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Ethical Conduct of Clinical Research Involving Children
A considerable body of research considers people’s reasoning and decision-making capacities more generally. Much of this research describes deficiencies in people’s reasoning capacities, for example, selectively focusing on information that supports one’s views (Stanovich and West, 2000). This underscores the importance of a careful process for helping prospective research participants reach decisions.
Comprehension of Research Purposes
In the end, it is only the benefit of furthering knowledge that can be honestly guaranteed to a potential research subject.
Advisory Committee on Human Radiation Experiments, 1995, p. 476
Most research evaluating people’s understanding of the difference between research and usual clinical care has involved adults consenting to research participation in their own right. It generally indicates that avoiding or overcoming the therapeutic misconception can be a formidable challenge. As Appelbaum and colleagues (1982) observed many years ago about participants in psychiatric research, “subjects’ ability to distort small aspects of the study design often had the effect of maintaining their therapeutic misconceptions, while they gave the appearance of having a good general understanding of the study” (p. 328).
Other studies also suggest that research participants may have difficulty understanding the purpose of research (see, e.g., Yuval et al., 2000 and Daugherty et al., 1995). When Edwards and colleagues (1998) reviewed 61 studies about attitudes toward clinical trials, they found that people mentioned self-interest more often than altruism as the reason for participating in trials. (Often, however, the specific questions and methods were not fully enough described to provide a clear picture of the results.) They also cited three studies from the 1990s that reported a near majority or majority of physicians believed that research participants did not understand the information given them or realize that they were participating in research.
Several studies suggest that research participants frequently have expectations of benefit, even in clinical trials that test safety but not efficacy (see, e.g., Daugherty et al., 1995; Schutta and Burnett, 2000; Meropol et al., 2003; and Weinfurt et al., 2003). Likewise, although they may understand and approve the knowledge-generating purpose of research in general, participants may view their own participation in research primarily in terms of benefit to themselves (Cassileth et al., 1982; Bevan et al., 1993; Wilcox and Schroer, 1994; Aby et al., 1996; Hutchison, 1998; Yoder et al., 1997; Cheng et al., 2000; Madsen et al., 2000). Individual reactions to