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

Decision Making Ethics, Medical Genome, Human High-Throughput Nucleotide Sequencing / ethics Humans Informed Consent / legislation & jurisprudence Practice Guidelines as Topic Exome Sequencing / ethics
Clinical Sequencing Exploratory Research (CSER1) consortium ELSI clinical genome and exome sequencing dynamic consent informed consent staged consent

Journal

Personalized medicine
ISSN: 1744-828X
Titre abrégé: Per Med
Pays: England
ID NLM: 101238549

Informations de publication

Date de publication:
07 2019
Historique:
pubmed: 18 7 2019
medline: 17 3 2020
entrez: 18 7 2019
Statut: ppublish

Résumé

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.

Identifiants

DOI: 10.2217/pme-2018-0076 PMID: 31313633 PMC: PMC6681646
pubmed: 31313633
doi: 10.2217/pme-2018-0076
pmc: PMC6681646
doi:

Types de publication

Journal Article Research Support, N.I.H., Extramural

Langues

eng

Sous-ensembles de citation

IM

Pagination

325-333

Subventions

Organisme : NHGRI NIH HHS
ID : R01 HG004500
Pays : United States
Organisme : NHGRI NIH HHS
ID : P50 HG007257
Pays : United States
Organisme : NHGRI NIH HHS
ID : R21 HG006613
Pays : United States
Organisme : NHGRI NIH HHS
ID : U01 HG007301
Pays : United States
Organisme : NHGRI NIH HHS
ID : R21 HG006596
Pays : United States
Organisme : NHGRI NIH HHS
ID : U41 HG006834
Pays : United States
Organisme : NHGRI NIH HHS
ID : R01 HG006615
Pays : United States
Organisme : NHGRI NIH HHS
ID : R01 HG007063
Pays : United States
Organisme : NHGRI NIH HHS
ID : U01 HG006500
Pays : United States
Organisme : NHGRI NIH HHS
ID : UM1 HG007301
Pays : United States
Organisme : NHGRI NIH HHS
ID : U01 HG007307
Pays : United States
Organisme : NHGRI NIH HHS
ID : UM1 HG006508
Pays : United States
Organisme : NHGRI NIH HHS
ID : U01 HG006546
Pays : United States
Organisme : NHGRI NIH HHS
ID : R01 HG006600
Pays : United States
Organisme : NHGRI NIH HHS
ID : P20 HG007243
Pays : United States
Organisme : NHGRI NIH HHS
ID : U01 HG009599
Pays : United States
Organisme : NHGRI NIH HHS
ID : R21 HG006612
Pays : United States
Organisme : NHGRI NIH HHS
ID : U01 HG006507
Pays : United States
Organisme : NHGRI NIH HHS
ID : U54 HG003273
Pays : United States
Organisme : NHGRI NIH HHS
ID : U01 HG006485
Pays : United States
Organisme : NIA NIH HHS
ID : U01 AG047109
Pays : United States
Organisme : NHGRI NIH HHS
ID : R01 HG006618
Pays : United States
Organisme : NHGRI NIH HHS
ID : R01 HG008605
Pays : United States
Organisme : NHGRI NIH HHS
ID : UM1 HG007292
Pays : United States
Organisme : NCI NIH HHS
ID : R01 CA154517
Pays : United States
Organisme : NHGRI NIH HHS
ID : K99 HG007076
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR002319
Pays : United States
Organisme : NCATS NIH HHS
ID : UL1 TR000423
Pays : United States
Organisme : NHGRI NIH HHS
ID : U01 HG008685
Pays : United States
Organisme : NHGRI NIH HHS
ID : U01 HG006379
Pays : United States
Organisme : NHGRI NIH HHS
ID : R21 HG006594
Pays : United States
Organisme : NHGRI NIH HHS
ID : U01 HG006487
Pays : United States
Organisme : NHGRI NIH HHS
ID : U01 HG006492
Pays : United States
Organisme : NHGRI NIH HHS
ID : R00 HG007076
Pays : United States

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Auteurs

Joon-Ho Yu (JH)

Department of Pediatrics, University of Washington, Seattle, WA 98195, USA.
Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital & Research Institute, Seattle, WA 98101, USA.

Paul S Appelbaum (PS)

Department of Psychiatry, Columbia University Medical Center, NY, 10032, USA.

Kyle B Brothers (KB)

Department of Pediatrics, University of Louisville, Louisville, KY 40202, USA.

Steven Joffe (S)

Department of Medical Ethics & Health Policy, Perelman School of Medicine, University of Pennsylvania, PA 19104, USA.

Tia L Kauffman (TL)

Center for Health Research, Kaiser Permanente Northwest, Portland, OR 97227, USA.

Barbara A Koenig (BA)

Program in Bioethics, University of California, San Francisco, CA 94143, USA.

Anya Er Prince (AE)

College of Law, University of Iowa, Iowa City, IA 52242, USA.

Sarah Scollon (S)

Department of Pediatrics, Baylor College of Medicine, Houston, TX 77030, USA.

Susan M Wolf (SM)

Law School; Medical School; Consortium on Law & Values in Health, Environment & the Life Sciences, University of Minnesota, Minneapolis, MN 55455, USA.

Barbara A Bernhardt (BA)

Division of Translational Medicine & Human Genetics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA 19104, USA.

Benjamin S Wilfond (BS)

Department of Pediatrics, University of Washington, Seattle, WA 98195, USA.
Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital & Research Institute, Seattle, WA 98101, USA.

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Classifications MeSH

questionsmedicales.fr › Phénomènes psychologiques › Processus mentaux › Pensée (activité mentale) › Prise de décision › Consent for clinical genome sequencing:...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Éthique › Déontologie › Éthique clinique › Déontologie médicale › Consent for clinical genome sequencing:...
questionsmedicales.fr › Phénomènes génétiques › Structures génétiques › Génome › Génome humain › Consent for clinical genome sequencing:...
questionsmedicales.fr › Techniques d'investigation › Techniques génétiques › Analyse de séquence › Séquençage nucléotidique à haut débit › Consent for clinical genome sequencing:...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Consent for clinical genome sequencing:...
questionsmedicales.fr › Organisations et économie des soins de santé › Contrôle social formel › Jurisprudence › Consentement libre et éclairé › Consent for clinical genome sequencing:...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Assurance de la qualité des soins de santé › Recommandations comme sujet › Guides de bonnes pratiques cliniques comme sujet › Consent for clinical genome sequencing:...
questionsmedicales.fr › Techniques d'investigation › Techniques génétiques › Analyse de séquence › Analyse de séquence d'ADN › Séquençage du génome entier › Séquençage de l'exome › Consent for clinical genome sequencing:...