Challenges Facing the European Infrastructure Network for Clinical Research. Perspectives to Bulgaria

Abstract

Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. While scientific research on humans complies with commonly accepted scientific standards, trials on humans are only to be allowed if the expected outcome and the goals set surpass and outweigh the risks to the condition of the participants. The Community has established a legal framework for a European Research Infrastructure Consortium (ERIC). In November 2013, with a view to strengthening the position of Europe and the member states in the field of clinical research, the European Commission adopted a Decision for setting up a European Clinical Research Infrastructure Network (ECRIN) with the legal form of a European Consortium for Research Infrastructure (ECRIN-ERIC). The domestic legislation of the Republic of Bulgaria foresees a procedure for obtaining an opinion from the Ethics Committee for Multicentre Trials, thus introducing a substantial change in clinical trials and non-interventional research. Activities executed within the framework of the European research infrastructure have an ethical dimension and impact clinical trial networks on both national and international level, which is why the ethics committees are of key importance to clinical trial management.