1.31 Observers at IRB Meetings

Last Revised: 2/11/26/20182025

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for allowing observers at a convened IRB meetings.meeting. For this policy, potential IRB members and persons who routinely attend to represent another regulatory or academic unit or committee (such as SRC, Privacy Office, Research Compliance Office) are not considered “observers.”

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2.0 Policy

• 2.1.

  It is the policy of the Organization that

  non-
  • 2.1. Non-members who have a legitimate reason,reason may be allowed to observe convened IRB meetings.
  • 2.2. It is the policy of the Organization that anAn investigator whose protocol is being reviewed by the IRB at thata convened meeting may attend that portion of the meeting for the purpose of providing information to, and answering questions of,from, the convened board.

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  3.0 JustificationGeneral for AttendanceComments

  • 3.1. With appropriate justification, the full IRB, theconvened IRB Executive Committee, or the IRB Executive Chair has authority to permit an observer at a convened meeting of any of the IRBsIRBs.
    • 3.1.1. In general, adequateappropriate justification would include a legitimate job job-related interest in the process of IRB review, or an academic interest in research ethics and the functioning of IRBs in general.
    • 3.1.2. Persons who are being considered as potential IRB members may observe one or more convened IRB meetings.
  • 3.2. In decidingconsidering whether to allow a particular observer, the full IRB, theconvened IRB Executive Committee, or the IRB Executive Chair willmight consider whether the same or similar benefit could be obtained from alternate experience (for example, an IRB orientation or didactic presentation).
• 3.3.2. The fullconvened IRB or the Executive Chair may invite an investigator whose protocol is being reviewed by the IRB at that convened meeting to attend that portion of the meeting,meeting for the purpose of providing information to, and answering questions of,from, the convened board.

3.3.

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All

4.0observers Procedure

• 4.1. The IRB Administrator responsible for coordinating the meetings will arrange for the appropriate meeting for the observer to attend.
• 4.2. The observer will be required tomust sign a confidentiality agreement prior to the scheduled meeting.
• 3.4.3. The presence of an observer will be recorded in the IRB minutes, as per HRPP policy 2.2 (Full IRB Review).
• 4.4. For observers:
  • 4.4.1.3.5. In general, observers will not participate in the discussion of agenda items.
  items
  • unless 4.4.2.specifically The observer may be required to leave the room during any discussion or vote as determinedrequested by thean ChairIRB chair or Executive Chair, or at the request of any board member.
  • 3.6. 4.4.Specific comments for (non-investigator) Observers:
    • 3.6.1. No observer will be permitted to attend a portion of the meeting where he/she has a COI, as per HRPP policy 1.7 (IRB Member, Consultant, Staff COI Identification and Management).
    • 3.6.2. The observer may be required to leave the room during any discussion or vote as determined by the Chair or Executive Chair, or at the request of any board member.
  • 3.7. 4.5.Specific Forcomments invitedfor Invited investigators:
    • 4.5.3.7.1. An invited investigator may only attend during the review of his/hertheir protocol.
    • 4.5.3.7.2. An invited investigators may provide information to, and answer questions of, the convened board. He/she may, at the request of the board, participate in the discussion regarding his/her protocol.
    • 4.5.3. The invited investigator will leave the room after he/shethey hashave provided the requested information, before final discussion or vote.

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  DOCUMENT HISTORY:

   Written: 2/26/2018 (Approved: 2/26/2018) - original author not recorded

   Revised 11/26/2025 – deleted procedures more appropriate for SOP; clarified persons not considered “observers” for the purpose of this policy; stylistic changes.