Objective Currently, an intensive debate regarding extending medical research involving children is taking place in The Netherlands and elsewhere. This presentation aims at contributing to this debate from an ethical point of view.
Discussion Ethical approval of research involving children is based on two pillars: review of the scientific merit of the research and the risks and burdens for participants by an institutional or national review board, and obtaining informed consent from the child or its legal guardians. Discussions on the ethical acceptability of a study generally focus on the first pillar, especially on the assessment of risks and burdens. The second pillar, obtaining informed consent, is often neglected. This presentation will discuss some of the pitfalls in obtaining informed consent, focusing on the criteria of a valid informed consent: knowledge, competence and voluntariness. Special emphasis is placed on the concept of the “therapeutic misconception”, ie, the misconception that participating in a study is the same as receiving individualised treatment. This concept is assessed in light of the fundamental difference between the research relationship (investigator–participant) and treatment relationship (physician–patient). Understanding the concept of therapeutic misconception is essential to explaining why it is often difficult to obtain valid informed consent for medical research.
Conclusion If extension of medical research with children will be permitted, the quality of the informed consent procedure needs special attention. Adequate training of physicians involved in the informed consent procedure to avoid pitfalls seems a necessary condition to be fulfilled before extending research involving children.