Abstract
ObjectiveTo explore parents’ perceptions and experience of being approached for enrolment of their preterm infant in more than one trial or study.DesignA qualitative study involving 17 in-depth semistructured interviews, with...
Highlights
Neonatal practice requires a strong evidence base but randomised controlled trials (RCTs) involving enrolment shortly after birth when parents may be anxious are challenging
Research teams must balance this additional stress against the need to achieve successful recruitment[1], whilst ensuring decisions are made in the infant’s best interests
Parents consider anticipated level of risk and benefit when deciding whether to join a study[6,7], but in many Neonatal Intensive Care Units (NICUs) it is common for parents to be approached for more than one study
Summary
Neonatal practice requires a strong evidence base but randomised controlled trials (RCTs) involving enrolment shortly after birth when parents may be anxious are challenging. Most studies suggest parents feel they made well-informed decisions achieving fully informed consent can be challenging[3,4,5]. Approach and enrolment to more than one study may raise ethical and scientific issues in the NICU8 these are seen in other settings[9]. Working with parents as part of patient public involvement (PPI) when planning, conducting and analysing studies is appropriately considered essential. Where co-enrolment does not compromise scientific integrity it might be considered unfair to deny parents a choice, and may improve generalisability of study findings[8]. Our aim here was to explore the perceptions and experiences of parents who were approached to take part in more than one research study
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
