Good day, Leigh!
I am sorry it has been so long since you posted! I thought for sure another awesome community member might have posted something before one of us Cayusians stepped in :-)!
So, the answer to your question is "yes" and it depends on the future involvement of this person for later use as a Subject Matter Expert (SME).
You "could" identify a Guest SME on your committee; however, beware that as a committee member (with those permissions in the system), they would have visibility to all IRB studies. If this person will be a regular, perhaps going through the process of making them a non-voting, ex officio or external lay member would work for CLU. This will of course depend on your IRB's willingness to allow that much visibility to an SME.
If this is rare occasion that you just need a review from a SME, then it might be wise to attach a non-disclosure or confidentiality agreement/introductory email invitation from the IRB laying out the ground rules for an external reviewer (perhaps even providing a "checklist" to them to ensure they're looking at the areas of the application specifically requiring their insight). This is what we did at my former institution to ensure the right eyes were on the right information at the right time.
Prior to review, the SME also had to complete a Conflict of Interest form (akin to what our members signed to be on the committee) as well to ensure they were not involved in the project and were coming in to the conversation specifically to consult on the aims, scientific merit, or other information that the IRB may not have expertise on to determine potential risk to a human subject.
Once those forms were in hour hands, we proceeded to send the PDF of the study to the SME with a deadline review of before the scheduled IRB meeting (if Full Board review) so that we could determine a potential vote at the meeting.
We also invited the SME (and later the PI). They waited in the waiting room (on MS Teams), or in the hallway (when we had meetings in person) until that protocol was up for discussion.
I hope this helps. Thank you for the awesome, thought-provoking questions you bring to the community!
I encourage anyone else reading this post to jump in with your best practice ideas also!
Warm regards,
Darlene
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Darlene Nawrocki, MBA
Sr. Solutions Consultant, Compliance
Cayuse
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Original Message:
Sent: 02-08-2024 09:06
From: Leigh Schectman
Subject: Guest Reviewer/Consultant
Hi,
We have a submission that needs Full Board Review. We need to have an outside person/faculty assist with the review as we do not have an expert in this particular area on the IRB Committee. Is there a way to add someone as a "Guest" to the committee so that they can review the submission within Cayuse or is it best just to create a pdf of the submission and then email?
Thank you.
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Leigh Schectman, MPH
Research Protections Coordinator
California Lutheran University
Thousand Oaks, CA
lschectman@callutheran.edu
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