Thanks to everyone who replied to my initial post. Based on your feedback, for now we have
Added a question to our Modification Submission "are you providing a post-approval document that couldn't be provided until RMU approved the project?" (our most common scenario)
We are processing these as exempt so staff can approve them.
We created a new letter template that states it was an "admin" review and the action was "acknowledged."
We have not yet worked out whether we will tag these studies, track them outside of Cayuse, or issue conditional approval/hold back stamped documents until we receive the document. Sometimes our PIs have multiple sites and only one letter of support is not available at submission.
Regards,
Darcy
It's not perfect or elegant, but will work for us for now.
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Darcy Hammar
Director, HRPP
Rocky Mountain University of Health Professions
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Original Message:
Sent: 04-08-2022 06:40
From: Darcy Hammar
Subject: Human Ethics - post-approval follow-up documents
Colleagues,
I will do my best to describe this briefly (esp on a Friday).
We have many PIs who are not co-located with our campus. We require a letter of support indicating permission to conduct the research at their site. Many sites won't sign the letter of support until IRB approval is granted, setting up a bit of a chicken and egg situation where the IRB ends up going first and issuing an approval letter so the letter of support can be obtained.
We use the Platform version of Human Ethics. We are trying to develop a workflow for submission and documentation of these post-approval letter of support documents. I've chatted with Support and our Success Manager, but wanted to throw it out here too. What we have thought of so far are:
Options for submission
- Modification - hope the PI only changes the question about the letter of support
- Renewal - add a choice of "follow up document" to the first question and display an appropriate Section
- Email - PI's email the document to staff; staff add the document as an attachment
Option for processing
- Designate Exempt and assign to an analyst. (Staff are not members of the IRB.)
Options for tracking
- Use one of the tags that we wouldn't normally use and agree it means "waiting for follow-up document."
- Track outside of Cayuse Human Ethics
What do your brilliant minds suggest?
Regards,
Darcy
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Darcy Hammar
Director, HRPP
Rocky Mountain University of Health Professions
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