Table 2.

Questions asked during the interview addressing the level of understanding

No.	Concept	Question
1	Participation in a research protocol	‘Is your child being treated as part of a research protocol?’
2	Aim of the protocol	‘What is the aim of this protocol?’
3	Course of the protocol	‘What is planned for your child in the framework of this protocol?’
4	Principle of randomisation	‘If 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?’
5	Individual benefit	‘What benefits do you expect your child to gain from participation in this protocol?’
6	Collective benefit	‘Could you describe the possible benefits to other children of the participation of your child in this protocol?’
7	Risks	‘What are the possible risks to your child of participating in this protocol?’
8	Alternatives	‘If you had not consented to the participation of your child in this protocol, what care would your child have received?’
9	Voluntary nature of participation	‘Was the participation of your child in this protocol voluntary?’
10	Duration of participation	‘How long were you told that the participation of your child in this protocol would last?’
11	Freedom to withdraw from the project at any time	‘Could you change your mind once the study had begun?’