title: Limitation of medical research in German law.
abstract: In Germany, pharmaceutical trials and the testing of medical devices is regulated by statute. Any other kind of medical experimentation is handled according to the Declaration of Helsinki. Medical experimentation has to be reviewed by an ethics committee before the start and there has to be an elaborate research protocol, which provides for the protection of the experimental subject. In case of an accident, there is compulsory accident insurance as far as pharmaceutical trials and the testing of medical devices are concerned. The third party accident insurance just covers material loss, there is no provision paying and suffering. The sum paid by the insurance company is set off against damages for negligence. There is no strict liability for medical experimentation, but the German courts are expected to set very high standards for medical care in experimentation. The data protection and medical confidentiality have been lessened because of the European law that requires the experimental subject to give his consent to the inspection of the data or the file and if he takes part in the experimentation, that his data and some of his cells might be with the pharmaceutical company forever. In general, the German law seems to be adequate to the protection of experimental subjects.
authors.affiliation: University of Göttingen, Federal Republic of Germany.
authors.forename: Erwin
authors.initials: E
authors.lastname: Deutsch
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence*; D032781:Codes of Ethics; D028744:Ethics Committees, Research; D005858:Germany; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence*; D006801:Humans