[Research Ethics Committees in Abruzzo: criticisms and prospects for developments].
The first legislative bills on Ethics Committee (EC) activity were adopted across the Italian Regions simultaneously (1998). This widespread implementation meant it was necessary to define new qualitative and quantitative standards (Decree Law, 12th May 2009), creating expectations about the EC's role in research and clinical practice and its potential to improve the quality of medical assistance. The present paper presents the results of a descriptive survey that maps out the framework, organization and operating methods of ECs in the Abruzzo Region in Italy. Differences between ECs have been outlined, with special concern for differences in organization and way of operating. It was found that interaction between the EC and the experimenter is limited to the authorization phase of the research protocol, with low level involvement in the planning and execution phases. Additionally, the exchange of information between the co-ordinating EC and EC practitioners is not well organized in multicentre experimentation. A certain amount of criticism emerged regarding those areas of activity that would help to place the EC at the centre of the cultural growth process with regards to Bioethics and Clinical Research (e.g. education, on-line news on Bioethics topics).These criticisms are part of the reality of the Abruzzo Region that lacks economic and structural resources which penalizes EC activity.
Leuter
C
C
Dipartimento di Medicina e Sanità Pubblica, Università degli Studi di L'Aquila. cinzia.leuter@cc.univaq.it
Altobelli
E
E
di Orio
F
F
D028744:Ethics Committees, Research; D007558:Italy