Implementing two-stage consent pathway in neonatal trials
Implementing two-stage consent pathway in neonatal trials
Perinatal trials sometimes require rapid recruitment processes to facilitate inclusion of participants when interventions are time-critical. A two-stage consent pathway has been used in some trials and is supported by national guidance. This pathway includes seeking oral assent for participation during the time-critical period followed by informed written consent later. This approach is being used in the fluids exclusively enteral from day one (FEED1) trial where participants need to be randomised within 3 hours of birth. There is some apprehension about approaching parents for participation via the oral assent pathway. The main reasons for this are consistent with previous research: lack of a written record, lack of standardised information and unfamiliarity with the process. Here, we describe how the pathway has been implemented in the FEED1 trial and the steps the trial team have taken to support sites. We provide recommendations for future trials to consider if they are considering implementing a similar pathway. Trial registration number: ISRCTN89654042.
ethics, intensive care units, neonatal, neonatology
F79-F82
Mitchell, Eleanor
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Oddie, Sam J.
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Dorling, Jon
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Gale, Chris
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Johnson, Mark John
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McGuire, William
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Ojha, Shalini
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15 December 2022
Mitchell, Eleanor
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Oddie, Sam J.
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Dorling, Jon
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Gale, Chris
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Johnson, Mark John
ce07b5dd-b12b-47df-a5df-cd3b9447c9ed
McGuire, William
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Ojha, Shalini
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Mitchell, Eleanor, Oddie, Sam J., Dorling, Jon, Gale, Chris, Johnson, Mark John, McGuire, William and Ojha, Shalini
(2022)
Implementing two-stage consent pathway in neonatal trials.
Archives of Disease in Childhood: Fetal and Neonatal Edition, 108 (1), .
(doi:10.1136/archdischild-2021-322960).
Abstract
Perinatal trials sometimes require rapid recruitment processes to facilitate inclusion of participants when interventions are time-critical. A two-stage consent pathway has been used in some trials and is supported by national guidance. This pathway includes seeking oral assent for participation during the time-critical period followed by informed written consent later. This approach is being used in the fluids exclusively enteral from day one (FEED1) trial where participants need to be randomised within 3 hours of birth. There is some apprehension about approaching parents for participation via the oral assent pathway. The main reasons for this are consistent with previous research: lack of a written record, lack of standardised information and unfamiliarity with the process. Here, we describe how the pathway has been implemented in the FEED1 trial and the steps the trial team have taken to support sites. We provide recommendations for future trials to consider if they are considering implementing a similar pathway. Trial registration number: ISRCTN89654042.
Text
archdischild-2021-322960.full (1)
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Accepted/In Press date: 2 December 2021
e-pub ahead of print date: 23 December 2021
Published date: 15 December 2022
Keywords:
ethics, intensive care units, neonatal, neonatology
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Local EPrints ID: 454355
URI: http://eprints.soton.ac.uk/id/eprint/454355
ISSN: 1359-2998
PURE UUID: 148c5187-09cd-4a86-a741-90a4a3a2a457
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Date deposited: 08 Feb 2022 17:33
Last modified: 17 Mar 2024 03:52
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Contributors
Author:
Eleanor Mitchell
Author:
Sam J. Oddie
Author:
Jon Dorling
Author:
Chris Gale
Author:
Mark John Johnson
Author:
William McGuire
Author:
Shalini Ojha
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