Hi Angela,
Thank you so much for your reply. I was thinking about some workflow/logic in a template within Cayuse that would allow for the capturing of appropriate information to determine. We often get a determination from a Hospital IRB with little information provided to us.
The guidance document is helpful.
The areas we struggle with are:
- sometimes "new" procedures are being implemented and it is a pre/post intervention change investigation
- We are unsure if the external entity is ok being identified by name in publications/presentations
- Most of these projects are doctoral students
- We are unsure if the investigator has access to the data as part of their normal duties or if they have the clearances to use the data the way they intend
- Particularly classroom research has been even confusing in this aspect - as students' often do not consent to their information/evaluations being used
I appreciate the guidance sheet. Do you incorporate this in to Cayuse at all?
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Nicky Cattano
Associate Professor (co-chair of IRB)
West Chester University Pennsylvania
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Original Message:
Sent: 01-05-2022 06:21
From: Angela Bain
Subject: QI/QA
Hi Nicky,
Are you looking to have the IRB review these QA/QI projects or is this form meant to help with determinations that they are or are not human subjects research? I have a human subjects research determination form that I have incorporated in our submission that is meant to help the researchers determine if their project requires IRB review. I also have a guidance document for QA/QI vs. Research that might be helpful.
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Angela Bain, CIP, CIM
Director, IRB Office
Kennesaw State University
Original Message:
Sent: 12-31-2021 03:27
From: Nicky Cattano
Subject: QI/QA
Hi there-
We are currently investigating a template that would work best for QI/QA projects. We have 3 doctoral programs whose protects often involve QI/QA projects- yet the distinction nbetween research and QI/QA has not been easily apparent.
Any advice from folks would be very much appreciated.
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Nicky Cattano
Associate Professor (co-chair of IRB)
West Chester University Pennsylvania
she/her
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