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The American Journal of Bioethics 3.4 (2003) 31-32



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Preventing Exploitation in Pediatric Research

Jeffrey R. Botkin
University of Utah

Lederer and Grodin (1994) claim that "The history of pediatric experimentation is largely one of child abuse. The vulnerable and disadvantaged were repeatedly exploited to further the 'medical advances' of physicians and scientists." While this conclusion might be a little too sweeping, the shocking exploitation of vulnerable individuals by researchers led to the succinct statement of the first principle of the Nuremberg Code: "The voluntary consent of the human subject is absolutely essential." While this can be interpreted as demonstrating an intrinsic respect for individual autonomy, it is also an effective mechanism to protect individuals from exploitation and abuse. One method to prevent exploitation and abuse is to permit research only with individuals who can "exercise free power of choice" (Nuremberg Code, cited in Grodin and Glantz 1994).

On its face, the first principle of the Nuremberg Code precludes research with children or anyone else without full decision-making capacities. While subsequent codes of research ethics permitted nontherapeutic research with young children, some scholars thought this original principle had it right.

It is better to leave the research imperative in incorrigible conflict with the principle that protects the individual human person from being used for research purposes without either his expressed or correctly construed consent.... It is immoral to use children who cannot themselves consent and who ought not be presumed to consent to research unrelated to their treatment. (Ramsey 1976)

In his classic debate with Ramsey, McCormick (1976) disagreed and argued for the permissibility of pediatric nontherapeutic research when there was no "discernable risks, no notable inconvenience, and yet [the] promise of considerable benefit." For McCormick, an example of an acceptable research burden for children was a buccal swab.

The regulations governing pediatric research were promulgated with a sensitivity to this ethical uncertainty. The "use" of children in nontherapeutic research was, at a minimum, morally perilous, so that it could be conducted only with stringent protections. The protections recommended by the National Commission included the peer review of protocols, guidelines establishing acceptable levels of risk, parental permission, child assent when capable, and the expectation that investigators would stop if the child expressed a deliberate objection. By "deliberate objection" the Commission meant that a child might be too young for assent but able to say, "I don't want that" (Levine 1978). Infants who cry when poked are not expressing a deliberate objection, presumably because there is no deliberation involved.

The point I am developing is that the fundamental purpose of the subsequent regulations was, and is, the protection of vulnerable children from harm. The promotion of autonomy or the respect for autonomy are, at least in part, one of several mechanisms by which this goal is pursued. As we grapple with the definitions and limits of concepts such as informed consent, assent, dissent, and deliberate objection, we should be guided primarily by the protection of children from exploitation and less by assumptions about formal decision-making capacities. More specifically, we should err on the side of respect for any "decision" by the child or on behalf of the child that would prevent their exploitation, whether autonomous or not.

Wendler and Shah conflate assent and informed consent. By demanding a high level of decision-making capacity for those who are offered the opportunity to assent, the difference between assent and informed consent becomes only the legal distinction between adults and minors. My perception of the literature agrees with Wendler and Shah that by age 12 or 14 many adolescents have decision-making capacities that appear equivalent to adults. But of course, we know that many adults do not comprehend the basic elements of consent that bioethicists believe are essential for making autonomous choices. Indeed many of us make choices on a daily basis without full information or understanding, but we are comfortable making decisions with sufficient information to meet our personal needs. Car buffs might be shocked that I would buy a car based on appearance and price alone. Don'...

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