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Understanding Unanticipated Problems in Research

Learn how to identify, assess, and report unanticipated problems in research, including risks to subjects and others. This presentation covers the nature, severity, and frequency of such issues to ensure ethical conduct. Developed by U-MIC.

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Understanding Unanticipated Problems in Research

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  1. To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter. Developed by: U-MIC

  2. Unanticipated problems involving risk to subjects or others Developed by: U-MIC University of Michigan IRB Collaborative

  3. Unanticipated problemsinvolving risk to subjects or others unanticipated problems • unexpected • nature • severity • frequency • related or possibly related • suggests greater risk • physical • psychological • economic • social Developed by: U-MIC

  4. Unanticipated problemsinvolving risk to subjects or others Developed by: U-MIC

  5. unanticipated problems adverse events Unanticipated problemsinvolving risk to subjects or others • unexpected • nature • severity • frequency • related or possibly related • suggests greater risk • physical • psychological • economic • social • physical or psychological • medical occurrence • sign • symptom • disease Developed by: U-MIC

  6. a a unanticipated problems adverse events Unanticipated problemsinvolving risk to subjects or others a • unexpected • nature • severity • frequency • related or possibly related • suggests greater risk • physical • psychological • economic • social • physical or psychological • medical occurrence • sign • symptom • disease a a a Developed by: U-MIC

  7. unanticipated problems adverse events Unanticipated problemsinvolving risk to subjects or others • unexpected • nature • severity • frequency • related or possibly related • suggests greater risk • physical • psychological • economic • social • physical or psychological • medical occurrence • sign • symptom • disease Developed by: U-MIC

  8. a unanticipated problems adverse events Unanticipated problemsinvolving risk to subjects or others a • unexpected • nature • severity • frequency • related or possibly related • suggests greater risk • physical • psychological • economic • social • physical or psychological • medical occurrence • sign • symptom • disease a a Developed by: U-MIC

  9. report problem as AE or ORIO • internal • UM IRB makes UaP determination • external • local PI or local IRB makes UaP determination; UM IRB acknowledges report Unanticipated problemsinvolving risk to subjects or others Developed by: U-MIC

  10. report problem as AE or ORIO • serious —within seven days • death • life-threatening circumstances • hospitalization • disability/incapacity • congenital anomaly or birth defect • intervention necessary to prevent above outcomes • non-serious —within fourteen days Unanticipated problemsinvolving risk to subjects or others Developed by: U-MIC

  11. Unanticipated problemsinvolving risk to subjects or others Unanticipated problems involving risk to subjects or others Developed by: U-MIC

  12. Brian Seabolt IRBMED thank you. Developed by: U-MIC

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