Table 3.

Consent Comprehension Questionnaire.

Each item began with “Please tell me…”

1. the researchers’ reasons for doing this study.

2. how much of your child’s (your) time is required while you are in this study.

3. the main things that your child (you) will need to do at each study visit.

4. about the study treatments that are being tested.

5. what the chances are that your child (you) will get one kind of treatment or another

6. how many other people will be in this study.

7. what bad things or risks there could be from being in this study.

8. what the good things or benefits there are from being in the study.

9. what other choices your child has (you have), aside from being in this study.

10. how the researchers will protect your child’s (your) privacy while being in this study.

11. who’s responsible for your child’s (your) medical costs if your child gets (you get) hurt or sick while your child is (you are) in the study.

12. who you (your parent) should call if your child has (you have) questions about the study.

13. what your child (you) should do if your child wants (you want) to stop being in the study.

14. if and why the researchers could take your child (you) out of the study without your permission.

15. why researchers would give your child (you) new information about this study while your child is (you are) in it.

16. what type of payment or rewards your child (you) will get for being in the study.

17. why your child is (you are) being asked to be in the study.