Report problems

Researchers are required to report all unanticipated occurrences associated with their research, such as:

Adverse events

Any undesirable experience or response by a study participant is considered an adverse event. These experiences may be emotional, psychological, or physiological in nature and include injury or a detrimental incident. These events are usually related to study participation or a result of the research procedures.

The Principal Investigator, or Faculty Supervisor in the case of student research, must report the adverse event by e-mail or telephone to the Director, Research Ethics, as soon as possible but no later than 24 hours following the event. Submission of the Adverse Event Reporting Form (PDF) can follow after the e-mail or telephone notification. 

The Principal Investigator or Faculty Supervisor is expected to respond to the adverse event immediately and according to the description originally outlined in the safeguards section of their ethics application. If the study is a clinical trial refer to the serious adverse event reporting requirements.

The following are examples of adverse events that must be reported:

  • Negative, physical, or allergic reactions to drugs administered in a study
  • Physical consequences from dietary manipulations (e.g., fainting)
  • Negative physical reactions in volunteers who have chronic diseases (e.g., heart conditions, diabetes)
  • Unexpected accidents that occur during the course of a research project (e.g., a participant in an exercise study falling off an exercise bike or treadmill)
  • Equipment failure during an experimental session should also be reported if it resulted in harm to a participant
  • 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

Protocol deviations

Protocol deviations are changes to a study that have not undergone ethics review and clearance. These are normally unanticipated or unintentional changes.

Minor protocol deviations generally impact administrative and logistical aspects of the study such as a study participant missing an appointment or changes in appointment dates.

Major protocol deviations may impact the research protocol, information consent document or other study materials, usually cannot be anticipated ahead of time and are often necessary to ensure the safety and welfare of the participants. Examples of major protocol deviations include:

  • Changes in procedures required to eliminate immediate risk to participants
  • Enrolment of participants outside the protocol inclusion/exclusion criteria
  • Significant deviation in the informed consent process such as use of incorrect version of the letter or form

Only major protocol deviations must be reported within 7 days of the deviation by e-mail or telephone to the Director, Research Ethics.  Submission of the Protocol Deviation Reporting Form (PDF) can follow after the e-mail or telephone notification. 

Incidental or secondary findings

Incidental findings are “discoveries made in the course of research but that are outside the scope of the research” (TCPS 2, Article 3.4).

Incidental findings may be anticipated or unanticipated, and are different from primary and secondary findings. Each of these is defined in the Panel on Research Ethics guideline: How to Address Material Incidental Findings. 

Researchers need to consider the types of data and information they will be collecting for their study and what these results might discover. Incidental findings mainly apply when:

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 of Research Involving Humans (TCPS2 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 an incidental finding is discovered during the research or in analyzing the findings, the Principal Investigator, or Faculty Supervisor in the case of student research, must report the finding by e-mail or telephone to the Director, Research Ethics as soon as possible and submit the Incidental Findings Reporting Form (PDF) within 72 hours (3 days) of learning of the finding. 

The Director, Research Ethics will  work with you to identify the best course of action for Research Ethics Board (REB) review of the finding and reporting to a study participant. Participants are not to be contacted about the finding until REB review of the finding is conducted.

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 to confidentiality as part of the information and consent process.

Updated November 2024

Waterloo ethics process