Die Ethik-Kommission an der Medizinischen Fakultät der (RWTH) Aachen (1981 - 2005) : Voraussetzungen und Entwicklung

The doctoral thesis presented here analyzes the development of the ethics committee of the University Hospital Aachen between 1981 and 2005. The main focus of this thesis was to investigate in how far the ethics committee in Aachen could establish itself as an institution and to explore whether a change of the researchers’ mindset occurred. To begin with a historical overview was given to outline the circumstances that led to the establishment of ethics committees thereby creating an understanding for the institution as such. Therein discussed repeated scandals concerning medical research with human subjects underline the importance of a regulatory body. Subsequently, the judicial framework involved in the work of ethics committees was portrayed. The dissertation is based on the research applications submitted to the ethics com-mittee in Aachen within the investigated time frame. Three years from each decade were included in the study and analyzed according to a selection of comparable parameters. The evaluation showed a steady increase of research applications, a diversification of the clinics/institutes submitting research applications, and an extension of research topics. This speaks for the establishment and acceptance of the ethics committee in Aachen. Although studies focusing on other German ethics committees overlook a shorter time frame they show similar results. Furthermore, the data reveals several trends. Changes in the judicial framework dealing with ethics committees and new technological developments have had a significant impact on the focus of research projects and their risk-benefit profile. Increasingly, the parameter ‘quality of life’ of the patient is being used as an outcome measure of medical research. This suggests that the welfare and opinion of the patient is attaining more importance as a means of evaluating the object of investigation. Additionally, an increase of research applications that could not be completed by a vote indicates difficulties in the process flow. If this is due to an unreasonably high expenditure of time and bureaucratic effort for researchers or a result of lacking accuracy when filling out the application remains unanswered at present