Pediatric oncology as a Learning Health System: Ethical implications for best available treatment protocols

INTRODUCTION: Pediatric oncology is often considered as a field in which research and care are highly integrated. We believe that this integration can be seen as a so‐called Learning Health System, a system in which research is considered an important means to continuously improve the practice of care. In order to substantiate our assumption of pediatric oncology as an LHS, we will analyze so‐called “best available treatment protocols.” These protocols always contain research elements, even if themain goal of these protocols is to treat children diagnosed with cancer. METHODS: We will analyze the implications for ethical review and informed consent if these protocols had to function as exponents of pediatric oncology an LHS. RESULTS: An analysis of best available treatment protocols teaches us how these protocols integrate care and research and how these protocols can be seen as exponents of a system where care and research need no longer be sharply distinct practices. DISCUSSION: Further intervention in the field of pediatric oncology is essential to also meet the requirements for an ethically responsible LHS. CONCLUSION: Best available treatment protocols, which combine research and care, can be seen as examples of pediatric oncology as an LHS. However, in order to prevent that research elements in these protocols will be overlooked, we will have to find new ways to accommodate for the oversight of these protocols, such as multifaceted review and risk‐adapted approaches. Moreover, informed consent process must be changed in order for patients to understand how care and research are integrated in these protocols.