https://doi.org/10.4081/mem.2012.139

Il dibattito sulla "Guide for Research Ethics Committee Members" del Consiglio d'Europa: il contributo dei Comitati di etica italiani al draft del documento

Vol. 61 No. 2 (2012)
Published: April 30, 2012
Etica medica, comitati etici per la ricerca, etica della sperimentazione clinica, ricerca biomedica / Medical ethics, research ethics commitees, clinical research ethics, biomedical research
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Authors

Adriano Bompiani
Presidente onorario del Comitato Nazionale per la Bioetica; Delegato italiano presso il Comitato Direttivo per la Bioetica del Consiglio d'Europa, Italy.
Daniela Marrani
d.marrani@palazzochigi.it
Ricercatore di Diritto internazionale, Facoltà di Economia, Università degli Studi di Salerno; esperto scientifico, Comitato Nazionale per la Bioetica, Italy.
Gli Autori hanno condotto una consultazione "aperta", e cioè senza l'uso di precisi questionari, rivolta a 30 Comitati etici per la ricerca operanti in varie strutture universitarie, non universitarie, assistenziali in Italia, riguardante un Progetto "Guide for Research Ethics Committee Members" curato e diffuso dal Comitato Direttivo per la Bioetica (CDBI) del Consiglio d'Europa. Le risposte ottenute documentano un forte interesse dei Comitati interessati soprattutto alla prassi funzionale dei Comitati stessi, ritenendo ormai definito il quadro bioetico e giuridico di riferimento. L'interesse alla prassi esecutiva e all'espressione dei pareri sui vari protocolli di cui hanno esperienza i Comitati consultati, porta a ritenere che ulteriore lavoro di approfondimento possa essere dedicato allo sviluppo di questo obiettivo. Per quanto limitata nell'estensione, l'iniziativa di questa consultazione sottolinea l'interesse di procedure di consulenza degli stessi Comitati prima ancora che documenti più complessi di carattere nazionale europeo o internazionale vengano adottati.
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The authors conducted an "open" consultation, i.e. without the use of detailed questionnaires, with 30 research ethics committees operating in various universities, non-academic, healthcare institutes in Italy, on a "Draft Guide for Research Ethics Committee Members", edited and published by the Steering Committee on Bioethics (CDBI) of the Council of Europe. The responses demonstrate a strong interest of the Committees on the functioning practice of the same committees, being defined yet the bioethical and legal framework of reference. The interest in practice and opinion expression of on the various protocols on which the consulted committees have experience, lead to believe that further work could be dedicated to the development of such goal. Even limited in extension, the initiative highlights the value of consulting committees before more complex national European or international documents are adopted.

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How to Cite

Bompiani, A., & Marrani, D. (2012). Il dibattito sulla "Guide for Research Ethics Committee Members" del Consiglio d’Europa: il contributo dei Comitati di etica italiani al draft del documento. Medicina E Morale, 61(2). https://doi.org/10.4081/mem.2012.139

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