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  • 1.  Deleting Submissions

    CAYUSE CHAMPION
    Posted 01-04-2023 07:16
    Hello and Happy New Year!

    New to Human Ethics and just wanted to see how other institutions handle this. If understanding correctly, only initial applications can be deleted (https://support.cayuse.com/hc/en-us/articles/360055251633-Deleting-a-Study-or-Submission). How do other institutions handle modifications, etc submissions that were submitted, returned but the PI is unable to delete the application? Also the Admin is unable to delete the application.

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    Amanda Hong
    IRB Coordinator
    Mount Sinai Hospital
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  • 2.  RE: Deleting Submissions

    RISING STAR CONTRIBUTOR
    Posted 01-20-2023 07:31
    Unfortunately, the best work around that we've found for this issue is to just ask PIs to remove everything that was made to a modification and to then use that same modification submission for future amendments. This is a very confusing and sloppy workaround, but it's the best one that we have found.

    The only other option that we've thought of but we've never used (although Cayuse has confirmed that it would work) is to use the decision of Disapprove. For modifications, this decision is supposed to close the submission but make it so none of the changes are incorporated into the application/protocol and future modifications copy from the previously approved submission. We've chosen not to use this approach since Disapprove has such an important meaning in the Common Rule that we'd never want an audit of our records to show that a bunch of submissions we disapproved. Technically, we could note in our SOPs and other documents how/why we use this workaround so that it could be explained/justified during an audit (we certainly have to do this for a number of other workarounds within Cayuse HE) but it's still something that we wouldn't feel comfortable implementing.

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    Scott Fisher
    Director for the Human Research
    New York University (NYU)
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  • 3.  RE: Deleting Submissions

    RISING STAR CONTRIBUTOR
    Posted 01-23-2023 05:28

    I actually tested the disapprove option on a test study because I was wondering if it could be an alternative to asking the PI to return everything to how it was previously approved. It did apply the changes that were requested with a disapprove decision and was not a reliable option for us. 


    Jennifer Boe, MA

    she/her/hers

    Sr. IRB Analyst    

    Human Research Protections Office

    Hennepin Healthcare Research Institute


    Provide feedback or comments for HRPO/IRB at: https://www.surveymonkey.com/r/TXG82DL  






  • 4.  RE: Deleting Submissions

    RISING STAR CONTRIBUTOR
    Posted 01-23-2023 06:42
    Oh my! Thank you for testing that Jenny. Looks like Cayuse may have misinformed us. We'll test it ourselves also and let Cayuse know that it needs to be fixed if we get the same result as you.

    I also should have noted in my prior post that you have to assign a submission for full board review in order to have Disapprove as a option (as it should be, since the regs require full board review for disapproval), but that's even more of a reason to NOT use it for the administrative purpose of closing/"deleting" a submission.

    Thanks again!

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    Scott Fisher
    Director for the Human Research
    New York University (NYU)
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  • 5.  RE: Deleting Submissions

    RISING STAR CONTRIBUTOR
    Posted 01-23-2023 07:20

    Please let me know what you find out! I tested it back in June 2022 so it is possible things have changed. But I agree with your reasons as well for why it isn't an ideal solution, even if it does not apply the changes. 


    Jennifer Boe, MA

    she/her/hers

    Sr. IRB Analyst    

    Human Research Protections Office

    Hennepin Healthcare Research Institute


    Provide feedback or comments for HRPO/IRB at: https://www.surveymonkey.com/r/TXG82DL  






  • 6.  RE: Deleting Submissions

    CAYUSE CHAMPION
    Posted 01-25-2023 07:16
    Appreciate everyone's feedback. This has been the most helpful tread so far. Please let us know if there are any changes you see or other work arounds. Will definitely try this out with our PIs and their coordinators.
    And continue advocating what changes we would like to see in Cayuse!

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    Amanda Hong
    IRB Coordinator
    Mount Sinai Hospital
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  • 7.  RE: Deleting Submissions

    RISING STAR CONTRIBUTOR
    Posted 01-30-2023 08:45
    We just tested the disapprove method and confirmed the same outcome as Jenny -- the changes to the disapproved modification appeared in the next modification. So this is definitely NOT an option for "deleting" submissions. Sorry for any confusion from my previous statements (they were based on what Cayuse told us...)

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    Scott Fisher
    Director for the Human Research
    New York University (NYU)
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  • 8.  RE: Deleting Submissions

    TEAM CAYUSE
    Posted 02-01-2023 09:58
    Edited by MK Karafonda 02-01-2023 09:58
    Thank you for bringing this to our attention.  This problem has been top of mind within our Product team.  In addition to resolving the disapprove defect, we are looking at ideally building out the workflow to allow submissions to be closed through a withdrawal that is initiated by either the PI or the analyst.  We expect to have this available within a future version of IRB this year.  Again, thank you for surfacing this.  We recognize that it is important for us to resolve this.


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    MK Karafonda
    Sr Product Manager
    Cayuse
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