Implications of the EU directive on clinical trials for emergency medicine

doi:10.1136/bmj.324.7347.1169

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Many trials in emergency medicine will not be possible

Ernst A Singer, chairman, ethics committee,
Marcus Müllner, clinical epidemiologist

Medical Faculty, University of Vienna, Vienna, Austria
Department of Emergency Medicine, Vienna General Hospital, University of Vienna

A laudable attempt by the European Union to implement good clinical practice in the conduct of clinical trials on drugs for human use will, unless amended, make impossible a range of potentially life saving studies after May 2004.

Directive 2001/20/EC, adopted in April last year, is an important and comprehensive document.1 It is a cornerstone of a Europe-wide harmonisation of the provisions governing clinical trials and can be expected to foster and facilitate multinational clinical research. It will be adopted by member states before 1 May 2003, and its provisions will be applied from 1 May 2004 at the latest.

Several articles in the directive deal with the protection of clinical trial subjects. Article 5 outlines the conditions for research in incapacitated patients unable to give informed consent. The article, however, is framed to address the needs of individuals who are incapacitated for long periods, many even permanently. A clinical trial can only be done if “informed consent of the legal representative has been obtained.” …