Quality Improvement Project Consultant Checklist - Intermountain - intermountainhealthcare 2025

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Yes. In certain cases, a QI project may constitute human subjects research that is also considered non-exempt. This means that the research does not meet one of the exempt categories defined in the regulations at 45 CFR 46.104.
In general, QI projects do not typically require the same ethical approval as research projects. Any ethical rules in place for the conduct of QI activities are often unclear. Furthermore, some QI projects do not require patient consent and clinician participation is not always voluntary.
Choose measures that allow you to track each of three steps in the improvement process: Test the acceptance and/or adherence to new or revised practices. Examine how and how much the new practices are affecting the delivery of patient-centered care. Assess how much patient experience of care is improving.
Determining if an activity is Research or Quality Improvement can be challenging. Federal regulations require human subject research to re reviewed and approved by the IRB, while strictly QI activities do not require IRB oversight. However, some QI activities may also be research and therefore need IRB approval.
Federal regulations require human subject research to reviewed and approved by an Institutional Review Board (IRB), while strictly QI activities do not require IRB oversight. However, some QI activities may also be research and therefore need IRB approval. INTENT Contribute to generalizable knowledge.
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What are examples of quality improvement in healthcare? Reducing hospital readmissions through follow-up care and patient education. Enhancing patient safety by implementing protocols to reduce medical errors and infections. Improving patient flow by streamlining processes and reducing wait times.
If the project does not include any interaction or intervention with human subjects or include any access to identifiable private information, then the project does not require IRB review.

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