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). RESULTS: Our analysis shows that, in this sample of observational studies, the rate of submission to the EC is 0%. In the second part of our study, the evaluations of the same protocol by the different ECs were extremely different and ranged from unconditioned approval to rejection. CONCLUSION: Our proposal is that clinicians should always notify their observational studies to ECs. On the other hand, ECs should simply accept the observational protocols (without introducing any modifications except cases of macroscopic errors). The heterogeneity in the evaluation of a single protocol by different ECs raises the need to develop some forms of intervention to solve this source of inconsistency.