Purpose: 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). Summary of key points: 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. Recommendations: 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.Key Words: assent, children, dissent, ethical issues, REB requirements, research participation Kelly B, MacKay-Lyons MJ. Ethics of involving children in health-related research: applying a decision-making framework to a clinical trial. Physiother Can. 2010;62:338-346
RÉ SUMÉObjectif : Cet article se penche sur les questions qui entourent la participation des enfants à la recherche en santé par l'application d'un modè le conceptuel (la structure dite de Miller et Kenny) à un essai clinique en cours sur les mé thodes de moulage de plâ tres dans les cas de pied bot é quin chez les enfants qui souffrent de paralysie cé ré brale (PC). Ré sumé des principaux points : La participation directe des enfants à la recherche en santé est importante pour le maintien et l'amé lioration des normes lié es à leurs soins cliniques. Les considé rations é thiques en ce qui a trait aux recherches qui mettent à contribution ce segment trè s vulné rable de la population sont complexes et elles exigent l'engagement de dé cideurs à plusieurs é chelons-gouvernements, comité s d'é thique en recherche, fournisseurs de soins de santé , parents et enfants eux-mê mes. La structure de Miller et Kenny est utile pour é tablir une distinction entre ces divers paliers et pour accroître la sensibilisation aux complexité s des enjeux lié s à la participation des jeunes à la recherche. Parmi les considé rations é thiques à prendre en compte, mentionnons le rô le des parents ou des personnes qui s'occupent de l'enfant dans la pri...