Motions & Voting

Motio​ns – Full Board IRB

How to

  • After discussion by the IRB, a motion is made from a board member.
  • Examples of IRB motions new project, modification and continuing review applications include:
    • A motion was made to approve
    • A motion was made to approve pending required actions
    • A motion was made to table
    • A motion was made to disapprove

A motion to Approve

  • Requires an assessment of the length of approval. The maximum approval is 365 days from the date of the meeting. The IRB can require a project to have review more frequently than annually – See the manual section called “CR – Criteria for More Frequent Review.”
  • Can only move to approve if no substantive changes required
  • If IRB asks for new procedures for consent/recruitment materials a motion to approve can only occur if:
    • IRB determines specific wording
    • IRB only makes minor wording changes (typos, grammar) Then, if there are no other changes, motion can be to approve and minutes will indicate that IRB made these changes.

A motion to Approve Pending Required Revisions

  • Requires an assessment of the length of approval. The maximum approval is 365 days from the date of the meeting. The IRB can require a project to have review more frequently than annually – See the manual section called “CR – Criteria for More Frequent Review.”
  • If changes requested require only simple concurrence by the PI/research team.

A motion to Table

  • When the IRB requests of the PI/research team: clarification, additional materials, explanation, justification, simplification, amplification, provide additional… for ANY part of the application.

A motion to Disapprove

  • Significant changes are needed
  • Unethical to conduct the study
In the case of the review of Reportable Event Forms (REFs), since the form records an event and the IRB role is to review the event, there is no “approval/disapproval.”
Examples of IRB motions with regard to REFs include:
  • A motion was made to accept the REF
  • A motion was made to accept the REF pending required actions
  • A motion was made to table the REF
  • A motion was made to withdraw the REF

Voting – Full Board IRB

IRB members vote to agree or disagree with the motion or the member can choose to abstain (abstain is effectively counted as disagree).
At the discretion of the Chair, this vote may be by written ballot or a show of hands.

What constitutes approval of the motion?

  • A majority count of “agrees” of the members present at the meeting is required for the motion to be approved.

What is recorded in the minutes regarding the motion & vote

  • The official meeting minutes record the motion that was made from the board and the number of votes which agree or disagree with the motion as well as the number abstaining.
  • In the event a member of the IRB is not present for the discussion and vote, the minutes record the identity of the individual who was not present and, if the member was recused, the reason for recusal.