The European Clinical Trials Directive was issued in 2001 and aimed to simplify and harmonise the regulatory framework of clinical trials throughout Europe, thus stimulating European research. However, significant complexity and inconsistency remains due to disparate interpretation by EU member states. Critical care research has been particularly impacted due to variable and often restrictive consenting procedures for incapacitated subjects, with some countries requiring a court-appointed representative, while others recognise consent from family members and occasionally professional representatives. Furthermore, the absence of a waiver of consent threatened to put an end to emergency research in Europe and was met with varied responses. Approval procedures by ethics committees are equally inconsistent, particularly those relating to provision of a single opinion for multi-centre trials. Although evidence is somewhat mixed, this complexity as well as a general increase in administrative and financial burden following the Directive has been shown to cause a reduction in clinical trial activity in Europe, particularly academic trials.
We aim to clarify some of these inconsistent procedures, particularly those relating to informed consent of incapacitated subjects, as well as discussing some general weaknesses and possible improvements of the Directive ahead of its planned revision in 2011.
- informed consent
- interests of health personnel/institutions
- mentally ill and disabled persons
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This paper describes the success and limitations of the European directive on clinical trails in intensive care and emergency medicine 5 years after implementation.
Peter Andrews is Professor in the Department of Anaesthesia, Critical Care & Pain Medicine, University of Edinburgh & Consultant in Critical Care, Western General Hospital. He has been chief investigator (CI) of an MRC funded critical care RCT in the UK and is CI of a large Pan-European clinical trail that will eventually recruit patients throughout the world. Katy Robinson is a post-graduate student studying medicine at the University of Edinburgh. Katy successfully gained competitive funding to undertake a summer studentship with PA. This involved considerable literature searching, email and web based retrieval of information, including correspondence with the competent authorities in most European countries. This work was undertaken to provide information to support the EUROTHERM3235Trial (ISRCTN 34555414).
Guarantor. Peter JD Andrews.
Funding Other funders: European Society of Intensive Care Medicine.
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.