Between Protection and Participation : Moral promises and perils in pediatric clinical research

This thesis aims to contribute to the optimal inclusion of children in pediatric clinical research in such a way that we can further clinical research to advance scientific knowledge and develop much-needed treatment options for children while protecting children against harm from research. Why do children and parents want to participate (or not)? What are their motivations and what is important to them in their decision? What expectations do they have of participation? Answers to these questions are indispensable in order to incorporate their views into the pediatric research enterprise and tailor the process of recruitment and informed consent to their needs and perspectives. When we know why children and parents consent or dissent to research and what elements they use in their decision, we know what they attach importance to in their decision. From this data, we learn which information they want and need to make a valid informed decision. This information helps us to increase both the moral and instrumental value of informed consent in pediatric clinical research; we obtain more informed consent and probably more informed consent.

The main research aims of this thesis are as follows:
1. To explore children’s and their parents’ motivations, views and expectations during recruitment and informed consent processes in pediatric clinical research.
2. To analyze these motivations, views and expectations and the factors that shape them from an ethical and legal perspective.
3. To develop a normative framework to support research professionals in the ethically sound inclusion of children in pediatric clinical research. This framework tailors the process of recruitment and informed consent to the perspective and the needs of children and their parents, who have the key role in decisions on research participation.