Skip to main content

1.31 Observers at IRB Meetings

Last Revised: 11/26/2025

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for allowing observers at a convened IRB 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.”

2.0 Policy

It is the policy of the Organization that

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

3.0 General Comments

  • 3.1. With appropriate justification, the convened IRB or the IRB Executive Chair has authority to permit an observer at a convened meeting of any of the IRBs.
    • 3.1.1. In general, appropriate justification would include a legitimate job-related interest in the process of IRB review, or an academic interest in research ethics and the functioning of IRBs in general. In considering whether to allow a particular observer, the convened IRB or the IRB Executive Chair might consider whether the same benefit could be obtained from alternate experience (for example, an IRB orientation or didactic presentation).
  • 3.2. The convened IRB or the Executive Chair may invite an investigator whose protocol is being reviewed by the IRB to attend that portion of the meeting for the purpose of providing information to, and answering questions from, the convened board.
  • 3.3. All observers must sign a confidentiality agreement prior to the scheduled meeting.
  • 3.4. The presence of an observer will be recorded in the IRB minutes, as per HRPP policy 2.2 (Full IRB Review).
  • 3.5. In general, observers will not participate in the discussion of agenda items unless specifically requested by an IRB chair or member.
  • 3.6. 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. Specific comments for Invited investigators:
    • 3.7.1. An invited investigator may only attend during the review of their protocol.
    • 3.7.2. The invited investigator will leave the room after they have provided the requested information, before final discussion or vote.

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.

Back to top