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Research@UIC > Protocol
Review > IRB > UPIRSOs:
Example of Events
 UPIRSOs:
Examples of Events
Examples of events that should be promptly reported to the IRB
- adverse events that are serious, unexpected, and related or possibly related;
- adverse events that are unexpected, related or possibly related, and,
although not serious, place subjects or others at increased risk of harm;
- unanticipated adverse device effects;
- major protocol violations (i.e., impact subject safety, compromise integrity
of study data, or affect subject’s willingness to participate);
- complaints made by research participants indicating an unanticipated risk;
- complaints that cannot be resolved by the research staff;
- unapproved changes made to research to eliminate an apparent immediate
hazard to a research participant;
- serious or unanticipated adverse event with research conducted at the
JBVAMC, even if it not meeting other criteria of an UPIRSO; and
- unanticipated findings (e.g., breach of confidentiality, loss of study
data) that are related or possibly related to research and may influence
safe conduct of research.
Examples of events not requiring prompt reporting to the IRB:
- adverse events that do not meet the criteria of an UPIRSO;
- reports (including IND safety reports) of external (non UIC sites) adverse
events, whether serious or not, that do not meet the criteria of an UPIRSO;
- adverse device effects that are non-serious, anticipated, or unrelated;
- deaths that are expected or are not attributed to the research;
- minor protocol deviations or violations;
- complaints made by research participants not involving risks;
- complaints that were resolved; and
- DSMB reports, Investigator Brochure updates, or other sponsor reports
not altering the risk/benefit profile.
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