Great discussion on Friday. Just a few points that came up -
1. We found the OHRP definition rather frustrating - They define "exempt" category: only for de-identified (or publicly available) data that existed before IRB evaluation. If there is prospective collection of data, then it should be classified as “expedited.” This was difficult for us to understand because all quality improvement work necessitates the collection of prospective data. This is the only way to know if a change has made an improvement.
2. When is work considered "research" and when is it considered "quality improvement?" Some of us suggested that this distinction is whether the information learned is considered generalizable (research) or if it is focusing on the process and what we can learn from that (quality improvement)....
3. What would an oversight committee look like? We are not sure. We are looking forward to hearing back from others as they pursue quality improvement at other institutions.
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