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The quality of health care for children depends much on the availability of relevant results from medical research with children as subjects. Yet, because of their vulnerability and assumed incompetence to take part in decision-making, children have often been excluded from taking part in medical research, so as to prevent them from harm. Empirical data on children’s competence to consent to such research used to be rare, but recent developments in this field have created more insights in the myths and realities concerning minor patients’ capacities to decide on medical research participation. Against the background of relevant international, European and domestic legal frameworks concerning the rights of children as participants in medical research, this article goes into instruments such as MacCAT-CR, a semi-structured interview format useable as a competence assessment tool for clinical research involving children. On the basis of this, several recommendations are defined to enhance such research, as these may do sufficient justice to the health interests and the capacities of children, while at the same time supporting researchers and child research participants when facing decisions about pediatric research options.

Medical Research Involving Children – Giving Weight to Children’s Views