title: [External regulation of clinical research requires a change].
abstract: Key findings and recommendations from a study comparing clinical research regulation in Finland with those in England, Canada (Ontario) and USA are presented. Data were collected with various methods, including interviewing key experts. While the norms and ethical codes were similar, the interpretation partly differed. In each country there were various actors in regulation and practical arrangements differed. Research ethics committees (REC) were crucial, as well as drug authorities in research with drugs. Recommendations include reforming the medical research law, widening the dimensions of ethics judgment, restricting the REC tasks, including a central committee, and introducing quality assurance and restricting the drug control authority tasks.
authors.forename: Elina
authors.initials: E
authors.lastname: Hemminki
mesh_terms: D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence*; D032781:Codes of Ethics; D004739:England; D026724:Ethical Review; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence*; D032984:Ethics, Research; D005387:Finland; D033161:Government Regulation; D006801:Humans; D007407:Interviews as Topic; D009864:Ontario; D014481:United States