Are ethics really ethical
III. Ethical aspects
The question of the ethical justification of biomedical research with minors is an extremely difficult problem within research ethics and has therefore been discussed intensively for a long time (see module Ethics of Research on Children: Status of Discussion). The particular difficulty of the problem lies in the fact that two conflicting moral intuitions collide: On the one hand, minors must be regarded as particularly in need of protection, which makes a general prohibition or at least extensive restriction of biomedical human experiments in the field of pediatrics seem plausible. On the other hand, a far-reaching restriction of pediatric research implies a significantly slower progress in medicine in this area, if not a standstill, and sets limits to the ethical imperative to check applied therapeutic methods through clinical studies for benefits and risks.
The informed consent (see module informed consent) represents one of the central principles of the ethics of research on humans. Human experiments can therefore only be considered ethically justifiable if the test subjects concerned are informed about the nature, meaning and scope (see module Essence , Meaning and scope of a medical experiment) have been informed about an experiment and have given their informed consent to participate. This idea can be found in all relevant research ethical codes as well as in the corresponding legal provisions. In contrast to adults, minors are often unable to give informed consent themselves due to a lack of cognitive skills. Therefore, according to one possible position, research on minors is ethically unjustifiable at least if it is not associated with any direct medical benefit for the underage test persons; only therapeutic research (see module therapeutic research and group benefits) would therefore be permitted. The American bioethicist Paul Ramsey, for example, took a corresponding position in his 1970 book “The Patient as Person” (see module Paul Ramsey, The Patient as Person).
The fact that medical research on minors is necessary in order to develop new and effective methods for pediatrics can be considered generally accepted. Since this is by no means a neutral objective, on the contrary, the provision of effective treatment options is morally highly desirable, many ethicists have sought arguments against the position of fundamental inadmissibility, such as that advocated by Ramsey. It is undisputed that the consent of a legal representative and the lack of alternatives are necessary conditions. In addition, we can roughly distinguish between three approaches: 1. the assumed consent, 2. the educational benefit as a justification, and 3. the concept of minimal risk and 4. the parents as representatives of the child's interests.
1. The imputed consent
A first approach is based on the assumption that given the moral value of participating in a human experiment, the consent of the minor can be assumed. Richard McCormick developed this position as a direct response (see module The Ramsey-McCormick Debate) to Ramsey's thesis of fundamental unreasonableness. According to McCormick's central argument, it is by no means necessary to assume that the underage test person will refuse to participate in a medical experiment. On the contrary, one could assume that, if he had the necessary skills, he would give his consent because it would be morally correct to make such a decision. For this reason, so the conclusion, Ramsey's thesis that research on minors is ethically unjustifiable is wrong. An obvious criticism of this approach is that a comparable assumption is not made with adults who are capable of giving consent and consequently it cannot be seen why it should be permitted with minors.
2. The educational benefit as a justification
The starting point for a second approach is the fact that research with minors is viewed as ethically justifiable if the research is of direct benefit to the minors. While a direct medical benefit is mostly assumed, advocates of this approach (see module The educational benefit) claim that other types of benefit can and must also be taken into account. Participation in a human experiment also has an educational benefit for underage test persons, insofar as it encourages basic social skills such as altruism and solidarity. Therefore, experiments without direct medical benefit could also be considered ethically justifiable. This seems plausible when one considers that in many cases children are subjected to the norms that are considered important or accepted in the family without being asked, since socialization and upbringing of children is hardly possible otherwise. On the one hand, it is disputed whether an educational benefit can really develop the alleged legitimizing power, on the other hand, critics claim that an understanding of altruistic behavior can only be assumed from a certain level of maturity and that research with smaller children cannot be justified by this approach.
3. The concept of minimal risk
A third approach, which is particularly important in the US debate, starts with the risk profile of human experiments. If, according to the idea, there are only minimal risks and burdens associated with a human experiment (see module minimal risk), some of which can only be understood as intervention against the background of a narrow definition of intervention, then the requirement for personal consent can be waived and the consent of the legal representative is sufficient for ethical justification. First of all, this approach raises the question of whether the use of people in medical experiments without their consent is fundamentally problematic from an ethical perspective, regardless of any risks and burdens. If this is the case, then the reference to only minimal risks and burdens cannot provide any ethical justification. Furthermore, this approach is confronted with problems raised by the concept of risk. In particular, many participants in the discussion consider it doubtful that it should be made sufficiently clear what constitutes only a minimal risk or whether an objective determination is suitable for adequately taking into account the evaluations of individual test subjects. According to a study, the opinion of German ethics committees differed even when evaluating group-profit research projects with more than minimal risk (see module Evaluation of group-profit research by chairmen of German ethics committees). Empirical studies show that specifications such as “minimum risk” (see module interpretation of the specifications for “risk” and “exposure”) or “minimum exposure” (see module interpretation of specifications for “risk” and “exposure”) are interpreted differently. For this reason, these initially abstract demarcations are increasingly concretized using clinical examples and linked to recommendations.
4. The parents as (preliminary) representatives of the child's interests
The medical ethicist Giovanni Maio, on the other hand, poses the question of whether research for the benefit of others actually represents an ethically unjustified use of the underage test subject. There is a tension between the prohibition of instrumentalization of the test subject and the requirement to identify possible assistance for future children. According to Maio, the inclusion of underage test persons in non-profit studies is only fundamentally illegitimate if the child's dignity is violated. Parents, representing the interests of the child, should therefore decide on the reasonableness in the interests of the child.
In addition, however, the underage test person himself should also be included in the decision-making process, depending on his or her mental maturity. In practice, it is often difficult to determine when a child is really capable of such consent. At least a refusal to participate in the study should, however, be respected before the point at which full decision-making is possible.
IV. Special cases in research with minors
Although identical legal requirements and ethical requirements apply to all areas of pediatrics, two main areas of pediatrics should be emphasized.
Pediatric oncology clearly stands out from other disciplines in terms of the establishment of studies. The implementation of multicenter studies and the treatment options derived from them increased the cure rate of underage cancer sufferers internationally from around 15% at the beginning of the 1970s to around 70% today. However, physicians and ethicists are faced with the difficult task of educating children and parents and weighing up the protection of the subjects and the gain of knowledge / benefit for the patient. The high number of studies also raises the question of whether significant differences between medical research and medical practice are not being disregarded.
According to experts, many drugs are used in neonatology that have not previously been tested on patient groups. The sometimes serious consequences for the health of newborns lead experts to the question of whether all treatments in neonatology should not be carried out as part of clinical studies. However, the distinction between research and medical practice would then also be put up for discussion.
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