Researchers are required to report unanticipated occurrences associated with their research, such as:
- adverse events with a research participant,
- deviations from the study protocol,
- incidental or secondary findings,
- participant complaints, or
- privacy breaches
If you are unsure of what type of report to submit, or if a report is needed, contact reb@uwaterloo.ca.
Using the ethics system to report a problem
- Go to the Reportable Events tab (located at the top of the ethics application).
- Click on Report an Event (top right side of page).
- Review the instructions on reporting an event.
- Select the form type for the event to report.
- Complete the event report.
- Submit the event report. Note: Only the Principal Investigator can submit the report.
- Make any needed updates to the report through the research ethics system.
Adverse events
An adverse event is an undesirable emotional, psychological, or physical response or injury experienced by a study participant. These events may be related to study participation or a result of the research procedures. Some procedures have known potential adverse events which are outlined within the ethics application and described to participants in the information letter. These anticipated adverse events only need to be reported if they occur at a frequency or severity that is unexpected. If you have a question about if the adverse event requires a report, please contact reb@uwaterloo.ca.
During a research project, examples of adverse events that are reportable include:
- negative, physical, or allergic reactions to study-administered drugs
- physical effects from dietary manipulations (e.g., fainting)
- unexpected accidents (e.g., falls)
- equipment failure causing harm or injury
- emotional distress during or after study tasks (e.g., interviews)
The Principal Investigator or Faculty Supervisor is expected to respond to the adverse event immediately and according to safeguards outlined in the research ethics application. For clinical trials, refer to the serious adverse event reporting requirements.
Report adverse events to the Director, Office of Research Ethics within 24 hours by email or phone: 519-888-4567 ext. 41068. Submit the reportable event form in the research ethics system after initial contact with the Director.
Protocol deviations
Protocol deviations are changes to a study that have not undergone ethics review. They may be:
- Minor deviations that affect study logistics (e.g., missed or rescheduled participant appointments)
- Major deviations that impact the research protocol, consent documents, or study materials and may impact data integrity or participant safety.
Examples of major protocol deviations include:
- Enrolling participants who do not meet inclusion/exclusion criteria
- Significant deviation in the informed consent or recruitment process such as use of incorrect version of the information letter or consent form, or recruitment posters or emails
Report major protocol deviations within 7 days to the Director, Office of Research Ethics by email or call the Director at 519-888-4567 ext. 41063. Submit the reportable event in the online ethics system.
Incidental or secondary findings
Incidental findings are "discoveries made in the course of research but are outside the scope of the research" (TCPS 2, Article 3.4). These may be anticipated or unanticipated, and differ from primary and secondary findings. Each of these is defined in the Panel on Research Ethics guideline: How to Address Material Incidental Findings.
Researchers should plan for incidental findings when collecting:
- physiological or biometric data
- tissues, specimen, scans, or images
- biological materials/data from repositories or banks
Researchers who propose to collect data or information as outlined above need to develop a plan for how they will handle and report an incidental finding to the Research Ethics Board (REB) and to a study participant or an authorized third party.
The Tri-Council Policy Statement: Ethical Conduct or Research Involving Humans (TCPS 2022) states: "researchers have an obligation to disclose to the participant any material incidental findings discovered in the course of research" if the participant wishes to be informed of these findings (Article 3.4). A sample notification letter can be obtained from the Research Ethics Office.
What do I need to do if an incidental finding is discovered?
If your protocol had a plan for handling incidental findings, then this should be followed. If you did not have an incidental findings plan, participants should not be contacted until the issue has been reported to the Director.
Report incidental findings within 72 hours by email or call the Director at 519-888-4567 ext. 41063. Submit the reportable event through the online ethics system. The Director and Research Ethics Board (REB) will help you to identify the best course of action for handling findings and reporting to study participants.
Participant complaint
The receipt of substantial participant complaints should be reported. Support will be provided to determine if additional follow-up is needed. Minor complaints or advice from participants such as advising that the font in the Letter or Information be larger or that they did not receive their remuneration or incentive due to a technical issue that is easily resolved does not need to be reported.
If a participant is harmed or has a significant unanticipated negative experience because of the study procedures, the incident should be document and reported using the Adverse Event reporting process.
Report complaints to the Director, Office of Research Ethics within 24 hours by email or phone: 519-888-4567 ext. 41068.
Privacy breach
A privacy breach occurs when personal information is stolen or lost, or collected, used or disclosed without authority. When conducting research, this includes identifiable or sensitive contact information or study data. Support will be provided to determine what follow-up is needed or reported to the University of Waterloo Privacy Office.
Report breaches to the Director, Office of Research Ethics within 24 hours by email or phone: 519-888-4567 ext. 41068.
Other reporting obligations
Researchers are expected to be aware of their legal reporting obligations, such as those set out in their professional codes of conduct or in legislation (e.g., child welfare or communicable disease legislation), that may require disclosure of information. Researchers should inform participants of the limits of confidentiality as part of the information and consent process.
Questions about other reporting obligations can be discussed during the initial ethics review process.
Updated October 2025