title: The protection of the person in medical research in Germany.
abstract: Because of its history Germany has many rules concerning the protection of persons in medical research. In fact Germany was the first state to issue a directive regulating medical experimentation with human beings in the year 1900. The ten principles of Nuremberg originated out of the medical case. Germany adheres to the Revised Declaration of Helsinki of the World Medical Association and will probably sign the European convention on biomedicine. The pharmaceutical act contains elaborate provisions for the protection of the patient or proband, e.g. informed consent, risk-benefit ratio, no experimentation on prisoners, approval of a local ethics committee. Moreover in pharmaceutical trials there has to be third party accident insurance for the experimental subject. There is no strict liability for medical experimentation, but the standard of care is high. In general the German law seems to be adequate for the protection of experimental subjects.
authors.affiliation: University of Göttingen.
authors.forename: E
authors.initials: E
authors.lastname: Deutsch
mesh_terms: D003219:Confidentiality / Q000331:legislation & jurisprudence; D017041:Ethics Committees / Q000331:legislation & jurisprudence; D004992:Ethics, Medical; D005858:Germany; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D007349:Insurance, Health, Reimbursement / Q000331:legislation & jurisprudence; D016365:Liability, Legal; D010344:Patient Advocacy / Q000331:legislation & jurisprudence*; D017410:Practice Guidelines as Topic; D011329:Prisoners / Q000331:legislation & jurisprudence; D012106:Research / Q000331:legislation & jurisprudence*