Standards and Procedures

OPRS SOP 304: Convened IRB Meeting Administration

  1. Office for the Protection of Research Subjects (OPRS)
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  3. OPRS SOP 304: Convened IRB Meeting Administration

Approved Date

Revised Date

Full Details

DEFINITIONS

a) Quorum

A quorum is defined as more than half of the regular voting members. A quorum consists of regular members or their alternate and includes at least one member whose primary concerns are in scientific areas, and one member whose primary concerns are in nonscientific areas.

POLICY

Except when an expedited review procedure is used, the IRB will review proposed research at convened meetings at which a quorum is present. Each IRB Panel will meet monthly, or at some other frequency determined by the IRB Chair and the IRB Director. Meeting space will be made available for the IRB.

PROCEDURES

  1. Procedures for Maintaining Quorum
    • The IRB meeting may not convene until quorum is established. It is the responsibility of the meeting facilitator to inform the IRB Chair when quorum has been established.
      • An alternate member may attend in the place of an absent regular member in order to meet the quorum requirements as defined in this policy.
      • Ad hoc consultant reviewer(s) may not be used to establish a quorum.
    • The meeting facilitator is responsible for monitoring the meeting for late arrivals and departures of members.
    • It is the responsibility of the meeting facilitator to inform the IRB Chair if quorum is lost during a meeting. If quorum is lost during the course of a meeting, the IRB Chair will not allow any further action or votes to be taken until quorum is restored. Quorum as defined in this policy (see “Definitions” above) must be maintained for each vote to occur.
  2. Procedures for Voting
    • A majority of members must vote in favor of an action for that category of action to be accepted by the IRB. Majority is defined as more than half of the total number of IRB members attending the meeting at which the vote takes place. Only regular and alternate members acting in place of absent regular members may vote.
    • The meeting facilitator is responsible for counting and documenting all votes.
  3. Procedures for the Use of Conferencing Technology During a Convened Meeting
    • Convened Meeting with a Member Joining Remotely
      Should a member not be able to be physically present during a convened meeting, but is available remotely, the meeting can be convened using video or audio conferencing. The member who is not physically present will be connected to the rest of the members via conferencing technology. The member must be able to hear the discussion and be heard by the convened members. In this manner, all members will be able to discuss the protocol even though one or more members are not physically present. Members participating by audio or video conferencing may vote, provided they have had an opportunity to review all the material the other members have reviewed.
    • Meetings Conducted Via Conferencing Technology (Virtual Meetings)
      Meetings may be convened via audio or video conferencing. To allow for appropriate discussion, all members must be connected simultaneously for an audio or video conference to take place. All members must be able to hear one another to allow for discussion.
      • A quorum (as defined above) must participate for the conference call meeting to be convened.
      • Members not present at the convened virtual meeting via audio or video technology may not vote on an issue discussed during that meeting. (Voting by proxy is not permitted).
      • Contacting members individually via telephone is not acceptable as a method to conduct a virtual meeting. However, using conferencing technology tools to poll members present in a virtual meeting is acceptable.
  1. Procedures for Managing Conflicts of Interest
    • Each meeting agenda includes a statement reminding IRB members to declare any potential conflict(s) of interest he/she may have with research that is reviewed.
    • The IRB Chair begins each meeting with a statement requesting IRB members to declare any potential conflict(s) of interest he/she may have with items on the agenda. A verbal declaration of any such conflict is recorded by the meeting facilitator in the minutes of the meeting. When the meeting facilitator is aware of conflicts prior to the meeting, he/she will inform the IRB Chair. The meeting facilitator will document specific IRB member recusals as they occur throughout a meeting in the meeting minutes.
      • IRB members are required to electronically sign the IRB Member Recusal Agreement initially and annually.
      • Ad hoc consultant reviewers are required to disclose to the IRB any real or potential conflicts of interests involving the review of any specific research protocol. The meeting facilitator provides the ad hoc consultant with the IRB Conflict of Interest Disclosure prior to the review of a research protocol. If a conflict of interest is disclosed, the IRB will not permit the requested ad hoc consultant to review the research project forming the basis for the conflict.
      • IRB members, alternates, or others with a conflicting interest may not participate in any portion of the review of research activities except to provide information requested by the IRB and must excuse themselves from the meeting during the IRB’s deliberative discussion and vote on the affected research.
      • IRB members, ad hoc consultants, and other attendees may excuse themselves from the discussion and vote for any reason, if he/she feels it is necessary to avoid any appearance of a conflicting interest.
  1. Procedures for Maintaining IRB Confidentiality Agreements
    • All material received by the IRB will be considered confidential and will be distributed only to meeting participants (regular members, alternate members and ad hoc consultant reviewers) for the purpose of review. All application materials will be stored in OPRS electronic file locations, with access limited to the IRB members and staff.
    • Ad hoc consultants and visitors will be expected to sign the IRB Confidentiality Agreement and will receive printed copies of applicable documents as necessary. The meeting facilitator is responsible to have each ad hoc consultant(s) or visitor(s) sign the IRB Confidentiality Agreement prior to the start of the meeting. These agreements will be maintained and filed by the OPRS Office staff.

IRB members are required to electronically sign the IRB Confidentiality Agreement initially and annually.