Managing Incidental Findings in Human Subjects Research: From Imaging to Genomics

Abstract:     
This 18-article symposium publishes a breakthrough set of interdisciplinary articles on the highly controversial question of whether researchers bear duties to return to research participants incidental findings of potential clinical or reproductive importance. Past practice in genetic and genomic research has been to avoid return of incidental findings, drawing a sharp distinction between clinician duties and less expansive researcher duties. Past practice in imaging research (neuroimaging and CT colonography) has included some return. However, empirical work reported in this symposium shows no consistent practice, guidance, or even terminology addressing the management of incidental findings in human subjects research.

The symposium grows out of a 2-year, NIH-funded project (grant #1-R01-HG003178) on "Managing Incidental Findings in Human Subjects Research" (Susan M. Wolf, Principal Investigator (PI); Co-Investigators: Jeffrey Kahn, Frances Lawrenz, Charles Nelson, and Jordan Paradise). The centerpiece of the symposium is a major new consensus document on identifying and managing incidental findings, including the ethical and regulatory obligations devolving on researchers. (Susan M. Wolf et al., Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations, 36 J.L. MED. ETHICS 219 (2008)). The symposium includes the work of more than 25 authors on the legal, ethical, clinical, and scientific issues. The problem of incidental findings deeply challenges current approaches to human subjects research and the conventional divide in health law and bioethics between research and clinical obligations.

Number of Pages in PDF File: 5

Keywords: Incidental findings, return of research results, human subjects research, genetics, genomics, neuroimaging, CT colonography, research ethics, health law, law and science, empirical studies

Accepted Paper Series