Events that Should be Reported
Any event that meets the following criteria:
  1. Protocol Deviation
  2. Adverse Event
  3. Other Unanticipated Event
Unanticipated Event: Any incident, experience, or outcome that meets all of the following criteria:
  • The incident is unexpected (in terms of nature, severity, or frequency) when considering the research procedures that are described in the protocols (eg, informed consent document[s], investigator brochure, product monograph, device manual, etc., or the characteristics of the research participant population being studied)
  • The incident or research approach places research participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized
  • The incident, experience, or outcome may have been caused by the investigational product(s) or procedures involved in the research

For more more information on unanticipated event reporting at UHN, please consult the following PDF document (requires Adobe Acrobat Reader): Unanticipated Problem Reporting Guidance.

To report an unanticipated event at UHN, please do so via CAPCR.

UHN REB's process for reporting unanticipated events (including adverse events and protocol deviations) follows the guidelines laid out by the 'Canadian Association of Research Ethics Boards’ (CAREB). To see the CAREB guidelines, click here.