31 March 2017
Ethics Committees are now deeply rooted and widespread in our healthcare facilities, yet they never seem to manage to progress from a perennial state of precariousness. Cultural precariousness emerges because even though the role of bioethics in society has been consolidated and institutionalized, it ends up sometimes giving the impression that it has turned into a strict bureaucratic routine, with its agendas and rituals, consequently detaching it from the expectations of those who are suffering. Legal precariousness emerges because even though the Law of 8 November 2012 defined a common framework for operations at national level, the differences between regions still remain significant, and the tasks falling outside the evaluation of trial protocols still remain largely undefined.
This rather unsatisfactory set-up will be called into question again by the implementation of (EU) Regulation 536/2014, which aims to make clinical trial protocols more rapid and homogeneous, concentrating as far as possible on procedures in a limited number of bodies with distinct technical functions. Moreover, in various ways and forms, the proposal has been put forward to institutionalize the practice, already adopted by some healthcare structures, of a "single ethical consultant" so as to provide a quick and informal solution to the most immediate problems. We are faced with two opposing tendencies, which nevertheless converge to resize the role of ethics Committees: one in the name of centralization and depersonalization of functions; the other in the name of capillarity and the individuality of care.
For these reasons, the NBC in line with what was previously stated in the opinions, Ethics Committees of 27 February 1992, Ethics Committees in Italy: recent issues of 18 April 1997, Guidelines for Ethics Committees in Italy of 13 July 2001, considered it appropriate to draw attention to the numerous counselling tasks carried out over the years by ethics Committees assisting on a wide range of issues and, more importantly, the role they will play in the future. These responsibilities require attention and expertise different from those required for the evaluation of protocols for pharmacological trials.
The NBC therefore hopes that clinical ethics Committees will be given due legislative and administrative attention within the current review process as a result of the implementation of EU legislation and, in this regard, indicate to the legislator some essential elements to be taken into account in relation to possible tasks, structure and composition, territorial dimension, the nature of the opinions expressed.
The NBC has also taken the opportunity to reiterate, in view of the possible establishment of a "single ethical consultant", that it is not possible to give up the multidisciplinary and pluralistic nature of ethical consultation which must be provided exclusively by clinical ethics Committees in the entirety of their components and in light of the variety of individual expertise.