Article 6.15 of the TCPS2 (2014) requires researchers to report any unanticipated issues or events to their respective REB. The REB considers unanticipated issues, in general, to include any incident, experience, or outcome that meets all of the following criteria:
1. Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the REB-approved research protocol and informed consent document; and (b) the characteristics of the participant population being studied;
2. Related or possibly related to participation in the research (where possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
3. Suggests that the research places participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
The REB recognizes that it may be difficult to determine whether a particular incident, experience, or outcome meets these criteria. The TCPS2 (2014) offers this guidance with respect to Article 6.15:
Unanticipated issues include unexpected reactions by participants to a research intervention (e.g., unintended stimulation of traumatic memories, unforeseen side-effects of a medication or natural health product), as well as unavoidable single incidents (e.g., a translator not available for a day, or a failure to follow correct research procedure for one participant on one occasion). They may be minor or serious in magnitude, with short- or long-term implications. Minor deviations from the research (e.g., a slight increase or decrease of testing time, a wording adjustment on a question) should not require immediate reporting to the REB, but may be summarized in annual status reports.
An incident, experience, or outcome that meets the three criteria above will generally warrant consideration of substantive changes in the research protocol or informed consent process/document or other corrective actions in order to protect the safety, welfare, or rights of participants or others. Examples of corrective actions or substantive changes that might need to be considered in response to an unanticipated problem include:
- Changes to the research protocol initiated by the investigator prior to obtaining REB approval to eliminate apparent immediate hazards to participants;
- Modification of inclusion or exclusion criteria to mitigate the newly identified risks;
- Implementation of additional procedures for monitoring participants;
- Suspension of enrolment of new participants;
- Suspension of research procedures with currently enrolled participants;
- Modification of informed consent documents to include a description of newly recognized risks; and
- Provision of additional information about newly recognized risks to previously enrolled participants.
The information you provide on the following report form will assist the REB in determining whether (and what) changes in your research protocol or process documents will be needed.