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  • 1.  QI/QA

    Posted 12-31-2021 03:28
    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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  • 2.  RE: QI/QA

    STAR CONTRIBUTOR
    Posted 01-05-2022 06:21
    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
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  • 3.  RE: QI/QA

    STAR CONTRIBUTOR
    Posted 01-06-2022 06:21
      |   view attached
    Attached is the guidance that I mentioned

    ------------------------------
    Angela Bain, CIP, CIM
    Director, IRB Office
    Kennesaw State University
    ------------------------------

    Attachment(s)



  • 4.  RE: QI/QA

    Posted 01-07-2022 05:28
    Thank you, Angela! This is a great resource.

    April

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    April Gravitt, M.S., CIP
    Associate Director - IRB
    The Chicago School of Professional Psychology
    Chicago, IL
    agravitt@thechicagoschool.edu
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  • 5.  RE: QI/QA

    Posted 01-06-2022 09:49
    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
    ------------------------------



  • 6.  RE: QI/QA

    STAR CONTRIBUTOR
    Posted 01-06-2022 12:20
      |   view attached
    I attached our initial submission form which has the determination of human subjects research form within.  I hope it is helpful.

    ------------------------------
    Angela Bain, CIP, CIM
    Director, IRB Office
    Kennesaw State University
    ------------------------------