Considerations on Ministerial Regulation of Ethics Committees in Italy. The experience of CEIOC in Brescia.

Abstract

This article takes into consideration the recent ministerial regulation about the constitution and the operativity of ethics committees (ECs). The ministerial decrees are object of critical analysis: the remarks regard in particular the exclusive feature of attention of the ministerial decrees on the clinical experimentations, the excess of bureaucratization introduced into the work of the ethics committees, the non-acknowledgment of the ECs of the private institutes, the insufficient clearness as to the responsibility of ECs members.

The problematic aspects underscored in the ministerial decrees can all be traced back to the topic of the very nature of ECs. The concern is that, due to bureaucratic tasks and legal terminologies, such organisms may lose their distinctiveness, i.e. the fact of operating inside the system of ethics, and not inside the system of the positive right or the one of the administrative-bureaucratic organization. It is underlined that the object of ECs discernment should be the ethical aspects connected to the decisions in the biomedical field, both when the committee deals with clinical praxis and when it examines research protocols: the constituent perspective of an ethics committee should be specifically the ethical one.

In conclusion, we put forward the experience of the EC of the catholic hospital institutions (CEIOC), established in 1989 on the initiative of the six catholic hospitals in Brescia (Italy). CEIOC is presented as an example of a local EC that has had to be conformed to the current regulations, both in an institutive modality and in its composition, and that has striven to keep its own original identity and to preserve, in continuity with the past, its more pertinent functions.