Parental Perspectives on a Trial Using Waived Informed Consent at Birth

Abstract

Abstract 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.