Paediatric research ethics evolves around a central dilemma. Either one has to accept that many childhood diseases cannot be (properly) treated and that many children receive treatments that are not (properly) tested in children, or one has to accept that children, i.e. vulnerable persons who cannot (fully) consent, in medical research that can possibly harm them. The main challenge in paediatric research ethics is to find the most reasonable balance between these positions.

This thesis discusses several background questions and three main questions that relate to this central dilemma. The main focus is on the ethical review process and on the monitoring of children who participate in medical research.
The main questions are
(1) to what extent are there elements without direct benefit in paediatrics intervention studies with direct benefit and vice versa, and are there practical drawback for using a procedure-level approach to ethical review?,
(2) what is the burden of several research procedures for children, according to paediatricians?, and
(3) when, and on what ground should signs of discontent and dissent lead to withdrawing a child from a trial?

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I.D. de Beaufort (Inez) , S. van de Vathorst (Suzanne) , A.E. Westra (Anna)
Erasmus University Rotterdam
Department of Medical Ethics and Philosophy of Medicine

Bos, W. (2017, September 19). Children in Medical Research : Ethical challenges. Retrieved from