7. Ongoing Reporting of Study Events

The following events and happenings must be reported to the REB if they occur during your study, in accordance with the Adverse Events and Unanticipated Problems Form. Here is a brief summary of these reportable events:

• Adverse Event: Any untoward occurrence affecting a study participant with a reasonable likelihood of being causally related to a study activity or intervention. For example, a data privacy breach or a situation where a participant faints or suffers distress.
• Material Incidental Finding: Any unanticipated discovery made in the course of research that is outside the scope of the research but that nevertheless will or may significantly affect a participant’s welfare. For example, a finding of suspected child abuse or that a participant has suicidal ideation, or some possibly significant cardiac abnormality on an ECG.
• Protocol Deviation: Any change or alteration from the study procedures provided in the REB-cleared study protocol, consent documents, or other study materials. A Protocol Deviation may be deliberate (e.g. to avoid potential harm) or unplanned (e.g. by error or oversight, or in response to unexpected circumstances). For example, by oversight, a participant signs an out-of-date version of the consent form or there is a change of location of a research activity.
• Other Unanticipated Problem: Any unanticipated event that may increase the level of risk to participants or that may affect participants’ welfare or willingness to continue to participate in the study or that may adversely affect data integrity. An Unanticipated Problem includes also the discovery of any new information that may have any of these effects. For example, that a relevant finding discovered in the published literature affects the safety or efficacy of some aspect of study interactions.

If your study involves interactions with people who, it is reasonable to suppose, might express suicidal feelings, you must follow CUREB’s Suicidal Ideation Protocol and submit a completed Suicidal Ideation Reporting Form if required to do so under the protocol.