Objective To evaluate the extent to which parents understand the information they are given when their consent is sought for the participation of their child in a phase III randomised clinical trial, and the reasons for their decision.
Patients and Method We carried out a prospective study, from January 2005 to September 2006. We included all parents whose consent was sought for the participation of their child in the FRALLE 2000 protocol (acute lymphoblastic leukaemia) at two of the participating centres. The parents were questioned twice by a qualified psychologist, using a semi-directed interview, one month and 6 months after their consent was sought.
Results We contacted 51 parents and 43 first interviews were carried out. Thirty-five parents (81%) felt that the information provided with the request for consent was appropriate. Eight parents (19%) did not realise that their child had been included in a research protocol. Sixteen parents (39%) did not understand the concept of randomisation. Half the parents could explain neither the aim of the clinical trial nor the potential benefit of inclusion to their child. Only one third of the parents were aware that they had an alternative. Twenty-two parents (52%) thought that they “had no choice” to participate. Confidence in the medical team was the chief element identified by parents as influencing their choice.
Conclusion Although the parents were satisfied with the information they received, their comprehension was mostly incomplete.