The legislation of Italy and the European Union requires a shift in terms of the organisation and national regulation of ethics committees and clinical trials. More generally, this affects the entire sphere of biomedical research. The first part of this contribution provides a brief review of the history of ethics committees in Italy. We then discuss the current situation and formulate proposals. There is a vital need for rules that promote efficiency of ethics committees, to guarantee that Italy's position remains competitive and attractive within the European Union.
