Reconstructing the concept of"incidental findings" in Japanese genomic research and medicine: A proposal of a classification method based on intention

The debate over an ethically appropriate way to handle incidental findings-whether researchers or clinicians should bear some duty to offer back such findings to research participants or patients-has also been the focus of attention in Japanese genomic research and medicine since the introduction of next generation sequencing. Those who engage in the debate in Japan, where one can see the strong influence of the American College of Medical Genetics and Genomics(ACMG)policy statement in 2013, tend to understand incidental findings in terms of the primary or the non-primary. In this classification, secondary findings as well as incidental findings fall into the latter category. Given the complicated discussion over the very concept of"incidental findings " in the West, this classification may still be intelligible but inconclusive. According to Presidential Commission for the Study of Bioethical Issues in 2013 and ACMG SF v2.0 in 2016, the most crucial distinction from an ethical point of view appears to be made by the concept of intention : both primary findings and secondary findings can be said to be intentionally sought, whereas incidental findings, whether anticipatable or unanticipatable, cannot. Thus, we can regard incidental findings as unintentional ones. This paper aims to propose a more appropriate classification method based on the concept of intention, with philosophical and ethical arguments for it, clarify the terminological or conceptual confusions which can be seen in Japan, and introduce a better term and its definition to express incidental findings in Japanese.