title: The ethics of clinical research and the conduct of clinical drug trials: international comparisons and codes of conduct.
abstract: Human research must respect most rigorous ethical standards to protect both the investigators and subjects. Codes of ethical practice relevant to such research are subjected to reviews around the world including The European Union (EU), the Canadian Tri-Council Policy Statement (including the Medical Research Council, the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council), the Finnish Parliament Research Act (April 1999) and the National Statement on Ethical Conduct in Research Involving Humans in accordance with the NHMRC Act 1992 (Cth) from the National Health and Medical Research Council of Australia. The Australian Statement was endorsed by the Australian Vice-Chancellors' Committee, the Australian Research Council, the Australian Academy of the Humanities, the Australian Academy of Science and the Academy of Social Sciences in Australia and supported by the Academy of Technological Sciences and Engineering. This reflects the extensive ramifications of human experimentation and the range of stack holders. Private organisations have also produced interpretations of minimum standards of good clinical practice. The paper that follows analyses approaches to human experimentation and the minimal ethical expectations in the conduct of such research.
authors.forename: R G
authors.initials: RG
authors.lastname: Beran
mesh_terms: D001315:Australia; D019985:Benchmarking / Q000331:legislation & jurisprudence / Q000592:standards*; D002170:Canada; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards*; D017041:Ethics Committees; D004992:Ethics, Medical; D005062:European Union; D006801:Humans; D017410:Practice Guidelines as Topic / Q000592:standards*; D011361:Professional Competence / Q000331:legislation & jurisprudence / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration