title: [Regulation of medical research--why and how].
authors.affiliation: Sosial- og helsedirektoratet, Postboks 8054 Dep, 0031 Oslo. simonsen@bredband.no
authors.forename: Sigmund
authors.initials: S
authors.lastname: Simonsen
authors.forename: Magne
authors.initials: M
authors.lastname: Nylenna
mesh_terms: D035843:Biomedical Research / Q000941:ethics / Q000266:history / Q000331:legislation & jurisprudence*; D016265:Conflict of Interest / Q000331:legislation & jurisprudence; D032984:Ethics, Research; D005062:European Union; D017408:Guidelines as Topic; D006381:Helsinki Declaration / Q000266:history; D049673:History, 20th Century; D006805:Human Experimentation / Q000941:ethics / Q000331:legislation & jurisprudence; D006806:Human Rights / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000331:legislation & jurisprudence; D009664:Norway; D028701:Patient Rights / Q000331:legislation & jurisprudence; D012106:Research / Q000331:legislation & jurisprudence*; D012108:Research Personnel / Q000941:ethics / Q000331:legislation & jurisprudence; D035842:Research Subjects / Q000331:legislation & jurisprudence*