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. 2021 Sep:23:100837.
doi: 10.1016/j.conctc.2021.100837. Epub 2021 Aug 18.

Festina lente

Carlo Petrini  1 , Walter Ricciardi  2
Affiliations

Festina lente

Carlo Petrini et al. Contemp Clin Trials Commun. 2021 Sep.

Abstract

The provisions adopted in Italy for clinical trials on medicinal products and medical devices for the epidemiological emergency caused by COVID-19 had an impact also on the functioning of Ethics Committees (ECs). All COVID-19 clinical trials are evaluated preliminarily by the Technical Scientific Committee of the Italian Medicines Agency (AIFA). They are then evaluated by the Clinical Trial Office of the Competent Authority (AIFA) and by the EC of the Lazzaro Spallanzani National Institute for Infectious Diseases. On the basis of this experience, several parties have recommended the adoption of a new structure that envisages the involvement of a single EC for the activation of new studies, similar to the system put in place for studies on COVID-19. Rather than a single EC with jurisdiction over the entire country, we could envisage the accreditation of a certain number of ECs, possibly subdivided by therapeutic fields, with the trials to be evaluated distributed among them, so that each is authorised to issue an opinion that is valid nationally.

Keywords: Bioethics; COVID-19; Ethics committee; Human experimentation; Regulation.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

References

    1. European Commission. Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic. https://ec.europa.eu/health/documents/eudralex/vol-10_en.
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    1. Italian Medicines Agency (AIFA) 22 May 2020. Circular on the Simplified Procedures for Studies and Compassionate Therapeutic Use Programmes for the COVID-19 Emergency.
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