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Per Med. 2015 Jun;12(3):269-282. doi: 10.2217/pme.14.88.

Genomics in the clinic: ethical and policy challenges in clinical next-generation sequencing programs at early adopter USA institutions.

Author information

1
Stanford Center for Biomedical Ethics, Stanford University School of Medicine, Stanford, CA, USA.
2
Center for Biomedical Ethics & Society, Departments of Pediatrics & Anthropology, Vanderbilt University Medical Center, Nashville, TN, USA.
3
Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.
4
Department of Bioengineering, Stanford University School of Medicine, Stanford, CA, USA.
5
Department of Genetics, Stanford University School of Medicine, Stanford, CA, USA.
6
Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.
7
Division of Medical Genetics, Department of Pediatrics, Stanford University School of Medicine, Stanford, CA, USA.
8
Stanford Center for Genomics & Personalized Medicine, Stanford University School of Medicine, Stanford, CA, USA.
9
Department of Pathology, Stanford University School of Medicine, Stanford, CA, USA.
10
Department of Microbiology & Immunology, Stanford University School of Medicine, Stanford, CA, USA.

Abstract

Next-generation sequencing (NGS) technologies are poised to revolutionize clinical diagnosis and treatment, but raise significant ethical and policy challenges. This review examines NGS program challenges through a synthesis of published literature, website and conference presentation content, and interviews at early-adopting institutions in the USA. Institutions are proactively addressing policy challenges related to the management and technical aspects of program development. However, ethical challenges related to patient-related aspects have not been fully addressed. These complex challenges present opportunities to develop comprehensive and standardized regulations across programs. Understanding the strengths, weaknesses and current practices of evolving NGS program approaches are important considerations for institutions developing NGS services, policymakers regulating or funding NGS programs and physicians and patients considering NGS services.

KEYWORDS:

clinical genomics; ethics; next-generation sequencing; policy; technology adoption

PMID:
29771644
DOI:
10.2217/pme.14.88

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