Hi Carla,
It looks like you asked this question to the IRB Forum, so hopefully you'll get a response there as well about what other IRBs are doing in general re: flex review.
Specific to Cayuse and IRB flex review, though, I'd say that when we've thought about possibly implementing flex review we felt that Cayuse HE wasn't set up well for it. For instance, many IRB's that use flex review create their own flex categories of approval, but Cayuse doesn't allow each institution to control the categories of approval on the Make Decision task. Similarly, institutions can't create their own review type in Cayuse HE, so they'd have to use one of the existing review types -- admin, exempt, expedited, full board -- to capture the flex reviewed studies. For many reasons we felt that any work arounds in Cayuse HE for these problems would just make things too unclear and potentially create problems (e.g., we didn't want a reviewer to accidently review something as flex when it was supposed to be non-flex expedited).
And I don't think that the benefits of flex review would outweigh the complications of using separate systems -- one for federally-funded, non flex and the other for flex -- so until Cayuse HE can better accommodate flex reviews I don't think that we'll consider implementing it.
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Scott Fisher
Director, Human Research Protection Program
New York University (NYU)
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Original Message:
Sent: 04-08-2025 06:55
From: Tina Aubut
Subject: IRB Flex Review process
We do have a Request for Determination of Human Subject Research form in Cayuse we built.
We moved to Cayuse so we could build what we wanted that fit our institution. We started with their template and continue to make it our own.
We are AAHRPP accredited, which does drive some parts of our forms and SOPs.
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Tina Aubut
Research Protection Assistant
University of Southern Maine
Office of Research Integrity and Outreach
PO Box 9300, 126 Bedford Street
Portland, Maine 04104
ph (207) 780-4517
Original Message:
Sent: 4/8/2025 9:45:00 AM
From: Sharla Miles
Subject: RE: IRB Flex Review process
Hi Tina,
Thanks so much for your reply-and for sharing those helpful links!
When I refer to a flex review, I'm thinking about a process we can use for human subjects research that does meet the federal definition of "research," but isn't subject to the Common Rule or FDA regulations-typically because it's not federally funded and our institution has unchecked the box.
Unchecking the box gives us some flexibility in how we review these studies, allowing us to design a process that's still grounded in ethical principles but more proportionate to the level of risk involved. It's a way to reduce administrative burden while maintaining appropriate protections for participants.
I appreciate you sharing how USM moved everything into Cayuse HE-that's really helpful as we think through the logistics of managing flex reviews within our own system.
Best,
Sharla Miles
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Sharla Miles, M.Ed., CIP
Research Compliance Specialist
Sam Houston State University
Huntsville, TX
(936) 294-4875
sharla_miles@shsu.edu
Original Message:
Sent: 04-08-2025 05:40
From: Tina Aubut
Subject: IRB Flex Review process
I can't seem to reply within Cayuse. Anyhoo, I'm not sure what you define as "flex review." All of our submissions are now in Cayuse HE. From paper and Google forms to Cayuse HE. It became too difficult to track over multiple platforms.
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Tina Aubut
Research Protection Assistant
University of Southern Maine
Office of Research Integrity and Outreach
PO Box 9300, 126 Bedford Street
Portland, Maine 04104
ph (207) 780-4517
Original Message:
Sent: 4/2/2025 11:37:00 AM
From: Sharla Miles
Subject: IRB Flex Review process
Good afternoon Cayuse Human Ethics Community,
I hope this message finds you well.
As part of my institution's FWA renewal this year (June 2025), we will be officially "unchecking the box"! In preparation for this change, I have been tasked with developing an IRB flex review process, including an SOP to guide our research community through this new approach.
I would greatly appreciate insights from SBER IRB administrators and IRB Chairs who have already implemented a flex review process at their institutions. Specifically, I'd love to hear about:
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How your institution approaches flex reviews and what the process entails.
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How submissions are processed-do you use an electronic system (Cayuse HE), and if so, is it the same system used for federally funded IRB submissions?
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Whether your IRB delegates flex reviews to IRB office staff or if the IRB still plays a role in the review process.
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What criteria your institution uses to determine eligibility for flex review.
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How you communicate the flex review process to researchers.
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What safeguards you have in place to ensure compliance with ethical standards.
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Any feedback you have received from researchers regarding the process that you would be willing to share with me.
Additionally, are there any key considerations or challenges you've encountered in implementing and managing flex reviews? Any guidance or lessons learned would be incredibly valuable.
Thank you in advance for your time and insights-I look forward to learning from your experiences!
P.S. You are free to reply directly to me at irb@shsu.edu if you don't feel comfortable replying here. Thank you again.
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Sharla Miles, M.Ed., CIP
Director, Research Compliance
Sam Houston State University
Huntsville, TX
(936) 294-4875
sharla_miles@shsu.edu
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