The integration of research and care in pediatric oncology: implications for review and consent

Abstract

The large majority of children with cancer participate in medical research. This varies from observational studies, to laboratory research on different types of tissue, to drug research, to supportive care studies. As such, pediatric oncology is a field where treatments are often provided in the research context, thereby integrating research with care. This thesis evaluates the challenges and advantages that come with the integration of research and care in pediatric oncology. The first part concerns the informed consent that parents (and older patients) provide for a child’s research participation, and to what extent this can be voluntary in an environment where the treating physician is often the one to obtain informed consent for a child’s research participation (within a dependent relationship). The second part analyzes to what extent research and care can and should be distinguished, and investigates the implications of the integration of research and care for ethical review and the informed consent procedure.

This project has contributed to the ethically sound inclusion of children with cancer in the following ways. First, we have studied voluntary informed consent for research within the dependent relationship with the treating physician. Although the dependent relationship does not constitute a direct threat for voluntariness of informed consent, it is a risk factor as it narrows the scope within which parents can make their decisions. In addition, the dependent relationship may enhance voluntary decision-making, for example if pediatric oncology professionals support parents to make decision based on their own values and preferences. To safeguard voluntary informed consent in a dependent relationship, we suggest a moment of reconsideration during the course of the study. Furthermore, we advise to appoint independent counselors, who can guide families during the decision making process (and afterwards).

We have also investigated treatment protocols that integrate research and care, the so-called best available treatment protocols. The current ethical oversight system does not accommodate for these ‘hybrid’ protocols. We argue that best available treatment protocols cannot be labeled as either research or care, but that in the current oversight system it is best to regard them as research with accompanying ethics review by a Research Ethics Committee. As such, this may prevent that research elements of hybrid protocols are overlooked. Also, we recommend that pediatric oncology professionals should clarify to patients and their parents that in a best available treatment protocol the research component is an inherent part of receiving treatment. They should explain that although best available treatment protocols aim to provide the child with the best current treatment, they also aim to investigate whether modifications to previous treatment regimens improve survival of future patients. Because the treating pediatric oncologist has optimal knowledge of the necessary cancer treatments, and will be the one to provide guidance and assistance throughout the treatment trajectory, it may acceptable that he or she provides information and includes own patients in the protocol. However, as a safeguard, it may be advisable that a research nurse is present during the official moment of signing the informed consent form.