Abstract
This article empirically examines how healthy volunteers evaluate andmake sense of the risks of phase I clinical drug trials. This is an ethicallyimportant topic because healthy volunteers are exposed to risk but can gain nomedical benefit from their trial participation. Based on in-depth qualitativeinterviews with 178 healthy volunteers enrolled in various clinical trials, we foundthat participants focus on myriad characteristics of clinical trials when assessingrisk and making enrolment decisions. These factors include the short-term andlong-term effects; required medical procedures; the type of trial, including itsdesign, therapeutic area of investigation, and dosage of the drug; the amount ofcompensation; and trust in the research clinic. In making determinations about thestudy risks, participants rely on information provided during the consent process,their own and others’ experiences in clinical trials, and comparisons amongstudies. Our findings indicate that the informed consent process succeeds incommunicating well about certain types of risk information while simultaneouslycreating lacunae that are problematically filled by participants through theircollective experiences and assumptions about risk. We discuss the ethicalimplications of these findings and make recommendations for improving the consentprocess in healthy volunteer trials.
Highlights
In clinical trials, the informed consent process has many objectives, but crucial among them is sharing information about risks of study participation in a manner that is meaningful to potential participants
Our intention here is not to suggest that phase I clinics have been remiss in their duty to secure informed consent from healthy volunteers, but our findings do underscore the importance of empirical research on trial participants’ perceptions of risk
Participants are neither passive recipients of risk information nor fully knowledgeable actors when it comes to making risk-related decisions; rather, their risk perceptions are constantly constructed, maintained, and negotiated within a larger community of serial participants and a culture of clinical research
Summary
The informed consent process has many objectives, but crucial among them is sharing information about risks of study participation in a manner that is meaningful to potential participants. The information provided should give a sufficient basis for individual decision-making regarding the reasonableness of trial risks (Faden and Beauchamp 1986). Risk perceptions are shaped by individuals’ broader views of medical research, the institution conducting the clinical trial, and the possibility for medical benefit (e.g., Lidz et al 2004; Corbie-Smith, Thomas, and St. George 2002; Kingori 2015). George 2002; Kingori 2015) Given this reality, it is important to explore empirically how risk perceptions precede and mediate formal informed consent processes and how they guide individual decision-making
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