, any applicable regulatory body, and OHRP of any (i) serious or continuing noncompliance with US, institutional, or IEC/IRB requirements; (ii) unanticipated problems involving risks to subjects or others in any covered research; and (iii) suspension or termination of IEC/IRB approval for US-supported research.

  6. The IEC/IRB should acknowledge that special protections are needed for vulnerable populations of subjects and should ensure the concurrence of the supporting US Agency prior to the involvement of pregnant women, prisoners, children, or fetuses in US-supported research for which the IEC/IRB is responsible.

  7. The IEC/IRB Chairperson, IEC/IRB members, IEC/IRB staff, and human subject research investigators should complete appropriate education and training before reviewing or conducting human subject research. Educational modules available on the OHRP website may be used for such training, or the IEC/IRB may utilize other appropriate educational materials of its own choosing.

  8. The IEC/IRB should ensure the existence of adequate education and oversight mechanisms (appropriate to the nature and volume of the research being conducted) to verify that research investigators, IEC/IRB members and staff, and other relevant personnel maintain continuing knowledge of, and comply with, relevant policies and procedures for the protection of human subjects. The IEC/IRB should require documentation of such training from research investigators as a condition for conducting US-supported human subject research.

  9. The IEC/IRB should endeavor to ensure that it is provided resources, professional staff, and support staff appropriate to the nature and volume of the research for which it is responsible.

  10. Information provided under this registration should be updated at least every 36 months in order to maintain active status. Failure to update this information may result in termination of the IRBís registration with HHS.

  11. The IEC/IRB should observe the following membership guidelines:

  1. Each IEC/IRB should have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IEC/IRB should 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 IEC/IRB should 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 IEC/IRB should therefore include persons knowledgeable in these areas. If an IEC/IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration should 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 should be made to ensure that no IEC/IRB consists entirely of men or entirely of women, including consideration of qualified persons of both sexes, so long as no selection is made to the IEC/IRB on the basis of gender. No IEC/IRB should consist entirely of members of one profession.

  3. Each IEC/IRB should 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 IEC/IRB should include at least one member who is not otherwise affiliated with the entity and who is not part of the immediate family of a person who is affiliated with the entity.

  5. No IEC/IRB should have a member participate in the IECís/IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IEC/IRB.

  6. An IEC/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 IEC/IRB. These individuals should not vote with the IEC/IRB.

  
Section Last Modified:
8/22/2010 10:37 PT
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