2. 1 Developed by: U-MIC 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.

3. UNANTICIPATED PROBLEMS INVOLVING RISK TO SUBJECTS OR OTHERS Developed by: U-MIC University of Michigan IRB Collaborative

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

5. Unanticipated problems involving risk to subjects or others 4 Developed by: U-MIC

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

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

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

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

10. Unanticipated problems involving risk to subjects or others 9 Developed by: U-MIC 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

11. Unanticipated problems involving risk to subjects or others 10 Developed by: U-MIC 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

12. 11 Developed by: U-MIC Unanticipated problems involving risk to subjects or others

13. THANK YOU. Brian Seabolt IRBMED 12 Developed by: U-MIC