Befangenheit von Mitgliedern der Ethik-Kommission im Rahmen klinischer Arzneimittelstudien

Due to unknown health risks, clinical drug trials on humans are subject to particularly rigid medical end ethical-legal standards. Their observance is monitored by the ethics commission in consultation with a higher federal authority. In light of the economic interest of pharmaceutical companies in the approval of the study, and of the limited number of experts, especially in specialist medical areas, conflicts of interest may occur in this context.
Against this background, the author deals with the requirements of the exclusion of commissioners, as well as with the consequences of unauthorised involvement. Due to the regulation (EU) No. 536/2014 and the following 4th amendment, the legal situation with respect to conflicts of interest, as well as the licensing procedure, was altered. The author discusses, in particular, the new allocation of responsibilities between the ethics commissions and the higher federal authority.