Europese regelgeving voor klinisch geneesmiddelenonderzoek bij minderjarigen en meerderjarige wilsonbekwamen

- Research involving people who are incapable of giving legal consent is acceptable, but only within strict limitations, as given in the medical literature as well as national and international directives or legislation. Recently the European Union issued a new directive concerning the clinical investigation of medicinal products. It enables non-therapeutic trials involving children to be carried out under strict conditions. However, it only permits the inclusion of incompetent adults under conditions such that phase II studies and placebo-controlled phase III trials are very difficult or even impossible to carry out. Another shortcoming is that it does not address the issue of clinical trials involving incapacitated patients in emergency situations. To hinder non-therapeutic research under people unable to give consent, means denying them the advantages of medical progress. Whether EU physicians will in future have to treat their patients with new medicines that can only be tested outside their countries, might depend on how member states implement the EU Directive within their national legislation and how ethical review boards interpret the new regulations.