Heterogeneity in the evaluation of observational studies by Italian ethics committees

Objective and method In Italy, observational research is rarely brought to the attention of ethics committees (ECs). This study assessed to what extent the observational studies conducted within the Careggi Hospital (2000 beds) and retrieved from MEDLINE after their publication could be traced back from the registries of our EC. Another aim was to compare the different opinions expressed by 28 ECs throughout Italy about the same multi-centre clinical protocol (an oncologic observational study).