Secondary Findings and Incidental Findings

Sometimes, new health-related knowledge about participants that is not directly related to the purpose of the research project can emerge. Such information can arise either entirely by chance (incidental findings) or as a result of analyses actively pursued in the project (secondary findings). Regardless of their origin, handling these kinds of findings and informing participants accordingly always requires special attention during the ethical review.

What's the difference?

Secondary findings, as mentioned, result from analyses or investigations actively carried out as part of the experiment but do not pertain to the experiment's primary purpose. This could include information about a participant's cholesterol levels from a comprehensive blood analysis conducted for a different purpose or information about disease risks specifically sought in a genetic analysis aimed at an entirely different objective. Incidental findings, on the other hand, arise without actively looking for them. This could be shadows on a scan image indicating cancer risk or signs of specific diseases in body organs. Incidental findings thus emerge more or less out of the blue, while secondary findings arise precisely because they are being sought after. For this reason, handling secondary findings can be planned more easily than incidental findings, as one knows in advance which analyses and investigations will be actively conducted as part of the experiment.

What are the ethical dilemmas?

Several ethical considerations can conflict when dealing with secondary and incidental findings, especially concerning the possibility of doing good. Information about new health-related findings can potentially benefit participants' health. For example, if one can prevent diseases or take other precautions, knowing this information can be greatly advantageous. On the other hand, such information can also cause unnecessary worry, especially in the case of non-validated studies or diseases that are very difficult to address. Poor handling of new health-related information can thus risk harming participants. Additionally, there's a consideration for participants' autonomy or self-determination. It plays a significant role in what participants themselves want to know and what they prefer not to know regarding new health-related information. Finally, there's also a consideration for research staff, who may have to hold information about participants' health, which can be uncomfortable not to be able to share, especially when working as a healthcare professional.

How should participants be best informed?

Participants should, in principle, be informed that there is a possibility of new health-related information arising during the experiment, and what character such findings could have. Otherwise, it's difficult to make an informed choice or refusal regarding whether one wishes to receive information about any new health-related findings that may emerge during the experiment. Participants should also be informed that the investigations in the experiment should not be confused with actual health examinations, as they are conducted for research purposes and not treatment. Therefore, the absence of feedback is not equivalent to the absence of disease, as it's possible that not everything is captured with the used investigations. Participants should always consult a doctor if they are concerned about their health.