RECENT GUIDELINE OF THE BELGIAN FEDERAL ADVISORY COMMITTEE ON BIOETHICS
Recently, the Federal Advisory Committee for Bioethics issued a new opinion on ethics committees in which the Committee makes recommendations on the recognition criterion, composition, and functioning of ethics committees. In this opinion the Committee focuses on the harmonisation of Belgian legislation with the EU Good Clinical Practice Directive, which came into force on 1 May 2004.5 The changes proposed in the Advisory Committee’s opinion are therefore primarily of a formal character (for example, composition, annual capacity, and know how of the committee) in order to ensure good clinical practice through adequate ethical review of research protocols, as envisaged by the European Guideline Good Clinical Practice.
The guideline of the Federal Advisory Committee for Bioethics, however, contains two interesting paragraphs with regard to clinical ethics. Firstly, the guideline proposes a change in the composition of the committees: from now on every ethics committee will have to include a philosopher or a representative of the humanities authorised to speak on medical ethics. A philosopher or representative of the humanities could play an important role in countering the formalisation of the ethical discussion, which could occur when an inflationary wave of legal stipulations and formal conditions, such as good clinical practice guidelines, starts to dominate and steer the ethical discussion. In a previous guideline the Advisory Committee already stated that this formalisation could lead to a "de-moralisation" of the ethical discussion, whereby the ethical reflection has to give way to conformism to procedures.6
Despite the fact that the Advisory Committee’s opinion mainly focuses on the review of experimental protocols, it stresses secondly that the ethics committees in Belgium are deemed to perform other tasks as well, referring to the guidance function and ethics consultation. No further recommendations, however, are made to optimise the efficacy of clinical ethics as embodied by the ethics committees.