The European Clinical Trials Regulation, approved in 2014, was implemented on January 31, 2022. The Italian Ethics Committees had still no indications how to operate, and this lack of directions caused delays. Finally, In February 2023, the Ministry of Health issued all necessary guidelines to make the new ECs fully operational. It is useful to underline that Italy has a good record for European clinical trials, running more than 21% of the total number of studies.
2023 promises to be a turning point in the history of Italian Ethics Committees (EC), both for factors related to the technical and scientific progress typical of recent years and for the regulatory and procedural revolution introduced by the new European legislation. Since the first formal institution, in 1998, of the Ethics Committees such as “independent bodies, created within a medical or scientific research institution according to interdisciplinary criteria”, different organizational models have followed one another.
“The swift and successful completion of the reorganization will depend on three key factors: the adaptability of existing Ethics Committees; the competence of the regions in correctly managing the transition phase and the appointments of the new components; the authority of the national coordination centre of the ethics committees in carrying out its monitoring and control functions towards the territorial ethics committees.”1
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References
- Cagnazzo, C., & Fagioli, F. (2023). THE NEW SHAPE OF THE ITALIAN ETHICS COMMITTEES. Annals of Research in Oncology, 03(01), 30. https://doi.org/10.48286/aro.2023.63
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