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  • SOP 006: IRB Meeting Conduct

SOP 006: IRB Meeting Conduct

Document Version # Effective Date
SOP-006 2.0 08/08/2022

  1. Purpose

    This SOP outlines procedures and responsibilities for conducting IRB meetings at WVU.

  2. Overview

    1. WVU IRBs have access to sufficient physical meeting space in the University building where WVU OHRP is located (when applicable).
    2. WVU IRB meetings are held online as of March 2020 and will continue in an online or hybrid fashion for the foreseeable future. The video conferencing system used for the meetings is approved by the institution and is considered secure.
    3. The WVU IRB members have access to the WVU OHRP staff as needed to support protocol reviews, record keeping, and meeting facilitation.
    4. The IRB Chair conducts the meetings.
    5. The IRB Chair must appoint someone to write and keep minutes.
    6. Investigators (PIs) are responsible for submitting all needed materials in the timeframe designated by WVU OHRP and the WVU IRB.
    7. WVU OHRP electronically delivers and/or makes accessible all meeting materials to IRB members at least five business days before the scheduled meeting.
    8. The IRB Chair or OHRP Director (or designee) has the authority to approve guests, including the PI, to attend the meeting.
    9. OHRP staff must ensure any guests of IRB meetings have signed confidentiality waivers.
    10. The IRB Chair must verify the quorum before beginning each IRB meeting. This quorum must exist for all matters that are voted on. Quorum is defined as more than half the voting members and must include one member whose primary concern is not scientific. If a matter involves FDA-regulated research, a physician must be present. If quorum is lost during a meeting, the IRB cannot take votes until the quorum is restored, even if more than half of the members are still present.
    11. One unaffiliated member and at least one member representing the general perspective of participants (the same individual can serve in both capacities) will be present at all IRB meetings. Although the IRB may, on occasion, meet without this representation, individuals serving in this capacity must be present for at least 80% of all IRB meetings.

  3. Procedures

    1. The agenda, submission materials, protocols, proposed informed consent forms, and other appropriate documents are available electronically to IRB members at least five days before the convened meeting.IRB members have sufficient time to review the material and can fully participate in each protocol submission review.
    2. The IRB Chair will ensure that a quorum is present at the beginning of each meeting.
    3. IRB members are considered present and can participate at a duly convened IRB meeting when either physically present or participating through electronic means (e.g., teleconferencing or video conferencing) which permits them to listen and speak during IRB deliberations and to vote.
    4. When not physically present, the IRB member must receive the required materials before the scheduled meeting and must be able to participate actively and equally in all discussions.
    5. Members participating through electronic means must vote according to procedure during the meeting using a planned method. Votes are taken within the video conferencing system polls feature that are pre-populated for each meeting. If a member has problems voting via the poll, they are instructed to verbally vote or submit their vote in the chat function. Votes are then documented in the meeting minutes.
    6. The Chair or Vice Chair will remind IRB members to recuse themselves from the discussion and vote by leaving the room where there is a conflict.
    7. The IRB will review and discuss the IRB minutes from the previous meeting(s) and determine if there are any revisions. If there are none, the minutes will be accepted as presented and considered final. If it is determined that revisions or corrections are necessary, the minutes will be amended and presented at a future IRB meeting.
    8. The IRB reviews all submissions for initial and continuing review, as well as requests for modifications.
    9. The primary (and in some cases secondary) reviewers present an overview of the research and lead the discussion by discussing the regulatory criteria for approval within the various reviewer checklists. Primary and/or secondary reviewers utilize the Criteria for Approval checklist as a guide in making determinations at the convened meeting. (See SOP 006: Criteria for IRB Approval.)
    10. All members present at a convened meeting have full voting rights, except in the cases of alternate members attending alongside full board members, cultural consultants, ex-officio members, or any member who discloses a conflict of interest (see SOP 004: IRB Membership, Authority, and Responsibilities). A majority of present voting members must vote for approval for the research to be approved.
    11. PIs must leave the room or the online meeting room prior to the discussion and vote on their research.
    12. WVU OHRP records the proceedings by taking and archiving minutes after each IRB meeting.

  4. References

    WVU Policies:

    Federal Regulations:

    • 45 CFR 46.109
    • 21 CFR 56.109

    AAHRPP:

    • Standard II.2.D