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Parent and practitioner experiences of opt-out consent in neonatal intensive care: a mixed methods study within a
Tracy Mitchell1, Izabela Andrzejewska2, Cheryl Battersby3
1Public Health, Policy and Systems, University of Liverpool, Liverpool, UK.
Insights
Verbal opt-out consent is acceptable in low-risk neonatal trials, but timing is crucial. Parents and staff found the neoGASTRIC trial
Area of Science:
- Neonatal research ethics
- Clinical trial recruitment strategies
- Informed consent processes
Background:
- Verbal opt-out consent is utilized in neonatal trials to improve efficiency and representativeness.
- Limited understanding exists regarding the operationalization and acceptability of opt-out consent in multicenter neonatal trials.
- The neoGASTRIC trial investigated routine versus no routine measurement of gastric contents in preterm infants.
Purpose of the Study:
- To explore parental and staff views and experiences of verbal opt-out consent within the neoGASTRIC trial.
- To assess the acceptability and operationalization of opt-out consent in a multicenter neonatal setting.
- To identify factors influencing the effectiveness of opt-out consent procedures in neonatal research.
Main Methods:
- A mixed-methods process evaluation was conducted, incorporating questionnaires, interviews, and focus groups.
- The study involved 253 participants (167 staff and 86 parents) across four UK neonatal units.
- Data collection focused on participants' experiences and perceptions of the verbal opt-out consent process.
Main Results:
- Both parents and staff generally supported opt-out consent, viewing the neoGASTRIC interventions as low-risk and non-invasive.
- Parents valued timely research discussions, though awareness of study information banners/posters was low (21%).
- Variations in operationalizing opt-out consent were observed, with some parents feeling overwhelmed when approached during or shortly after labor; some staff used modified opt-in approaches.
Conclusions:
- Appropriately timed verbal opt-out consent is acceptable and proportionate for low-risk neonatal trials comparing accepted clinical practices.
- The findings from the neoGASTRIC trial provide valuable insights for refining consent procedures in similar neonatal research settings.
- This study highlights the importance of considering parental capacity and the timing of information provision in opt-out consent models.
Background:
In neonatal trials, verbal opt-out consent has been used to reduce burden on families and make recruitment more efficient and representative. It involves information provision through posters and leaflets before randomisation, and parents can verbally 'opt out' of their baby being randomised to the trial. There is limited understanding of how opt-out consent is operationalised in a multicentre neonatal trial, and its acceptability to staff and parents.
Objective:
To explore views and experiences of verbal opt-out consent in neoGASTRIC, a neonatal randomised trial comparing routine and no routine measurements of gastric contents in preterm babies.
Methods:
A mixed methods (questionnaires, interviews and focus groups) process evaluation within a trial.
Setting:
Four UK neonatal units.
Participants:
253 participants: 167 staff (149 questionnaires; 18 across two focus groups), 86 parents (85 questionnaires; 15 interviews; 14 took part in both).
Results:
Parents and staff supported opt-out consent in neoGASTRIC as interventions were viewed as low risk and non-invasive. Parents appreciated an appropriately timed research conversation; only 21% noticed study information banners/posters. Operationalisation of opt-out consent varied in terms of when information was provided and randomisation timing. Women approached during labour or within hours of birth reported feeling overwhelmed and lacking capacity to consider research. Some staff operationalised a modified opt-in approach.
Conclusions:
An appropriately timed verbal opt-out approach to consent was seen acceptable as proportionate in the neonatal context in a low-risk trial comparing different accepted clinical, non-pharmaceutical, practices. Findings informed neoGASTRIC and will guide approaches to consent in this setting.
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