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Management of Incidental Research Findings

Incidental Findings

As per TCPS 2 Chapter 3, an “incidental finding” is a discovery about research participants or prospective participants that is made in the course of research, but is outside the objectives of the research study.

 

Determining the Materiality of Incidental Findings

Incidental findings are considered to be material incidental findings if they are reasonably determined to have significant welfare implications for the participant or prospective participant.

 

Consider the below criteria:

  • Will disclosure of the finding have significant welfare implications for the participant?
  • Does the finding meet generally accepted criteria of scientific and clinical validity (criteria widely recognized by the medical community)?
  • Does the finding have clinical utility for the participant (e.g., benefits associated with communication of results outweigh risks, prevention or treatment available, individual, familial, and social factors considered)?

 

Assistance may be required in interpreting and determining whether an incidental finding is material. The researcher should refer to professional guidelines and standards and if needed, seek external expertise relevant to the finding. Material incidental findings may appear at any stage of the research.

 

Management of Foreseeable and Non-Foreseeable Material Incidental Findings

Where material incidental findings are foreseeable, researchers shall inform participants, as part of the initial consent process, of the likelihood of discovering material incidental findings, and where applicable, should provide information on their strategy to disclose such findings to participants. In this situation, researchers should outline a management plan as part of their Harmony Health Research Application.

 

Upon discovery of an unforeseen material incidental finding, the researcher shall report the discovery in Harmony using the Material Incidental Findings Form. The researcher should describe the process used to determine the materiality of the finding(s) and present a plan for disclosing such findings to the participants. Clinically significant Material Incidental Findings should be reported in Harmony within seven days of becoming aware of the finding.  Non-clinically significant findings may be reported within 15 days.

 

Any proposed letter(s) to be sent to participants or changes to the informed consent form(s) as a result of these findings should also be submitted as an amendment to the Harmony Health Research Application Form.

 

Regardless of whether the material incidental findings were foreseeable, REBs should assess the researcher’s plan to disclose material incidental findings to participants. If there is uncertainty on the need for a plan, the final decision rests with the REB.

 

Consent and Departures from Consent

The communication of the findings determined to be material can only be done when participants or their authorized third parties have consented to receiving them initially or as part of the ongoing consent process. See TCPS 2 Articles 3.1, 3.2, and 3.3 for the consent process and Article 13.3 for human genetic research).

 

Where the researchers have undertaken, in the course of the consent process, not to disclose material incidental findings, and researchers discover an unforeseeable material incidental finding that can be addressed with a potentially significantly beneficial intervention, researchers should consult their REBs to determine whether there is a sufficient ethical basis to disclose the finding to the participant, and if so, how to disclose it.

 

There may be limitations to the consent to receiving material incidental findings. For example, in the case of children, authorized third parties, who, by law, must always exercise their authority in the best interest of the child, must receive any findings for the child that are actionable immediately or during childhood.

 

Researchers should exercise care and sensitivity in determining who discloses material incidental findings that may have a negative impact on the welfare of participants, and how that disclosure is made. Researchers should assist participants in understanding the material incidental finding(s) and direct them to a qualified professional to discuss the possible implications of material incidental findings for their welfare. In some cases, incidental findings may trigger legal reporting obligations. Researchers should be aware of these obligations and, as part of the initial consent process, should inform participants of the limits to confidentiality (TCPS 2 Article 5.1).

 

Exceptions to the Obligation to Disclose

Researchers may also request an exception to their obligation to disclose material incidental findings, based on the impracticability or impossibility of disclosing such findings to the participant. Disclosure may be impossible or impracticable when participants or their authorized party may be deceased or difficult to track due to insufficient identifiers, cost, or time elapsed. The onus is on the researcher to justify the need for the exception in their Harmony application.

 

Please review additional information on the management of material incidental findings here:

https://ethics.gc.ca/eng/incidental_findings.html