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The American Journal of Bioethics 3.4 (2003) 33-34



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Children under Age 14 Deserve More

Holly A. Taylor
Johns Hopkins University

David Wendler and Seema Shah (2003) argue that a child's ability to assent should be measured by their ability to "understand and appreciate the more abstract elements of informed consent" and state that in the context of nonbeneficial research it is the purpose of the research—"to develop generalizable knowledge that might help future patients"—that is the most abstract element of consent. The proposed "conservative" cutoff age of 14 implies that Wendler and Shah believe that the majority, if not all, 14-year-old children possess the ability to understand the abstract purpose of nonbeneficial research. They provide no empirical evidence to support this particular claim. Wendler and Shah do cite a number of empirical studies in the body of their article that report on children's understanding of some elements of informed consent. They fail to report evidence from these same studies that indicate that children over the age of 14 routinely fail to understand the purpose of research. Susman, Dorn, and Fletcher (1992) found that only 1 in 44 obese patients and patients with cancer under the age of 20 responded correctly when asked to provide the purpose of the trials in which they were enrolled. Nine of the children understood that their enrollment might benefit others.1 Ondrusek et al. (1998) found that only 4 of the 18 subjects in their sample, which included children up to age 18, reported that the purpose of the nonbeneficial nutrition study in which they were enrolled was to measure normal values for body muscle, fat, and water and to benefit future children. Ondrusek etal. note that none of the four was able to express how these two concepts were linked. More recently, Tait, Voepel-Lewis, and Malviya (2003) found that 50% of children (n = 27) between the ages of 15 and 18 who had assented to enrollment in six different clinical trials of anesthesia or surgery understood the purpose of the study in which they had been enrolled. While Wendler and Shah acknowledge in their proposal that additional empirical evidence is warranted, Nelson and Reynold's (2003) critique of Wendler and Shah's review of the altruism literature also applies here: "sufficient data exist to place their proposal in doubt."

Even if we had empirical evidence that as soon as children turn 14 they have the capacity to understand the abstract elements of informed consent, I remain skeptical [as do others (Joffe 2003; McGee 2003)] that adding such a cutoff to U.S. federal regulations is the best way to assure that pediatric research subjects are engaged as much as their capacity allows in the deliberations about their participation in research. At the worst, providing an age cutoff gives a message to institutional review boards and research investigators that children under 14 are incapable of being fully engaged in the deliberations and need only be warned of what is about to happen to them. I strongly advocate that additional empirical research be conducted in the area of how to successfully engage children in deliberations about their enrollment in research with the intent of developing best practices rather than pursuing a bright line between those children who are considered worthy of engagement and those who are not. Ashcroft et al. (2003) provide a wonderful example of the type of work that needs to be done in this area.

I would like to return to the quotation from Wendler and Shah's article with which I began this commentary and make an additional point. Assessing children's ability to provide assent based on their understanding of abstract elements of informed consent seems to hold children to a higher bar than we currently hold adults. There is plenty of evidence that adults fail to recall all the elements of informed consent, including the purpose of nonbeneficial research, when quizzed about them afterward. For example, a majority of adults approached to enroll in Phase I oncology trials who believed they...

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