OPRS SOP 201: Management and Composition of the IRB
a) Alternate Member
Alternates are members appointed on any of the other University of Illinois Urbana-Champaign IRB panels. These members may substitute for another member on a different panel if his/her role are comparable as determined by the Meeting Facilitator.
b) Nonscientific Member
Nonscientific member(s) may include individuals whose main concerns are unambiguously in nonscientific areas. Nonscientific members are individuals whose education, training, work, experience or other interests are not solely in medical, biological, or other scientific areas.
c) Scientific Member
Scientific member(s) may include physicians and Ph.D. level physical, biological or behavioral scientists, nurses, pharmacists, and other biomedical health professionals. Such members satisfy the requirement for at least one scientist.
d) Unaffiliated Member
An unaffiliated member has no affiliation with the University of Illinois Urbana-Champaign or its Human Research Protection Program, either self or immediate family member. Unaffiliated member(s), who can be either scientific or nonscientific reviewers, should be knowledgeable about the local community and be willing to discuss issues and research from that perspective. Consideration should be given to recruiting individuals who speak for the communities from which the University of Illinois Urbana-Champaign will draw its research subjects. The unaffiliated member(s) should not be vulnerable to intimidation by the professionals on the IRB, and their services should be fully utilized by the IRB.
Each 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. Each IRB should also be able to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.
Therefore, each IRB must consist of at least five regular, voting members. Qualified persons from multiple professions and of both sexes are considered for membership. The institution will make every effort to have a diverse membership appointed to the IRB, within the scope of available expertise needed to conduct its functions. Composition of the membership of the IRB is to be adequate in light of the anticipated scope and complexity of Illinois’ research activities, the types of subject populations likely to be involved, and the size and available resources of the Institution.
Each IRB panel includes at least one scientific member and at least one nonscientific member whose primary concerns are in nonscientific areas. Each IRB panel must include at least one unaffiliated member. One member can be unaffiliated with the institution and have a primary concern in a non-scientific area. This individual would satisfy two of the membership requirements of the regulations.
The IRB includes members who are knowledgeable about the concerns of participants who may be vulnerable (e.g. children, prisoners, pregnant women, and handicapped or mentally disabled persons, etc.). Examples of such members might be nurses, social workers, chaplains, teachers or previous prisoners. In general, a member representing a vulnerable group of participants should provide at least one of the following:
- A direct affiliation to the special group(s)
- Work or life experience with the special group(s)
- Research experience with special group(s)
- Hold certification or licensures that permits the treatment, counseling, or other direct relationship of the special group(s)
Individuals responsible for business development the University of Illinois Urbana-Champaign or affiliated institutions will not serve as voting members of the IRB. This may include, but is not limited to, the following individuals:
- Employees of the institutions’ granting or research contracting offices
- Employees of the institutions’ Vice Chancellor for Research and Innovation offices
The management of the membership of the IRBs and oversight of member appointments, IRB related activities, communications, and other administrative details are the responsibility of the IRB Director or designee.
The Vice Chancellor for Research and Innovation along with the Assistant Vice Chancellor for Research – Compliance and IRB Director will review the resources allocated to the human research protection program to the IRBs and other components within the human research protection program.
- Procedures for Appointing IRB Members
The Vice Chancellor for Research and Innovation and/or the Assistant Vice Chancellor for Research - Compliance in consultation with the IRB Chair and IRB Director have the authority to appoint members to the IRB. Members will be solicited from the University of Illinois Urbana-Champaign and greater Champaign communities.
Participation by University of Illinois Urbana-Champaign faculty, staff, or students is considered a component of their job responsibilities as established by their supervisors.
The University’s insurance coverage applies to employees and any other person authorized to act on behalf of the University or acts or omissions within the scope of their employment or authorized activity. IRB memberships is considered an authorized activity.
- The IRB Director and IRB meeting facilitators conduct an annual review of IRB membership to ensure the composition of the IRB meets regulatory and organizational requirements.
- Based upon the annual evaluation or any interim need to adjust the composition of the IRB, the IRB Director requests appointment of new IRB members. The Academic Senate, Vice Chancellor for Research and Innovation and/or the Assistant Vice Chancellor for Research - Compliance in consultation with the IRB Chair and IRB Director have the authority to appoint members to the IRB.
- Appointed members, including the IRB Chair and alternates, will serve on the IRB for a term of three years. Reappointment for additional terms may occur, by mutual agreement of the IRB Chair, Vice Chancellor for Research and Innovation, and Assistant Vice Chancellor for Research – Compliance.
- Procedures for Appointment of the IRB Chair(s)
The IRB Chair will be a highly respected individual, from the University of Illinois Urbana-Champaign or its affiliated institutions, fully capable of managing the IRB and the matters brought before it with fairness and impartiality.
- The IRB Director sends written notification to Department heads and current IRB members regarding a vacancy for the appointment of IRB Chair(s). The written notification requests any nominations or persons who wish to volunteer be submitted to the IRB Director. The IRB Director will review the nominations and volunteers with the Assistant Vice Chancellor for Research - Compliance and the current IRB Chair(s) for qualified candidates. Qualified candidates will be selected based on (but not limited to) their current standing with the University and community, IRB experience (if any), research experience with human subjects (if any), education and professional background, professional and personal interests.
- Once qualified candidates have been determined, the Assistant Vice Chancellor for Research - Compliance, the IRB Director and current IRB Chair(s) will conduct interviews with each individual. In a collaborative effort, the three most qualified candidates will be selected from the interview process and will be re-interviewed with the Vice Chancellor for Research and Innovation, the Assistant Vice Chancellor for Research - Compliance, the IRB Director and current IRB Chair. The Vice Chancellor for Research and Innovation will make the final appointment of the qualified candidate for IRB Chair.
- Procedures for Evaluation of IRB Members
- Performance of the IRB members is evaluated no less than annually by the IRB Chair and/or IRB Director (and may include input from the OPRS staff). A member may be removed at the discretion of the IRB Chair and/or IRB Director before the conclusion of his/her term. A member may resign before the conclusion of his/her term. Vacancies are filled as quickly as possible.
- The IRB Chair(s)’ performance and role is evaluated no less than annually by the Vice Chancellor for Research and Innovation (and may include the Assistant Vice Chancellor for Research - Compliance and IRB Director). Interim evaluations of the IRB Chair(s) may occur more frequently, as determined by the Vice Chancellor for Research and Innovation, Assistant Vice Chancellor for Research – Compliance or the IRB Director.
- Feedback from the evaluations will be provided by the IRB Director to the IRB Chairs and IRB members in writing.
- Procedures for Maintaining Roster and Board Member Information
- To ensure that board members meet the needs of the IRB in its review of research, board member information forms and current CV’s/résumés are completed or updated at the initiation of each term of service. A Confidentiality Agreement and Recusal Agreement are submitted by each board member at the beginning of their term of service.
- In order to maintain rosters of IRB membership, the following information is collected and maintained by OPRS staff: member names; earned degrees; scientific status; representative capacity; indications of experience sufficient to describe each member's chief anticipated contribution to the IRB’s deliberations; employment or other relationship between each member and the IRB and/or the University of Illinois Urbana-Champaign (e.g., full-time employee, etc.); affiliation status; and office/membership status (e.g. vice-chair, etc.).
- Procedures for Maintaining Sufficient Resources
- The University of Illinois Urbana-Champaign will provide meeting space and sufficient staff to support the IRB’s review and recordkeeping duties. The University of Illinois Urbana-Champaign will provide the IRB administrative staff with resources sufficient to conduct IRB duties.
- The adequacy of the existing IRB(s) is evaluated at least annually by the Assistant Vice Chancellor for Research – Compliance and IRB Director to meet the anticipated scope of research activities and the types of participant populations likely to be involved and the appropriateness of the proposed and initial and continuing review procedures in light of probable risks, and the size and complexity of the University of Illinois Urbana-Champaign.
- The IRB Director may prepare a report consisting of but not limited to the following:
- Number of new studies submitted;
- Number of studies according to risk assessment;
- Review process (i.e. expedited, convened board) for initial studies, modifications, continuing review, and unanticipated problems, if applicable;
- Time required for approval of each type of application;
- Number of studies from Social/Behavioral Research versus Biomedical Research;
- Number of studies involving vulnerable populations.
- The Assistant Vice Chancellor for Research - Compliance and the IRB Director discuss the findings of the report to evaluate whether the number of IRBs is appropriate for the volume and types of human subject research being reviewed, and whether the review process is being accomplished in a thorough and timely manner.