Commentary: Can we facilitate the ethical approval of international observational studies?

icinal products for human use. 5 Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. 6 International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing for Biomedical Publication. February 2006. http://www.icmje.org/ (10 July 2007, date last accessed). 7 Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects. 2002. http:// www.cioms.ch/frame_guidelines_nov_2002.htm (10 July 2007, date last accessed). 8 Act No. 78-17 of 6 January 1978 on Data Processing, Data Files and Individual Liberties (Amended by the Act of 6 August 2004 Relating to the Protection of Individuals With Regard to the Processing of Personal Data). 2004. www.cnil.fr/fileadmin/ documents/uk/78-17VA.pdf (10 July 2007, date last accessed). 9 IEA. Good Epidemiological Practice (GEP) Conduct in Epidemiologic Research. 2007. http://www.dundee.ac.uk/ iea/GEP07.htm (10 July 2007, date last accessed). 10 European Commission-European Medicines Agency. Report on the Conference on the Operation of the Clinical Trials Directive (Directive 2001/20/EC) and Perspectives for the Future. 2007. http://www.emea.europa.eu/pdfs/ conferenceflyers/clinicaltrials/report.pdf (3 February 2008, date last accessed).