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 voluntary consent of the human subject is essential. This means that the
person involved should have the legal capacity to give consent; should be so situated as
to be able to exercise free power of choice, without the intervention of force, fraud,
deceit, duress, overreaching or other ulterior form of constraint or coercion; and should
have sufficient knowledge and comprehension of the subject matter involved as to enable
him to make an understanding and enlightened decision. (1948)
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:
Exceptionally and under the protective conditions prescribed by law, where
research has not the potential to produce results of direct benefit to the health of the
person concerned, such research may be authorized subject to the conditions [for
therapeutic research] laid down in paragraph 1, sub-paragraphs I, iii, iv, and v above,
and to the following additional conditions: i the research has the aim of contributing,
through significant improvement in the scientific understanding of the individual's
condition, disease or disorder, to the ultimate attainment of results capable of
conferring benefit to the person concerned or to other persons in the same age category or
afflicted with the same disease or disorder or having the same condition. ii the research
entails only minimal risk and minimal burden for the individual concerned. (1997)
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.
As a parent, I found it no more difficult to target my outrage against the
father who ordered his ten year old son to 'just get your arm up on that table and let the
doctor take the blood.' It reminded me of the painful experiences I have had watching
fathers at Little League baseball games raising their kind of boys' by forcing them to
play even when they were exhausted, sick, or even injured. (1982)
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.
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