Ethics of Involving Children in Health-Related Research: Applying a Decision-Making Framework to a Clinical Trial

Abstract

This paper explores ethical issues related to the involvement of children in health-related research through the application of a conceptual model (the Miller and Kenny framework) to a current clinical trial on casting protocols for equinus gait of children with cerebral palsy (CP). The direct involvement of children in health-related research is important for maintaining and improving standards of paediatric clinical care. Ethical considerations around investigations involving this highly vulnerable population are complex, however, requiring the involvement of many levels of decision makers-government, research ethics boards (REBs), health care providers, parents, and children. The Miller and Kenny framework is useful in distinguishing these levels and heightening awareness of the complexities of the issues around engaging children in research. Considerations include the role of parents/caregivers in decision making, individual assessment of the child's decisional capacities, close attention to the child's context and life experience, provision of developmentally appropriate information about the research study, and careful assessment of dissent prior to withdrawing the child from the study. Physical therapists involved in paediatric clinical practice and/or research must be knowledgeable about ethical principles, policies, and REB requirements. The Miller and Kenny framework is a helpful guide to clarify decision-making roles around children's participation in research.