Currently, an intensive debate regarding medical research involving children is taking place in the Netherlands. In this paper we aim at contributing to this debate, using the field of pediatric oncology as an example. We discuss the two pillars on which the medical-ethical assessment of research with children is based: 'review' by an institutional or national review board, and 'informed consent' by the child or its parents/legal care-takers. Review includes assessing risks and burdens for the child participating in research. Due to current Dutch law research without therapeutic intention is not allowed. This includes early clinical trials, such as phase I studies. We discuss whether this is acceptable, and offer suggestions to make more research possible. This may be achieved by implementing some changes in the Dutch law, following the European law which is less restrictive in this respect. If extension of medical research with children will be permitted, the quality of the informed consent procedure needs additional focus. There are many pitfalls in obtaining a valid informed consent. By allowing phase I research in pediatric oncology, additional requirements are needed to ensure the quality of the informed consent procedure. Instead of the review board playing an overly protecting role, it is then up to the parents and children to make an assessment in the individual case whether participation is justified. Adequate training of physicians involved in the informed consent procedure seems a necessary condition to be fulfilled before extending research involving children.
|Vertaalde titel van de bijdrage||Mogelijkheden tot uitbreiden van geneesmiddelenonderzoek bij kinderen Afweging van risico's en belasting en de informed consent-procedure in de kinderoncologie|
|Tijdschrift||Tijdschrift voor Kindergeneeskunde|
|Nummer van het tijdschrift||2|
|Status||Gepubliceerd - apr. 2009|