|Bioethics and Medical
Medical Research and Dependent People
ABSTRACT: How may children and other dependent individuals are subjects in research projects to which they cannot consent and from which they cannot benefit? This topic was much discussed in the United States about twenty-five years ago, but has recently reemerged in the discussion of the European Convention on bioethics and through current discussion in the medical literature of the kinds of consent and experiments appropriate in the Third World. I summarize the U.S. discussion and "solution," present the current European discussion, and conclude with a proposal for understanding and organizing the participation of dependent people in medical experiments. Most of the attempts to understand dependent individuals participation in non-therapeutic experiments have attempted to assimilate that participation to a model of informed consent appropriate for adults. I argue that such understanding is false to the nature both of dependency and non-therapeutic experiments. The dependency of childhood, which serves my model, is best viewed in the context of a family committed to the full development of children. Given that commitment, the family involves itself in many activities in the hope of the physical, intellectual and moral development of its members. Non-therapeutic experiments are best seen, not in terms of risk, but in terms of the time and energy commitments they require of participants. Given these understandings of dependency and non-therapeutic experiments, I argue that care-givers are competent to involve themselves and their dependents in scientific work.
How may children and other dependent individuals be subjects in research projects to which they cannot consent and from which they cannot benefit? Such research might involve regularly drawing blood from healthy infants to establish average values for blood gasses. This topic was much discussed in the United States about twenty-five years ago. It has recently reemerged in the discussion of the European Convention on bioethics and there is a current discussion in the medical literature of the kinds of consent and experiments appropriate in the third world. This paper summarizes the U. S. discussion and "solution," presents the current European discussion, and concludes with a proposal for understanding and organizing the participation of dependent people in medical experiments.
The U.S. Discussion Ever since the revelation of the atrocious Nazi "medical" experiments, informed consent has been the standard for protecting individuals from exploitation in scientific experiments. As the tribunal at Nuremberg put it:
The Nuremberg Tribunal took consent of individual adults is the standard against which other forms of participation may be measured. In the U.S. discussion, various intellectual devices were used to assimilate other cases to the standard. Current U.S. Department of Health and Human Services (DHHS) guidelines state that non-therapeutic research on those unable to consent on their own behalf is acceptable when "either the risk to the subjects is insignificant or, . . . although some risks exist, the potential benefit is significant, and outweighs the risks. (1977)
The significance of the Nuremberg principles and the Helsinki declaration was not immediately recognized in the United States. James H. Jones observed in his study of the U.S. Public Health Service's experiment on untreated syphilis that there was no evidence the Tuskegee Study was ever discussed in the light of the Nuremberg code. (1981, p. 180) The Nazi experiments were regarded as aberrations that happened elsewhere. The sensitivity to be gained by contemplating them was not relevant to the U.S. situation. In 1964 the World Health Organization observed that American government agencies did not adequately protect human subjects. (Cited in Jones, 1981, p. 189) Recent revelations of radiation exposure experiments conducted in the 1950s and 1960s confirm the appropriateness of the WHO's advisory.
In 1968 The American Academy of Arts and Sciences organized a conference on the ethics of human experimentation. Professor Hans Jonas delivered a paper to that conference in which he tried to place the principle of informed consent in a philosophical context. The human subjects in an experiment, Jonas argued, must come to participate in the very process of the experiment. In this way the experimental subject escapes some of the transformation from a living, active subject to a passive, inert object. This reification, which inevitably accompanies becoming a subject in scientific work, is at least diminished by the subject's volunteering. As Jonas puts it: "Mere 'consent' (mostly amounting to no more than permission) does not right this reification. Only genuine authenticity of volunteering can possibly redeem the condition of thinghood to which the subject submits." (1979)
The objections of those who reject children's or other dependent individuals' participation in experiments are largely based on the impossibility of their consenting, much less volunteering. While the U.S. discussion was couched in terms of parental consent for young children, the same issues arise for consent by caregivers or guardians responsible for the development of individuals not previously or presently capable of making their own moral commitments. Paul Ramsey argued that "No parent is morally competent to consent that his child shall be submitted to hazardous or other experiments having no diagnostic or therapeutic significance for the child himself."(1977, p. 13) Ramsey based his conclusion on the fact that children cannot themselves volunteer, and there is no such thing as "being volunteered." In the case of non-therapeutic research, Ramsey claimed that parental consent is irrelevant. Parents may consent to procedures for their children only when the procedures are for the child's benefit. The child has no obligation to participate in experiments because the child does not yet enjoy the freedom of moral agency and therefore has no obligations at all. Parents may not, he concluded, give valid consent for their children's participation in non-therapeutic experiments. (1976, p. 27)
Ramsey and others reacted so strongly to the involvement of children in non-therapeutic experiments because of the consequentialist justification which is often advanced for such involvement. As Ramsey put it, "the battle line is drawn between a medical ethics shaped by the Judeo-Christian tradition with its wholehearted concern for the individual patient and a futuristic ethics of net medical benefit." If the DHHS guidelines cited above are read in a consequentialist way, as they often are, the door is open to the standard fears about consequentialism, namely that future benefits can justify atrocious sacrifices of the individual. Interestingly, the principles of respect for persons, beneficence, and justice, cited as the intellectual basis of the DHHS guidelines, have not dominated the interpretations of the guidelines. Those who are concerned about the implications of consequentialist ethical standards for the treatment of research subjects, therefore, have reason to be concerned by these rules. But Ramsey's position seems to preclude a great deal of research which is both innocuous to the subjects and very valuable.
Two of the ways, then, in which we can think of parents consenting for their children are inapplicable to consent for non-therapeutic experiments. We can think of parents acting in the interests of the child, but this does not apply to non-therapeutic experiments because such experiments are, by definition, not in the child's interest. Second, we can think of the parents' acting as proxies, acting in place of the child, but this standard does not apply either because children have no developed wishes of their own on this subject, much less the ability to express them. Underlying the rejection of both proposed justifications is that they try to force both childhood and experimentation into categories which lawyers and philosophers have used to deal with other ethical issues in medicine. They do not present a realistic picture of childhood or parenting. They also present an unrealistic view of participating in experiments, considering experiments almost solely in terms of risk. The end result of the U. S. discussion is the intellectually unstable truce reflected in the DHHS Guidelines - an experiment is acceptable if it does not hurt too much.
The European Discussion
In November, 1996 the Committee of Ministers of the Council of Europe approved a Convention on Human Rights and Biomedicine. Many member states signed this document as a treaty in April, 1997. The statements in the treaty (Chapter V, Article 17, 2) relevant to non-therapeutic research on children and other dependent individuals read as follows:
The European Convention thus adopts the "U. S. solution," saying in effect that, if the experimentation is minimally risky or troublesome, then it is acceptable to proceed.
The German government as well as political parties in Germany have raised strenuous objection to this provision understandable given Germany's especially terrible history on the subject of human experimentation. Maurice A. M. De Wachter has provided a lengthy recount of the debate in Germany. Research, especially non-therapeutic research, on those unable to give consent was a significant factor in the protest of many German groups against the proposed Convention. By De Wachter's account, German law prohibits any such participation. The German government was very unwilling to have its own stricter regulation compromised by an international treaty. (1997)
But the appeal against the provisions of the code have invoked primarily the World Health Organization's (Helsinki) standards of informed consent.(1964, 1975, 1997) And those standards make a number of significant medical experiments impossible. Is there any intellectually honest and coherent way around this impasse?
Experiment and Risk
A more careful consideration both of the nature of childhood and the nature of experiments will show why it is possible for children and other dependent people to be involved in experiments unrelated to their own care. It is important to clarify what participating in medical science often involves. Most discussions have focused on the risks of science and medicine. Paul Ramsey observed that even the routine weighing of infants has a risk of accident. The (U.S.) National Commission for the Protection of Human Subjects bases its recommendations on the ratio of risks to benefits. It allows for the participation of children when there is minimal risk which it defines as the "probability and magnitude of physical harm that is normally encountered in the daily lives, or in the routine medical or psychological examination of healthy children." The commission considers experiments involving more than minimum risk to be acceptable if the risk is only slightly increased over the minimum and if the research will significantly benefit others. (1977)
Problems with this risk-benefit analysis appear when one tries to compare the risks which may be considered unjustified in the course of a scientific experiment with the wide variety of risk in "normal" life. E. L. Patullo recounts the ironic difficulty of an institutional review board's questioning very well-educated subjects' participation in a minor experiment compared with the freedom of these same people to assume the extraordinary risks of skydiving or drag racing. (1982, p. 1157) Especially given a narrow view of benefits, construing our lives in terms of risks and benefits would prevent our doing very much at all. Think of the parents who, by sheltering their children from many risks, deprive them of the rough and tumble of childhood. If we need to describe what we are doing in terms of rational economic analysis, participating in science is closer to an opportunity cost than a balance between risks and benefits. That is, involvement in the scientific enterprise is an opportunity, something we choose, while recognizing that the opportunity has a price. Risk is certainly part of that price. But the primary price of involvement in research is time.
Young children and the mentally handicapped do not make plans about spending their lives, but families and other caregivers do make plans that involve the moral, social, and personal development of those in their care. In many scientific experiments, the burdens are borne more by the parents or caregivers than by the children. It is the parents who transport the children, and wait, and take the children through the procedure. In terms of risk, there is often more in driving children to and fro than there is in the scientific procedures themselves. So the participation of children in a scientific experiment is really a matter of time and commitment.
Describing such a commitment in terms of risk is too narrow. And describing such commitment in terms of consent is too passive. Although some may want to argue for familial obligations of benevolence, narrowing that general obligation to the specific work of medical science would require a highly developed theory of obligation. A more plausible account is that some families, seeing the need for knowledge in certain areas of medicine, will become interested in working to fill that need. As with blood or organ donation, if properly approached, families may show an interest and commit themselves to it. The family, then, would put itself forward, would volunteer and not merely consent to participate. While the family should be cognizant of any risk that may be involved, the risks are not measured against benefits but become warnings against over-commitment.
The Mayo Clinic recently conducted some research that, in part, follows the model suggested here. In a study titled "Pediatric Reference Intervals for 19 Biologic Variables in Healthy Children," researchers took blood samples from 572 healthy children to compare their blood levels of biologically active substances with levels typically found in adults. They also compared levels of these substances between females and males in their sample and also documented changes over age. The research revealed areas of sameness and difference among the groups compared, results that the authors contend have significance for medical practice.(1990, p. 329)
The subjects of this research were paid volunteers, children of Mayo Clinic employees. The fact that the "volunteers" were paid immediately raises questions. But the fact that they were from the families of Clinic employees could mean that the families or caregivers are committed to both research and patient care and are willing to spend time and effort advancing these values.
If we are to answer the question of children's participation in non-therapeutic experiments in terms of children's becoming involved in family interests, it is important to consider the scope of legitimate family interests. Paul Ramsey narrowly defines the scope of family interests when they involve children.(1976) Against the view that proxy consent is sufficient to involve children in non-therapeutic research, he argues that "there is nothing capricious or arbitrary about proxy consents if they are anchored in the child's single minded orientation toward the unimpaired life to which nature inclines in infancy." It seems more plausible that nature inclines infants and children toward being adults rather than toward unimpaired life. It is the business of parenting to advance this process in the historical and cultural milieu of the family. Their involvement in non-therapeutic research can be looked on as part of the process of development.
William Bartholome argued that families may involve children in non-therapeutic research as part of the children's moral development. The involvement of children at an early age can lead them to full and genuine consent at a later age. Children benefit from involvement in scientific work in that they become open to certain positive moral values. "Parents are obligated to encourage their children to take advantage of these opportunities for moral growth. In order that children may become more sensitive to moral obligations and develop a disposition toward that which is good, they must experience situations in which that sensitivity is required and which enhance this disposition."(1976) Parents may not force their children to develop virtues, Bartholome argues, but parents may stimulate children to develop positive dispositions toward virtuous behavior. Quite plausibly, he suggests that this is a way to think of the involvement of children between the ages of five and fourteen because younger children are not yet accessible to such moral function, and informed consent is directly applicable to older children.
The morally formative value of such activity obviously depends on how it is carried out. Bartholome suggests that parents and children both become involved in these activities. In a later article on children and consent, Bartholome expresses outrage at the way some parents handle their children's moral formation.
There is no guarantee, therefore, that moral formation or social development will be well carried out. But the multitude of our failures does not mean that the whole enterprise is illegitimate.
While informed consent is important, therefore, it is not the key to understanding how children may be involved in non-therapeutic experiments. Customary ways of getting consent can even interfere with the moral formation which is one of the purposes of involvement. The overall problem of justification should be considered again by thinking about the family, community, or other care giver committed to the individual's development. Families can act as moral persons, entities with enough moral density, cohesion, and self-control to make moral judgments about their actions. Families, therefore, may act as moral units to involve themselves in scientific work, even though not every member of the family is able to consent to such activity. Where families or other social entities have so committed themselves, it is appropriate to admire and praise them for their contributions to science.
William Bartholome, "Parents, Children, and the Moral Benefits of Research," Hastings Center Report (1976) 6:44
William Bartholome, "In Defense of a Child's Right to Assent," Hastings Center Report (1982) 12.
M. F. Burritt et al., "Pediatric Reference Intervals for 19 Biologic Variables in Healthy Children," Mayo Clinic Proceedings (1990) 65:329 - 336.
Council of Europe, Convention on Human Rights and Biomedicine, (Oviedo, April 4, 1997)
Maurice A. M. de Wachter, "The European Convention on Bioethics," Hastings Center Report, (1997) 27: 13 - 23.
Hans Jonas, "Philosophical Reflections on Experimenting with Human Subjects," Daedalus, 98 (1979)
James Jones, Bad Blood: The Tuskegee Syphillis Experiment (New York, 1981), p. 180.
E. L. Patullo, "Institutional Review Boards and the Freedom to Take Risks," NEJM (1982) 307:1157.
Paul Ramsey, The Patient as Person (New Haven, 1973).
Paul Ramsey, "The Enforcement of Morals: Nontherapeutic Research on Children," Hastings Center Report 6(1976), 26 - 28.
Paul Ramsey, "Some Rejoinders, Journal of Religious Ethics (1976) 4:215 - 223.
Trials of War Criminals before the Nuremberg Military Tribunals (Washington, D.C. 1948), reprinted in Mappes and DeGrazia, Biomedical Ethics, 4th ed. (McGraw-Hill, 1996), p. 199.
United States National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Research Involving Children: Report and Recommendations (Washington, D.C., 1977).
World Medical Association, Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects, Reprinted in JAMA, (1979) 277: 925 - 926.