title: [Take-over of the risk-benefit by the clinical study subject and its regulation].
abstract: There should be two levels of the risk-benefit consideration related to all the clinical trials. At the individual trial subject's level, whose rights should be protected against the interest of the society. At the level of the community, the main interest is to improve the therapeutical procedures, to provide more efficacious health care for the present and future patients. The summary intends to shed light, whether the guidelines has been shifted from the absolute defend of the individual subject's interest towards the considerations of the interest of the society since the Nürnberg-Code or not.
authors.affiliation: PAREXEL Magyarország Kft. janos.antal@parexel.com
authors.forename: János
authors.initials: J
authors.lastname: Antal
mesh_terms: D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000592:standards; D032781:Codes of Ethics; D026690:Ethics, Clinical; D032984:Ethics, Research; D006381:Helsinki Declaration; D006805:Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence / Q000592:standards; D006801:Humans; D006814:Hungary; D007391:International Cooperation; D035842:Research Subjects / Q000331:legislation & jurisprudence*; D012306:Risk; D012955:Societies, Medical; D014481:United States; D014486:United States Food and Drug Administration