Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: qualitative study of parents' and health professionals' views and experiences
Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: qualitative study of parents' and health professionals' views and experiences
Background: more effective recruitment strategies like alternative approaches to consent are needed to facilitate adequately powered trials. Witholding Enteral feeds Around Transfusion was a multicentre, randomised, pilot trial that compared withholding and continuing feeds around transfusion. The primary clinical outcome was necrotising enterocolitis. The trial used simplified opt-out consent with concise parent information and no consent form.
Objective: to explore the views and experiences of parents and health professionals on the acceptability and feasibility of opt-out consent in randomised comparative effectiveness trials.
Methods: a qualitative, descriptive interview-based study nested within a randomised trial. Semistructured interview transcripts were analysed using inductive thematic analysis.
Setting: eleven neonatal units in England.
Participants: eleven parents and ten health professionals with experience of simplified consent.
Results: Five themes emerged: ‘opt-out consent operationalised as verbal opt-in consent’, ‘opt-out consent normalises participation while preserving parental choice’, ‘opt-out consent as an ongoing process of informed choice’, ‘consent without a consent form’ and ‘choosing to opt out of a comparative effectiveness trial’, with two subthemes: ‘wanting “normal care”’ and ‘a belief that feeding is better’.
Conclusion: introducing a novel form of consent proved challenging in practice. The principle of a simplified, opt-out approach to consent was generally considered feasible and acceptable by health professionals for a neonatal comparative effectiveness trial. The priority for parents was having the right to decide about trial participation, and they did not see opt-out consent as undermining this. Describing a study as 'opt-out' can help to normalise participation and emphasise that parents can withdraw consent.
ethics, neonatology, qualitative research
F244-F250
McLeish, Jenny
0206978a-ab4e-43b1-a26f-ca9c41a8df4f
Alderdice, Fiona
09c6e5b9-33af-4bc0-81cc-b843798dd111
Robberts, Helen
62e836cc-1c40-4631-a21e-327b731ee09e
Cole, Christina
afad743e-25f2-4887-b0d0-14e987432cc4
Dorling, Jon
e55dcb9a-a798-41a1-8753-9e9ff8aab630
Gale, Chris
210b7c81-9a39-460a-9ab3-54fe92a69f8e
20 April 2021
McLeish, Jenny
0206978a-ab4e-43b1-a26f-ca9c41a8df4f
Alderdice, Fiona
09c6e5b9-33af-4bc0-81cc-b843798dd111
Robberts, Helen
62e836cc-1c40-4631-a21e-327b731ee09e
Cole, Christina
afad743e-25f2-4887-b0d0-14e987432cc4
Dorling, Jon
e55dcb9a-a798-41a1-8753-9e9ff8aab630
Gale, Chris
210b7c81-9a39-460a-9ab3-54fe92a69f8e
McLeish, Jenny, Alderdice, Fiona, Robberts, Helen, Cole, Christina, Dorling, Jon and Gale, Chris
(2021)
Challenges of a simplified opt-out consent process in a neonatal randomised controlled trial: qualitative study of parents' and health professionals' views and experiences.
Archives of Disease in Childhood: Fetal and Neonatal Edition, 106 (3), .
(doi:10.1136/archdischild-2020-319545).
Abstract
Background: more effective recruitment strategies like alternative approaches to consent are needed to facilitate adequately powered trials. Witholding Enteral feeds Around Transfusion was a multicentre, randomised, pilot trial that compared withholding and continuing feeds around transfusion. The primary clinical outcome was necrotising enterocolitis. The trial used simplified opt-out consent with concise parent information and no consent form.
Objective: to explore the views and experiences of parents and health professionals on the acceptability and feasibility of opt-out consent in randomised comparative effectiveness trials.
Methods: a qualitative, descriptive interview-based study nested within a randomised trial. Semistructured interview transcripts were analysed using inductive thematic analysis.
Setting: eleven neonatal units in England.
Participants: eleven parents and ten health professionals with experience of simplified consent.
Results: Five themes emerged: ‘opt-out consent operationalised as verbal opt-in consent’, ‘opt-out consent normalises participation while preserving parental choice’, ‘opt-out consent as an ongoing process of informed choice’, ‘consent without a consent form’ and ‘choosing to opt out of a comparative effectiveness trial’, with two subthemes: ‘wanting “normal care”’ and ‘a belief that feeding is better’.
Conclusion: introducing a novel form of consent proved challenging in practice. The principle of a simplified, opt-out approach to consent was generally considered feasible and acceptable by health professionals for a neonatal comparative effectiveness trial. The priority for parents was having the right to decide about trial participation, and they did not see opt-out consent as undermining this. Describing a study as 'opt-out' can help to normalise participation and emphasise that parents can withdraw consent.
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Accepted/In Press date: 10 September 2020
e-pub ahead of print date: 2 November 2020
Published date: 20 April 2021
Additional Information:
Funding Information:
Funding This study was funded by the UK Medical Research Council: MR/ N008405/1.
CG reports grants from the National Institute for Health Research during the conduct of the study; grants from National Institute for Health Research, Mason Medical Research Foundation, Rosetrees Foundation and from Canadian Institute for Health Research outside the submitted work. He reports grants and personal fees from Chiesi Pharmaceuticals outside of the submitted work; the grant is for a research study and the personal fee was to support attendance at an educational meeting. He was an unremunerated member of the Neonatal Data Analysis Unit Board, which oversees the National Neonatal Research Database. Patient consent for publication Not required.
Keywords:
ethics, neonatology, qualitative research
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Local EPrints ID: 485005
URI: http://eprints.soton.ac.uk/id/eprint/485005
ISSN: 1359-2998
PURE UUID: 4b9cae72-a849-44b2-aee7-848f07e27ad8
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Date deposited: 28 Nov 2023 17:33
Last modified: 18 Mar 2024 04:16
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Contributors
Author:
Jenny McLeish
Author:
Fiona Alderdice
Author:
Helen Robberts
Author:
Christina Cole
Author:
Jon Dorling
Author:
Chris Gale
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