title: [Ethical problems in the clinical evaluation of drugs--role of ethics committees].
abstract: The most important item in clinical trials is the informed consent. Information of the patient/subject has to be provided in a clear, for medically not educated people understandable language. Consent has to be given voluntarily and not under duress. The Ethic Committees should--among other things--fulfill the following requirements: Review of the written information sheets, checking of the benefit/risk profile (placebo control group?) and--in the future--perhaps to insist to make the results of the study available to the public.
authors.affiliation: Institut für Hypertoniker, Kinderspitalgasse 10, A-1090 Wien. Bluthochdruck@eunet.at
authors.forename: G
authors.initials: G
authors.lastname: Hitzenberger
mesh_terms: D001317:Austria; D002986:Clinical Trials as Topic / Q000941:ethics*; D017041:Ethics Committees; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D010344:Patient Advocacy / Q000331:legislation & jurisprudence; D010919:Placebos / Q000627:therapeutic use
chemical_list: D010919:Placebos