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ARTICLES: S.Y.H. Kim, R. G. Holloway, S. Frank, C. A. Beck, C. Zimmerman, R. Wilson, and K. Kieburtz Volunteering for early phase gene transfer research in Parkinson disease Neurology 2006; 66: 1010-1015 [Abstract] [Full text] [PDF]

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Volunteering for early phase gene transfer research in Parkinson disease

Jack E. Riggs, Laurie Gutmann, Gerald R. Hobbs   (25 September 2006)

Reply from the authors

Scott Y.H. Kim, Robert G. Holloway, Chris A. Beck, Samuel Frank, Renee M. Wilson, and Karl Kieburtz.   (25 September 2006)

Volunteering for early phase gene transfer research in Parkinson disease 25 September 2006
Jack E. Riggs, West Virginia University Department of Neurology, Health Sciences Center, Morgantown, WV 26506-9180, Laurie Gutmann, Gerald R. Hobbs Send Correspondence to journal: Re: Volunteering for early phase gene transfer research in Parkinson disease jriggs{at}wvu.edu Jack E. Riggs, et al.	We read with interest the article by Kim et al on patient willingness to participate in a hypothetical medical research. [1] They found no correlation between risk perception (RP) and risk tolerance (RT) and showed these risk parameters independently predicted willingness to participate. Kim et al quantified the odds ratio for willingness to participate at 1.087 for each one point increase in RT score and 0.912 for each one point increase in RP score. Using these values, a table displaying the effect of compounding these independent odd ratios was constructed (Table) which illustrates the relative likelihood of willingness to participate based upon individual RP and RT scores. An arbitrary value of “1” was assigned to an individual with RP and RT scores of 50. As shown, an individual with a RP score of 25 and a RT score of 75 is over 6000 times more likely to participate than an individual with a RP score of 75 and a RT score of 25. This difference in likelihood to participate challenges the comment by Kim et al that, "Tolerance of risk associated with willingness to participate seems rational and ethically unproblematic." [1] Is the decision to participate "rational" when the likelihood to participate is determined by subjective individual interpretation of situational RP and RT? Is tolerance of risk "ethically unproblematic"? If you were a passenger in a plane approaching bad weather, would you prefer that your pilot have a high RP score and low RT score or a low RP score and a high RT score? The concepts and roles of RP and RT in individual choice have been examined in automobile drivers and aircraft pilots, individuals in whom interpretation of risk has obvious consequences for others. [2] Similarly, risk taking preferences of subjects can have consequences for their families, investigators, and medical research sponsors. The work of Kim et al is intriguing and presents concepts of risk that have received far too little attention in the area of subject recruitment and selection in human research and experimentation. Table References 1. Kim SYH, Holloway RG, Frank S, et al. Volunteering for early phase gene transfer research in Parkinson disease. Neurology 2006;66:1010-1015. 2. Oppe S. The concept of risk: a decision theoretic approach. Ergonomics 1988;31:435-440. Disclosure: The authors report no conflicts of interest.
Reply from the authors 25 September 2006
Scott Y.H. Kim, Department of Psychiatry, University of Michigan, Ann Arbor Bioethics Program, 300 North Ingalls Street, 7C27, Ann Arbor, MI 48109, Robert G. Holloway, Chris A. Beck, Samuel Frank, Renee M. Wilson, and Karl Kieburtz. Send Correspondence to journal: Re: Reply from the authors scottkim{at}med.umich.edu Scott Y.H. Kim, et al.	Riggs et al object to our statement, "Tolerance of risk associated with willingness to participate seems rational and ethically unproblematic." Their objection is based on an analogy with airline safety and on a quantitative point, but both arguments are problematic. Their analogical argument about an airline pilot is misplaced because the normative role of risk tolerance in airline safety is different from the informed consent context. For duly reviewed and approved research studies involving gene transfer for PD, the effect of a potential subject’s risk tolerance on his willingness to participate is ethically unproblematic because, at the point of deciding whether to participate in research, it is precisely the individual’s preferences and values that ought to matter. At this point, it is a matter of personal values and preferences of the potential subjects. Of course, their decision may indeed have an impact on those around them but one would hope that it is the subject’s preferences that have priority since it is he/she who takes on the risk of neurosurgery and gene transfer. Riggs et al’s quantitative argument is problematic because it combines the effects of risk perception and risk tolerance; this approach magnifies the effects and increases the drama but misses the normative distinction between risk tolerance and risk perception. The independent effect of risk tolerance in the informed consent setting is ethically unproblematic because, as noted already, it reflects personal values and preferences and indeed is the very thing that ought to matter in informed consent decisions. As for the effect of risk perception, since it is something that can be more or less accurate and not merely a subjective preference, the ethics of its impact should be evaluated primarily on its accuracy. The goal in informed consent ought to be to improve accuracy of risk perception and to allow subjects to exercise their preferences regarding risk. Disclosure: The authors report no conflicts of interest.