Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.
Bibliographical noteFunding Information:
Prof. Wolf, Dr. Berry, and Prof. Greely report grants from NIH during the conduct of the study. Dr. Ossorio reports personal fees from Roche-Genentech and from Eli Lilly and grants from NIH outside of the submitted work. Dr. McGuire reports grants from the NIH during the conduct of this study, personal fees from Geisinger Research, Morgridge Institute of Research, Danaher Life Sciences, and the Greenwall Foundation outside the submitted work. Dr. Penny reports other support from Biogen outside of the submitted work. Ms. Terry reports other support from Genome Medical, other support from LunaDNA, and grants from Illumina outside of the submitted work. Acknowledgments
Preparation of this article was supported by National Human Genome Research Institute and National Cancer Institute of the National Institutes of Health (NIH) under award number R01HG008605 for “LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application.” The content is solely the responsibility of the authors and does not necessarily represent the views of the funders. Thanks to Ellen Wright Clayton, Barbara Evans, and Leslie Wolf for helpful review and to Kate Hanson, Travis Panneck, and Noah Sattler for research assistance.
© 2020 American Society of Law, Medicine & Ethics.