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Festina lente.

Carlo Petrini1, Walter Ricciardi2

  • 1Bioethics Unit, Istituto Superiore di Sanità (Italian National Institute of Health), Via Giano della Bella 34, 00162, Rome, Italy.

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This summary is machine-generated.

Italy

Keywords:
BioethicsCOVID-19Ethics committeeHuman experimentationRegulation

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Area of Science:

  • Clinical research ethics
  • Regulatory affairs in medicine

Background:

  • COVID-19 pandemic necessitated rapid adaptation of clinical trial regulations in Italy.
  • Existing Ethics Committee (EC) structures faced challenges in managing the surge of COVID-19 related trials.
  • Current Italian regulations involve multiple review stages by different authorities.

Purpose of the Study:

  • To analyze the impact of COVID-19 emergency provisions on Ethics Committee operations in Italy.
  • To propose an optimized model for clinical trial review and approval by Ethics Committees.

Main Methods:

  • Review of provisions for clinical trials during the COVID-19 emergency in Italy.
  • Analysis of the evaluation process for COVID-19 clinical trials involving the Italian Medicines Agency (AIFA) and a specialized Ethics Committee.
  • Examination of recommendations for future Ethics Committee structures.

Main Results:

  • The COVID-19 emergency led to a centralized preliminary review by AIFA's Technical Scientific Committee and Clinical Trial Office.
  • A specialized Ethics Committee (Lazzaro Spallanzani National Institute) was involved in the review process.
  • Recommendations emerged for a streamlined, potentially national or regionally accredited, Ethics Committee system.

Conclusions:

  • The COVID-19 experience highlights the need for a more efficient Ethics Committee system for clinical trials.
  • A model with accredited, possibly specialized, Ethics Committees with national validity of opinions could improve trial activation.
  • This proposed structure aims to balance efficiency with rigorous ethical review for medicinal products and medical devices.