Ethical, Legal, and Social Issues (ELSI) in Clinical Genetics Research

Abstract

ELSI (Ethical, Legal, and Social Issues) is a widely used acronym in the bioethics literature that encompasses a broad range of research examining the various impacts of science and technology on society. In Canada, GE³LS (Genetics, Ethical, Economic, Environmental, Legal, Social issues) is the term used to describe ELSI studies in the context of genetics and genomics research. It is intentionally more expansive in that GE³LS explicitly brings economic and environmental issues under its purview. ELSI/GE³LS research is increasingly relevant in recent years as there has been a greater emphasis on "translational research" that moves genomic discoveries from the bench to the clinic. The purpose of this chapter is to outline a range of ELSI-related work that might be conducted as part of a large scale genetics or genomics research project, and to provide some practical insights on how a scientific research team might incorporate a strong and effective ELSI program within its broader research mandate. We begin by describing the historical context of ELSI research and the development of GE³LS research in the Canadian context. We then illustrate how some ELSI research might unfold by outlining a variety of GE³LS research questions or content domains and the methodologies that might be employed in studying them. We conclude with some practical suggestions about how to build an effective ELSI/GE³LS team and focus within a broader scientific research program.

Keywords: Clinical genetics; Ethical; GE3LS; Genomics; Legal; Mixed methods; Social issues (ELSI).