Parent views on a two-step consent process used in emergency neonatal research in the delivery room in Eastern Uganda
Alice Nakiyemba1, Agnes Napyo2, Martha Muduwa3
1Busitema University, Tororo, Uganda.
Insights
The two-step consent process, involving initial verbal and later written consent, is acceptable for delivery room research in low-resource settings. This approach balances ethical considerations with the urgent needs of parents with sick or preterm infants.
Area of Science:
- Medical Ethics
- Clinical Trials
- Neonatal Research
Background:
- Obtaining informed consent for delivery room research involving critically ill newborns presents significant ethical and practical challenges, especially in low-resource settings.
- Traditional consent methods are often insufficient due to time constraints and the critical condition of mothers and infants.
- Alternative strategies like deferred consent have limitations in high-mortality contexts and interventional trials.
Purpose of the Study:
- To explore the acceptability of a two-step consent process (initial verbal, followed by written consent) for delivery room research.
- To assess parental and caregiver perspectives on this consent model in a low-resource setting.
- To inform ethical and practical approaches for consent in time-sensitive neonatal research.
Main Methods:
- A qualitative study nested within a pilot randomized controlled trial of continuous positive airways pressure (CPAP) for very low birthweight infants (<1500g) in Uganda.
- Three focus group discussions (FGDs) were conducted with purposively selected mothers, fathers, and caregivers of enrolled infants.
- Inductive thematic analysis of FGD transcripts, coded using NVivo 12, explored participants' shared and divergent views.
Main Results:
- Mothers found the two-step consent process acceptable, viewing verbal consent as adequate for initial decisions and written consent as appropriate post-stabilization.
- Mothers valued the autonomy provided by initial verbal consent, with digital recording and scripts enhancing consistency.
- Fathers desired to be informed, but mothers asserted their independent decision-making capacity, though many preferred paternal presence.
Conclusions:
- The two-step consent process is a feasible and acceptable method for ethical research in delivery rooms within low-resource settings.
- Parental acceptance was enhanced through collaboration with community advisory boards.
- Continued refinement of consent approaches is crucial to ensure ethical robustness, practical feasibility, and cultural acceptability in diverse clinical contexts.
Background:
Obtaining ethically valid consent for delivery room research from parents facing the imminent birth of a sick or preterm infant is particularly challenging. While deferred consent has been used successfully in some delivery room studies - especially in low-risk observational research - its application is more complex in settings with high neonatal mortality and in the context of interventional trials. In such contexts, alternative approaches such as two-step consent - where initial verbal consent is obtained at enrolment, followed by full written informed consent after maternal and neonatal stabilisation - have been proposed. This study explores the acceptability of this approach.
Methods:
This qualitative study from March 2023 and February 2024, was nested within a pilot randomised controlled trial of immediate continuous positive airways pressure (CPAP) in the delivery room for very low birthweight infants (< 1500 g) at a government hospital in Uganda. Focus group discussions were held with 6-12 purposively selected mothers, fathers, and other caregivers of infants enrolled in the trial, with a total of three FGDs conducted. Groups were mixed by caregiver type. Data were analysed inductively using a thematic approach, allowing codes and themes to emerge directly from the data. Transcripts were coded using NVivo 12 to facilitate analysis and explore shared and divergent perspectives across participants.
Results:
Mothers generally viewed the two-step consent process positively. Verbal consent was seen as sufficient for an initial decision despite limited understanding, while written consent was considered more appropriate once the mother and infant were stabilised. Mothers valued the autonomy that the initial verbal consent gave them. Digital recording was acceptable to all, and the use of a script supported consistency. Fathers wished to be informed, but mothers emphasised their capacity to decide independently, while many preferred fathers to be present.
Conclusion:
Delivery room trials in low-resource settings involve complex ethical and practical challenges related to obtaining informed consent in time-sensitive situations. In this study, the two-step consent process was found to be acceptable to parents and caregivers, supported by collaboration with the community advisory board. Further research should continue to refine consent approaches to ensure they remain ethically robust, practically feasible in emergency settings, and acceptable to parents across diverse cultural and clinical contexts.
Trial Registration:
Study is registered on Pan African Clinical Trials Registry (PACTR) PACTR202208462613789. Registered 08 August 2022. https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=23888 .
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