Objective To gain insight into neonatal care providers’ perceptions of deferred consent for delivery room (DR) studies in actual scenarios.
Methods We conducted semistructured interviews with 46 neonatal intensive care unit (NICU) staff members of the Leiden University Medical Center (the Netherlands) and the Hospital of the University of Pennsylvania (USA). At the time interviews were conducted, both NICUs conducted the same DR studies, but differed in their consent approaches. Interviews were audio-recorded, transcribed and analysed using the qualitative data analysis software Atlas.ti V.7.0.
Results Although providers reported to regard the prospective consent approach as the most preferable consent approach, they acknowledged that a deferred consent approach is needed for high-quality DR management. However, providers reported concerns about parental autonomy, approaching parents for consent and ethical review of study protocols that include a deferred consent approach. Providers furthermore differed in perceived appropriateness of a deferred consent approach for the studies that were being conducted at their NICUs. Providers with first-hand experience with deferred consent reported positive experiences that they attributed to appropriate communication and timing of approaching parents for consent.
Conclusion Insight into providers’ perceptions of deferred consent for DR studies in actual scenarios suggests that a deferred consent approach is considered acceptable, but that actual usage of the approach for DR studies can be improved on.
- data collection
- qualitative research
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Contributors MCdB and MH drafted the initial version of the manuscript, and all authors participated in critical revision of the manuscript for important intellectual content. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.
Funding ABtP is recipient of an NWO Innovational Research Incentives Scheme (VIDI 91716428).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval This study was reviewed by the Ethics Review Committee of the LUMC. In concordance with laws and guidelines, a statement of no objection against execution of the study at the LUMC and the HUP was issued (P16.316).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request.