The role of the Ethics Committees in Scientific Research in Italy: from research protocols to publication – A narrative review of the regulatory framework.
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Abstract
OBJECTIVE
The growing volume of scientific research and the increasing methodological complexity of clinical trials have made a robust ethical and regulatory framework essential; however, some uncertainties persist. Furthermore, as artificial intelligence (AI) and machine learning (ML) tools become more prevalent in biomedical research, additional ethical and methodological challenges emerge. In this context, the Ethics Committee plays a central role in ensuring the ethical and scientific integrity of research protocols. At the same time, scientific journals are tasked with providing editorial oversight to ensure that published studies comply with international ethical standards (COPE, ICMJE).
MATERIALS AND METHODS
A narrative review of the scientific literature was conducted by consulting National and European regulatory documents, institutional guidelines, and publications from international organizations (COPE, ICJME) on clinical research, personal data protection, and publication ethics.
RESULTS
The analysis of Italian and European legislation and literature reveals a complex and multifaceted framework designed to safeguard all parties involved in scientific research.
CONCLUSIONS
To promote consistency in decision-making and greater efficiency, it is advisable to harmonize procedures across regional ethics committees and to provide ongoing, specialized training on emerging technologies. Coordination between Ethics Committees and scientific journals should be enhanced - for example, through shared databases of ethical approvals - to prevent the publication of studies lacking ethical review.
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