Minutes are taken at each IRB Committee review meeting. Minutes include a list of all studies that were voted on at the meeting, and include separate deliberations, actions, and votes for each protocol undergoing initial or continuing review by the convened IRB. The vote on all IRB actions include the number of persons voting for, against, and abstaining, in order to document the continued existence of a quorum. The minutes include the documentation of risk as well as the names of any members not participating in the review due to actual or perceived conflicts of interest. The minutes also include documentation of all expedited and exempt applications that were reviewed since the last meeting, and their current status (e.g., approved, pending).
The UNI IRB meets monthly on the 2nd Thursday of the month in East Bartlett Hall. The agenda includes approval of minutes, announcements, review of protocol applications requiring full board review, review of any expedited, exempt, or continuing protocols that members believe need full board discussion, education/training activities for Board members, special topic discussions, and IRB operational business. If no protocols are pending review by the full IRB and no other pressing business is on the agenda, the Chair and IRB Administrator may elect to cancel a meeting. Special meetings may also be called as needed to attend to urgent matters.
Investigator and Visitor Attendance
Protocol reviews are considered confidential, but visitors who wish to address the Board or discuss a particular issue should notify the IRB Administrator of their desire and request to be placed on the agenda for a specific time. Investigators with applications under review by the Board are very welcome and encouraged to attend their portion of the meeting. They should likewise inform the IRB Administrator of their intention to attend the meeting. Attendance by the PI often moves the review along more quickly and increases the likelihood that the protocol can be approved following minor adjustments (rather than needing to be taken up again at the next monthly meeting). Investigators or visitors arriving to participate in a discussion of their application or issue should be seated in the reception area and wait to be called into the meeting at the appropriate time. In the event that the PI chooses not to attend, the IRB member facilitating that review (typically the Chair) will send an email to the PI following the meeting, outlining the discussion and any requests made by the IRB for edits or procedural adjustments.
A quorum is required in order to take formal action on a given application in a convened IRB meeting (voting to approve or disapprove). Quorum is comprised of a simple majority of members eligible to participate in that particular review. All regular members count towards the quorum unless they have a conflict of interest with a particular application, in which case they are requested to leave the room during final discussions and voting. If there is no regular nonscientist present and eligible to participate, an alternate nonscientist may be considered in the quorum count. Similarly, scientist alternates may substitute for scientist regular members. If the study requires the presence of a prisoner advocate, the individual designated to serve in that capacity will be counted in the quorum, whether s/he is a regular or alternate member.
Timing of Submissions
A meeting schedule is posted for the convenience of the campus which shows the IRB meeting dates, along with the dates by which a protocol should be submitted to the IRB office in order to leave sufficient time for IRB members to consider it before the meeting date. Minimal risk protocols may be submitted at any time during the month.