Methodological aspects of observational studies discussed by Ethics Committees: a multicentre, cooperative study

The Italian Medicines Agency (AIFA) has recently introduced a set of rules on the classification, planning and conduction of observational studies in pharmacological research. Even though the AIFA rules are aimed mainly at studies involving drugs, they are expected to make an important contribution to improving the quality assurance of all observational studies, which is often still inadequate despite the fact that much biomedical research is observational. The aim of this study was to depict the quality of the observational study protocols presented to some Italian ethics committees (ECs) and to provide a basic framework for evaluating the effectiveness of the AIFA rules, introduced in March 2008. To this end, a survey of six ECs was conducted. A total of 364 protocols presented as observational before March 2008 were examined by two trained and independent reviewers, not EC members at any of the participating centres. The overall quality of the protocols was very similar to that reported in other papers, both international and national. Although the main aspects of the studies were clearly defined in several cases, particularly in the multicentre studies, there emerged a fairly high percentage of protocols that, on post-hoc comparison, were found not to comply with the AIFA rules in spite of the fact that these rules summarize indications that are widely agreed and accepted.