Journal article
Parent and practitioner experiences of opt-out consent in neonatal intensive care: a mixed methods study within a trial
- Abstract:
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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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Version of record, pdf, 504.4KB, Terms of use)
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- Publisher copy:
- 10.1136/archdischild-2025-328693
Authors
- Publisher:
- BMJ Publishing Group
- Journal:
- Archives of Disease in Childhood. Fetal and Neonatal Edition More from this journal
- Volume:
- 111
- Issue:
- 2
- Pages:
- F162-F168
- Publication date:
- 2025-08-31
- Acceptance date:
- 2025-08-12
- DOI:
- EISSN:
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1468-2052
- ISSN:
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1359-2998
- Language:
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English
- Pubs id:
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2285409
- Local pid:
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pubs:2285409
- Source identifiers:
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W4413872872
- Deposit date:
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2025-09-02
- ARK identifier:
Terms of use
- Copyright holder:
- Mitchell et al.
- Copyright date:
- 2025
- Rights statement:
- © Author(s) (or their employer(s)) 2026. Re-use permitted under CC BY. Published by BMJ Group. This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made.
- Licence:
- CC Attribution (CC BY)
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