How does the ethical review process work in Switzerland and which are the designated ethics committees?
Research Ethics Committees must be distinguished from other kinds of ethics committees, particularly the national ethics committees (CNE) and Clinical Ethics committees (CEC):
- The CNE is a special case in the sense that it does not issue opinions on research projects, but has an advisory role. It takes an ethical stand on social, scientific and legal issues relating to scientific developments and their application to human health and disease. It is an independent extra-parliamentary committee.
- CECs are purely institutional committees. They are directly attached to institutions such as hospitals, with the purpose of helping physicians and health care providers to take real-life decisions in connection with medical practice and the care of patients.
The ethical evaluation of research projects occurs at two levels: at the cantonal level through the REC, and at the federal level through The Swiss Agency for Therapeutic Products (Swissmedic) and the Federal Office of Public Health (FOPH).
At the cantonal level, RECs can be organized under one of two models:
- The REC can be established by an act of government (ordinance, decision). The State Council appoints the members and regulates the organisation.
- The REC can be established independently, but is recognised by cantonal authorities. In the Geneva, Vaud and Zurich cantons, RECs were established by university hospitals. In the Valais, it was established by the central institute for Valais hospital, which is a foundation (an institution under private law), but which operates under legislative delegation on the basis of a service agreement issued by the State Council.
Between the early 1990s and 2007, the number of RECs fell progressively from over a hundred to about fourteen. All cantons do not necessarily have their own REC. There are several intercantonal agreements for the mutual recognition of Committees. This is the case for Bâle-Ville and Bâle-Campagne; Jura, Neuchâtel and Fribourg; Lucerne, Nidwald, Obwald, Schwyz, Uri and Zoug; and Zurich, Glaris and Schaffhouse. These agreements came into being because the number of research projects is relatively low in some cantons. In order to reduce administrative costs, the cantons in question recognise the REC of a canton which has greater research activities. Schaffhouse, for example, expects on average 15 clinical research projects per year to be submitted to the Research Ethics Committee of Zurich, whereas there are more than 500 in the Zurich canton.
The organisation of RECs remains a prerogative of cantons under art. 29 of OClin. Nonetheless, regardless of the type of affiliation of the Committee, it must conduct an ethical, scientific and technical examination of the protocol submitted and if needed, call on outside expert opinion if it does not possess the necessary in-house expertise.