Changes in the Dutch law on medical research

Excerpt

The European Union Directive on Clinical Research 2001/20/EC was approved 5 years ago (European Parliament and European Council, 4 April 2001; http://www.ccmo-online.nl/hipe/uploads/downloads/EU-2001–20_ENG.pdf). It mandates that EU member states implement the Directive in their national laws effective as of May 2004. However, in the Directive was implemented only recently in the Dutch law on Medical Research Involving Human Subjects (WMO; http://www.ccmo-online.nl/hipe/uploads/downloads_catw/WMO%20per%201%20maart%202006.pdf). This took more time than anticipated mainly because the draft was under discussion in the Upper House of Parliament. The House felt it necessary to arrange an additional round of questions. The WMO concerns all medical/scientific research concerning persons subjected to procedures or required to follow rules of behavior. Its first version was implemented in 1999. The main problem until recently for intensive care medicine was that parents, adult children, and siblings were not considered representatives for incompetent patients [1]. Intensivists, among others, made this point clear, resulting in an  amendment in May 2005 to overcome the problem. These representatives were then included in a hierarchic structure for the providing of informed consent. The change made it easier to obtain consent for clinical research in critically ill patients incapable of giving informed consent, for instance, the mechanically ventilated elderly person without a living partner. That was the situation in The Netherlands until March 2006. The situation in other EU members was recently reviewed in a contribution to the Intensive Care Medicine [2, 3]. …