Compréhension de l'information et décision parentale pour la participation de leur enfant dans un protocole de recherche

In oncology, unlike in other disciplines, inclusion in research studies is the rule rather than the exception, with the aim of improving the management of affected children. For the protection of the children involved, their parents (or legal representatives) receive an information document and are allowed time to reflect on its contents before having to give a response concerning the participation of their children in research protocols. We have been working on consent in cancer research studies for the last 10 years. We have used two approaches. The first relates to the points of view of the parents and children, collected through semi-directed interviews. The second approach concerns written information and focuses on evaluations of the readability of the documents provided to parents when they are asked about the possible participation of their child in a study. We have found that almost 20% of the parents signing informed consent forms do not realize that they are agreeing to the participation of their child in a research protocol. Most parents understand general notions (collective benefit, voluntary nature of participation, duration of participation, alternatives, right to withdraw). By contrast, less than half the parents understand more specific items of information (aim of the study, randomization, treatment phases, risks). Parental decisions seem to be linked to the trust that the parents have in the clinical trial investigator and their relationship with him or her. The children have various degrees of understanding of certain elements of the information with which they were provided, such as the aims of the study, and potential benefits and risks, which are crucial elements of the process of information. The readability of the documents provided was found to be very poor, corresponding to a university-level education, even for documents destined for children.