IRB Member Responsibilities

To conduct thorough reviews, IRBs are required to have members with varied expertise and backgrounds. Membership includes individuals from various academic disciplines, medical backgrounds, areas of specific expertise, as well as individuals not affiliated with the institution (community members). IRB members must receive training and continuing education that is sufficient in helping them understand regulatory and ethical requirements for the conduct and documentation of IRB protocol reviews. The composition and duties are prescribed by regulation, most notably HHS regulations at 45CFR46 and FDA regulations at 21CFR50 and 56, as well as University policies.

The board consists of voting members, non-voting members, alternate members, and ad hoc members who serve terms of up to three years, with potential re-appointment for additional terms.

  • Voting Members review non-Exempt research, including research reviewed by expedited procedures and both minimal risk and more than minimal risk research reviewed at convened meetings (“Full board review”). Voting members may also be asked to review exempt research. Voting members can be faculty, staff, or community members.
  • Alternate members Are no different than voting members except that they are indicated on the official roster to serve as a voting member in the absence of a specified voting member, or a member with similar expertise, during convened meetings.  Alternate members conduct reviews of both non-exempt and exempt protocols.
  • Ex-officio members are members with specific areas of expertise who provide expert or specialty area reviews. Ex-officio appointments are connected to a person’s position at WSU. Ex-officio members may be either voting or non-voting.
  • Non-voting members serve on the board in an advisory capacity. Representatives from IT, compliance offices, and representatives from WSU’s Attorney General Office typically fill these roles.
  • Ad-hoc members are members with specific areas of expertise who provide expert or specialty area reviews. Ad-hoc members are not appointed members of the IRB and are also referred to as consultants.
  • IRB Chair: The IRB Chair runs convened meetings of the IRB with support from HRPP staff, makes decisions regarding agenda items of importance and determinations regarding non-compliance, adverse events or other protocol related occurrences. Like other voting members, the Chair is appointed for a term of 1-3 years that may be renewed.
  • IRB Vice Chair: The Vice Chair manages convened meetings in the absence of the Chair, or if there is a need for the Chair to recuse due to their association with a protocol under discussion. Vice Chairs may also be tasked with leading sub-committees assigned to policy or procedure development issues or complex non-compliance investigations.

IRB members are covered under the institution’s liability insurance for their service on the Board.

The approximate time commitment per month for reviews, preparing for IRB meetings, and attending the meetings varies from member to member based on availability to commit service time. The expectations for various levels of service commitment are outlined below.

  • 20% service: IRB Chairs, Vice Chairs, as well as most voting members will spend up to 8 hours per week/32 hours per month on IRB service, this includes but is not limited to:
    • Attendance of most convened meetings, 4-6 hours/month: Convened meetings (4-5 hours per month) and required training or continuing education (approximately 3-6 hours twice a year).
    • Review of non-exempt protocols (full board or expedited reviews), 8-16 hours per month: a minimum of 2-4 assigned protocol reviews per month at an average of 3-4 hours per review (includes re-reviews as needed).
    • Review of full board materials, including protocols, 2-8 hours per month: Review of agenda items to be discussed at convened meetings, including review of protocol materials and assigned reviewer comments for protocols to be reviewed at convened meetings.
    • Other, including participation in compliance, IRB review process (e.g., “pre-IRB” meetings and policy related activities): At least 2 hours per month.
  • 10% service: All voting members and most alternate members will be asked to commit to this level of service which requires approximately 16 hours per month.
    • Attendance of at least half of the convened meetings, 3-5 hours/month: Convened meetings, especially when acting as an assigned reviewer (2-4 hours per month) and required training or continuing education (approximately 4-6 hours twice a year).
    • Review of non-exempt protocols (full board or expedited reviews), 4-8 hours per month: a minimum of 1-2 assigned protocol reviews per month at an average of 3-4 hours per review (includes re-reviews as needed).
    • Review of full board materials, including protocols, 2-4 hours per month: Review of agenda items to be discussed at convened meetings, including review of protocol materials and assigned reviewer comments for protocols to be reviewed at convened meetings.
    • Other, including participation in compliance activities, IRB review process discussions (e.g., “pre-IRB” meetings and policy related activities): Up to 2 hours per month.
  • 5% service: This level of service is reserved for members whose expertise falls in areas that are high demand for IRBs, such as MDs or cultural/local context reviewers, but due to their availability cannot commit to the full 10 or 20% service levels. This service level requires a minimum commitment of 8 hours per month. Due to time intensive commitment to train new members, anyone who cannot commit to at least this level of service may serve only as an ad-hoc reviewer (consultant).
    • Attendance at convened meetings, 2-4 hours/month: Convened meetings when assigned as a reviewer (2-3 hours per month) and required training or continuing education (approximately 4-6 hours twice a year).
    • Review of non-exempt protocols (full board or expedited reviews), 3-4 hours per month: typically, 1 assigned protocol review per month at an average of 3-4 hours per review (includes re-reviews as needed).
    • Review of full board materials, including protocols, 2 hours per month: Review of agenda items to be discussed at convened meetings, including review of protocol materials and assigned reviewer comments for protocols to be reviewed at convened meetings.
    • Other, including participation in compliance activities, IRB review process discussions (e.g., “pre-IRB” meetings and policy related activities): As needed.

The WSU IRB meets twice a month, with meetings scheduled for 2.5 hours each. The maximum time commitment per month for IRB meetings is 5 hours. Time commitment for reviews may vary greatly depending on a member’s particular expertise and the volume of protocols submitted for review. Generally, reviewers are assigned between 1-3 protocols to review a month, with an approximate timeline of 2-4 hours per review.

Member Expectations:

  1. Training: Members are expected to meet the minimum requirements for initial training and continuing education established by the institution. This includes initial new member orientation consisting of:
    • At least one training session with HRPP staff covering basic IRB operations and how to conduct and document a review.
    • Mentored protocol review with an experienced member of the IRB or HRPP staff. Each new member will be asked to complete at least one.
    • CITI training for members:
      • Complete initial CITI IRB Member training and;
      • Complete refresher training once every five years or as assigned by the HRPP (typically only occurs when there has been a change in the regulations).
      • WSU required Responsible Conduct of Research training (RCR)
    • Bi-Annual Continuing education sessions: Usually offered at the beginning of the fall semester and end of Spring semester, with up to four hours of time commitment each.
    • Alternative to bi-annual training: If bi-annual trainings are not possible due to staff limitations within the HRPP, alternative trainings will be offered throughout the year during convened meetings of the IRB. Alternative training information will be shared with all members via email and/or SharePoint.
      • Members may be asked to affirm that they have received and read the information.
      • Other forms of continuing education may be substituted upon request by the member and approval by the Assistant Director in the Office of Research Assurances. Acceptable alternatives include but are not limited to: Attendance of a national IRB specific meeting or training (e.g. PRIM&Rs AER, SBER, IRB 101 or IRB 301, or HCCA annual meeting).
  2. Reviews: Members are assigned 1-4 reviews per month depending on the number of submissions received by the HRPP and the expertise required by individual protocols, as well as an individual member’s service commitment. If a member is unable to meet the time commitment required to complete review of a protocol assigned to them, they should communicate this to HRPP staff as soon as possible (preferably within 48-72 hours) so that the review may be re-assigned. Delays in re-assigning reviews have a negative impact on the performance of the IRB and by extension on the research community.
  3. Attendance: Most members are expected to attend as many convened meetings of the IRB as possible, but no less than ½ of the convened meetings during a year.  Voting members are expected to notify HRPP staff as soon as practicable (but no later than 48 hours prior to a convened meeting) if they will be unable to attend. This is necessary to ensure that an alternate member can attend in their place so that the board can achieve quorum (a majority of the voting membership) for a convened meeting. Without quorum, a convened meeting cannot be held, and the meeting must be re-scheduled.
    • Members are expected attend convened meetings where they served as either the primary or secondary reviewer for a protocol under consideration or;
    • If a member is unable to attend a meeting when they were assigned as a primary or secondary reviewer, they are expected to communicate this to the IRB office so that a tertiary reviewer or another IRB member with appropriate expertise can present the details of their review.
    • Alternate members are both welcome and encouraged to attend any convened meetings and may be called upon to act as a voting member in place of another member with similar expertise when another member is unable to attend on short notice or must recuse themselves (e.g. due to a conflict of interest).
  4. Confidentiality: IRB members review documents that may contain personal, confidential, and/or proprietary information. Members are responsible for maintaining all IRB proceedings and documents in strict confidence, within the limit of applicable state and federal laws. Such information may not be used for any purpose other than the IRB review and many not be disclosed to anyone outside of the IRB except as allowed by law or with documented permission.
    • Any paper copies of IRB materials should be shredded and electronic copies should be deleted appropriately.
    • WSU requires that all oversight committee members sign a certificate of confidentiality affirming their agreement with the above terms.
  5. Conflict of interest: Any member with a conflict of interest involving a protocol under review by the IRB must disclose the conflict of interest to the IRB Chair or HRPP staff as soon as possible. The conflicted member may take part in the pre-vote discussion, in particular when their specific knowledge may be helpful in answering questions of the IRB, however; They may not serve as reviewer, make a motion, vote, or be present during voting. They will be asked to recuse themselves prior to final discussion and voting. If the Chair has a conflict, either the Co-Chair, Vice-Chair or another voting member will need to be appointed by HRPP staff to act as Chair for the duration of the protocol review(s).
  6. Member conduct: IRB members are expected to act according to professional standards of courtesy and respect during discussions with other IRB members regarding the researchers and research under review.

As part of the overall quality assurance program, the HRPP periodically evaluates the performance of the IRB and IRB members. These evaluations will be used to confirm that members have been able to commit to the number of hours of service associated with their agreed upon service level (5, 10 or 20%). These evaluations will occur at least 1-2 times per year. If an issue is noted, the member (and their corresponding college/department leadership when appropriate) will be contacted regarding any need to re-evaluate the level of their service commitment (increase or decrease).

Evaluations will include assessment of the number of protocol reviews assigned, number completed, number re-assigned/not completed and average review times compared to published schedules and the overall average for the combined committee.