Please utilize this algorithm to determine if this event requires prompt reporting to the All Children's Hospital IRB. You will be guided to the appropriate action based on your answers to the following questions:
1.
Is the event unexpected in nature, severity and frequency?
Action
The event does not need to be promptly reported to the IRB, however a summary should be provided at continuing review.
2.
Is the event related or possibly related to participation in the research?
Action
The event does not need to be promptly reported to the IRB, however a summary should be provided at continuing review.
3.
Does the event suggest that the research places subjects or others at a greater risk of physical or psychological harm than was previously known or recognized?
Action
The event does not need to be promptly reported to the IRB, however a summary should be provided at continuing review.
Action
Event must be promptly reported to the IRB. Please login to IRIS and submit an "Unanticipated Problem Form".
