An exploratory study to determine how parents decide whether to enrol their infants into neonatal clinical trials

Neonatology is a relatively young discipline with many aspects of care as yet not investigated. Consequently parents of sick newborn babies are often approached to consider enrolling their infants into clinical trials. The aim of this qualitative study was to determine how parents decide whether to enrol their baby into such trials. The findings illustrate parents make their decision following a typical journey. Once the initial shock of having a baby admitted to the Neonatal Intensive Care Unit (NICU) subsides, they weigh-up the risks and benefits of the trial against the need to protect their baby from perceived harm. Parents who chose to participate believe there was no harm to their baby. They display altruistic principles stating they were pleased to be helping future babies. Parents who decline see the risks to their baby as being too great. Upon reflection these parents experienced guilt at not participating in a trial. Parents are supportive of neonatal research providing they see the benefits out-weighing the risks.