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

Joon Ho Yu, Paul S. Appelbaum, Kyle B. Brothers, Steven Joffe, Tia L. Kauffman, Barbara A. Koenig, Anya Er Prince, Sarah Scollon, Susan M. Wolf, Barbara A. Bernhardt, Benjamin S. Wilfond

Research output: Contribution to journalReview articlepeer-review

5 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)325-333
Number of pages9
JournalPersonalized Medicine
Volume16
Issue number4
DOIs
StatePublished - 2019

Bibliographical note

Funding Information:
Preparation of this article was supported by the National Cancer Institute (NCI) and National Human Genomic Research Institute (NHGRI) including: K99R00 HG007076 (JHY), R21 HG006596 (PSA), P50 HG007257 (PSA), R01 CA154517 (BK, SW), P20 HG007243 & U01 HG009599 (BK), R01 HG008605 (SW); UM1 HG007292 (BW), U01 HG006492 (SJ). The research described in this report was also funded by grants U01HG0006546, U01HG006485, U01HG006500, UM1HG007301, UM1HG006508, U01HG006487, U01HG006507, U01HG007307, U01HG006379, U41HG006834, U54HG003273, R01HG006600, R01HG006600, R01HG004500, R01HG006618, R21HG006594, R01HG006615, R21HG006612, 5R21HG006613, R01HG007063, HG008685, UL1TR000423 and UA01AG047109. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript. The authors wish to acknowledge the involvement of the members of the Clinical Sequencing Exploratory Research Consortium Informed Consent and Governance Working Group who participated in discussions of this manuscript during its development: PS Appelbaum, S Berg, BA Bernhardt, S Biswas, J Boyer, KB Brothers, J Childerhose, EW Clayton, K East, C Eng, C Finnila, SM Fullerton, A Goldenberg, R Hart, GE Henderson, IA Holm, MH Lewis, SC Hull, S Joffe, E Juengst, TL Kauffman, BM Knoppers, BA Koenig, N Lockhart, L McCullough, J McEwen, DW Parsons, A ER Prince, V Raymond, M Roche, L Rodriguez, S Scollon, K Spector-Bagdady, BS Wilfond, SM Wolf and J-H Yu. The authors would like to thank all of the Clinical Sequencing Exploratory Research (CSER) participants for their involvement in this research.

Funding Information:
Preparation of this article was supported by the National Cancer Institute (NCI) and National Human Genomic Research Institute (NHGRI) including: K99R00 HG007076 (JHY), R21 HG006596 (PSA), P50 HG007257 (PSA), R01 CA154517 (BK, SW), P20 HG007243 & U01 HG009599 (BK), R01 HG008605 (SW); UM1 HG007292 (BW), U01 HG006492 (SJ). The research described in this report was also funded by grants U01HG0006546, U01HG006485, U01HG006500, UM1HG007301, UM1HG006508, U01HG006487, U01HG006507, U01HG007307, U01HG006379, U41HG006834, U54HG003273, R01HG006600, R01HG006600, R01HG004500, R01HG006618, R21HG006594, R01HG006615, R21HG006612, 5R21HG006613, R01HG007063, HG008685, UL1TR000423 and UA01AG047109. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.

Publisher Copyright:
© 2019 Future Medicine Ltd.

Keywords

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

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