title: The European clinical trials directive and its impact on critical care and emergency research.
abstract: OBJECTIVE
  The European Clinical Trials Directive was issued in 2001 and aimed to simplify and harmonize the regulatory framework of clinical trials throughout Europe, thus stimulating European research. However, significant complexity and inconsistency remains due to disparate interpretation by European Union member states, creating substantial financial and administrative challenges for investigators.
  
  
  RESULTS
  Critical care research has been particularly impacted by the Directive due to variable and often restrictive consenting procedures for incapacitated patients. Furthermore, the absence of a waiver of consent threatened to put an end to emergency research in Europe. Approval procedures by ethics committees are equally inconsistent, particularly those relating to provision of a single opinion for multicentre trials. This complexity as well as a general increase in administrative and financial burden following the Directive has been widely shown to cause a reduction in clinical trial activity in Europe.
  
  
  CONCLUSIONS
  Various changes to the Directive have been called for by clinical researchers from diverse disciplines, including a risk-based approach to ethical approval, insurance, and monitoring; clarification of terms; and a general simplification of administrative procedures to reduce complexity and cost. This widespread advocacy has led to a planned revision of the Directive in 2011.
authors.affiliation: College of Medicine and Veterinary Medicine, University of Edinburgh, Edinburgh, Scotland, UK.
authors.forename: Katy
authors.initials: K
authors.lastname: Robinson
authors.forename: Peter J D
authors.initials: PJ
authors.lastname: Andrews
mesh_terms: D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D003422:Critical Care / Q000331:legislation & jurisprudence*; D005060:Europe; D033161:Government Regulation; D006302:Health Services Research / Q000331:legislation & jurisprudence*; D006801:Humans