Differences in Conceptual Understanding of the “Actionability” of Incidental Findings and the Resultant Difference in Ethical Responsibility: An Empirical Study in Japan

Abstract

BackgroundThe issue of incidental findings encountered in medical researches and in clinical practices becomes controversial in recent years. In what situations should researchers and clinicians disclose incidental findings to study participants or patients? According to previous studies, the concept of “actionability” is one of most important notions in determining the management of incidental findings, however, the understanding of this concept is also inconsistent among people and the inconsistency can affect the management of incidental findings. That is why we surveyed the difference in conceptual understanding of “actionability” for incidental findings with genomic researches in Japan. Methods: We conducted focus groups with individuals conducting genomics research or genetic testing at the National Centers in Japan, all of which are expected to contribute significantly to genomics research and subsequent clinical practice in Japan. Results: As far as our survey and analysis, there exists crucial discrepancy; one might consider that an “actionable” finding should be one that would be useful in treatment or prevention; another might consider if the finding could lead to a definitive diagnosis, it should be considered “actionable,” regardless of the treatment potential of the disease; moreover another might considered that a finding that would lead to the opportunity to participate in a clinical trial was “actionable”. Conclusion: Based on the present study which we conducted, we have examined thus far the concept of “actionability”, which may influence the management of incidental findings. The present study revealed discrepancies in the understanding of this concept among the National Centers in Japan, which all bear similar expectations from society. And this difference in “actionability” would lead to variations in management of incidental findings.