title: What is the role of ethics committees after Regulation (EU) 536/2014?
abstract: 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.
authors.forename: Carlo
authors.initials: C
authors.lastname: Petrini
mesh_terms: D000066491:Clinical Decision-Making / Q000941:ethics; D002986:Clinical Trials as Topic / Q000941:ethics / Q000331:legislation & jurisprudence; D003657:Decision Making; D028741:Ethics Committees, Clinical / Q000331:legislation & jurisprudence*; D028744:Ethics Committees, Research / Q000331:legislation & jurisprudence*; D005062:European Union; D006801:Humans
keywords: Clinical trials; Ethics Committees/Consultation; Law; Regulation