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Per Med. 2019 Jul;16(4):325-333. doi: 10.2217/pme-2018-0076. Epub 2019 Jul 17.

Consent for clinical genome sequencing: considerations from the Clinical Sequencing Exploratory Research Consortium.

Author information

1
Department of Pediatrics, University of Washington, Seattle, WA 98195, USA.
2
Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital & Research Institute, Seattle, WA 98101, USA.
3
Department of Psychiatry, Columbia University Medical Center, NY, 10032, USA.
4
Department of Pediatrics, University of Louisville, Louisville, KY 40202, USA.
5
Department of Medical Ethics & Health Policy, Perelman School of Medicine, University of Pennsylvania, PA 19104, USA.
6
Center for Health Research, Kaiser Permanente Northwest, Portland, OR 97227, USA.
7
Program in Bioethics, University of California, San Francisco, CA 94143, USA.
8
College of Law, University of Iowa, Iowa City, IA 52242, USA.
9
Department of Pediatrics, Baylor College of Medicine, Houston, TX 77030, USA.
10
Law School; Medical School; Consortium on Law & Values in Health, Environment & the Life Sciences, University of Minnesota, Minneapolis, MN 55455, USA.
11
Division of Translational Medicine & Human Genetics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.

Abstract

Implementing genome and exome sequencing in clinical practice presents challenges, including obtaining meaningful informed consent. Consent may be challenging due to test limitations such as uncertainties associated with test results and interpretation, complexity created by the potential for additional findings and high patient expectations. We drew on the experiences of research teams within the Clinical Sequencing Exploratory Research (CSER1) Consortium on informed consent for clinical genome and exome sequencing (CGES) to negotiate consensus considerations. We present six considerations for clinicians and 12 key points to communicate as they support patients in deciding whether to undergo CGES. These considerations and key points provide a helpful starting point for informed consent to CGES, grounded in the Clinical Sequencing Exploratory Research (CSER1) experience.

KEYWORDS:

Clinical Sequencing Exploratory Research (CSER1) consortium; ELSI; clinical genome and exome sequencing; dynamic consent; informed consent; staged consent

PMID:
31313633
PMCID:
PMC6681646
[Available on 2020-07-01]
DOI:
10.2217/pme-2018-0076

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