Small Samples, Big Questions: An Ethical Analysis of Consent in Pediatric Biobanking

Whereas research on biological samples already exists for many years, developments in information and research technologies have triggered an increase of biobanking activities both in size and number. Also, research on children’s biological material may yield valuable information and can be important for the development of (pediatric) health care. Children, however, are usually considered incompetent to make an autonomous decision on research participation, which gives rise to specific ethical issues in pediatric biobanking. In view of the rapid developments in pediatric biobanking, it is important to address the question of how consent should take shape in this field. The ethical analysis on consent in pediatric biobanking in this thesis is enriched with a case study on the interpretation and use of consent in current pediatric biobanking practice. Three main questions are addressed in this thesis. First, it is questioned what the appropriate consent procedure for the inclusion of residual samples in biobanks is. It is concluded that in general an opt-out procedure is sufficient for the inclusion of residual tissue, when the following conditions are fulfilled: (1) awareness is raised among people about inclusion of residual tissue as the default position, (2) adequate information is provided, and (3) a genuine possibility to object is presented and objections are adequately registered. This can be referred to as a thick opt-out. In certain situations, however, an opt-in method is required. All stages of biobank research, inclusion, storage, and usage of biological material, should be considered when selecting an opt-in or opt-out procedure. Second, it is scrutinized what the appropriate role for children in the consent procedure is at the time of sample inclusion. It is concluded that assent should be understood from an engagement point of view, which means that both the content and the process of assent need to be adjusted to the individual child. This is referred to as personalized assent. An investment from the biobank in the assent procedure is a requirement for including children’s samples. By contrast, since not all children can or want to give assent, it would be strange to impose an affirmative agreement of the child as a strict requirement on researchers. Investing in a personalized assent procedure both shows respect for the child and may contribute to the quality and success of the research. Third, it is addressed whether children should be re-contacted at maturity to obtain their consent for (or to give them the opportunity to withdraw from) the continued use of their samples and data. Four policies are discussed, ranging from an opt-out policy (participants can withdraw their samples, but the biobank does not re-contact the participant) to a strict opt-in (samples will be destroyed when participants do not give their consent). It is concluded that a thick opt-out policy should be the default, meaning that participants are re-contacted by the biobank and given the opportunity to withdraw. By balancing the interests of participants, biobanks and society, this thesis aims to contribute to morally sound pediatric biobank research.