Mitchell, Eleanor, Oddie, Sam J, Dorling, Jon et al. (4 more authors) (2022) Implementing two-stage consent pathway in neonatal trials. Archives of disease in childhood-Fetal and neonatal edition. pp. 79-82. ISSN 1468-2052
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.
Metadata
Item Type: | Article |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © Author(s) (or their employer(s)) 2021 |
Dates: |
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Institution: | The University of York |
Academic Units: | The University of York > Faculty of Social Sciences (York) > Centre for Reviews and Dissemination (York) The University of York > Faculty of Sciences (York) > Hull York Medical School (York) |
Depositing User: | Pure (York) |
Date Deposited: | 20 Apr 2022 09:10 |
Last Modified: | 14 Jan 2025 00:18 |
Published Version: | https://doi.org/10.1136/archdischild-2021-322960 |
Status: | Published |
Refereed: | Yes |
Identification Number: | 10.1136/archdischild-2021-322960 |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:185878 |
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Filename: archdischild_2021_322960.full.pdf
Description: Implementing two-stage consent pathway in neonatal trials
Licence: CC-BY 2.5