“We know what to do for you, but we can't do it:” How actionability is coordinated and contested in genomics research

Abstract

Over the last few decades, an influential movement has emerged in genomics research advocating for the return of “actionable” findings to research participants. This movement argues that actionable findings constitute clinically significant information that can be used to inform preventive care, and that research projects may therefore have a responsibility to disclose such findings. Using a document analysis of institutional and expert guidance, this article traces how the notion of actionability became a predominant justification for the disclosure of research findings, and explores how this guidance has failed to account for local and structural coordination of actionability. The paper presents two case studies of US-based research projects, Geisinger Health System's MyCode Initiative and the National Institutes of Health's All of Us Research Program, to characterize how the disclosure of actionable findings has been implemented in research programs, and to reveal how a decontextualized approach to actionability threatens to undermine the promised clinical utility of genomic findings and exacerbate inequalities in healthcare access. As research projects increasingly adopt clinical actionability as a stand-in for clinical utility, exchanging evidence of improved health outcomes with opportunities for preventive interventions, coordination of the responsibilities and resources for realizing actionability is essential. This analysis indicates the possible consequences of contested actionability, and points to the need for further investigation of how actionable findings are implemented in practice.