Appendix A QUESTIONNAIRE TO DETERMINE VALIDITY OF INFORMED CONSENT
From: Neonatal Research and the Validity of Informed Consent Obtained in the Perinatal Period
1. | Were you asked to allow your baby to participate in the study before or after the baby was born? | Before | After |
2. | Did you sign the consent before the baby was born or after the baby was born? | Before | After |
3. | Did you feel you got a complete explanation of the study? | Yes | No |
4. | If you answered no to the last question, what other information would you like to have been given? | Â | Â |
5. | Did you get a copy of the consent form to review and keep? | Yes | No |
6. | Did you feel you had enough time to review the consent and ask questions before enrolling your baby? | Â | Â |
7. | Can you tell us what the purpose of the study was? | Â | Â |
| Â | 1 | 3 | 5 |
| Â | Don't know | Â | Pain control in tiny babies. Better mental outcomes with pain control. Prevent death. Prevent brain bleeding. Prevent brain damage, or softening of brain tissue. |
| Â | Comments: | Â | Â |
8. | Do you remember what we were asking to do to your baby? | Â | Â |
| Â | 1 | 3 | 5 |
| Â | Don't remember | Â | Give morphine. Give pain medicine. |
| Â | Comments: | Â | Â |
9. | Were you told of any possible risks or danger to the baby from the study? | Â | Â |
| Â | Yes | No | Â |
10. | What risks do you remember being told about? | Â | Â |
| Â | 1 | 3 | 5 |
| Â | Don't know | Â | Breathing problems. Blood pressure problems. Vomiting. Urinary retention. Slower movement of the intestines. Higher level of jaundice. Seizures. |
| Â | Comments: | Â | Â |
11. | Do you remember what benefits your baby might get from being in the study? | Â | Â |
| Â | 1 | 3 | 5 |
| Â | Don't know | Â | Pain control in tiny babies. Better mental outcomes with pain control. Prevent death. Prevent brain bleeding. Prevent brain damage, or softening of brain tissue. |
| Â | Comments: | Â | Â |
12. | Did you ever feel pressured or forced to participate in the study? | Â | Â |
13. | If yes to #12, what in particular made you afraid not to enter your baby in the study? | Â | Â |
14. | Did you feel that all of the questions you had about the study got answered to your satisfaction? | Â | Â |
15. | Did you know whether you could take your baby out of the study or did the baby have to stay in the study until it was over? | Â | Â |
16. | Did anyone help you decide whether or not to enter the study? | Â | Â |
| Â | Yes | Â | No |
| Â | Who: | Â | Â |
17. | What in particular made you decide to enter your baby in the study? | Â | Â |
18. | Did you have any fears about entering your baby in the study? | Â | Â |
19. | Did anyone talk to you about the study after your baby was signed up? | Â | Â |
20. | Now that it is all done, if you had a chance to do it over, would you enter your child in the study? | Â | Â |
