Discriminating Between Research and Care in Paediatric Oncology—Ethical Appraisal of the ALL-10 and 11 Protocols of the Dutch Childhood Oncology Group (DCOG)

Abstract

Paediatric oncology is a classic example of a field in which research and care are closely intertwined. Moreover, bioethicists have argued that in environments such as paediatric oncology we should no longer draw sharp distinctions between research and care. Recently, two Dutch protocols for the treatment of children with Acute Lymphoblastic Leukaemia (ALL) have been categorised in two different ways, one as research (ALL-11) and the other as treatment (ALL-10). We analysed these protocols in order to explore whether the distinction between research and care in paediatric oncology is morally relevant. We applied several characteristics of research to the ALL-10 and 11 protocols: the goal of producing generalisable knowledge; systematic collection of data; potentially high and uncertain risks; burdens and risks unrelated to treatment; and provision of treatment according to detailed protocols. Both ALL-protocols exhibit general characteristics of research. At the same time, both protocols also clearly satisfy the objective of delivering the best available treatment. Therefore, it remains to be discussed how to review these kinds of protocols that integrate a research goal with the objective of providing individual patients with best current treatment. A change in both research ethics regulation and oversight of conventional care is needed. More case studies are essential to expand the moral evaluation of the intertwinement between research and care in paediatric oncology.