1. Purpose
This SOP outlines procedures and responsibilities for conducting IRB meetings at WVU.
2. Overview
2.1. WVU IRBs have access to sufficient physical meeting space in the University building where WVU OHRP is located (when applicable).
2.2. 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.
2.3. The WVU IRB members have access to the WVU OHRP staff as needed to support protocol reviews, recordkeeping, and meeting facilitation.
2.4. The IRB Chair conducts the meetings.
2.5. The IRB Chair must appoint someone to write and keep minutes
2.6. Investigators (PIs) are responsible for submitting all needed materials in the
timeframe designated by WVU OHRP and the WVU IRB
2.7. WVU OHRP electronically delivers and/or makes accessible all meeting materials
to IRB members at least five business days before the scheduled meeting.
2.8. The IRB Chair or OHRP Director (or designee) has the authority to approve guests,
including the PI, to attend the meeting.
2.9. OHRP staff must ensure any guests of IRB meetings have signed confidentiality
waivers.
2.10. 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.
2.11. 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
3.1. 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.
3.2. The IRB Chair will ensure that a quorum is present at the beginning of each meeting.
3.3. 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.
3.4. 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.
3.5. 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.
3.6. 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.
3.7. 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.
3.8. The IRB reviews all submissions for initial and continuing review, as well as
requests for modifications.
3.9. 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.)
3.10. 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.
3.11. PIs must leave the room or the online meeting room prior to the discussion and
vote on their research.
3.12. WVU OHRP records the proceedings by taking and archiving minutes after each
IRB meeting.
4. References
WVU Policies:
SOP 006: Criteria for IRB Approval
SOP 019: Full Review
Federal Regulations:
45 CFR 46.109
21 CFR 56.109
AAHRPP:
Standard II.2.D