Open Access 12.11.2019 | Original Research
Picking and Choosing Among Phase I Trials
A Qualitative Examination of How Healthy Volunteers Understand Study Risks
Erschienen in: Journal of Bioethical Inquiry | Ausgabe 4/2019
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This article empirically examines how healthy volunteers evaluate and
make sense of the risks of phase I clinical drug trials. This is an ethically
important topic because healthy volunteers are exposed to risk but can gain no
medical benefit from their trial participation. Based on in-depth qualitative
interviews with 178 healthy volunteers enrolled in various clinical trials, we found
that participants focus on myriad characteristics of clinical trials when assessing
risk and making enrolment decisions. These factors include the short-term and
long-term effects; required medical procedures; the type of trial, including its
design, therapeutic area of investigation, and dosage of the drug; the amount of
compensation; and trust in the research clinic. In making determinations about the
study risks, participants rely on information provided during the consent process,
their own and others’ experiences in clinical trials, and comparisons among
studies. Our findings indicate that the informed consent process succeeds in
communicating well about certain types of risk information while simultaneously
creating lacunae that are problematically filled by participants through their
collective experiences and assumptions about risk. We discuss the ethical
implications of these findings and make recommendations for improving the consent
process in healthy volunteer trials.
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