The Role of Law in the Debate Over Return of Research Results and Incidental Findings: The Challenge of Developing Law for Translational Science

Abstract

The vigorous debate over return of individual results and incidental findings to participants in human subjects research is increasingly vexed by anxiety over law. This article addresses emerging legal concerns, including that return of these findings mistakes research for clinical care. The article argues that many of the legal concerns expressed to date are misplaced and threaten to derail development of sound policy and ultimately sound law. The core challenge posed by the debate over return of results is to develop an appropriate and workable approach that recognizes return of results and incidental findings as a problem in the zone between research and clinical care — a problem of translational science.

Keywords: Return of Results, Incidental Findings, Research Ethics, Human Subjects Research, Bioethics, Genetics, Genomics