Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics

Susan M Wolf; Pilar N Ossorio; Susan A Berry; Henry T Greely; Amy L McGuire; Michelle A Penny; Sharon F Terry; LawSeq Framework Task Force

doi:10.1177/1073110520916996

Integrating Rules for Genomic Research, Clinical Care, Public Health Screening and DTC Testing: Creating Translational Law for Translational Genomics

J Law Med Ethics. 2020 Mar;48(1):69-86. doi: 10.1177/1073110520916996.

Authors

Susan M Wolf¹, Pilar N Ossorio¹, Susan A Berry¹, Henry T Greely¹, Amy L McGuire¹, Michelle A Penny¹, Sharon F Terry¹; LawSeq Framework Task Force¹

Affiliation

¹ Susan M. Wolf, J.D., is McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; and Professor of Medicine at the University of Minnesota. She is also Chair of the University's Consortium on Law and Values in Health, Environment & the Life Sciences. She is a Principal Investigator on an NIH-supported project on "LawSeq: Building a Sound Legal Foundation for Translating Genomics into Clinical Application" (NHGRI/NCI # R01HG008605; Wolf, Clayton, Lawrenz, PIs). Pilar N. Ossorio, Ph.D., J.D., is Professor of Law and Bioethics at the University of Wisconsin-Madison, where she is on the faculties of the Law School and the Department of Medical History and Bioethics at the Medical School. She is Ethics Scholar-in-Residence at the Morgridge Institute for Research, Co-Director of UW's Law and Neuroscience Program, a faculty member in the UW Masters in Biotechnology Studies program, and Program Faculty in the Graduate Program in Population Health. Susan A. Berry, M.D., is Division Director for Genetics and Metabolism in the Department of Pediatrics at the University of Minnesota. She is a Professor in the Departments of Pediatrics, Ophthalmology and Genetics, Cell Biology and Development. She is a member of the Minnesota Department of Health Newborn Screening Advisory Committee, a Fellow of the American Academy of Pediatrics, and a Fellow of the American College of Medical Genetics. Henry T. Greely, J.D., is the Deane F. and Kate Edelman Johnson Professor of Law and Professor, by courtesy, of Genetics at Stanford University. He chairs the California Advisory Committee on Human Stem Cell Research and the steering committee of the Stanford University Center for Biomedical Ethics, and directs the Stanford Center for Law and the Biosciences and the Stanford Program in Neuroscience and Society. Amy L. McGuire, J.D., Ph.D., is the Leon Jaworski Professor of Biomedical Ethics and Director of the Center for Medical Ethics and Health Policy at the Baylor College of Medicine. She served on the National Advisory Council for Human Genome Research 2011-15 and is immediate past-President of the Association of Bioethics Program Directors. Michelle A. Penny, Ph.D., is Head of the Translational Genome Sciences Group at Biogen. She is Co-Chair of the National Academy Roundtable on Genomics and Precision Health and the Industry Pharmacogenomics Working Group. Sharon F. Terry, M.A., is President and Chief Executive Officer of Genetic Alliance and co-founder of the Genetic Alliance Registry and Biobank. She has served in a leadership role on organizations including the Precision Medicine Initiative Cohort Advisory Panel; Cures Acceleration Network Review Board and Advisory Council, National Center for Accelerating Translation Science, NIH; National Academy Roundtable on Genomics and Precision Health; Global Alliance for Genomics and Health; and International Rare Disease Research Consortium Executive Committee. Organizations are listed here for author identification only.

Abstract

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.

Publication types

Research Support, N.I.H., Extramural

MeSH terms

American Recovery and Reinvestment Act
Direct-To-Consumer Screening and Testing / legislation & jurisprudence*
Genomics / legislation & jurisprudence*
Health Insurance Portability and Accountability Act
Humans
Infant, Newborn
Informed Consent / legislation & jurisprudence*
Legislation as Topic
Liability, Legal*
Neonatal Screening / legislation & jurisprudence
Privacy / legislation & jurisprudence*
Public Health
Quality Assurance, Health Care / legislation & jurisprudence
United States

Grants and funding

R01 HG008605/HG/NHGRI NIH HHS/United States