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  • 1.  Submission form types

    CAYUSE CHAMPION
    Posted 06-03-2021 05:59
    I am finally working on creating split-off submission forms for Not Human Research determinations and Single IRB. Does anyone have templates that they would care to share?

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    Angela Bain, CIP, CIM
    Director, IRB Office
    Kennesaw State University
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  • 2.  RE: Submission form types

    CAYUSE CHAMPION
    Posted 06-03-2021 11:09
    For not human subjects research, we usually handle via a telephone consult and then issue a not human subjects determination letter.  We don't require an application for not human subjects.  I'm curious to see what others do, too!

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    Kris A. Monahan, Ph.D.
    Director Sponsored Projects and Research Compliance
    Providence College
    Providence, RI
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  • 3.  RE: Submission form types

    CAYUSE CHAMPION
    Posted 06-03-2021 11:44

    Angela,

    At Southeast Missouri State, we have a form to help determine whether a project is human subjects research. In addition, our IRB chair will also discuss the project with the PI to help make the determination. 



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    Pamela Vargas
    Director, Research & Grant Development
    Southeast Missouri State University
    Cape Girardeau MO
    573-651-2018
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  • 4.  RE: Submission form types

    CAYUSE CHAMPION
    Posted 06-03-2021 13:26
    Hey, Pamela--I'd love to see your form!

    cheers,
    -Lisa

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    Lisa Churchill
    Sr. Grants Information Manager
    The Salk Institute for Biological Studies
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  • 5.  RE: Submission form types

    CAYUSE CHAMPION
    Posted 06-03-2021 13:43
    Edited by Simon Helton 06-14-2021 10:33
    I'm currently on the road, but you should be able to view it here:

    https://semo.edu/pdf/psych-HumanResearchDeterminationForm.pdf
    Semo remove preview
    View this on Semo >

    And I think we borrowed a lot from others. 😊

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    Pamela Vargas
    Director, Research & Grant Development
    Southeast Missouri State University
    Cape Girardeau MO
    573-651-2018
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  • 6.  RE: Submission form types

    CAYUSE CHAMPION
    Posted 06-03-2021 11:45
    About this I know nothing.  But our IRB people are goddesses of form creation.  If you want me to connect you to them, I certainly can.


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    Andrea Buford
    Director, Office of Sponsored Programs
    Oakland University
    Rochester MI
    (248) 370-3789
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  • 7.  RE: Submission form types

    CAYUSE CHAMPION
    Posted 06-03-2021 13:23
    There are often multiple variables to consider in making a determination of Not Human Research, so we employ the hands-on approach described by Kris, and at this point it's manual (the Grant Administrator sees an indication that human materials are involved, yet the human subjects question is ticked as no, for instance: email the PI and IRB secretary suggesting a conversation).  When we migrate to the platform, we plan to structure the IPF questions such that certain scenarios like that will automatically trigger an IRB team email notification.

    For Single IRB, we don't have a great deal of non-exempt human subjects research, but I believe the plan is to keep it simple and formally designate the lead institution's IRB in those cases.

    cheers,
    -Lisa

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    =+=+=+=+=+=+=+=+=+=+=+=+=+=+=+=+
    Lisa Churchill
    Sr. Grants Information Manager
    The Salk Institute for Biological Studies
    ------------------------------



  • 8.  RE: Submission form types

    CAYUSE CHAMPION
    Posted 06-04-2021 06:18

    Hi Angela,

    We created this form a while ago, so it may need to be refreshed a bit to better conform to some of the 2018 changes.  It is not designed to be an official determination, but has been pretty useful for many of the marginal cases.

    https://www.american.edu/irb/irb-determination.cfm

    If they need an official determination, the researcher could use Cayuse to fill out only the required fields, or if we have previously discussed, we can generate a letter manually.  If the research is funded we would push them to use Cayuse for the synergy with SP.

    If you would like me to share the Google form so you can edit, let me know!


    https://www.american.edu/irb/irb-determination.cfm



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    Matt Zembrzuski
    Research Compliance Manager
    American University
    Washington, D.C. DC
    202-885-3447
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  • 9.  RE: Submission form types

    CAYUSE CHAMPION
    Posted 06-14-2021 06:20
    Thank you all. I used your templates to create one that I think I like.  I imbedded it our submission form also to provide an additional pathway for making that determination.  I find so many submissions that are class projects and not research, even though we have guidance on our website.  I decided to add a question about it on the submission form to see if I can get that number down.  I'll let you all know how well it works.

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