Francesca Spera -

The National Coordination Center for Ethical Committees (CCNCE) report highlights critical issues and recommendations for Italy’s 40 Territorial Ethical Committees (CET) overseeing clinical trials.

Critical issues:

  • Operational Challenges: not all CETs are fully integrated with the European Clinical Trial Information System (CTIS), affecting their operational readiness.
  • Standardization Needed: there are discrepancies in committee compositions, impacting the quality of clinical trial evaluations, therefore uniform standards are essential.
  • Financial Stability: financial sustainability is a concern, with some CETs operating at a deficit, threatening their independence and effectiveness.
  • Resource Allocation: there is significant variability in staffing and resources, with some CETs lacking adequate support to perform their duties effectively.
  • Legislative Reforms: legislative updates are needed to address these issues, ensuring standardized operations, adequate funding, and comprehensive oversight.


Final Recommendations:

  • Ensure all CETs are fully operational and integrated with necessary systems.
  • Standardize committee compositions to meet professional requirements.
  • Establish consistent funding mechanisms for financial stability.
  • Allocate sufficient resources to all CETs.
  • Update legislation to support uniform and effective CET operations.


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