[Commentary note on the Italian translation of the Council for International Organizations of Medical Sciences 2002 Guidelines].

The new CIOMS International Ethical Guidelines on Biomedical Research Involving Human Subjects were published in August 2002. The aim of the present paper was to prepare a reasoned Italian translation of the guidelines. A preliminary version was submitted to a group of bioethicists and scientific research experts. Besides verifying the correctness and the adherence of the Italian version to the original text, a number of problematic terms were analysed. Some uncertainties emerged about the translation of expressions such as "ethical review committee" and "sponsor" and the difficulty to distinguish between "should" and "must". In the present globalisation era the need was apparent for a new approach to produce faithful translations based on a multidisciplinary approach that takes into account specific contexts and local peculiarities, but remains respectful to the original text.