Finding Fault?: Exploring Legal Duties to Return Incidental Findings in Genomic Research

56 Pages Posted: 30 Mar 2013 Last revised: 27 Jul 2015

See all articles by Elizabeth R. Pike

Elizabeth R. Pike

U.S. Department of Health & Human Services

Karen H. Rothenberg

University of Maryland Francis King Carey School of Law

Benjamin E. Berkman

Georgetown University - The O'Neill Institute for National and Global Health Law

Date Written: March 28, 2013

Abstract

The use of whole genome sequencing in biomedical research is expected to produce dramatic advances in human health. The increasing use of this powerful, data-rich new technology in research, however, will inevitably give rise to incidental findings (IFs), findings with individual health or reproductive significance that are beyond the aims of the particular research, and the related questions of whether and to what extent researchers have an ethical obligation to return IFs. Many have concluded that researchers have an ethical obligation to return some findings in some circumstances, but have provided vague or context-dependent approaches to determining which IFs must be returned and when. As a result, researchers have started returning IFs inconsistently, giving rise to concerns about legal liability in circumstances in which notification could have potentially prevented injury. While it is clear that ethical guidance should not be automatically codified as the law, and that crafting ethical obligations around legal duties can be inappropriate, the ethical debate should not proceed unaware of the potential legal ramifications of advancing and implementing an ethical obligation to return IFs.

This article is the first to assess the legal claims that could be brought for a researcher’s failure to return IFs. The potential for researchers to be held liable in tort is still uncertain and turns largely on a number of factors — including customary practice and guidance documents — that are still in flux. Unlike medical care, which has a well-defined duty into which evolving scientific knowledge about genetics and genomics can readily be incorporated, a researcher’s duty to return IFs is less well defined, making it difficult to determine at the outset whether and when legal liability will attach.

This article advocates for a clearer, ethically sound standard of requiring that researchers disclose in the informed consent document which approach to offering IFs will be taken. This approach enables participants to know at the outset which findings will be returned, allows researchers to ascertain when their failure to appropriately return incidental findings will give rise to liability, and enables courts to make determinations that will produce consistent legal guidance.

Keywords: Bioethics, Research ethics, Tort liability, Genetics, Genomics, Whole genome sequencing

JEL Classification: K13

Suggested Citation

Pike, Elizabeth R. and Rothenberg, Karen H. and Berkman, Benjamin E., Finding Fault?: Exploring Legal Duties to Return Incidental Findings in Genomic Research (March 28, 2013). Georgetown Law Journal, Forthcoming, U of Maryland Legal Studies Research Paper No. 2013-20, Available at SSRN: https://ssrn.com/abstract=2241241

Elizabeth R. Pike (Contact Author)

U.S. Department of Health & Human Services ( email )

200 Independence Ave., SW
Washington, DC 20201
United States

Karen H. Rothenberg

University of Maryland Francis King Carey School of Law ( email )

500 West Baltimore Street
Baltimore, MD 21201-1786
United States

Benjamin E. Berkman

Georgetown University - The O'Neill Institute for National and Global Health Law ( email )

600 New Jersey Avenue, NW
Washington, DC 20001
United States
202-662-9777 (Phone)

HOME PAGE: http://www.publichealthlaw.net

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