Parental experiences of being approached to join multiple neonatal clinical trials: a qualitative study (PARENT)

Objective: To explore parents’ perceptions and experience of being approached for enrolment of their preterm infant in more than one trial or study. Design: A qualitative study involving 17 in-depth semi-structured interviews, with parents who had been approached for multiple studies, and subsequently consented for their infant(s) to join at least one. Parents who declined all studies were not approached. Setting and participants: Parents of preterm infants receiving care at one of 3 neonatal intensive care units in the north of England. Findings: Most parents did not view concurrent participation in multiple trials or studies as a significant issue within the wider context of their infant’s care. Most parents did not feel pressured into enrolling their infant into more than one study, but some suggested that participation in several provided justification for the subsequent refusal to join others, articulating feeling of guilt at saying ‘no’, and others appeared fatigued by multiple approaches. Parents focused upon the perceived risks and benefits of each individual study and, whilst acknowledging that making a fully informed decision was not possible, largely agreed due to their belief in the benefits of research, trust in the health professionals caring for their baby and a range of complex personal motivations. Conclusions: Parents valued the autonomy to make decisions about participation and felt, with hindsight, that their decisions were right. Research teams could be more aware of parental feelings of guilt or gratitude that may motivate them to give consent. Similarly, the capacity of parents to fully remember details of multiple studies when they are stressed, and their infant is sick, should be taken into consideration and continued efforts made to ensure ongoing consent to participation.