The European Union Directive on Clinical Research: present status of implementation in EU member states’ legislations with regard to the incompetent patient
[en] 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.
Disciplines :
Anesthesia & intensive care
Author, co-author :
LEMAIRE, François
Bion, J.
Blanco, J.
Damas, Pierre ; Université de Liège - ULiège > Soins intensifs
The European Union Directive on Clinical Research: present status of implementation in EU member states’ legislations with regard to the incompetent patient
Publication date :
2005
Journal title :
Intensive Care Medicine
ISSN :
0342-4642
eISSN :
1432-1238
Publisher :
Springer Verlag, New York, United States - New York