Proxy Consent in the Experimentation Situation

PROXY CONSENT IN THE EXPERIMENTATION SITUATION RICHARD A. MC CORMICK, SJ. * It is widely admitted within the research community that if there is to be continuing and proportionate progress in pediatric medicine, experimentation is utterly essential. This conviction rests on two closely interrelated facts. First, as Alexander Capron has pointed out [1], "Children cannot be regarded simply as 'little people' pharmacologically. Their metabolism, enzymatic and excretory «systems, skeletal development and so forth differ so markedly from adults' that drug tests for the latter provide inadequate information about dosage, efficacy, toxicity, side effects, and contraindications for children." Second, and consequently , there is a limit to the usefulness of prior experimentation with animals and adults. At some point or other, experimentation with children becomes necessary. Legal Consideration At this point, however, a severe problem arises. The legal and moral legitimacy of experimentation (understood here as procedures involving no direct benefit to the person participating in the experiment) is founded above all on the informed consent of the subject. But in many instances, the young subject is either legally or factually incapable of consent. Furthermore, it is argued, the parents are neither legally nor morally capable ofsupplying this consent for the child. As Dr. Donald T. Chalkley of the National Institutes of Health puts it: "A parent has no legal right to give consent for the involvement of his child in an activity not for the benefit of that child. No legal guardian, no person standing in loco parentis, has that right" [2]. It would seem to follow that infants and some minors are simply out of bounds where clinical research is concerned. Indeed, this conclusion has been explicitly drawn by the well-known ethician Paul Ramsey. He notes: "If children are incapable of truly consenting to experiments having unknown hazards for the sake *Kennedy Center for Bioethics, Georgetown University, Washington, D.C. 20007. 2 I Richard A. McCormick · Proxy Consent of good to come, and if no one else should consent for them in cases unrelated to their own treatment, then medical research and society in general must choose a perhaps more difficult course of action to gain the benefits we seek from medical investigations" [3, p. 17]. Does the consent requirement taken seriously exclude all experiments on children? If it does, then children themselves will be the ultimate sufferers. If it does not, what is the moral justification for the experimental procedures? The problem is serious, for, as Ramsey notes, an investigation involving children as subjects is "a prismatic case in which to tell whether we mean to take seriously the consent-requirement" [3, p. 28]. Before concluding with Shirkey that those incompetent of consent are "therapeutic orphans" [4], I should like to explore the notion and validity of proxy consent. More specifically, the interest here is in the question , Can and may parents consent, and to what extent, to experiments on their children where the procedures are nonbeneficial for the child involved? Before approaching this question, it is necessary to point out the genuine if restricted input of the ethician in such matters. Ramsey has rightly pointed up the difference between the ethics of consent and ethics in the consent situation. This latter refers to the meaning and practical applications of the requirement of an informed consent. It is the work of prudence and pertains to the competence and responsibility of physicians and investigators. The former, on the other hand, refers to the principle requiring an informed consent, the ethics of consent itself. Such moral principles are elaborated out of competences broader than those associated with the medical community. A brief review of the literature will reveal that the question raised above remains in something of a legal and moral limbo. The Nuremberg Code states only that "the voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent" [5]. Nothing specific is said about infants or those who are mentally incompetent. Dr. Leon Alexander, who aided in drafting the first version of the Nuremberg Code, explained subsequently that his provision for valid consent from next of kin where mentally ill patients are concerned was dropped by the Nuremberg...