Incidental findings in clinical research: the case of the ‘known unknowns’

Abstract

The practical implications of developing a standardized set of obligations for the research community to adhere to, in the management of current and future incidental findings (IFs), is a staggering exercise to contemplate. Consider the growing use of research biobanks (which is a repository of biological samples), the evolving field of genomic research, and the potential of patients seeking subsequent care based on a incidental clinical research finding could lead to significant additional time and resources to an already burdened enterprise [1]. Although maintaining the public’s trust in research remains vital; the stakes involved in how IFs are to managed are quite high for participants, researchers and the health system. In academia, seeking out common language and terminology are crucial to fostering productive dialogue in the exploration of any issue. However, the literature on IF continues to make reference to an unwieldy array of terms: abnormal, incidental, accidental, secondary, significant, unexpected, unrelated, unforeseen, unusual and variant, are some of the potential adjectives that have been used to precede the word ‘finding’ [2]. For the purposes of this editorial, I will apply a classic definition to explicate the concept of IF as it relates to clinical research: IF is 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 [3]. For example, envision a medical imaging researcher that is examining structural attributes of the frontal cortex in healthy volunteers and in the course of research discovers that a participant has a glioblastoma, which is a brain tumor. In its earliest consideration, IFs were considered to be so rare and uncommon that researchers merely considered their discovery as being something that was stumbled upon in the moment and they had no idea whether or not to share this information with research participants. This phenomenon became affectionately called the ‘stumble strategy’ [4] and remained the status quo until the past decade. However, the following small sampling of recently reported occurrences of IF in clinical care tell another story: