Good practice in observational epidemiological research: guidelines for biostatisticians on Ethics Committees

The problem of defining and approving observational studies has attracted growing attention in the clinical and epidemiological research sector since the Italian Ministry of Health’s publication, on 2 September 2002, of its circular n.6 on the work of ethics committees. It is known that observational studies are not covered by the implementing legislation of European directive 2001/20/EC on good clinical practice in the conduct of clinical trials, as defined by Italian Legislative Decree n. 211 of 24 June 2003. Following the publication of the abovementioned circular there was a significant increase in the number of “observational” (or “non-interventional”) study protocols submitted to ethics committees for evaluation. The considerable problems ethics committees faced in interpreting and implementing the existing legislation underlined the need for better definition and regulation of these studies. The promotion of epidemiological research, and of instruments that may improve its quality, is one of our association’s primary objectives. We therefore see it as our duty to seek to remove obstacles and barriers of all kinds, administrative, regulatory and cultural, and to develop opportunities for discussion, as well as training and study programmes targeting methodological issues. These various considerations prompted SISMEC to set up a special working group on observational studies, appointed by the board of the association, and to entrust it with drawing up guidelines aimed at biostatisticians who sit on ethics committees. The resulting guidelines, presented in this paper, are an elaboration of an initial document devoted to this topic, published on the SISMEC website in October 2005.