The European Directive 2001/20 for clinical research: friend or foe?

Excerpt

In their contribution to Intensive Care Medicine Veelo et al. [1] show how a recent modification to the Dutch law on research humans will, or at least could, improve inclusions in clinical trials. The new provision allows family members to act as legal representatives for granting consent/assent in case the patient is himself incapacitated, whereas the previous legislation restricted that possibility only to the spouse. Such a strange limitation had raised an outcry in the medical community, as described in this journal by Kesecioglu et al. [2]. Apparently the lobbying by our Dutch colleagues toward their policymakers proved efficient, which is a good news to all the European investigators still fighting against inadequate, if not inept, provisions in their own national legislations. It is worth remembering that these new hurdles are not always imposed by the implementation of EU directives and other Brussels “guidance” but by national policymakers. The other important information in their contribution is that patients interviewed as to how they felt about their representatives gave them unequivocally good ratings. This confirms similar findings recently reported in this journal by British investigators [3]. …