Parental Perspectives on a Trial Using Waived Informed Consent at Birth

OBJECTIVES: To determine parental perspectives in a trial with waived consent. STUDY DESIGN: Biological parents of non-vigorous term infants randomized using a waiver of consent for a delivery room intervention completed an anonymous survey after discharge. RESULTS: 121 survey responses were collected. Most responding parents reported that this form of consent was acceptable (92%) and that they would feel comfortable having another child participate in a similar study (96%). The majority (> 90%) also reported that the information provided after randomization was clear to understand future data collection procedures. Four percent had a negative opinion on the study’s effect on their child’s health. CONCLUSIONS: The majority of responding parents reported both acceptability of this study design in the neonatal period and that the study had a positive effect on their child’s health. Future work should investigate additional ways to involve parents and elicit feedback on varied methods of pediatric consent.