Читать книгу Pediatric Epidemiology - Группа авторов - Страница 12

Because of their lack of ability to provide consent, children as probands are especially vulnerable to being misused by researchers [2, 3]. The ability to be able to provide informed consent is related to their ability to discern and understand all aspects of the research process. And for children and young people, these are qualities that are yet in the developing stages. So the decision to include children in research cannot be based on legal majority or legal competence. Minors, incompetent children and young people can be regarded as those with an ability to provide consent, depending on their individual stages of development and the gravity of the operation involved; their will should neither be ignored nor consciously transgressed. Fundamentally, the ability to provide consent is the prerequisite for participation in a study. According to the (German) Pharmaceuticals Law [Arzneimittelgesetz], §§ 40–42a, since 1976, the legal custodian of children decides on the participation of children who are unable to provide consent in interventional clinical research projects; the custodian is entrusted with the responsibility of protecting the interests of the children and to save them from abuse. In addition, probands who are minors must each be enlightened according to their level of individual degree of maturity; a refusal from the child’s end must be respected in all cases. The Ethics Commission decides on the general admission of a research project involving minors and must be consulted before embarking on the project. Epidemiological studies that are not covered by all these conditions in Germany require, according to the (Muster-) Berufsordnung für die in Deutschland tätigen Ärztinnen und Ärzte¹ 15, that they be examined and advised upon by the Ethics Commission.

In research on patients who are unable to give consent, a series of ethical questions must be administered to them. Protection of the dignity of man, which is anchored in the German constitution, must be the first goal. An offence against the dignity of a human being occurs when a human being is instrumentalised. So as to see to what extent probands are exposed to the danger of instrumentalisation within a study, as a rule, 3 different kinds of researches on human beings are distinguished. Research that accompanies the care of patients and thus is of advantage to the patient does not generally represent a breach of the prohibition of instrumentalisation. This is to be distinguished from the so-called group use research, the results of which are useful to a group similar to that of the probands (with regard to basic illness, gender, age, etc.) but not to the probands themselves. Such research is, for example, when the validity of a diagnostic early detection method for a certain illness is examined using a patient diagnosed with that same illness (this is true for children, too, since the AMG change of law in 2004). To what extent this type of group use research is ethically legitimate is much debated. From the ethical point of view, the argument that this is instrumentalisation of a patient is difficult to refute. Attempts to justify such a transgression of basic individual rights with the great usefulness for a group of people are likewise to be repudiated from an ethical standpoint. The well-being of the proband outweighs, in every case, the usefulness for a group. If the well-being of the proband is not affected, or only slightly affected, by a study, such a study can, in individual cases, be justified, but the ethical problem of principle has not been solved by this. A third form of research is that which is basically useful for other groups than those being examined. All types of basic research belong to this category, as this does not lead to an improvement in the care of the probands themselves or of a comparable group. Research useful for outside groups cannot be justified when using patients unable to give consent, as this is a clear case of instrumentalisation. Although epidemiological research is to be strongly distinguished from clinical research for the above-named reasons, the principle of protection of the individual dignity of the proband is valid here too. For paediatric epidemiology, it is important to observe whether and to what extent probands can benefit from the research, and what the other interests are in such research, be they purely scientific or even economic. In studies on probands who are unable to give consent, there can be no justification from an ethical standpoint for even a slight risk of a serious transgression of the dignity of the proband.

Research projects can be distinguished, however, by another criterion too. If one takes the degree of damage or the endangering of the proband into consideration, then various forms of research in epidemiology (gathering data from medical records, interviews, questionnaires, and so on, up to and including physical examination within the framework of the study, and invasive interventions) may be distinguished. Among the possible risks, apart from stress and anxiety, are the breach of privacy, the breach of confidentiality, and those risks associated with even a minor intervention such as taking a blood sample. Although the research methods in epidemiology show rather minimal risks as a rule [2], the evaluation of the risk of damage in the context of paediatric epidemiology may deviate from the research on consenting patients. Independently of this, differences in the evaluation of a risk may remain as minimal [2]. To be able to undertake an evaluation of a study, an evaluation orientated to probands, the criterion of vulnerability should be taken into consideration for a more differentiated evaluation of studies. From an ethical point of view, one must ask which criteria must be met in the concrete case in order to do justice to the vulnerability aspect of children.

The vulnerability of children results from various factors, among which is the inability to consent. Children often do not have the social means at their disposal to enable them to assert their own interests in hierarchically formed social contexts. In relation to parents [1], physicians or researchers, there is a clear asymmetry of power and knowledge. Children are dependent in many ways, and have only a few possibilities at their disposal to actively influence this. From this results not only the danger of forcing children to participate against their will in studies, or to feel forced, but also questions may arise with regard to the private sphere of children and young people, which is particularly needful of protection, also with regard to parents. It is thus paramount in the case of young people able to consent that the confidentiality of information given is preserved and clearly communicated not only to the parents, but also to the proband.