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

• Published in: The Journal of law, medicine & ethics Vol. 48; no. 1; pp. 69 - 86
• Main Authors: Wolf, Susan M., Ossorio, Pilar N., Berry, Susan A., Greely, Henry T., McGuire, Amy L., Penny, Michelle A., Terry, Sharon F.
• Format: Journal Article
• Language: English
• Published: Los Angeles, CA SAGE Publications 01.03.2020; Cambridge University Press
• Subjects: Accountability; American Recovery and Reinvestment Act; Clinical trials; Consent; Consumers; Direct-To-Consumer Screening and Testing - legislation & jurisprudence; Genomics; Genomics - legislation & jurisprudence; Health Insurance Portability & Accountability Act 1996-US; Health Insurance Portability and Accountability Act; Health services; Humans; Infant, Newborn; Informed Consent - legislation & jurisprudence; Law; Legislation as Topic; Liability; Liability, Legal; Medical screening; Neonatal Screening - legislation & jurisprudence; Patients; Precision medicine; Privacy; Privacy - legislation & jurisprudence; Public Health; Quality Assurance, Health Care - legislation & jurisprudence; State laws; United States; United States
• ISSN: 1073-1105; 1748-720X
• DOI: 10.1177/1073110520916996

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.