The European Union Directive on Clinical Research: present status of implementation in EU member states’ legislations with regard to the incompetent patient

Excerpt

A European-wide response is slowly emerging to the European Union Directive on Clinical Research (2001/20/CE) establishing good practice in the conduct of clinical trials on medicinal products [1]. The Directive was to have been incorporated and made effective in member states’ national laws by 1 May 2004. Among many other aspects of this wide-ranging Directive passed by the European Parliament on 4 April 2001 is the requirement for prior informed consent by a legal representative for research involving incompetent patients. A preliminary survey conducted by this group in 2002 demonstrated that many states did not possess clear definitions for a legal representative in matters of health, and in the absence of a waiver of informed consent none could validly recruit patients to clinical trials in emergency situations. The Directive therefore had the potential to make clinical research very difficult in intensive care, and impossible in emergency situations such as cardiopulmonary resuscitation. We now report current progress among member states in implementing the Directive. …