title: Ethics in pharmacologic research in the child with a disability.
abstract: This article reviews the unique ethical concerns that face clinicians, researchers, and family members in the realm of research involving children and youth with childhood-onset disabilities. Presented are the contemporary legal and regulatory environments in which we work and a synopsis of relevant articles on bioethics in this sector of the scientific literature. The most important ethical themes that emerged for children with disabilities include justice in research, consent and assent, child-centered communication, child- and family-centered decision making, participation in multiple studies, and therapeutic misconception. Two publicly recorded clinical studies are profiled to illustrate common considerations and concerns that arise during our ethical review of drug studies involving children with disabilities. It is concluded that the balance of access to current research and treatments must be weighed against risk for all involved. Collaborative planning amongst those involved in the development, review, approval, conduct, and oversight of drug study protocols can lead to effective scientific inquiry within the context of core ethical principles and child- and family-centered care.
authors.affiliation: Bloorview Research Institute, Holland Bloorview Kids Rehabilitation Hospital, 150 Kilgour Road, Toronto, ON, M4G 1R8, Canada, prumney@hollandbloorview.ca.
authors.forename: Peter
authors.initials: P
authors.lastname: Rumney
authors.forename: James A
authors.initials: JA
authors.lastname: Anderson
authors.forename: Stephen E
authors.initials: SE
authors.lastname: Ryan
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics*; D019988:Children with Disabilities; D064420:Drug-Related Side Effects and Adverse Reactions / Q000517:prevention & control; D006801:Humans