https://doi.org/10.4081/mem.2017.515
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Profili storici della Convenzione di Oviedo e protocolli addizionali. Il protocollo sulla ricerca biomedica e il caso della sperimentazione di emergenza / Historical profiles of the Oviedo Convention and additional protocols. The protocol on biomedical research and the case of emergency experimentation

Autori

Daniela Marrani
Dipartimento di Scienze Economiche e Statistiche, Università di Salerno, Salerno, Italy.
Emanuela Midolo
emilymidolo@gmail.com
Istituto di Bioetica e Medical Humanities, Facoltà di Medicina e chirurgia "A. Gemelli", Università Cattolica del Sacro Cuore, Roma, Italy.
Antonio G. Spagnolo
Istituto di Bioetica e Medical Humanities, Facoltà di Medicina e chirurgia "A. Gemelli", Università Cattolica del Sacro Cuore, Roma, Italy.
A venti anni dalla Convenzione di Oviedo traspare ancora la sua attualità e importanza nel definire i principi dell'etica biomedica. Nonostante il cruciale ruolo ricoperto dalla Convenzione di Oviedo e dai suoi Protocolli aggiuntivi, gli Stati Membri presentano una disomogenea adozione degli stessi. In particolar modo, l'Italia ha iniziato il processo di ratifica nel lontano 2001, ma tale processo non essendosi mai concluso lascia un vuoto normativo in alcuni settori importanti come quello della sperimentazione clinica. Tale vuoto risalta maggiormente con l'adozione del nuovo Regolamento EU 536/2014, il quale - sostituendo la Direttiva CE 20/2001 - apporta numerosi cambiamenti ed introduce la possibilità di applicare la sperimentazione in emergenza su soggetti incapaci di fornire consenso informato. Vari sono i dilemmi normativi ed etici che sorgono in relazione a questo tipo di sperimentazione sui soggetti vulnerabili.
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Twenty years after the Oviedo Convention, its relevance and importance in defining the principles of biomedical ethics is not questioned. Despite the crucial role played by the Oviedo Convention and its additional Protocols, Member States showed a disparity in their adoption. Particularly, Italy has started the ratification process in the 2001, but this process is not yet completed and this produced a regulatory gap on clinical trials on human subjects. This gap stands out with the adoption of the new EU Regulation no. 536/2014, which - replaces EC Directive 20/2001 - introduces many changes and the possibility to start emergency trials on patients which are incapable to provide informed consent. There are several legal and ethical dilemmas that arise in the light of this specific emergency trial on vulnerable subjects.

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Marrani, D., Midolo, E., & Spagnolo, A. G. (2018). Profili storici della Convenzione di Oviedo e protocolli addizionali. Il protocollo sulla ricerca biomedica e il caso della sperimentazione di emergenza / Historical profiles of the Oviedo Convention and additional protocols. The protocol on biomedical research and the case of emergency experimentation. Medicina E Morale, 66(6), 707–716. https://doi.org/10.4081/mem.2017.515

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