title: [The rights of clinical research, especially in the area of psychiatry].
abstract: The freedom of research is guaranteed in Art. 5 sub. 3 of the German Basic 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 analogy for other medical research is called for, because health and well-being of a person should be promoted even outside the area of pharmaceutical products. The international instrument of the Revised Declaration of Helsinki by the World Medical Association also requires an adequate risk and the information of the patient. Even medical research concerning the mentally ill is admissible when it is directed at the illness itself. In this case the informed consent of the guardian is normally sufficient.
authors.affiliation: Abteilung für Arzt- und Arzneimittelrecht des Juristischen Seminars der Universität Göttingen.
authors.forename: E
authors.initials: E
authors.lastname: Deutsch
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D004992:Ethics, Medical; D005858:Germany; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D001523:Mental Disorders / Q000188:drug therapy; D011570:Psychiatry / Q000331:legislation & jurisprudence*; D011619:Psychotropic Drugs / Q000627:therapeutic use
chemical_list: D011619:Psychotropic Drugs