We have previously demonstrated that it is difficult to obtain a representative subject sample when conducting a randomized controlled trial (RCT) at or near the time of birth and obtaining antenatal consent. Waiver of consent has been used in neonatal trials, but parents’ reactions to being enrolled in these trials have never been reported.
The parents enrolled in a RCT involving a waiver of consent with a post-delivery discussion were asked to take part in a brief survey. The survey questions included the timing of when parents were informed about the study, and how they felt about their infants being included in the study.
Forty-nine parents completed the online survey. Sixty-nine percent (
Our study demonstrates that the majority of responding parents of infants who have actually participated in a RCT with a waiver of consent process had a positive response, a minority had a neutral response, and none had a slightly negative or highly negative response to participation in the study.