The Ethics of Incidental Findings in Population-Based MRI Research

Domains of contemporary and future ethical dilemmas.

“…Although estimates vary from study to study, as a function of methodology and type of scan, the occurrence of incidental findings has been estimated to affect as many as 84% of scans (Alphs et al, 2006; King, 2018; Kumra et al, 2006; Wolf et al, 2008). Such findings are most often without clinical significance and are the result of normal variations in anatomy or artefacts of the image itself (Hoffmann & Schmücker, 2014; King, 2018). In fact, only a small fraction of such findings (estimated to be between 2% and 8%) have clinical consequences (Illes, 2006; King, 2018).…”

A Social Constructivism Decision-Making Approach to Managing Incidental Findings in Neuroimaging Research

“…Across nations and institutions, and even within nations and institutions, standardization of protocols to manage IFs is limited because of the complexities encountered in formulating a protocol appropriate for all situations. Although policies from the United States, Canada, and Europe have served as broad guidelines for handling IFs in neuroimaging research worldwide, in some countries little guidance is provided for handling IFs in neuroimaging research (Fujita et al, 2014; Hoffman & Schmucker, 2014). For example, until recently, the only guidelines for handling IFs in Japan were provided by the Japanese Neuroscience Society, and adherence to these guidelines was limited to members of the society (Fujita et al, 2014).…”

“…An incidental finding is broadly defined as “a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of the study” (Wolf et al, 2008, p. 219). Although IFs can include findings of clinical significance, such as an unexpected mass, aneurysm, bleed/stroke, evidence of current or past trauma to the brain, malformation, or anatomic evidence of dementia, they can also include findings that typically lack any clinical significance, such as normal variations in anatomical structure, benign abnormalities, or artifacts of the image itself (Hoffman & Schmucker, 2014; Wolf et al, 2008). Critically, IFs are findings that are unintended in a given research protocol and are characterized by the potential to be of importance to an individual’s health.…”

“…Critically, IFs are findings that are unintended in a given research protocol and are characterized by the potential to be of importance to an individual’s health. IFs are not contingent on any resulting clinical significance following further investigation (Hoffman & Schmucker, 2014). …”