Gruppennützige Forschung an Kindern und Jugendlichen

Abstract

In national and international directives and guidelines the acceptance of non-therapeutic medical research in minors is connected to its degree of risks and burdens. Normally the so-called minimal risk and the so-called minimal burden are defined as the threshold for the acceptance of non therapeutic-research in minors. Furthermore the positive attitude of the minor concerned is less or more a precondition for his or her participation in a study. Research Ethics Committees survey future research projects and decide wheter they are to be realized or not. This dissertation examines to what degree the chairpersons of the German Research Ethics Committees - against the background of a non concise legal position - orientate these decisions at the degree of risk and burden of a future project and furthermore at the positive attitude of a minor towards his or her participation in a study.In this dissertation the most important basic conditions for medical research in children from Germany are explained. The ethical terms they base their decisions on are characterized and discussed. To obtain an overview on what kind of research in minors is done in a German university hospital, the demands to the Research Ethics Committee of the Georg-August-University in Göttingen, Germany which were posed within the years 1999-2003 were analysed. These results confirm the relevance of the other empirical study, presented in this dissertation. In that second project a questionnaire containing six clinical vignettes was designed, representing research projects in pediatrics or pediatric psychiatry, based on realistic projects that differed in their degree of risks and burdens. These questionnaires were adressed at the chairpersons of all German Research Ethics Committees. They were questionned towards their attitude of acceptance of each research project and their opinion towards the importance of agreement or rejection of a study participation of children in different ages.The results of the study show a large and heterogenous spectrum of the chairpersons towards non-therapeutic research in minors with more than minimal risks and burdens. One third of the chairpersons do not accept minimal risk or minimal burden as important criteria while surveying non-therapeutic research in minors. Their attitude towards including minors in the decision-process fit in the preconditions of directives and guidelines. However, the younger the children the less their personal opinion was considered as important. A further specification and firm establishment of the terms of risks and burdens is neccessary even after the pass of the 12th Novel of the German Arzneimittelgesetz . Furthermore, there is a strong need to clarify how studies in minors with more than minimal risks and more than minimal burdens should be dealt with.