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The basis for a responsibly perceived role in research, also in health training and health policies, is a corresponding way of sensitizing to the questions discussed above in health training and further training (as this was already required with reference to research in the Reich guidelines of 1931). Independently of the ethical competence within epidemiology, the establishment of Research Ethics Commissions appears desirable for epidemiological studies too, which do justice to their own ethical questions in contrast to clinical research [8].

Ethical bases for epidemiological research have been demanded since the 1970s [29]. Besides questions of data protection, the choice of method, and the design of studies, questions of the rights of probands or the position of probands within the study [5], and the suitable and responsible way to deal with patients have all been discussed [30]. Not the least, there is an increasing uncertainty in the population at large about the partly contradictory results of epidemiological research, and a controversy that is present within the discipline about the task and placement of epidemiology within the context of health research and enlightenment has contributed to the formulation of ethical fundaments for epidemiological research in several places since the beginning of the 1990s [31]. The ethical guidelines first worked out for epidemiological research (Industrial Epidemiology Forum 1989, Council for International Organizations of Medical Sciences (CIOMS) 1990, International Epidemiological Association 1990, International Society for Environmental Epidemiology 1996, [31]) reacted to numerous ethical questions in the context of epidemiological research. However, there was criticism [31] that important aspects had not been taken into consideration. Thus, neither the value of ethics in training nor the role of epidemiologists in the context of health policies had been adequately discussed in the guidelines. In addition, there was insufficient evaluation of individual topics of specialised epidemiological research (e.g., molecular research), and the increasing importance of data protection guidelines in the context of changing information and communication technologies. In order to react to the dynamic development of the field, there was a demand already at the end of the 1990s for new or extended guidelines [31]. Especially in view of the ethical questions posed above with regard to the vulnerability of children as probands, it would pay to discuss whether and what form vulnerability in general and with reference to children as probands in particular should be recognised in the guidelines. Guidelines have an important function in the legitimation and (self-)definition of independent disciplines and professions [31]. As far as specific ethical questions are valid for paediatric epidemiology, these should be recognisable in the guidelines, on the one hand, to establish obligatory standards for research and on the other hand to lend expression to the self-image of epidemiology as a discipline.

Besides existing guidelines of national epidemiological societies and associations, in 2008 the International Ethical Guidelines for Epidemiological Studies was developed by the CIOMS in cooperation with the WHO.

The guidelines of the CIOMS refer, in various contexts, to the specific conditions of research on children and other vulnerable groups. Guideline 14 explicitly reveals the requirements for research with children. Basically, this should be without an alternative, that is, not replaceable by research on persons capable of consent. In addition, children, within the framework of their ability to understand, should be personally convinced of their participation; in every case, a refusal must be respected with no ifs or buts. In view of the minimal risks to the participants, the guidelines of the CIOMS permit studies of use to third parties, for example, when the influence of environmental factors during childhood on illnesses in the adult are to be investigated. However, in this it seems problematic that there is no explanation of what an acceptable risk is, that is, the criterion of minimal harm is not formulated by the study participants themselves but by those conducting it.

In 2004, the Deutsche Gesellschaft für Epidemiologie (German Society for Epidemiology, formerly Deutsche Arbeitsgemeinschaft Epidemiology, German Epidemiology Cooperative) the currently valid re-working of the Leitlinien und Empfehlungen zur Sicherung von “Guter Epidemiologischer Praxis” (Guidelines and Recommendations for Ensuring “Good Epidemiological Practice”), which had first appeared in 1999. These guidelines do not deal explicitly with vulnerable groups. Only guideline 1 refers explicitly to the ethical dimension: “epidemiological investigations must be carried out in harmony with ethical principles and respect the dignity and rights of man” [32]. According to the guidelines, ethical principles result from different legal foundations, as ethical duties are valid beyond the legal aspect for epidemiological practice. The basic requirement of respecting the dignity of the individual, however, often runs into complex considerations in practice. For this reason, the guideline prescribes the obligatory consultation of an Ethics Commission, which is to be carried out on the basis of the Checkliste zur ethischen Begutachtung epidemiologischer Studien (Deutsche Arbeitsgemeinschaft Epidemiologie 1999). This checklist makes the ethical requirements for epidemiological studies explicit and emphasises in particular the need for obtaining informed consent as a condition for participation in a study. Apart from cases in which, because of the type of data collecting the explicit consent of all participants cannot be obtained, the checklist does not, however, deal with any other cases of lack of consent. This is problematic, particularly from the viewpoint of paediatric epidemiology. The existing dilemma of having to carry out research on vulnerable participants unable to give consent, but at the same time having to fulfill the obligations of the special need for protection on the part of children, is not taken up either in the checklist or in the guidelines. In guideline 2 [32], it is established that the “population groups to be investigated [...] (must be motivated) with regard to the research question” [32]. In research with vulnerable groups, the question of to what extent the study could be carried out on other non-vulnerable groups must be considered central. The guidelines aim at a use/risk consideration, but as shown above, because of the lack of ability on the part of children to provide consent, the acceptance of even slight risks must appear questionable from an ethical point of view. To take into consideration the respect of vulnerability as a principle in judging the suitability of a group of probands means emphasising the fundamental principle of human dignity in the tendentially utilitarian question of the general use of a study. From the ethical viewpoint, in addition, guideline 11 seems especially relevant, which deals with the communication of research results and their implementation within the framework of public health measures. The guideline requires open and transparent communication of results and methods. Additionally, necessary consequences arising from the research need to be responsibly formulated and communicated. It is obvious that this is only partly achievable in studies on children; so it is the responsibility of paediatric epidemiology to work out measures for health training and elucidation in the context of child welfare.