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J Empir Res Hum Res Ethics. 2016 Feb;11(1):21-30. doi: 10.1177/1556264615624078. Epub 2016 Feb 28.

Participants and Study Decliners' Perspectives About the Risks of Participating in a Clinical Trial of Whole Genome Sequencing.

Author information

1
Baylor College of Medicine, Houston, TX, USA jill.robinson@bcm.edu.
2
Rice University, Houston, TX, USA.
3
Baylor College of Medicine, Houston, TX, USA.
4
Harvard Medical School, Boston, MA, USA.
5
Harvard Medical School, Boston, MA, USA Partners Personalized Medicine, Boston, MA, USA.

Abstract

An increasing number of individuals are being recruited to whole genome sequencing (WGS) research. When asked hypothetically, the majority of the public express willingness to participate in this type of research, yet little is known about how many individuals will actually consent to research participation or what they perceive the risks to be. The MedSeq Project is a clinical trial exploring WGS in clinical care. We documented primary reason(s) for declining participation and reviewed audio-recorded informed consent sessions to identify participants' concerns. Of 514 individuals recruited, 173 (34%) actively declined, 205 (40%) enrolled, and the remaining 136 (26%) were ineligible, unresponsive or waitlisted. Although the majority of active decliners cited logistical barriers, 40% cited risks related to the ethical, legal, and social implications (ELSI) of WGS research. Participants similarly discussed ELSI-related concerns but felt the potential benefits of participation outweighed the risks. Findings provide insight into the perspectives of potential WGS research participants and identify potential barriers to participation.

KEYWORDS:

informed consent; participant and decliner perspectives; risks of WGS research; whole genome sequencing

PMID:
26928896
PMCID:
PMC4842131
[Available on 2017-02-28]
DOI:
10.1177/1556264615624078
[Indexed for MEDLINE]
Free PMC Article

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