ADMISSIBILITY OF CLINICAL RESEARCH ESPECI ALLY IN THE REALM OF PSYCHIATRY

The freedom of research is guaranteed in Art. 5 sub. 3 of the German B asic Law (GG) as against intrusion by the state. Sec.s 40 AMG contain requirements for the clinical trials for pharmaceutical products which range from medical admissibility to informed consent all the way to a positive evaluation by an ethics committee. From there a route to ana logy for other medical research is called for, because health and well -being of a person should be promoted even outside the area of pharmac eutical products. The international instrument of the Revised Declarat ion of Helsinki by the World Medical Association also requires an adeq uate risk and the information of the patient. Even medical research co ncerning the mentally ill is admissible when it is directed at the ill ness itself. In this case the informed consent of the guardian is norm ally sufficient.