Abstract:

On the basis of the Treaty on European Union and the functioning of the Regulation number 723/2009 of the Council concerning the legal framework of the European Communities for a consortium of research infrastructures (ERIC), in November 2013 the European Commission decided to create a European network infrastructure for conducting clinical trials (ECRIN) under the form of a consortium of European research infrastructure (ECRIN-ERIC). Its aim is to strengthen Europe´s and the Member States in the field of clinical research worldwide, as well as to strengthen cooperation in the Union. ECRIN-ERIC provides information, advice and services to clinical investigators and sponsors of international studies, as well as consultations with national and European authorities and politicians. Based on the analysis of the nature and characteristics of the consortium of research infrastructure of the Republic of Bulgaria and the opportunities to take part in a consortium of European infrastructure, it is necessary to strengthen the role of the Ethics Commission in the evaluation of multicenter studies.

Keywords: European infrastructure network, Bulgaria, rules of the Ethics Commission