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Published on: January 17, 2011
Parental perceptions of informed consent in a study of tracheal intubations in neonatal intensive care
Susanne Tippmann1, Janine Schäfer1, Christine Arnold2
1Division of Neonatology, Department of Pediatrics, University Medical Center of the Johannes Gutenberg-University Mainz, Mainz, Germany.
Insights
Parents in neonatal emergency research found clinical trials beneficial and valued informed consent. The timing of consent, whether before or after the intervention, appeared less critical to parental satisfaction.
Area of Science:
- Neonatal research
- Clinical trials
- Informed consent
Background:
- Informed consent in neonatal emergency research presents unique challenges.
- Parental perceptions of consent processes are crucial for ethical research conduct.
Purpose of the Study:
- To assess parental perceptions of informed consent.
- To evaluate satisfaction with the consent process in neonatal emergency care clinical trials.
Main Methods:
- Supplementary analysis of a randomized controlled trial on neonatal endotracheal intubation.
- Self-administered questionnaires to parents regarding their perceptions of clinical trial participation and consent.
Main Results:
- Most parents (89.8%) agreed infants should participate in clinical trials and (85%) that consent should be obtained.
- A high percentage of parents (86.7%) found the informed consent process satisfactory.
- Satisfaction with consent timing varied, with a small percentage (13.3%) feeling pressure.
Conclusions:
- Parents generally value neonatal emergency research and the informed consent process.
- The timing of consent (before or after intervention) may be less critical than obtaining consent itself.
- Further research is needed to determine the most acceptable consent methods for parents in specific neonatal studies.
Background And Objective:
Obtaining informed consent in neonatal emergency research is challenging. The aim of this study was to assess parental perceptions of informed consent following participation in a clinical trial in neonatal emergency care.
Methods:
This was a supplementary analysis of a randomised controlled trial comparing video and direct laryngoscopy for neonatal endotracheal intubation in the delivery room and neonatal intensive care unit. After obtaining informed consent for the clinical trial, parents were asked to answer a series of self-administered questions about their perceptions of clinical trial participation and the consent process. Informed consent had been given either before birth, after birth but before inclusion in the trial, or after inclusion in the trial.
Results:
We received responses from 33 mothers and 27 fathers (n = 60) of the 63 preterm and term infants who participated in the study. Fifty-three (89.8%, n = 59) parents agreed that infants should participate in clinical trials, and 51 (85%, n = 60) parents agreed that parents should be asked for informed consent. Fifty-three (89.8%, n = 59) parents felt that their infant's participation in this particular trial would be beneficial. Fifty-two (86.7%, n = 60) parents felt that the informed consent process was satisfactory. One parent (100%, n = 1) approached before birth, 23 parents (82.1%, n = 28) approached after birth but before enrolment and 26 (83.9%, n = 31) parents approached after enrolment were satisfied with the timing of the consent process. Eight (13.3%, n = 60) parents felt some pressure to provide informed consent. Of these, two (25%) were approached before enrolment and six (75%) were approached after enrolment.
Conclusion:
Parents valued their infant's participation in an emergency neonatal clinical trial and considered it important to be asked for consent. In this study, it seemed less important whether consent was obtained before or after the intervention. Future studies may need to investigate which form of consent is most acceptable to parents for the individual study in question.
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