Parental views on prospective consent: experience from a pilot neonatal randomized control trial

Parental views on prospective consent: experience from a pilot neonatal randomized control trial
Original Research
Hannah Skelton, Patricia Viola, Traci-Anne Goyen, Pranav Jani
Frontiers in Pediatrics, November 2023
Abstract
Objective
To explore parental perceptions of the consenting process and understanding of the study in a pilot Randomized Controlled Trial wherein extremely premature infants (<29 weeks’ gestation) were recruited either antenatally or by 4-hours of age. We prospectively interviewed parents who had consented, declined consent and missed eligible infants in the Positioning Preterm Infants for Neuroprotection (PIN) study, a low-risk intervention study. Structured interview questions explored the process and acceptability of the consenting approach by the parents and their knowledge of the study. Additional comments made by the parents were transcribed verbatim.
Results
Sixty-two parents participated in the interviews, of those 41 had provided their consent, 8 declined consent and 13 were parents of missed eligible infants. Overall, most parents reported they understood the study well before providing their consent and approaching them for consenting did not create a burden for them. A verbal explanation of the study by the study team, especially by the medical practitioners, was viewed as beneficial. It was suggested that the 4-hour period for obtaining postnatal consent may be too short. A deferred consent with a follow-up opportunity for obtaining informed consent could be a suitable alternative. Parents found the consenting process acceptable and that they had sufficient understanding of the study to provide an informed consent. Deferred consent should be explored for future, low-risk intervention studies as an alternative to prospective consent where infants need to be recruited in the immediate neonatal period.