How does the ethical review process work in Slovenia and which are the designated ethics committees?
The National Medical Ethics Committee (NMEC) currently reviews most biomedical research on human subjects. The multidisciplinary composition, appointment of members, duration of their mandate, duties and responsibilities have been determined by the Ministerial Order, published in the Official Gazette of the Republic of Slovenia No. 30, 2nd June 1995 (9). Based on the respective internal regulations, all multi-centre and multinational controlled clinical trials must be reviewed by the NMEC.
There are two regional ethical committees linked to regional medical centres (Maribor and Celje). They review biomedical research conducted in their area, but are not authorised to grant independent approvals for multi-centre and multinational controlled clinical trials.
At present, 2 specialised RECs exist in Slovenia: an REC for oncological research taking place at the National Institute of Oncology, and a State Committee on Biomedically Assisted Procreation, which is responsible for pre-assessment of research projects in this field, reporting its opinion to the NMEC, which then takes the final decision.
As soon as the new Law on protection of human rights with regard to genetics (14) is adopted, a specialised REC will also be established for pre-reviewing research projects in this field. It is likely that the final decision for these projects will remain within the responsibility of the NMEC.