Incidental findings in population imaging revisited

Abstract

Imaging techniques are deployed in human subjects research on an increasingly large scale. Worldwide, images of the brain, the abdomen or the whole body are acquired in clinical and population-based cohort studies, and in neuroscience, cognitive science and behavioural science studies. Many of these imaging studies are performed in volunteers who are presumed healthy and free of any symptoms. Yet, even in healthy volunteers, structural abnormalities are detected quite frequently, in approximately 2–3 % of MRI scans of the brain [1, 2], and possibly in over a third of whole-body MRI scans [3]. So-called incidental findings may be of clinical or reproductive significance to research participants. Incidental findings have commonly been regarded as findings that are unrelated to the aims of the study and are discovered unexpectedly in the course of conducting research [4]. The word ‘incidental’ literally means “being likely to ensue as a chance or minor consequence” or “occurring merely by chance or without intention or calculation” [5]. Incidental findings have historically been understood as observations ‘stumbled upon’ by researchers or radiologists. This presupposes a passive, unprepared observer, upon whom an abnormality ‘happens’ by chance. The ethics of incidental findings has generally aligned with this notion. Ethical guidance on the detection, management and communication of incidental findings requires researchers or institutions to have (no more than) a ‘contingency plan’ in place: if researchers stumble upon something that may be relevant to the health of the participant, then they should act. Most guidance documents do state that the actions to be taken (e.g. consultation of an expert radiologist for confirmation of the finding, communication of the finding to the participant or their physician) should be outlined in a predesigned protocol or pathway to be approved by an institutional review board [4, 6, 7], which should be communicated beforehand with research participants. Thus, current ethical guidance covers mostly what happens after incidental findings have been detected, but it does not expressly address whether incidental findings should be detected or what actions should be taken to avoid or ensure the detection incidental findings. A prominent topic of debate is whether routine review of research scans is required. Practices vary considerably across countries and studies [7, 8]: among the largest population-based studies currently being conducted in Europe, approaches for the detection of incidental findings range from only limited handling of those findings that are stumbled upon by radiographers during scan acquisition [9] to having all scans read by dedicated radiologists [10]. In what follows we explain why the research community must take a proactive role and resolve this debate.

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