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ETHICS
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ITALY

How does the ethical review process work in Italy and which are the designated ethics committees?

 

There are local ethics committees situated in health facilities or authorised research institutes which were given legal status in the 90s, firstly by a Ministerial Decree of 27 April 1992 and subsequently by a Decree of 15 July 1997. There were already ethics committees in existance but they operated within research institutes on a voluntary basis. More detailed regulations were given by 2 decrees of the MInistry of Health of 18 March 1998. One of these contains guidelines concerning the establishment and operation of ethics committees. The EC Directive 2001/20/EC was implemented by Legislative Decree No. 211 of 23 June 2003. They are supervised by the Ministry of Health.

 

Regional Bioethics Committees were created in 2000 that act as co-ordinators for local RECs and also provide a link between them and the National Bioethics Committee. In some regions where there is only a regional REC they review research proposals

 

The National Bioethics Committee was established by a Prime Minister's Decree of 28 March 1990 and it acts as a consultative body of the Council of Ministers. Parliament, research centres, local ethics committees and individuals can approach them for advice. They also assist in preparing legislation.

 

The National Ethics Committee for Research and Clinical Trials was established by Legislative Decree no.502 of 30 December 1992 and regulated in detail through a Ministerial Decree of 23 November 1999. It advises the Ministry of Health on ethical and scientific issues and is in charge of co-ordinating ethical and scientific review of multi-centre clinical trials of substantial national interest.

 

Regione: Piemonte

 

ALESSANDRIA

CUNEO

NOVARA

TORINO

 

Regione: Valle d'Aosta

AOSTA

 

Regione: Lombardia

BERGAMO

BRESCIA

COMO

CREMONA

LECCO

LODI

MONZA E DELLA BRIANZA

MILANO

MANTOVA

PAVIA

SONDRIO

VARESE

 

Regione: Trentino-Alto Adige

BOLZANO-BOZEN

TRENTO

 

Regione: Veneto

BELLUNO

PADOVA

ROVIGO

TREVISO

VENEZIA

VICENZA

VERONA

 

Regione: Friuli-Venezia Giulia

GORIZIA

PORDENONE

TRIESTE

UDINE

 

Regione: Liguria

GENOVA

IMPERIA

LA SPEZIA

SAVONA

 

Regione: Emilia-Romagna

BOLOGNA

FORLI'-CESENA

FERRARA

MODENA

PIACENZA

PARMA

REGGIO NELL'EMILIA

 

Regione: Toscana

AREZZO

FIRENZE

GROSSETO

LIVORNO

LUCCA

MASSA-CARRARA

PISA

PRATO

PISTOIA

SIENA

 

Regione: Umbria

PERUGIA

 

Regione: Marche

ANCONA

PESARO E URBINO

 

Regione: Lazio

FROSINONE

LATINA

RIETI

ROMA

VITERBO

 

Regione: Abruzzo

L'AQUILA

CHIETI

PESCARA

TERAMO

 

Regione: Molise

CAMPOBASSO

ISERNIA

 

Regione: Campania

AVELLINO

BENEVENTO

CASERTA

NAPOLI

SALERNO

 

Regione: Puglia

BARI

BRINDISI

BARLETTA-ANDRIA-TRANI

FOGGIA

LECCE

TARANTO

 

Regione: Basilicata

MATERA

POTENZA

 

Regione: Calabria

COSENZA

CATANZARO

CROTONE

REGGIO DI CALABRIA

VIBO VALENTIA

 

Regione: Sicilia

AGRIGENTO

CALTANISSETTA

CATANIA

ENNA

MESSINA

PALERMO

RAGUSA

SIRACUSA

TRAPANI

 

Regione: Sardegna

CAGLIARI

CARBONIA-IGLESIAS

NUORO

OGLIASTRA

ORISTANO

OLBIA-TEMPIO

SASSARI

MEDIO CAMPIDANO

·  COMITATO ETICO DELLA ASL DI SANLURI (VS)

  Italian Ethics Committee Weblinks  
 

Ministero della Salute

 
     
 
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