Participants and Study Decliners' Perspectives About the Risks of Participating in a Clinical Trial of Whole Genome Sequencing. (February 2016)

• Record Type: Journal Article
• Authors: Robinson, Jill Oliver; Carroll, Thomas M.; Feuerman, Lindsay Z.; Perry, Denise L.; Hoffman-Andrews, Lily; Walsh, Rebecca C.; Christensen, Kurt D.; Green, Robert C.; McGuire, Amy L.
• Is Part Of: Journal of empirical research on human research ethics. Volume 11:Number 1(2016)
• Page Start: 21
• Page End: 30
• Publication Date: 2016-02
• Subjects: whole genome sequencing -- informed consent -- participant and decliner perspectives -- risks of WGS research; Medical ethics -- Research -- Periodicals; Research -- Moral and ethical aspects -- Periodicals; 174.205
• DOI: 10.1177/1556264615624078
• Languages: English
• ISSNs: 1556-2646

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.