OCREAC Unanticipated Issues and Adverse Events Form

 
Unanticipated issues and adverse events related to OCREAC approved research studies must be reported to the OCREAC Chair immediately by submitting this form.

This form is to be used to report:

Adverse Events: Any unfavourable or unintended occurrence in the health (mental, emotional or psychological) or wellbeing of a research participant. Adverse events may be expected in any study where potential risks (even minimal) have been identified (i.e., studies with minimal risk or more). Researchers should already have safeguards in place to deal with such events (e.g., resources, information, procedures).

Unanticipated Issues: Any incident, experience, or outcome that is:

• Unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the application documents (e.g. the OCREAC-approved research protocol, informed consent) and/or the characteristics of the research participant population being studied
• Related or possibly related to participation in the research (the event, experience, or outcome may have been caused by the study procedures or methods)
• Indicative that the research places research participants or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized
• May have immediate or potential implications for current or future participants

OCREAC recognizes that it may be difficult to determine whether a particular incident, experience, or outcome is unexpected and whether it is related or possibly related to participation in the research. An incident, experience, or outcome that meets the criteria for an unanticipated issue will usually warrant consideration of 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 changes that might need to be considered in response to an unanticipated issue include:

• Changes to the research protocol initiated by the investigator to eliminate apparent risks to participants;
• Modification of inclusion or exclusion criteria to mitigate the newly identified risks;
• Implementation of additional procedures for monitoring participants;
• Suspension of recruitment of new participants;
• Suspension of research procedures in current 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.

Researchers interested in viewing the form prior to completing should use the following PDF copy. All sections of this application must be completed in full. 
If you have any questions regarding the completion of this electronic form, please contact: ocreac@ocdsb.ca

Personal information collected on this form is collected under the authority of the Education Act and in accordance with the Municipal Freedom of Information and Protection of Privacy Act. If you have any questions or concerns about the collection or use of personal information, please contact the Chair of OCREAC.