What should happen if an IRB member who is also the Principal Investigator must recuse themselves during deliberation?

When an Institutional Review Board (IRB) member who is also the Principal Investigator must recuse themselves from deliberation on a proposal, it typically affects the quorum requirements necessary for conducting a meeting and making decisions. Quorum refers to the minimum number of members needed to be present to make the meeting's proceedings valid and to ensure that decisions reflect a collective, unbiased judgment.

If a member recuses themselves, depending on the rules governing the specific IRB, this could result in a situation where there are not enough members remaining to meet the quorum requirement. Consequently, to maintain integrity and adherence to ethical standards in the review process, it would be necessary to defer the proposal to the next meeting rather than proceeding without proper quorum. This ensures that all proposals are given fair and thorough consideration by a complete set of IRB members, thereby upholding the ethical review process and protecting study participants.