Researchers are required to report all unanticipated occurrences associated with their research, such as:
- adverse events that occurred with a research participant,
- deviations from the study protocol, or
- incidental or secondary findings.
Any undesirable experience or response by a study participant is considered an adverse event. They may be emotional, psychological, or physiological in nature and include injury or a detrimental incident experienced by a research participant. 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 the Director, Research Ethics, as soon as possible but no later than 24 hours following the event. Submission of the Adverse Event Reporting Form - Form 106 (PDF) must follow within one (1) business day of the e-mail 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 (Section E2) of the approved application (Form 101). 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 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 and are to be reported within 7 days of the deviation using the Protocol Deviation Reporting Form - Form 107 (PDF) .
Incidental findings are “discoveries made in the course of research but that are outside the scope of the research” (Article 3.4, Application) and/or “results that are outside the original purpose for which a test or procedure was conducted” (Presidential Commission for the study of bioethical issues, 2013).
Incidental findings may be anticipated or unanticipated, and are different from primary and secondary findings. Each of these is defined in the Guideline for reporting incidental and secondary findings to study participants (PDF).
Researchers need to consider the types of data and information they will be collecting for their study and what these results might discover. Incidental or secondary findings mainly apply to studies that:
- Collect physiological or biometric data and/or tissues/specimens/scans/images from participants in their studies
- Access biological materials/data (e.g., tissue, specimens, and scans) from existing repositories or banks
- Establish and operate specimen/tissue banks/repositories (i.e., referred to as bank)
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 or secondary finding to the Research Ethics Committee (REC) and to a study participant.
The Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans (TCPS) 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).
If an incidental or secondary finding is discovered in the course of the research or in analyzing the findings, the Principal Investigator, or Faculty Supervisor in the case of student research, must report incidental or secondary finding by e-mail or phone to the Director, Research Ethics as soon as possible.
Submission of the Incidental and Secondary Findings Reporting Form - Form 108 (PDF) must follow 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 Committee (REC) review of the finding and reporting to a study participant.
Participants are not to be contacted about the finding until REC review of the finding is conducted.