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From the Department of Psychiatry, the Bioethics Program, and the Center for Behavioral and Decision Sciences in Medicine (S.Y.H.K.), University of Michigan, Ann Arbor; Departments of Neurology (R.G.H., C.Z., R.W., K.K.) and Biostatistics and Computational Biology (C.A.B.), University of Rochester, NY; and the Department of Neurology (S.F.), Boston University, MA.
Address correspondence and reprint requests to Dr. Scott Y.H. Kim, Bioethics Program, 300 North Ingalls Street, 7C27, Ann Arbor, MI 48109; e-mail: scottkim{at}umich.edu
Background: For early phase trials of novel interventions—such as gene transfer for Parkinson disease (PD)—whose focus is primarily on safety and tolerability, it is important that participants have a realistic understanding of the goals of such research. Recently, some have expressed concern that patients with PD may have unrealistic expectations.
Methods: The authors examined why patients with PD might volunteer for invasive early phase research by interviewing 92 patients with PD and comparing those who would (n = 46) and those who would not (n = 46) participate in a hypothetical phase I gene-transfer study.
Results: The two groups' demographic, clinical, functional, and quality of life measures, as well as their understanding of the research protocol, were similar. The groups did not differ on their perception of potential for personal benefit nor on the level of likelihood of benefit they saw as a precondition for volunteering. However, those willing to participate tended to perceive lower probability of risk, were tolerant of greater probability of risk, and were more optimistic about the phase I study's potential benefits to society. They also appeared more decisive and action-oriented than the unwilling group.
Conclusions: It is likely that the decision whether to participate in early phase PD gene transfer studies will depend mostly on patients' attitudes regarding risk, optimism about science, and an action orientation, rather than on their clinical, functional, or demographic characteristics.
Additional material related to this article can be found on the Neurology Web site. Go to www.neurology.org and scroll down the Table of Contents for the April 11 issue to find the title link for this article.
Editorial, see page 964
This article was previously published in electronic format as an Expedited E-Pub at www.neurology.org.
Supported as a subproject of U54-NS45309 from the National Institutes of Health (Howard Federoff, Principal Investigator). Dr. Kim is also a recipient of grant K23 MH64172 from the NIH.
Disclosure: The authors report no conflicts of interest.
Received October 10, 2005. Accepted in final form December 1, 2005.
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