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700-4-Management and Composition of the IRB

Title: Management and Composition of the IRB
Owner: IRB
Last Update/Revised: 5/1/2024

Policy: The USU IRB is composed of members in accordance with federal regulations. The IRB’s primary responsibility is to evaluate the acceptability of proposed research activity in terms of institutional commitments and regulations as well as standards of professional conduct and practice to safeguard the rights and welfare of human subjects.

The institution will make every effort to have a diverse membership within the scope of available expertise needed to conduct its functions. Composition will reflect the anticipated scope and complexity of the projects and research activities conducted, the types of subject populations likely to be involved, and the size and available resources of the institution.

The management of the membership of the USU IRB and oversight of member appointments, IRB related activities, communications, and other administrative details are the responsibility of the IRB Chair or designee.

The Provost in consultation with the IRB Chair, has the authority to appoint members to the IRB. Members are solicited from the USU community and as well as communities served by the USU research community.

Specifics about the USU IRB are listed below.

  • Composition of the IRB consists of at least five regular voting members and at least one alternate.
    • The HHS regulations at 45 CFR part 46 do not address the designation of alternate IRB members; at USU, alternates are board members appointed by the IRB Chair. An alternate may substitute for another member if their role (nonscientist or scientist) is comparable as determined by the IRB Chair.
  • The IRB includes at least one scientific member and at least one nonscientific member.
    • Members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline are considered a scientist while members whose training, background, and occupation would incline them to view research activities from a standpoint outside of any biomedical or behavioral scientific discipline are considered a nonscientist.
  • The IRB includes at least one unaffiliated member.
    • An individual with no affiliation with USU, other than as an IRB member, is considered unaffiliated. Unaffiliated members may include people whose only association with the institution is that of a patient, subject, or former student. Conversely, an employee or agent of USU (or a member of that person’s immediate family) is considered affiliated. Affiliated members include, but are not limited to, individuals who are: part-time employees; current students; members of any governing panel or board of the institution; paid or unpaid consultants; and volunteers working at USU on business unrelated to the IRB. Paying unaffiliated members for their services does not make the member “otherwise affiliated” as stated in the regulations or cause the member to have a conflicting interest. At USU, unaffiliated members are compensated with an annual stipend of $500 and $100 for each convened meeting.
  • A single member may fill two roles (for example, be unaffiliated with the institution and have a primary concern in a non-scientific area).
  • The IRB does not include individuals responsible for business development as voting members.
  • The USU IRB includes members who are knowledgeable about the concerns of research subjects who may be vulnerable. Such members might include nurses, social workers, chaplains, teachers, etc. In general, a member representing a vulnerable group of participants has 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), and/or
    • certification or license that permits the treatment, counseling, or other direct relationship of the special group(s).

Procedures:

  1.  Appointment of the IRB Chair
    1. The Provost will send written notification to Deans and current IRB members regarding a vacancy for the appointment of the IRB Chair. The written notification will request any nominations or persons who wish to volunteer to submit their request to the Provost. The Provost will review the nominations and volunteers with the current IRB members for qualified candidates.
    2. Qualified candidates will be selected based on (but not limited to) their current standing with the University and community, IRB experience, research experience with human subjects, education and professional background, and professional and personal interests.
    3. Once qualified candidates have been determined, the Provost and current IRB members (as appropriate) will interview each individual. Up to three and at least two of the most qualified candidates will be selected from the interview process and will be re-interviewed by the Provost and current IRB Chair or designee. The Provost will make the final appointment of the qualified candidate for IRB Chair.
  2. Appointing IRB Members
    1. The IRB Chair conducts an annual review (each January) of IRB membership to ensure the composition of the IRB meets regulatory and organizational requirements.
    2. Based upon the annual evaluation or any interim need to adjust the composition of the IRB, the IRB Chair requests the appointment of new IRB members and alternates. The Provost appoints members to the IRB.
    3. Members and alternates are appointed for 3-year terms and may be re-appointed indefinitely by mutual agreement of the IRB Chair and Provost.
  3. Stipends for Unaffiliated Members
    1. Unaffiliated members are compensated via an annual stipend of $500 paid each January. The IRB Chair initiates payment.
    2. For each convened meeting an unaffiliated member attends, they receive a stipend of $100 dollars. The IRB Chair initiates payment.
  4. Stipends for Adjunct Faculty
    1. Adjunct faculty members are compensated for their CITI training, at $500. For each convened meeting an adjunct faculty member attends they receive a stipend of $100 dollars. The IRB Chair initiates payment.
  5. Evaluation of IRB Members
    1. IRB members complete a self-evaluation and are evaluated by the IRB Chair after their first year of service and at the end of each term (3 years). Interim evaluations of IRB members may occur more frequently, as determined by the IRB Chair.
    2. A summary of the evaluation (IRB Member Evaluation Form) will be provided by the IRB Chair to the IRB member via email. The evaluation will be retained as part of the member’s profile in the IRB Google Drive in a section accessible only to the IRB Chair and Provost.
    3. A member may be removed at the discretion of the IRB Chair before the conclusion of the term, and a member may resign before the conclusion of a term. Vacancies are filled as quickly as possible.
    4. The IRB Chair completes a self-evaluation and is evaluated by the Provost annually. Interim evaluations of the IRB Chair may occur more frequently, as determined by the Provost. Evaluations of the IRB Chair are stored with the Human Resources Department.
  6. Maintaining Roster and Board Member Information
    1. All board member information is stored in the IRB Google Drive.
    2. To ensure that board members meet the needs of the IRB in its review of research, board member information is updated annually via a request by the IRB Chair or designee.
    3. Each board member submits a Confidentiality Agreement at the beginning of their term of service.
    4. An IRB Roster with the following information is collected and maintained in the RB Google Drive: member names, highest earned degree, scientific status, representative capacity, indications of experience sufficient to describe each member's chief anticipated contribution to the IRB’s deliberations, employment/relationship between each member and USU (e.g., full-time employee, etc.), affiliation status, membership status (e.g., IRB Chair, etc.), and CITI Training expiration date.
  7. Maintaining Sufficient IRB Resources
    1. USU provides sufficient staff and resources to support the IRB’s review and record-keeping duties.
    2. The adequacy of the existing IRB is evaluated at least annually (January) by the Provost to meet the anticipated scope of research activities, the types of participant populations likely to be involved, the appropriateness of the proposed and initial and continuing review procedures in light of probable risks, and the size and complexity of the research conducted by the USU community.
    3. Quarterly, the IRB Chair will create a report consisting of but not limited to the following:
      1. Number of initial IRB Review submissions
      2. Number of activities with a not human subjects research determination
      3. Number of activities with an exempt research determination
      4. Number of activities reviewed as expedited and actions taken
      5. Number of activities reviewed at a convened board and actions taken
      6. Number of submissions for amendments, continuing review, and unanticipated problems
      7. Number of Final Project Reports received
      8. Time required for review of each type of submission
      9. Number of submissions from each college
      10. Number of studies involving vulnerable populations
    4. The final report will be shared with the IRB committee, the Deans, and Program Directors for doctoral programs.
    5. The Provost and the IRB Chair will discuss the findings of the report to evaluate whether the composition of the IRB and related resources are appropriate for the volume and types of submissions being reviewed and whether the review process is being accomplished in a thorough and timely manner.

Purpose: This policy outlines IRB resources, the composition of the IRB, and the procedure to appoint and evaluate members.

Scope: This policy applies to the USU IRB.

Documents and Forms:

Confidentiality Agreement (available on IRB Google Drive)

IRB Member Evaluation Form (available on IRB Google Drive)