Claudia Wiesemann

Definition of the problem: Medical research with children, especially non-therapeutic research, requires particular consideration. In the current situation this kind of research is not clearly regulated by law in Germany. This entails practical problems in evaluating clinical studies from an ethical point of view. Arguments and conclusion: To develop a new policy framework the international ethical discussion is reviewed. The article analyzes the historical development of research with minors from an ethical perspective, the notion of minimal risk, criteria for evaluating risk and harm in research, consent and assent procedures, and the participation of parents and children in the planning of clinical studies. A list of proposals for minimal standard in ethical regulation of research with minors is developed.

A typical problem of modern medicine results from the gap between scientific knowledge and its application in individual cases. Whereas scientific knowledge is generalized and impersonal information, medical practice takes place under conditions which are singular, individual and irreversible. The paper examines whether prognosis is able to bridge this gap or hiatus theoreticus. It is shown that diagnosis of a single case always relies on prognostic considerations. The individual prognosis (as distinguished from the nosologic prognosis of a certain disease) enables doctors to apply scientific knowledge and practice according to the actual situation, the history and personal preferences of the patient. Prognosis – not diagnosis – therefore legitimizes medical interference. A methodology of individual prognosis as the basis for a theory of practice is discussed.