Table 1

Questions asked during the interview addressing the level of understanding

NoConceptQuestion
1Participation in a research protocolIs your child being treated as part of a research protocol?
2Aim of the protocolWhat is the aim of this protocol?
3Course of the protocolWhat is planned for your child in the framework of this protocol?
4Principle of randomisationIf you gave consent for a protocol in which two different treatments might be given, do you know how the treatment given to your child was chosen? If yes, how?
5Individual benefitWhat benefits to you expect your child to gain from participation in this protocol?
6Collective benefitCould you describe the possible benefits to other children of participation of your child in this protocol?
7RisksWhat are the possible risks to your child of participating in this protocol?
8AlternativesIf you had not consented to the participation of your child in this protocol, what care would your child have received?
9Voluntary nature of participationWas the participation of your child in this protocol voluntary?
10Duration of participationHow long were you told that the participation of your child in this protocol would last?
11Freedom to withdraw from the project at any timeCould you change your mind once the study had begun?