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

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

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

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

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      

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

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    

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

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

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

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