What is the role of ethics committees after Regulation (EU) 536/2014?

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. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/