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Adverse Events/Unanticipated Problems Assessment Flowchart

Version: August 23, 2022

Guidance

Not all adverse events constitute unanticipated problems that need to be reported to the University of Utah IRB. How do you determine whether to submit a report of an adverse event to the IRB? Use the flowchart below to decide whether the event meets IRB reporting requirements.

Flowchart for evaluating Adverse Events (AEs) in research. After an AE occurs, the local PI (and sponsor, if applicable) evaluates it. If the AE is unexpected, assess whether it was unforeseen or not in the consent form. If expected, it doesn’t need IRB reporting but must be documented. If unexpected, determine if it is definitely or probably related to the research. Related AEs may require reporting; unrelated or uncertain events may not meet reporting thresholds unless more info emerges.

Continuation of AE evaluation flowchart. If AE is not related to research, stop—no IRB report needed, but document it. If related, assess whether it places participants at greater risk of harm than previously known (e.g., physical, psychological). If no greater risk, stop—no IRB report needed, but document. If greater risk, the AE may be a possible unanticipated problem and should be reported to the IRB via a report form. A note states investigators must report possible unanticipated problems to the IRB within 10 working days (5 for VA).

Please contact the IRB Office at (801) 581-3655 or irb@hsc.utah.edu for additional guidance.