title: Ethical procedures and patient consent differ in Europe.
abstract: BACKGROUND
  Research ethics approvals, procedures and requirements for institutional research ethics committees vary considerably by country and by type of organisation.
  
  
  OBJECTIVE
  To evaluate the requirements and procedures of research ethics committees, details of patient information and informed consent based on a multicentre European trial.
  
  
  METHODS
  Survey of European hospitals participating in the prospective observational study on chronic postsurgical pain (euCPSP) using electronic questionnaires.
  
  
  METHODS
  Twenty-four hospitals in 11 European countries.
  
  
  METHODS
  From the 24 hospitals, 23 local investigators responded; 23 answers were analysed.
  
  
  METHODS
  Comparison of research ethics procedures and committee requirements from the perspective of clinical researchers. Comparison of the institutions' procedures regarding patient information and consent. Description of further details such as costs and the duration of the approval process.
  
  
  RESULTS
  The approval process lasted from less than 2 weeks up to more than 2 months with financial fees varying between 0 and 575 &OV0556;. In 20 hospitals, a patient information sheet of variable length (half page up to two pages) was provided. Requirements for patients' informed consent differed. Written informed consent was mandatory at 12, oral at 10 and no form of consent at one hospital. Details such as enough time for consideration, possibility for withdrawal and risks/benefits of participation were provided in 25 to 30% of the institutions.
  
  
  CONCLUSIONS
  There is a considerable variation in the administrative requirements for approval procedures by research ethics committees in Europe. This results in variation of the extent of information and consent procedures for the patients involved.
  
  
  BACKGROUND
  euCPSP in Clinicaltrials.gov identifier: NCT01467102; PAIN-OUT in Clinicaltrials.gov identifier: NCT02083835.
authors.affiliation: From the Department of Anaesthesiology and Pain Medicine, Inselspital and Department of Clinical Research (UMS, NN, FS), Unit for Clinical Ethics, Inselspital, University of Bern, Bern, Switzerland (RP), Clinical Trial Network, European Society of Anaesthesiology, ESA Office Bruxelles, Brussels, Belgium (BL), Department of Anaesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany (WM), and Service d'Anesthésie Réanimation, Hôpital Raymond Poincaré, Garches, France (DF).
authors.forename: Ulrike M
authors.initials: UM
authors.lastname: Stamer
authors.forename: Nadja
authors.initials: N
authors.lastname: Naef
authors.forename: Rouven
authors.initials: R
authors.lastname: Porz
authors.forename: Frank
authors.initials: F
authors.lastname: Stuber
authors.forename: Brigitte
authors.initials: B
authors.lastname: Leva
authors.forename: Winfried
authors.initials: W
authors.lastname: Meissner
authors.forename: Dominique
authors.initials: D
authors.lastname: Fletcher
mesh_terms: D017041:Ethics Committees / Q000706:statistics & numerical data*; D032984:Ethics, Research; D005060:Europe; D006761:Hospitals / Q000941:ethics / Q000706:statistics & numerical data*; D006801:Humans; D007258:Informed Consent / Q000706:statistics & numerical data*; D010149:Postoperative Pain / Q000453:epidemiology; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D013997:Time Factors