title: Trials, Regulation and tribulations.
abstract: BACKGROUND
  Regulation EU 536/2014 EU introduces a separation between two parts (technical-scientific aspects and locally relevant ethical aspects) in the assessment of applications for approval of trials and provides for each 'Member State concerned' to arrive at 'one single decision' regarding the application for authorisation to conduct a trial.
  
  
  METHODS
  The Regulation should be implemented in such a way as to avoid a separation between scientific assessment and ethical assessment; guarantee the absence of conflicts of interest in the institutions responsible for decision-making; promote efficiency on the part of ethics committees. In particular, (i) it is not appropriate to assess Parts I and II of the application for approval to conduct a trial separately (scientific soundness is the principal requisite for ethical soundness); (ii) conflicts of interest should be avoided, especially as regards links with the national authority responsible for drugs regulation; (iii) decision-making in each state should be the responsibility of a single coordinating ethics committee divided into sections specialising in different therapeutic fields; (iv) local committees affiliated to institutions where trial participants are recruited should be able to interact with the coordinating committee, provide consultation services-including on issues of clinical ethics-and promote training in the field of biomedical ethics.
authors.affiliation: Istituto Superiore di Sanità (Italian National Institute of Health), Viale Regina Elena 299, 00161, Rome, Italy. carlo.petrini@iss.it.
authors.forename: Carlo
authors.initials: C
authors.lastname: Petrini
authors.affiliation: Mario Negri Institute for Pharmacological Research, Via La Masa, 19, 20156, Milan, Italy.
authors.forename: Silvio
authors.initials: S
authors.lastname: Garattini
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D003657:Decision Making; D017041:Ethics Committees / Q000331:legislation & jurisprudence; D006801:Humans
keywords: Ethics committee; Europe; Regulation; Trial