We handle it inside the initial submission template. The first section an investigators sees after the introduction statement is called "Getting Started." In that section they can choose the option "I need to know if my activity is considered "Human Subjects Research." which takes them through the determination questions. If their responses indicate HSR, they are "routed" to continue with the remaining Initial Submission sections. If their responses indicate possible NHSR, they are given the option of requesting an official determination. If they want an official determination, they provide a brief description of the HSR activities and complete a few additional Initial Submission sections. Then the ORCA staff review it and make the determination.
We use an off-site google form for a self-determination, but stipulate that it is NOT an official determination.We chose this after attempting to integrate it into the main form for a few reasons1) We would be bombarded by student projects, oral histories, and journalistic papers that do not need IRB review, and do not need official determinations. 2) Since there is only one initial submission type, we found many of our users get confused with too many choices at the beginning of the form. For example, we tried having the smart form check if a reliance agreement is in place, or if the study qualifies for IRB review. Too many users filled this incorrectly and the submission had to be returned several times with emails outside of the system guiding them correctly. I suppose for some researchers, trying to find a way out of IRB review was worth more effort than completing the streamlined application?3) If the work is seeking or has funding, or if an official determination is needed, we would ask for an initial submission with basic descriptions that can lead to NHSR determination. This way the determination is synced with the SP file. We do have an NHSR determination in our letters template We generally do not track the determinations as most are unofficial.
If you are interested in the Google form we use, it is here - https://forms.gle/VN6Y5cXP3jcNRfM78
------------------------------Matt ZembrzuskiResearch Compliance ManagerAmerican University------------------------------
This is part of why we added the process I noted in my prior post. Namely to track NHSR determinations as part of our office workload and to assess the potential need for educational outreach.Jenn
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