Picking and Choosing Among Phase I Trials
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ORIGINAL RESEARCH
Picking and Choosing Among Phase I Trials A Qualitative Examination of How Healthy Volunteers Understand Study Risks Jill A. Fisher & Torin Monahan & Rebecca L. Walker
Received: 9 August 2018 / Accepted: 9 October 2019 # Journal of Bioethical Inquiry Pty Ltd. 2019
Abstract 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 shortterm 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 J. A. Fisher (*) : R. L. Walker Department of Social Medicine and Center for Bioethics, University of North Carolina at Chapel Hill, CB 7240, Chapel Hill, NC 27599-7240, USA e-mail: [email protected]
R. L. Walker e-mail: [email protected] T. Monahan Department of Communication, University of North Carolina at Chapel Hill, CB 3285, Chapel Hill, NC 27599-3285, USA e-mail: [email protected]
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. Keywords Healthy volunteers . Phase I clinical trials . Risk perceptions . Informed consent . Decision-making
Introduction 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. As an ethical standard, the information provided should give a sufficient basis for individual decision-making regarding the reasonableness of trial risks (Faden and Beauchamp 1986). At the same time, we know that prospective participants bring to bear their own medical histories, knowledge about health and illness, and motivations to enrol in clinical trials (e.g., Kent 1996; Siminoff, Caputo, and Burant 2004; Fisher 2009). Risk perceptions are also 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, a
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