title: Administrative complexities for a European observational study despite directives harmonising requirements.
abstract: OBJECTIVE
  For pharmacoepidemiological studies in Europe, accessing data should require only authorisation by the relevant data protections committees, as expected from the 1995 Data Protection Directive (95/46/EC). Our experience from a multinational observational study across seven European countries shows that this is certainly not the case.
  
  
  METHODS
  The study was a multicentre, multinational, case-population study in European liver transplant centres in seven countries, retrospectively evaluating a 3-year period. Before data collection started, the procedures to obtain the necessary authorisations for the participating countries were defined.
  
  
  CONCLUSIONS
  In France, a single opinion from a single data protection committee was enough to start the study. In Italy, Portugal, Greece and the UK, there was a national authority, but the hospitals requested the approval by their local committees/bodies irrespective of whether the authorisation of the national committee came after or before that of local ones. In Ireland, only one hospital participated, and the opinion of its ethics committee was sufficient. In the Netherlands, the opinion of the institutional review board of the local coordinating centre was necessary to obtain the opinions from the institutional review boards of the other hospitals. The information requested by the different committees and the time to obtain the approvals varied, even within the same country.
  
  
  CONCLUSIONS
  This degree of complexity and disharmony, and resulting cost, was observed in a simple retrospective study. Regulators will need to be aware that these time-consuming, expensive and useless complexities must be factored in when estimating the time and cost of a study.
authors.affiliation: Départment de Pharmacologie, Université de Bordeaux, INSERM CIC-P0005, Bordeaux, France. sinemezgi.gulmez@u-bordeaux2.fr
authors.forename: Sinem Ezgi
authors.initials: SE
authors.lastname: Gülmez
authors.forename: Séverine
authors.initials: S
authors.lastname: Lignot-Maleyran
authors.forename: Corinne S
authors.initials: CS
authors.lastname: de Vries
authors.forename: Miriam
authors.initials: M
authors.lastname: Sturkenboom
authors.forename: Sophie
authors.initials: S
authors.lastname: Micon
authors.forename: Fatima
authors.initials: F
authors.lastname: Hamoud
authors.forename: Patrick
authors.initials: P
authors.lastname: Blin
authors.forename: Nicholas
authors.initials: N
authors.lastname: Moore
mesh_terms: D028744:Ethics Committees, Research / Q000941:ethics / Q000331:legislation & jurisprudence / Q000458:organization & administration*; D005062:European Union; D006801:Humans; D007391:International Cooperation; D016031:Liver Transplantation / Q000941:ethics / Q000331:legislation & jurisprudence*; D012189:Retrospective Studies; D009927:Tissue and Organ Procurement / Q000941:ethics / Q000331:legislation & jurisprudence*