Abstract

The articles of the Convention of Human Rights and Biomedicine connect any medical intervention with the »informed consent« of the patient out of respect to Human Dignity by physicians as weil as for treatments and research projects. Nevertheless it becomes apparent that the observation of this principle looses its significance for patients who are incapacitated because of temporal or permanent incompetance to represent their own interests or who are too young to do so. In these cases other attributes of Human Dignity and their observation have to replace the »informed consent«. For inclusion of patients who can't give their consent in clinical studies the MRK formulated strict conditions which exceed the legal prerequisites in Germany. Here clearly the investigation has to benefit each patient directly. The MRK widens this condition to investigations which may not benefit the patient himself, but serve a group of patients with the same illness or solve problems related to the desease. The deciding bodies will have to inform themselves very carefully not only about the facts for urgent research with incapacitated patients, but also must define terms like »no direct benefit « before German Law will allow adaptation to and ratification of the MRK