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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Original Message:
Sent: 01-04-2023 07:16
From: Amanda Hong
Subject: Deleting Submissions
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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