The Dutch Medical Research Involving Human Subjects Act (WMO) limits non-therapeutic research in children by means of the absolute requirement of negligible risk and minimal burden. The European Clinical Trials Directive, however, allows clinical research with medicinal products in children when, among other requirements, the investigation has any direct benefit for the group of patients involved. In addition, pain, discomfort, fear and other anticipated risks should be minimised. This European Directive has been implemented in the WMO, but the Dutch restriction on non-therapeutic research with children was not adjusted. An expert committee has now advised the Dutch government to bring the WMO in line with the Clinical Directive for all forms of medical interventional and observational research involving children, except for observational studies in children younger than 12 years. In these children, the strict limits of minimal risk and burden should be maintained.
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