Presumed consent in emergency neonatal research

Abstract

Current methods of obtaining consent for emergency neonatal research are flawed. They risk aggravating the distress of parents of preterm and other sick neonates. This distress, and the inevitable time constraints, compromise understanding and voluntariness, essential components of adequately informed consent. Current practice may be unjust in over-representing babies of more vulnerable and deprived parents. The research findings may thus not be generalisable. Informing parents antenatally about the possible need for emergency neonatal research, with presumed consent and scope for opting out, would address these problems. It would spare parents of sick neonates, already terrified by their baby's illness, further distress. Experience with opting out suggests that recruitment might increase, thus generating earlier results, without compromising parental understanding of the nature and purpose of the research.