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  • 1.  Hazard Safety (IBC) Application - How do you handle this logic of the Human/NHP section?

    Posted 13 days ago

    Hi All,
    When our PIs indicate that they're using Human/Non-Human Primate materials on the Options page of our IBC application, four pages animate -- one of which is "Cell Lines Details" -- for covering the use of cultured cell lines.  However, for investigators using human blood, saliva, semen, purified hormone, etc., the questions regarding cultured cell lines aren't relevant.  There's nothing they can click on this page to indicate "not applicable" and move on, which is confusing.  As far as I can tell, our application came with this logic.  How are you all thinking about this and using it?  Or did you have Cayuse change the logic?  We would rather not clutter up our "cell line" data dictionary with all sorts of non-cell line entries and force PIs to complete this page.



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    Caitlyn Conley
    Administrative Support
    Oakland University
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  • 2.  RE: Hazard Safety (IBC) Application - How do you handle this logic of the Human/NHP section?

    CAYUSE CHAMPION
    Posted 13 days ago
    Hi Caity,
    I am so glad this message came through when it did. My institution is currently at the final stages of the Hazard Safety implementation, so this will give me a chance to confirm if our application is set up in this manner. Hopefully, my consultant will be able to configure the form to include a way to indicate N/A. Thank you.

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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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  • 3.  RE: Hazard Safety (IBC) Application - How do you handle this logic of the Human/NHP section?

    Posted 12 days ago
    I just had this issue with our implementation!

    I provided instructions on what they should select, and created a "HNHP cell line" in the dictionary that is "N/A (samples only)" as well as an "Acquisition Source" designated "N/A."

    On the Cell Lines screen, the instructions say:
    If you are only using human specimens, please "Add Cell Line" and follow the instructions on that page.

    The Cell Line edit screen has these instructions:

    Start typing in the box to search for the cell line

    All questions with red asterisks require an answer

    If you are not using cell lines but only human samples:

    • Select "N/A" in the search field below
    • Select the appropriate biosafety level
    • Choose "N/A" for the Acquisition Source
    • Choose "Primary (Fresh)" for the Passage

    I hope this helps!

    Kristine

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    Kristine F. Nowak, Ph.D.
    Director of Research Compliance
    Kennesaw State University
    knowak@kennesaw.edu
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  • 4.  RE: Hazard Safety (IBC) Application - How do you handle this logic of the Human/NHP section?

    CAYUSE CHAMPION
    Posted 12 days ago
    Hi Caitlyn,

    We faced similar confusion from our PIs on this topic, and so added "NONE" as an option under HNHP Cell Lines in the IBC List setup for IBC Agents.

    We also have issues with the term "Agents" in this area because these are not Select Agents, which also causes confusion.

    Hope this is helpful.

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    Sherrie Hixon
    Director, Strategic Research Initiatives & Innovation
    California State University, Northridge (CSUN)
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  • 5.  RE: Hazard Safety (IBC) Application - How do you handle this logic of the Human/NHP section?

    TEAM CAYUSE
    Posted 12 days ago

    Hello Caity,
    You are correct in assuming that is the correct logic for the system. What you can do, is add Not Applicable to your HNHP Cell Lines in your dictionary. It would be best to add further instructions for your PIs on how they should address any other required information on that page. Hope this helps.



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    Shelley Phillips
    Professional Services Consultant
    Cayuse
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  • 6.  RE: Hazard Safety (IBC) Application - How do you handle this logic of the Human/NHP section?

    Posted 10 days ago
    Hi All,

    Thanks for your replies!  It's instructive to know that others are encountering the same confusion that we are.  Kristine and Sherrie -- I really appreciate the descriptions of how you've dealt with this situation.  And Sharla -- good luck with your implementation!  I'd be interested to hear what solution you and your consultant work out.

    Shelley, if this is the correct logic for the system, can you explain the rationale for requiring completion of the Cell Lines Details page when the PI is using HNHP materials that aren't cell lines, rather than differentially animating the Cell Lines Details page based on the answer to a question like "Will you be using cultured cells?"?

    Thanks!



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    Caitlyn Conley
    Administrative Support
    Oakland University
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  • 7.  RE: Hazard Safety (IBC) Application - How do you handle this logic of the Human/NHP section?

    TEAM CAYUSE
    Posted 6 days ago
    Hello Caitlyn,

    This is the out-of-box form, which was designed based on input from many different customers. During implementation/focus sessions, we would address and update the from/questions to match your institution.

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    Shelley Phillips
    Professional Services Consultant
    Cayuse
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