Managing incidental genomic findings: legal obligations of clinicians.

Clayton EW, Haga S, Kuszler P, Bane E, Shutske K, Burke W.

Source

1] Center for Biomedical Ethics and Society, Vanderbilt University, Nashville, Tennessee, USA [2] School of Law, Vanderbilt University, Nashville, Tennessee, USA.

Abstract

Purpose:Clinical whole-exome and whole-genome sequencing will result in a broad range of incidental findings, but clinicians' obligations to identify and disclose such findings are a matter of debate. We sought legal cases that could offer insights into clinicians' legal liability.Methods:We searched for cases in which incidental findings were related to the cause of action, using the search engines WestLaw, WestLaw Next, Lexis, and Lexis Advance.Results:We found no case law related to incidental findings from genetic testing but identified eight cases involving incidental findings in medical imaging. These cases suggest that clinicians may face liability for failing to disclose incidental findings that would have offered an opportunity for interventions to improve health outcome, if under the applicable standard of care, they fail to identify or appreciate the significance of the incidental finding or they negligently fail to notify other clinicians and/or the patient of the identified incidental finding. Other cases support liability for failure to refer appropriately to a clinician with greater expertise.Conclusions:Clinicians may face liability if they fail to disclose incidental information that could inform interventions to improve health outcome; information lacking clinical actionability is likely to have less import.Genet Med advance online publication 28 February 2013Genetics in Medicine (2013); doi:10.1038/gim.2013.7.