Hi Robin,
Following up on Darlene's reply, I would add that we use Incident submissions to process reports of noncompliance (i.e., PIs reports it and the IRB reviews/makes decisions about) but not to track noncompliance (i.e., report on/extract data about).
I don't believe there's any direct/straightforward way to track/report on noncompliance in the system. For instance, if an IRB "noted" a submission but determined that it included serious/continuing noncompliance or an unanticipated problem involving risks to subjects or others but didn't suspend the study, then there's no straightforward way to get this data out of the system (i.e., there are no reportable/searchable fields for this).
I'm hesitant to suggest this because I prefer not to use workarounds like this, but if there are any flags that you know your IRB would never use, then you could "recode" these flags for other purposes (you can't change the flags in the system, so within your office you'd need to keep track of how the flags are recoded). For instance, you could say that "HIGH PRIORITY" represents noncompliance. This would allow you to flag all studies that include noncompliance with HIGH PRIORITY and then report on that flag (although you couldn't report on the number of instances of noncompliance for an individual study since the flags are reportable at the study, not submission, level).
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Scott Fisher \
Director, Human Research Protection Program
New York University (NYU)
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Original Message:
Sent: 10-04-2023 16:50
From: Darlene Nawrocki
Subject: Processing & Tracking Noncompliance in Human Ethics
Good day, Robin!
There is an "Incident" form where a PI can self-report non-compliance (i.e., adverse events, protocol deviations). Is this something that you are implementing in your environment? If so, generally, the outcomes of these if/when added to meetings might be "noted" (as you mentioned) or the ability to determine to "suspend" a study since we are not really "approving" a reportable event. Incidents can have letter templates associated with them as well. Within your form, you might determine to add a section where a PI can attach or spell out how they intend to course correct moving forward and the steps they have taken in identifying the non-compliance and how they intend to resolve it. If the IRB is unsatisfied and feel moved to suspend the study, that is a determination that can result from an "Incident" as well. I'm happy to jump on a call with you if you require additional assistance! Feel free to send me an email and we'll set something up.
Warm regards,
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Darlene Nawrocki
Sr. Solutions Consultant, Compliance
Cayuse
Original Message:
Sent: 10-04-2023 11:14
From: Robin Devine
Subject: Processing & Tracking Noncompliance in Human Ethics
Hello-
We are in the process of implementing HE and I am wondering how other Institutions process and track noncompliance in HE. There is no decision of noncompliance and I don't see any flags involving noncompliance. I know that I can include a question in my reviewer worksheet (but that is not searchable for reports) and I can create a specific letter, but i don't see a way to keep track of it through reporting or to even look through all of the submissions in a study and know which one involves noncompliance.
If an event is submitted with an appropriate action plan, is the only action to 'note' it?
Any help would be appreciated.
Thanks
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Robin Devine, DO, CIP
Sr Medical Director, Academic Research & Human Subjects Protections
OhioHealth
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