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1.6 IRB Composition, Leadership, Qualifications, and Responsibilities

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for IRB composition, leadership, member qualifications, and responsibilities.

2.0 Policy

It the policy of the Organization that the membership of its IRBs will include an appropriately diverse mixture of backgrounds, gender, and race/ethnicity in accordance with HHS regulations at 45 CFR 46.107 and FDA regulations at 21 CFR 56.107.

3.0 Composition of the IRBs

    3.1. Each IRB will have at least five members. 3.2. Each 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. 3.3. Each IRB shall include persons knowledgeable in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice to be able to ascertain the acceptability of proposed research. 3.4. Every effort will be made to ensure that the IRB does not consist entirely of men or entirely of women. No appointment will be made to the IRB on the basis of gender alone. 3.5. The IRB shall not consist entirely of members of one profession. 3.6. Each IRB will include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. In order to qualify as a non-scientist member the individual must have little or no scientific training or experience. 3.7. Each IRB will include at least one member that is not affiliated with the Institution.
      3.7.1. The unaffiliated member should be able to represent the general perspective of research subjects. In general, such members will qualify based upon factors such as experience in counseling, patient and family advocacy, experience as a patient or research subject, and experience on local committees, national committees or organizations devoted to various aspects of research, illnesses, or ethnic/cultural related concerns. These members should be particularly cognizant of the need to protect subjects vulnerable to coercion and undue influence. 3.7.2. The unaffiliated member must not have any professional relationship with the Institution as an employee, consultant, volunteer faculty, or student, or have a family member (first and second degree relative) who has such a professional relationship with the Institution. Before being appointed it will be determined through an interview that the individual qualifies as an unaffiliated IRB member. 3.7.3. It is expected that at least one unaffiliated member will be present at each meeting of each IRB. 3.8. When the IRB reviews community-based participatory research, a consultant will provide education to the IRB and advise the Board on issues pertinent to the community and the nature of the research. 3.9. A member of the IRB may fill multiple membership position requirements (for example, an unaffiliated member may also serve as a non-scientist member). 3.10. The IRBs will include one or more members who are knowledgeable about and experienced in working with the following vulnerable subjects: children, pregnant women, fetuses, neonates, and decisionally impaired individuals. 3.11. The IRB-04 will include a predominance of members who are knowledgeable about and experienced in working with children and neonates. 3.12. In situations where prisoners will be/are involved in research under IRB review: 1) the majority of the Board (exclusive of the prisoner member) will have no association with the prison(s) involved, apart from their membership on the IRB; and 2) the Board will include a prisoner representative with appropriate background and experience to serve in that capacity. This individual must have a reasonable working knowledge, understanding, and appreciation of prison conditions and be able to act in the best interests of the prisoners who will participate in the research. 3.13. Any IRB member with a conflict of interest related to a specific study will be recused from participating in the discussion and vote except to offer information as requested by the IRB. This applies to both full board review and expedited review. A conflict of interest will be determined in accordance with HRPP policy 1.7 (IRB Member, Consultant, Staff COI Identification and Management). 3.14. When review of a proposal requires medical or scientific expertise or specific knowledge about vulnerable subjects that is not available on the Board, the IRB will request assistance from an expert consultant. Consultants will provide guidance/information in accordance with the following procedures:
        3.14.1. Either before or during review of a protocol, the IRB Executive Chair/designee, assigned IRB reviewer, or the IRB itself may determine there is a need for appointment of an expert consultant, in accordance with the provisions of 45 CFR 46.107(f) (or rev 45 CFR 46.107(e)) and 21 CFR 56.107(f). Depending upon the nature and magnitude of the problem or concern, the IRB may seek more than one consultant. 3.14.2. Consultants may be selected from within or from outside the Organization, based upon the required expertise. 3.14.3. Consultants will be officially appointed by the IRB Executive Chair/designee. 3.14.4. Consultants must certify in writing that they do not have any conflict of interest as described in HRPP policy 1.7 (IRB Member, Consultant, Staff COI Identification and Management). 3.14.5. Consultants will produce written reviews upon request which will be provided to IRB members in advance of, or at the IRB meeting. 3.14.6. Consultants may participate in the IRB’s discussion of the protocol but they may not vote and must be recused before a vote is taken. 3.15. IRB alternate members are appointed according to discipline and membership category. They may represent more than one named IRB member. The alternate member’s professional specialty, qualifications, and experience must be comparable to those of the primary member to enable them to adequately fulfill the role of the member to be replaced. Alternate members may attend any IRB meeting; however, alternates are not permitted to vote unless the designated regular member is not present. All alternate members have access to IRB review materials regardless of whether or not they attend an IRB meeting. 3.16. The UNMC Chief Compliance Officer will regularly attend IRB meetings as a consultant, but will not vote. 3.17. Any Organizational representatives responsible for business development are prohibited from serving as an IRB member or in carrying out the day-to-day operations of the IRB review process. Organizational leadership may attend IRB meetings as necessary but will not vote. 3.18. When the IRB membership changes, the HHS/FDA IRB registration will be modified by the IRB Administrator responsible for membership documentation, in accordance with 45 CFR 46.505(b) and FDA regulations. 3.19. A full listing of IRB members will be maintained by the ORA. This list will include for each IRB member:
          3.19.1. Name 3.19.2. Earned degree(s) 3.19.3. Representative capacity 3.19.4. Scientific/nonscientific status 3.19.5. Affiliation status of the IRB member with the organization, and, if an affiliation exists, the nature of the affiliation (e.g., employment or other relationship). 3.19.6. Indications of expertise sufficient to describe the IRB member’s chief anticipated contribution to IRB deliberations. 3.19.7. When applicable, identify alternate members and the IRB member or class of IRB member for whom the alternate member can substitute. 3.20. The ORA will not release the names of any IRB members except as required by federal regulations or state law. However, the IRB will provide a list of members by specialty and role.

          4.0 IRB Leadership

            4.1. IRB Executive Chair
              4.1.1. The IRB Executive Chair is a senior faculty member and preferably is a nationally recognized as an expert in the ethics and regulation of human subject research. 4.1.2. The IO will appoint an IRB Executive Chair to serve for renewable 3 year terms. Any change in appointment, including reappointment or removal, will require written notification. 4.1.3. The IRB Executive Chair reports directly to the IO on all matters pertaining to the IRB and related HRPP issues. 4.1.4. The IRB Executive Chair also has a direct line to the UNMC and UNO Chancellors, as well as Executive Leadership for Nebraska Medicine and CHMC on all matters as necessary concerning compliance with HRPP policies and procedures. 4.1.5. The IRB Executive Chair performs all the duties of the IRB Chair in section 5.2 B-E below. 4.1.6. The IRB Executive Chair is the Chair of the IRB Executive Committee, and serves as a member of the IRB Compliance Subcommittee and ad hoc IRB subcommittees. 4.1.7. The IRB Executive Chair is a signatory for correspondence in accordance with HRPP policy 1.19 (IRB Signature Authority). 4.1.8. The IRB Executive Chair appoints qualified IRB members to perform expedited review, in accordance with HRPP policy 2.3 (Expedited Review).
              4.1.9. The IRB Executive Chair advises the IO, on an on-going basis about performance and competence of the IRB Vice-Chair(s), IRB members and ORA staff. 4.1.10. The performance of the IRB Executive Chair will be reviewed in accordance with HRPP policy 1.22 (Assessment of Effectiveness and Efficiency of the HRPP).
              4.1.11. The IRB Executive chair must satisfy continuing education requirements per HRPP policy 1.24 (HRPP Training Requirements for IRB Members), section 5.0. 4.1.12. The IRB Executive Chair must keep current with all updates in federal regulations and guidance, as well as attend regional and national conferences in human research subject protections. 4.2. IRB Chairs 4.2.1. The IRB Chair(s) is appointed by the IO, in consultation with the IRB Executive Chair, for a renewable 3 year term. The Chair must: 4.2.1.1. Have at least four years of IRB experience. 4.2.1.2. Be knowledgeable about regulatory and institutional requirements for protection of human subjects. 4.2.1.3. Be committed to serving in a leadership role 4.2.2. The IRB Chair conducts the IRB meetings, performs expedited reviews, reviews adverse events, unanticipated problems involving risk to the subject or others, protocol deviations, noncompliance, provides continuing education of IRB members and investigators, and participates in the development of policies, procedures, IRB forms and checklists. 4.2.3. If the IRB Chair is an MD (or equivalent) he/she will review requests for emergency use of a test article under 21 CFR 56.104(c) 4.2.4. The IRB Chair is a signatory for correspondence in accordance with HRPP policy 1.19 (IRB Signature Authority). 4.2.5. The IRB Chair appoints qualified IRB members to perform expedited review, in accordance with HRPP policy 2.3 (Expedited Review).
              4.2.6. The IRB Chair advises Executive Chair, on an on-going basis, about performance and competence of the IRB Vice-Chair(s), IRB members and ORA staff. 4.2.7. The performance of the IRB Chair will be reviewed in accordance with HRPP policy 1.22 (Assessment of Effectiveness and Efficiency of the HRPP). 4.2.8. The IRB Chair(s) must satisfy continuing education requirements per HRPP policy 1.24 (HRPP Training Requirements for IRB Members), section 5.0. 4.3. IRB Vice Chairs 4.3.1. The IRB Vice-Chair(s) is appointed by the IO, in consultation with the IRB Executive Chair, for a renewable 3 year term. The Vice-Chair must: 4.3.1.1. Have at least two years of IRB experience. 4.3.1.2. Be knowledgeable about regulatory and institutional requirements for protection of human subjects. 4.3.1.3. Be committed to serving in a leadership role.
              4.3.2. The IRB Vice-Chair(s) work closely with the IRB Chair and Executive Chair and serve in the absence of the IRB Chair and Executive Chair.
              4.3.3. The IRB Vice-Chair(s) are also involved in the activities described in Section 4.5.4 of this policy. 4.3.4. The IRB Vice-Chair(s) are members of the IRB Executive Committee, the IRB Compliance Subcommittee, and ad hoc IRB subcommittees. 4.3.5. The IRB Vice-Chair(s) must satisfy continuing education requirements per HRPP policy 1.24 (HRPP Training Requirements for IRB Members), section 5.0. 4.3.6. The IRB Vice-Chair(s) should keep current with all updates in federal regulations and guidance, as well as attend regional and national conferences in human research subject protections. 4.3.7. The performance of the Vice-Chair(s) will be reviewed in accordance with HRPP policy 1.22 (Assessment of Effectiveness and Efficiency of the HRPP).

              4.4. IRB Executive Committee 4.4.1. The IRB Executive Committee is comprised of the IRB Executive Chair, the IRB Chair(s), the IRB Vice-Chair(s), and the UNMC Chief Compliance Officer.
              4.4.2. The IRB Executive Committee meets quarterly or more often if needed. 4.4.3. IRB Administrators attend the IRB Executive Committee meetings as non-voting members on a rotating basis. 4.4.4. The purpose of the IRB Executive Committee is to: 4.4.4.1. Perform ongoing assessment of the IRBs. 4.4.4.2. Assist in the development of HRPP policies and procedures. 4.4.4.3. Assist in the development of IRB forms. 4.4.4.4. Address concerns of any nature which impact the effectiveness of the HRPP in assuring the protection of the rights and welfare of research subjects. 4.4.5. All four IRBs will be advised of Executive Committee deliberations that impact the HRPP. 4.5. IRB Members 4.5.1. IRB members will normally be identified and recruited by the IRB Executive Chair, IRB Chair(s) and the IRB Vice-Chairs. However, unsolicited nominations may be submitted to the IRB Executive Chair or the ORA at any time. 4.5.2. Prior to appointment to the board, the prospective member will be interviewed by the IRB Executive Chair or designee, to determine the relevant experience of the prospective member that will describe his/her chief anticipated contribution to IRB deliberations (AAHRPP element II.1.A). 4.5.3. IRB members are appointed by the IO, in consultation with the IRB Executive Chair, for a renewable 3 year term. 4.5.4. Each IRB member is expected to be fully engaged in the HRPP and will be involved in carrying out the following responsibilities as assigned: 4.5.4.1. Participate in all assigned IRB meetings and subcommittees with full voting privileges.
              4.5.4.2. Serve as a primary or secondary reviewer for new protocols. 4.5.4.3. Serve as a primary reviewer for applications for continuing review. 4.5.4.4. Serve as an expedited reviewer once they are sufficiently experienced. 4.5.4.5. Serve as a primary reviewer for internal unanticipated problems involving risk to the subject or others. 4.5.4.6. Serve as a primary reviewer for changes in protocol and/or consent documents. 4.5.4.7. Serve as a primary reviewer for incidents of noncompliance. 4.5.4.8. Serve on IRB ad hoc subcommittees as needed. 4.5.4.9. Serve on the IRB Compliance Subcommittee as needed. 4.5.4.10. Serve on a quality improvement assessment team as needed. 4.5.5. IRB members are expected to attend the majority of scheduled meetings, and are required to attend all meetings for which they have been assigned reviews, unless prior arrangements have been made (e.g., written comments sent). IRB member attendance records will be maintained by the ORA in accordance with HRPP policy #1.22 (Assessment of the Effectiveness and Efficiency of the HRPP). 4.5.6. IRB members must satisfy initial and on-going education requirements as per HRPP policy 1.24 (HRPP Training Requirements for IRB Members), section 5.0. 4.5.7. The performance of all IRB members will be reviewed in accordance with HRPP policy 1.22 (Assessment of Effectiveness and Efficiency of the HRPP). 4.5.8. Upon completion of a member’s term, the IRB Executive Chair, Chairs and Vice-Chairs, in consultation with the IRB Administrators, and based in part upon the performance evaluation (per HRPP policy 1.22: Assessment of the Effectiveness and Efficiency of the HRPP), will determine whether an additional term is offered. 4.5.9. Members accepting an additional term will be polled to evaluate changes in their roster information (per section 3.20 above). 4.5.10. An IRB Administrator may serve as a voting, or alternate voting, member of the IRB. 4.5.10.1. IRB administrators serving as voting or alternate members will be classified as scientist or non-scientist based on specific degree or education. Alternately, administrators with greater than 3 years prior work experience in a scientific field, or with greater than 3 years experience with review of biomedical protocols in current administrator position, may qualify as a scientist with approval of the IRB Executive Chair or Assistant VC for Regulatory Affairs. 4.5.10.2. An IRB administrator serving as a voting or alternate member of the IRB will have the same responsibilities and requirements as noted in section 5 above, except (1) term of appointment will be indefinite (section 5.3), and (2) an IRB administrator may not serve as reviewer for a new protocol, continuing review, adverse event or UP, or non-compliance incident, for a protocol which they are the primary administrator (section 5.4).

              4.6. IRB Alternate Members 4.6.1. The appointment and function of IRB alternate members is the same as that for regular IRB members.
              4.6.2. The alternate member must qualify in terms of expertise and role in order to serve in place of the regular member.
              4.6.3. The alternate member may serve as a voting member of the IRB when the regular member is unavailable to attend a convened meeting or perform expedited review.
              4.6.4. When an alternate member substitutes for a regular member, the alternate member will receive and review the same materials prior to the IRB meeting that the regular member received or would have received. 4.6.5. IRB Alternate members must satisfy initial and on-going education requirements as per HRPP policy 1.24 (HRPP Training Requirements for IRB Members), section 5.0. 4.6.6. The IRB roster identifies the regular members(s) for whom each alternate member may substitute.
              4.6.7. The alternate member will not be counted as a voting member unless the regular member is absent.
              4.6.8. The IRB minutes will document when an alternate member replaces a regular member.

              4.7. Attendance Requirements 4.7.1. IRB members should attend all meetings for which they are scheduled. If an IRB member is unable to attend a scheduled meeting, he/she should inform the designated IRB Administrator.
              4.7.2. If an IRB member is to be absent for an extended period of time the IRB Executive Chair and/or designated IRB Administrator must be notified and an appropriate replacement obtained. If the IRB member has a designated alternate, the alternate can serve during the regular member’s absence. 4.8. Training/Ongoing Education of IRB Members Training of new and established IRB members and alternates is described in HRPP policy 1.24 (HRPP Training Requirements for IRB Members). 4.9. Liability Coverage for IRB Members The Organization’s insurance coverage applies to employees and any other person authorized to act on behalf of the Organization within the scope of their employment or authorized activity.

              ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

              POLICY AMENDED:  REVISED MARCH 27, 2018  INITIAL APRIL 11, 2016

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