TY - JOUR T1 - What is the role of ethics committees after Regulation (EU) 536/2014? JF - Journal of Medical Ethics JO - J Med Ethics SP - 186 LP - 188 DO - 10.1136/medethics-2015-103028 VL - 42 IS - 3 AU - Carlo Petrini Y1 - 2016/03/01 UR - http://jme.bmj.com/content/42/3/186.abstract N2 - EU Regulation 536/2014 stipulates that when assessing applications for authorisation to conduct clinical trials, Member States should formulate a ‘single decision’. This raises the problem of identifying: (1) the facility designated to express this ‘single decision’ and (2) the role of ethics committees in the decision-making process. The article addresses the consequences of the requirement that for each Member State the assessment of an application for approval to conduct a trial must take the form of a ‘single decision’ by the Member State concerned. Three possible approaches to the procedures for expressing that ‘single decision’ and to the role of ethics committees in the decision-making process are described, one of which is indicated as the preferred option. ER -