Waiver of Consent in a Trial Intervention Occurring at Birth—How Do Parents Feel?

Abstract

BackgroundWe 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.MethodsThe 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.ResultsForty-nine parents completed the online survey. Sixty-nine percent (n = 34) remembered a physician discussing their premature baby with them prior to delivery. Thirty-four percent (17) indicated the physician had discussed participation in the study prior to delivery. Sixty-nine percent (34) indicated that they had a positive or strongly positive feeling about the studies impact on their baby’s health.ConclusionOur 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.

Parental opinion of consent in neonatal research

“…This approach has been evaluated in peri-partum research in the CONsent methods in childreN’s emergEncy medicine and urgent Care Trials (CONNECT) study which found that parents and practitioners, while initially expressing concerns about deferred consent in the CATheter infections in CHildren trial (CATCH) trial, later described support for deferred consent in emergency trials to facilitate progress in this area, if the intervention was already in use in routine clinical practice 10. A survey of parents whose babies had participated in a randomised controlled trial evaluating two different methods of placental transfusion to premature infants which involved a deferred consent process reported an overall positive (69%) response to their baby’s involvement 11. ‘Waiver of consent’ describes a different process, whereby informed consent is not a requirement of the study.…”

“…This again presents concerns for patient autonomy and ethically conducted research. Neonatal trials where low-risk interventions or standard of care are being evaluated have employed a waiver of consent; however, parental understanding and acceptance of this has not been evaluated in depth 11…”

Deferred consent for the enrolment of neonates in delivery room studies: strengthening the approach

“…In this study, most parents preferred a prospective consent approach 31. Rich and Katheria, however, suggested that deferring consent for DR studies is acceptable for parents 32. They reported a lack of negative parental reaction on the usage of a deferred consent approach for a specific DR study, although bias may have occurred as all questioned parents agreed for the study participation of their child.…”

Deferred consent for delivery room studies: the providers’ perspective

“…Interviewed providers with first-hand experience with approaching parents for deferred consent suggested that these concerns can be overcome by appropriate communication with parents and timing of the consent procedure. Rich and Katheria37 reported positive parental perceptions with deferred consent, as in the postnatal period there was more time in a non-stressful environment to inform parents about study procedures, allowing parents to truly recall and understand their child being in a DR study. Further studies on parental experiences with deferred consent, including experiences of parents of neonates that passed away or parents that refused deferred consent, may provide insight into the best way to approach parents for deferred consent.…”