title: Participants and Study Decliners' Perspectives About the Risks of Participating in a Clinical Trial of Whole Genome Sequencing.
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.
authors.affiliation: Baylor College of Medicine, Houston, TX, USA jill.robinson@bcm.edu.
authors.forename: Jill Oliver
authors.initials: JO
authors.lastname: Robinson
authors.affiliation: Rice University, Houston, TX, USA.
authors.forename: Thomas M
authors.initials: TM
authors.lastname: Carroll
authors.affiliation: Baylor College of Medicine, Houston, TX, USA.
authors.forename: Lindsay Z
authors.initials: LZ
authors.lastname: Feuerman
authors.affiliation: Harvard Medical School, Boston, MA, USA.
authors.forename: Denise L
authors.initials: DL
authors.lastname: Perry
authors.affiliation: Harvard Medical School, Boston, MA, USA.
authors.forename: Lily
authors.initials: L
authors.lastname: Hoffman-Andrews
authors.affiliation: Harvard Medical School, Boston, MA, USA.
authors.forename: Rebecca C
authors.initials: RC
authors.lastname: Walsh
authors.affiliation: Harvard Medical School, Boston, MA, USA.
authors.forename: Kurt D
authors.initials: KD
authors.lastname: Christensen
authors.affiliation: Harvard Medical School, Boston, MA, USA Partners Personalized Medicine, Boston, MA, USA.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Green
authors.affiliation: Baylor College of Medicine, Houston, TX, USA.
authors.forename: Amy L
authors.initials: AL
authors.lastname: McGuire
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001290:Attitude; D035843:Biomedical Research; D005260:Female; D016678:Genome; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D009042:Motivation; D057285:Precision Medicine; D012306:Risk; D017422:Sequence Analysis, DNA; D011795:Surveys and Questionnaires; D055815:Young Adult
keywords: informed consent; participant and decliner perspectives; risks of WGS research; whole genome sequencing