Implementing two-stage consent pathway in neonatal trials

Mitchell, Eleanor; Oddie, Sam J; Dorling, Jon; Gale, Chris; Johnson, Mark John; McGuire, William; Ojha, Shalini

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.

Citation

Mitchell, E., Oddie, S. J., Dorling, J., Gale, C., Johnson, M. J., McGuire, W., & Ojha, S. (2023). Implementing two-stage consent pathway in neonatal trials. Archives of Disease in Childhood. Fetal and Neonatal Edition, 108(1), F79-F82. https://doi.org/10.1136/archdischild-2021-322960

• Journal Article Type: Article
• Acceptance Date: Dec 2, 2021
• Online Publication Date: Dec 23, 2021
• Publication Date: 2023-01
• Deposit Date: Jul 11, 2024
• Publicly Available Date: Jul 24, 2024
• Journal: Archives of Disease in Childhood - Fetal and Neonatal Edition
• Electronic ISSN: 1468-2052
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 108
• Issue: 1
• Pages: F79-F82
• DOI: https://doi.org/10.1136/archdischild-2021-322960
• Keywords: Obstetrics and Gynecology; General Medicine; Pediatrics, Perinatology and Child Health
• Public URL: https://nottingham-repository.worktribe.com/output/7351954
• Publisher URL: https://fn.bmj.com/content/108/1/79