https://doi.org/10.4081/mem.2017.521

I soggetti vulnerabili nella ricerca clinica europea: dalla Convenzione di Oviedo al Regolamento (UE) N. 536/2014 / Vulnerable subjects in European clinical research: from the Oviedo Convention to Regulation (EU) No 536/2014

V. 66 N. 6 (2017)
Ricevuto: gennaio 25, 2018
Accettato: gennaio 25, 2018
Pubblicato: gennaio 25, 2018
soggetti vulnerabili, sperimentazioni cliniche, beneficio diretto, rischio minimo / vulnerable subjects, clinical trials, direct benefit, minimal risk
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Autori

Antonio Rimedio
antonio.rimedio@tiscalinet.it
Centro di Ricerca in Etica clinica (CREC) del Dipartimento di Biotecnologie e Scienze della vita, Università dell'Insubria; Conferenza regionale per le sperimentazioni cliniche della Regione Piemonte, Italy.
Il confronto tra la Convenzione di Oviedo e il Regolamento (UE) N. 536/2014 ha consentito di strutturare lo "standard etico-giuridico" europeo relativo alle misure di protezione dei soggetti vulnerabili coinvolti nelle sperimentazioni cliniche. Tale standard è stato analizzato seguendo il filo conduttore dei tre principi fondamentali della ricerca, enunciati dal Belmont Report: rispetto per la persona, beneficialità e giustizia. Le discrepanze riscontrate al suo interno hanno fatto emergere le criticità di talune categorie di base, ad esempio la distinzione tra beneficio diretto o beneficio sul gruppo e la nozione del rischio minimo. A 20 anni di distanza dalla Convenzione di Oviedo, documento di riferimento della bioetica europea ed internazionale, viene argomentata la necessità di ripensare criticamente quella dimensione "difensiva" della vulnerabilità, che prevale nella normativa europea e occidentale.
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The comparison between the Oviedo Convention and the Regulation (EU) No. 536/2014 has allowed to discover and structure the European "ethical-legal standard" on the protection measures for vulnerable subjects involved in clinical trials. This standard was analyzed following the three fundamental principles of research, as outlined by the Belmont Report: respect for persons, beneficence and justice. The discrepancies found inside have highlighted the criticalities of some basic categories, such as the distinction between direct benefit or benefit on the group and the notion of minimal risk. Twenty years after the Oviedo Convention, a reference document for European and international bioethics, there is a need to rethink critically the "defensive" dimension of vulnerability, that prevails in European and Western legislation.

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Come citare

Rimedio, A. (2018). I soggetti vulnerabili nella ricerca clinica europea: dalla Convenzione di Oviedo al Regolamento (UE) N. 536/2014 / Vulnerable subjects in European clinical research: from the Oviedo Convention to Regulation (EU) No 536/2014. Medicina E Morale, 66(6), 793–809. https://doi.org/10.4081/mem.2017.521

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