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

被引：8

作者：

Yu, Joon-Ho ^{[1
,2
]}

Appelbaum, Paul S. ^{[3
]}

Brothers, Kyle B. ^{[4
]}

Joffe, Steven ^{[5
]}

Kauffman, Tia L. ^{[6
]}

Koenig, Barbara A. ^{[7
]}

Prince, Anya E. R. ^{[8
]}

Scollon, Sarah ^{[9
]}

Wolf, Susan M. ^{[10
,11
,12
]}

Bernhardt, Barbara A. ^{[13
]}

Wilfond, Benjamin S. ^{[1
,2
]}

机构：

[1] Univ Washington, Dept Pediat, Seattle, WA 98195 USA

[2] Seattle Childrens Hosp & Res Inst, Treuman Katz Ctr Pediat Bioeth, Seattle, WA 98101 USA

[3] Columbia Univ, Dept Psychiat, New York, NY 10032 USA

[4] Univ Louisville, Dept Pediat, Louisville, KY 40202 USA

[5] Univ Penn, Perelman Sch Med, Dept Med Eth & Hlth Policy, Philadelphia, PA 19104 USA

[6] Kaiser Permanente Northwest, Ctr Hlth Res, Portland, OR 97227 USA

[7] Univ Calif San Francisco, Program Bioeth, San Francisco, CA 94143 USA

[8] Univ Iowa, Coll Law, Iowa City, IA 52242 USA

[9] Baylor Coll Med, Dept Pediat, Houston, TX 77030 USA

[10] Univ Minnesota, Law Sch, Minneapolis, MN 55455 USA

[11] Univ Minnesota, Med Sch, Minneapolis, MN 55455 USA

[12] Univ Minnesota, Consortium Law & Values Hlth Environm & Life Sci, Minneapolis, MN 55455 USA

[13] Univ Penn, Perelman Sch Med, Div Translat Med & Human Genet, Philadelphia, PA 19104 USA

来源：

PERSONALIZED MEDICINE | 2019年 / 16卷 / 04期

关键词：

clinical genome and exome sequencing; Clinical Sequencing Exploratory Research (CSER1) consortium; dynamic consent; ELSI; informed consent; staged consent; INCIDENTAL FINDINGS; SECONDARY FINDINGS; INFORMED-CONSENT; PATIENTS VIEWS; CANCER-RISK; EXOME; RETURN; PREFERENCES; RECOMMENDATIONS; IMPLEMENTATION;

D O I：

10.2217/pme-2018-0076

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.

引用

页码：325 / 335

页数：11

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