Parental perceptions of informed consent in neonatal emergency research

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 intubation. After obtaining informed consent for the clinical trial, parents were asked to answer a series of self-administered questions about their perceptions of 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 Of the 63 preterm and term infants who participated in the study, we received responses from 33 mothers and 27 fathers (n = 60). Fifty-four (91.5%, n = 59) parents agreed that infants should participate in clinical trials. Fifty-one (85%) parents agreed that parents should be asked for their consent to participate in research studies involving their children. A minority of six (10%) parents would prefer not to be asked to consent to their infant participating in the study. Fifty-three (89.8%, n = 59) parents felt that their infant's participation in this particular trial would be beneficial. Twelve (20%) parents thought that infants who take part in clinical trials generally get better treatment. Almost all parents (56 (93.3%)) felt well informed about the purpose of the trial. Fifty-two (86.7%) 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%) parents felt pressured to agree to participate in the study. Of these, two (25%) were approached before enrolment and six (75%) were approached after enrolment. When asked about the best time to discuss consent with parents in clinical trials in neonatal emergency care, 20 (33%) parents said it was before birth, while 40 (67%) parents said it was after birth.

Conclusion Parents valued their infant's participation in a clinical trial in neonatal emergency care and considered it important to be asked for consent. Timing seemed to be less important. Deferred consent appears to be a feasible approach to obtaining informed consent for clinical trials in neonatal emergency care. However, future studies need to investigate whether parents feel more pressured to give consent in this way.

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Artikel online veröffentlicht:
06. Juni 2023