Institutional Review Board (IRB) Membership
University of Louisville Institutional Review Board members or alternates (hereafter referred to collectively as members) will be appointed by the Executive Vice President for Research in accordance with 45 CFR 46 and 21 CFR 56 to safeguard the rights and welfare of human subjects in research. Committee members, chairs, and vice-chairs serve at the discretion of the Executive Vice-President for Research.
II. Guidelines for Member Selection
The Executive Vice President for Research, considering advice from the Chairs of the Institutional Review Boards (IRBs) and the Director, Human Subjects Protection Program (HSPP), will appoint IRB members utilizing the following criteria:
- Each IRB will consist of at least five and not more than twenty-one voting members, with varying backgrounds to promote complete and adequate review of human research activities commonly conducted by the institution.
- Each IRB will be sufficiently qualified through the experience, expertise, and 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.
- No IRB will consist entirely of men or entirely of women. Qualified persons of both sexes will be considered so long as no selection is made to the IRB only on the basis of gender.
- Each IRB will consist of members of various professions including at least one scientist, one nonscientist, and 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 (community member).
When a vacancy occurs on an IRB, the Chairs of the IRBs and the Director, HSPP, shall contact the Dean and Department Chair of the appropriate University college/school/division or the administration of the affiliated institution, and request that a nomination be made to fill the vacancy. The name of the nominee and a current curriculum vita should be returned to the Director within one month. Once the nomination has been returned, the Chairs and the Director, HSPP, will review the credentials. Qualified nominees will be scheduled to interview with the Chairs, the Director, and HSPP staff.
The IRB Chairs, Director, and HSPP staff will review the duties and responsibilities with the nominee to ensure that the nominee realizes the time commitment needed for service on this committee.
Once the nominee has agreed to participate as a member of the IRB, a recommendation for appointment may be sent to the Executive Vice President for Research, indicating whether the appointment is as a full-committee member or an alternate; upon which committee the nominee will serve; and term of service with the IRB.
Once appointed, the IRB member will complete the following forms:
- Disclosure of Significant Financial Interest (annually)
- Non-disclosure agreement (annually).
The Director, HSPP, will ensure that these forms are forwarded to the Research Integrity Program.
Length of Term/Service and Description of Staggered Rotation
The length of service for an appointed IRB member will be five years. Usually, no more than one fifth of membership may be considered for renewal/replacement each year. If a member resigns prior to the end of their term, a nominee may be appointed to complete the original term.
During the first year of the IRB member’s initial term, the IRB chair may assign a senior committee member to serve as a mentor for the new appointee. This mentor will assist the new member, when requested, in preparing for committee meetings, contacting investigators for additional information, and working through any problems noted with the IRB submission, before the scheduled IRB meeting.
Near the end of the five-year term, the HSPPO staff will inquire as to whether or not the appointee wishes to continue to serve. If the IRB member wishes to continue to serve on the IRB, the HSPPO staff will submit a request, to the appropriate IRB chair, for the member to remain on the committee. The HSPPO staff, in consultation with the IRB Chair and Executive Vice President for Research, may extend an invitation for a committee member to remain for an additional five years.
IRB Member Training and Continuing Education Requirement
Once an IRB member has been appointed, the IRB member will meet with the IRB chairs and Director, HSPP, to learn about IRB forms and IRB review guidelines, and to receive an IRB member guidebook and policies and procedures manual. The HSPP staff will prepare an application form for the IRB member to join both the Applied Research Ethics National Association (ARENA) and Public Responsibility in Medicine and Research (PRIM&R). These are the two national associations for IRB members and administrators. The HSPP pays the annual dues for each member for these two organizations.
New IRB members should enroll in the New Member Track, and attend new member offerings in their first year attending the ARENA/PRIM&R meetings. If possible, new IRB members should attend the annual ARENA/PRIM&R meetings held each fall. Costs for attendance at these two meetings (held back-to-back) are an HSPP expense. IRB members are required to follow appropriate University travel regulations in order to obtain reimbursement for their travel to these meetings.
If available, IRB members are encouraged to attend one other local or regional IRB educational meeting during the course of each calendar year if they are unable to attend the PRIM&R/ARENA Annual Meeting.
Duties and Responsibilities
The IRB member shall:
- Protect the rights and welfare of research subjects.
- Determine that subject risks are minimized. IRB members will ensure that the investigators:
- use procedures which are consistent with sound research design and which do not expose subjects to risk, and
- whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- Determine that risks to the subjects are reasonable in relation to the anticipated benefits to subjects, if any, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB member 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 member should not consider possible long-range effects of applying knowledge gained in the research.
- Determine that selection of subjects is equitable. In making this assessment, the following should be taken into account:
- the purpose(s) of the research and the setting in which it is conducted; and
- should be particularly cognizant of special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, cognitively or mentally impaired persons, or economically or educationally disadvantaged persons.
- Determine whether the informed consent is adequate, and if not, request clarifications and changes in the consent form to adequately explain the purpose of the research, the risks and benefits entailed therein, and contains all other federally or locally mandated elements.
- Determine that the research plan makes adequate provision for monitoring the data collected to ensure the safety of the subjects.
- Determine that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data.
- Ensure additional safeguards are in place to protect the rights and welfare of subjects that are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, cognitively or mentally impaired persons, or economically or educationally disadvantaged persons.
Before the IRB meeting, the IRB member should:
- Review the assigned projects to be presented.
- Get any questions answered before the IRB meeting.
- Discuss any questions about the assigned projects with the investigator, other IRB members, or consultants prior to the IRB meeting.
- Decide whether you feel the investigator should attend the meeting to discuss any problems or concerns noted with the project.
- If specific changes are needed in the consent form, come to the meeting with recommended wording to be transmitted to the investigator.
During the second through fifth years of an IRB member’s term, the committee member will prepare and present initial submission reviews at full-committee meetings. If assigned, the committee member will review and present Continuation and Review materials at full-committee meetings; present serious adverse event information at full-committee meetings, and recommend any changes additions or deletions in any of the above actions.
Attendance at committee meetings
The Biomedical IRB holds meetings the first, third, and fourth Thursdays of each month. If a committee meeting date falls on a scheduled University holiday, the meeting will be rescheduled at a time more convenient for committee members and IRB staff. In December of each year, the upcoming new year list of committee meeting dates will be published on the HRPP website.
The Social/Behavioral/Educational IRB holds meetings the first Wednesday of each month. A meeting will be cancelled or rescheduled at a time more convenient for committee members and IRB staff If a committee meeting date falls on a scheduled University holiday.
Committee members are expected to attend as many scheduled committee meetings as their schedule will allow. The committee welcomes alternate members to attend all committee meetings. All full-committee members and alternates receive copies of the agenda and meeting materials unless they have notified the HSPPO that they will not attend a specific meeting.
If a situation arises whereby the committee member is assigned as a primary reviewer for the meeting and cannot attend, the committee member should contact the appropriate IRB Coordinator and/or his/her alternate and request that the alternate attend and present the project to committee. If the alternate committee member cannot attend, the committee member should request that the project be reassigned to another primary reviewer.
If committee members miss more than two-thirds of the total meetings per year, the Director and the appropriate IRB chair may meet with the appropriate department chair to ensure that chair is aware of the importance of the IRB member’s attendance at committee meetings, and is aware of the significant workload of an IRB committee member. If the IRB member is not allowed sufficient leeway to attend scheduled meetings, the IRB Chair and the Director will send a letter to the Executive Vice President for Research requesting assistance in obtaining relief from departmental obligations.
When a committee member consistently fails to attend IRB meetings or fails to meet expectations, the appropriate IRB chair and Director, HSPP, and will meet with the committee member to determine the cause. If the IRB member indicates an inability to continue to function effectively as an IRB member, the appropriate IRB chair or Director, HSPP, will request assistance from the Dean and/or department chair in obtaining a replacement member to serve on the IRB.
Subject: Institutional Review Board (IRB) Membership | Policy and Procedure | Author: Institutional Review Board | Original Effective Date: 9-22-2005 | Last Revised Date: 6-22-2010