Objective: To assess the impact of time on parental decision-making for research participation for neonates with congenital heart disease.
Study design: Interviews were conducted with 37 parents of 19 neonates with congenital heart disease who were eligible for three different studies: genetic etiology of congenital heart disease, heart rate variability (HRV) and structural and functional cranial magnetic resonance imaging (MRI). All parents were asked the same questions: (1) 'Did you have adequate time to make a decision about research?' and (2) 'Why?' Differences between groups (reporting adequate and inadequate time) were evaluated using Fisher's exact tests; central themes were examined using qualitative analysis.
Result: Of those parents who reported having adequate time to make their decision (22 of 37), the majority chose to participate when compared to those who reported inadequate time (genetics study, P<0.01; HRV, P=0.05; MRI, P<0.01). For the parents reporting inadequate time, consistent themes emerged: insufficient time to make an educated choice (n=10), consideration of study logistics (n=8), spouse not present at the time of decision (n=7) and insufficient time to discuss the studies (n=4).
Conclusion: Parental perception of adequate time to decide about research participation was associated with parental willingness to enroll the child in research. Despite any time limitations, parents were satisfied with the decisions they made. Optimizing the time available for the parental permission process could enhance research participation in the neonatal period.