title: Finding Fault? Exploring Legal Duties to Return Incidental Findings in Genomic Research.
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. Although it is clear that ethical guidance should not be automatically codified as 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 assesses 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, if any, 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 more consistent legal guidance.
authors.affiliation: Senior Policy and Research Analyst, Presidential Commission for the Study of Bioethical Issues. At the time of this work, Elizabeth Pike was a post-doctoral fellow in the Department of Bioethics at the National Institutes of Health. This Article was written by Elizabeth Pike in her private capacity. No official support or endorsement by the Presidential Commission for the Study of Bioethical Issues or the Department of Health and Human Services is intended, nor should it be inferred.
authors.forename: Elizabeth R
authors.initials: ER
authors.lastname: Pike
authors.affiliation: Marjorie Cook Professor of Law, founding Director of the Law & Health Care Program, former Dean of the University of Maryland School of Law, and Visiting Professor, Berman Institute of Bioethics, Johns Hopkins University. Professor Rothenberg currently serves as Senior Advisor on Genomics & Society to the Director of the National Human Genome Research Institute and Visiting Scholar in the Department of Bioethics at the National Institutes of Health.
authors.forename: Karen H
authors.initials: KH
authors.lastname: Rothenberg
authors.affiliation: Deputy Director of the Bioethics Core at the National Human Genome Research Institute, and faculty member, Department of Bioethics at the National Institutes of Health. © 2014, Elizabeth R. Pike, Karen H. Rothenberg & Benjamin E. Berkman. With special thanks to Ellen Wright Clayton, Bryan Dayton, the Honorable Stephen H. Glickman, Dianne Hoffmann, and Amy McGuire for their insightful comments.
authors.forename: Benjamin E
authors.initials: BE
authors.lastname: Berkman