What do I do if some unexpected harm or distress is experienced by my participants during the course of the study?
Adverse Events are defined as occurrences with an undesirable outcome for the participant. As a researcher, you have the responsibility to report to the REB any unanticipated issues or events that may increase the level of risk to participants, or has other ethical implications that may affect participants' welfare. Some examples of adverse events that must be reported include: Participants showing signs of emotional upset in conjunction with or following interviews or other tasks associated with participation; Any release, even inadvertent, of research participants' identities or personal information; Partial or complete data loss.
You will need to notify the Chair of the REB immediately and fill out an Adverse Event form. The more detailed process for reporting an Adverse Event can be found on the Ongoing Review / Annual Status Report webpage.
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