title: Voluntary Informed Consent in Paediatric Oncology Research.
abstract: In paediatric oncology, research and treatments are often closely combined, which may compromise voluntary informed consent of parents. We identified two key scenarios in which voluntary informed consent for paediatric oncology studies is potentially compromised due to the intertwinement of research and care. The first scenario is inclusion by the treating paediatric oncologist, the second scenario concerns treatments confined to the research context. In this article we examine whether voluntary informed consent of parents for research is compromised in these two scenarios, and if so whether this is also morally problematic. For this, we employ the account of voluntary consent from Nelson and colleagues, who assert that voluntary consent requires substantial freedom from controlling influences. We argue that, in the absence of persuasion or manipulation, inclusion by the treating physician does not compromise voluntariness. However, it may function as a risk factor for controlling influence as it narrows the scope within which parents make decisions. Furthermore, physician appeal to reciprocity is not controlling as it constitutes persuasion. In addition, framing information is a form of informational manipulation and constitutes a controlling influence. In the second scenario, treatments confined to the research context qualify as controlling if the available options are restricted through manipulation of options. Although none of the influences is morally problematic in itself, a combination of influences may create morally problematic instances of involuntary informed consent. Therefore, safeguards should be implemented to establish an optimal environment for parents to provide voluntary informed consent in an integrated research-care context.
authors.forename: Sara A S
authors.initials: SA
authors.lastname: Dekking
authors.forename: Rieke
authors.initials: R
authors.lastname: Van Der Graaf
authors.forename: Johannes J M
authors.initials: JJ
authors.lastname: Van Delden
mesh_terms: D002648:Child; D003858:Dependency, Psychological; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D008495:Medical Oncology / Q000941:ethics*; D009369:Neoplasms / Q000188:drug therapy; D010290:Parents; D005791:Patient Care / Q000941:ethics*; D010372:Pediatrics; D010565:Persuasive Communication; D012108:Research Personnel
keywords: children with cancer; informed consent; paediatric oncology; research ethics; voluntariness