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?’ |