Objective Consent is an important issue in paediatric research ethics. In the case of adolescents (children >12 years of age), Dutch law requires that physician-investigators ask true informed consent (instead of only assent) from both child and parents. Especially in the paediatric oncology research setting, this informed consent seems difficult to attain, as extensive literature confirms. The oncology setting has distinctive features, such as the integration of research and treatment in standard protocols, which limit the participation of adolescents in discussions concerning research. Our aim was to establish how physicians deal with this limited participation.
Methods In-depth semi-structured interviews with 15 paediatric haemato-oncologists at two oncology institutions.
Results Physicians deem poor informed consent from adolescents acceptable because of three arguments: (1) they consider most adolescents not capable of giving “adult” consent; (2) they have proxy consent from parents; (3) investigator integrity: they know the ins and outs of the study (eg, risks, burdens) and think it is safe to include a child.
Conclusion Discussion should focus on the appropriateness in the research setting of the model used by the physicians, in which attention to the best interests of the adolescent (by proxy consent and investigator integrity) functions as a substitute for the adolescent’s consent. This model needs to be balanced with the moral weight of the principle of autonomy. Because of the fundamental differences between the research and treatment relationship, we claim that, although sometimes acceptable for treatment decisions, informed consent by adolescents in the research setting can never be ignored.