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What is the role of ethics committees after Regulation (EU) 536/2014?
  1. Carlo Petrini
  1. Correspondence to Dr Carlo Petrini, Bioethics Unit, Office of the President, Italian National Institute of Health (Istituto Superiore di Sanità), Via Giano della Bella 34, Rome I-00162, Italy; carlo.petrini{at}


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.

  • Clinical trials
  • Ethics Committees/Consultation
  • Law
  • Regulation

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