Ethically Navigating the Transition to the Precision Medicine Era in Pediatric Oncology

Advances in precision medicine offer hope for a future of improved survival rates and decreased treatment-related toxicity for children with cancer. In order to achieve these substantial goods for children, however, there must be testing and clinical trials in actual children. Pediatric oncologists and clinical research organizations who are navigating this frontier therefore must carefully consider when it is ethically justifiable to present newly diagnosed families with the opportunity to participate in experimental trials from the beginning of treatment as an equal alternative to a reasonably effective standard of care. This matter is complicated by a few important factors: the inherent risk of serious harm,including death, of research to participating children; the concerns regarding a physician scientist’s conflicts of interest between scientific and clinical goals; and protection of parents’ autonomy despite their potentially reduced decision-making capabilities following an emotional diagnosis for their children. In this paper, I argue that despitethese challenges, further expanding access to clinical research in the pediatric population by offering opportunities to participate in promising research at the start of treatment promotes and protects the ethical principles of respect for persons, beneficence, and justice by enabling the holistic flourishing of participating children. I also offer three considerations as a first approximation for how this change can be incorporated into current practice.