Isabell Haase-Saebel¹, Christoph Schickhardt¹

¹ Institute for Medical and Data Ethics, School of Medicine, Heidelberg University

Background: Broad consent in the context of secondary use encompasses the use of treatment data – including genetic data and, where applicable, biomaterials – for research well into the future. The application of broad consent to minors, as a vulnerable group, presents ethical challenges. Parents, acting as deputies for their child, make a decision that extends far into the child’s future. Due to their cognitive development, children can scarcely comprehend the significance of the decision given the enormous time horizon of their consent.

Research question: How does broad consent affect children’s right to an open (informational) future? How should the interventions be weighed against the potential benefits of the research for other children (and their parents, as well as society)?

Method: Following a literature review on the ethical aspects of broad consent in adults and children, we analysed broad consent documents from national and international paediatric practice with regard to their consideration of children’s rights, specifically the right to an open informational future.

Results: Broad consent infringes upon children’s right to an open informational future, as personal data collected may be used for research projects over decades, potentially extending well into the child’s adult life. There are several approaches to mitigating these infringements:

It is becoming increasingly common to obtain both the consent (legally binding agreement) of the parents and the assent (approval) of the children, provided they are cognitively capable of giving it. Another measure involves writing to the children at a later stage, when they are around 16 or approaching the age of majority, to make them aware of how their data is being used and of their rights, for example by offering them the option to opt out. However, data from projects already underway at that point can no longer be withdrawn.

Discussion and outlook: This gives rise to a moral dilemma between the interests of the children currently affected in having a future free from information-related constraints, and the interests of future sick children, who have a right to the best possible medical care; this can be addressed through balancing considerations and mitigation strategies. New technologies such as organoids or PDX models will (with the support of AI) further exacerbate this dilemma.