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Who makes the assessment of whether an unanticipated problem constitutes a UPIRTSO?

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Who makes the assessment of whether an unanticipated problem constitutes a UPIRTSO?

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The IRB relies on the U of M researcher to provide an assessment of whether UPIRTSO criteria are met for a given event. As the person most familiar with and ultimately responsible for the conduct of the study, the researcher should provide his or her informed opinion of whether an event meets UPIRTSO criteria. The IRB will then review the researcher’s assessment of the event to determine if any changes to the approved study should be made as a result of the report.

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