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Implementing two-stage consent pathway in neonatal trials
  1. Eleanor Mitchell1,
  2. Sam J Oddie2,
  3. Jon Dorling3,
  4. Chris Gale4,
  5. Mark John Johnson3,5,
  6. William McGuire6,
  7. Shalini Ojha7,8
  1. 1 Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK
  2. 2 Department of Neonatal Medicine, Bradford Teaching Hospitals NHS Foundation Trust, West Yorkshire, UK
  3. 3 Department of Neonatal Medicine, University Hospital Southampton NHS Foundation Trust, Southampton, UK
  4. 4 Neonatal Medicine, School of Public Health, Faculty of Medicine, Imperial College London, London, UK
  5. 5 NIHR Southampton Biomedical Research Centre, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton, UK
  6. 6 Centre for Reviews and Dissemination, University of York, York, UK
  7. 7 Population and Applied Health Sciences, School of Medicine, University of Nottingham, Nottingham, UK
  8. 8 Neonatal Unit, University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK
  1. Correspondence to Eleanor Mitchell, Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham NG7 2UH, UK; eleanor.mitchell{at}nottingham.ac.uk

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.

  • intensive care units
  • neonatal
  • neonatology
  • ethics

Data availability statement

Data sharing not applicable as no datasets generated and/or analysed for this study.

https://creativecommons.org/licenses/by/4.0/

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. See: https://creativecommons.org/licenses/by/4.0/.

http://dx.doi.org/10.1136/archdischild-2021-322960

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    Data availability statement

    Data sharing not applicable as no datasets generated and/or analysed for this study.

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    Footnotes

    • Twitter @eleanor_mitch, @DrCGale, @MarkJohnson800, @shaliniojha7

    • Collaborators This article is written on behalf of the FEED1 trial collaborative group (in alphabetical order): Josie Anderson (Bliss), Jon Dorling (University Hospital Southampton NHS Foundation Trust), Chris Gale (Imperial College, London), Rachel Haines (University of Nottingham), Mark Johnson (University Hospitals Southampton NHS Foundation Trust), Charlotte Kenyan (PPI contributor), William McGuire (University of York), Alan Montgomery (University of Nottingham), Eleanor Mitchell (University of Nottingham), Garry Meakin (University of Nottingham), Hema Mistry (University of Warwick), Sam Oddie (Bradford Teaching Hospitals NHS Foundation Trust), Reuben Ogollah (all University of Nottingham), Phoebe Pallotti (all University of Nottingham), Christopher Partlett (all University of Nottingham), Shabina Sadiq (all University of Nottingham), Shalini Ojha (University of Nottingham and University Hospitals of Derby and Burton NHS Foundation Trust), Kate Walker (all University of Nottingham).

    • Contributors EM is a co-investigator on the FEED1 trial, has co-led activities to support clinicians in the use of the two-stage consent pathway and wrote the first draft of the manuscript. SJO is a clinical co-investigator and has co-led consent pathway support. SO is the Chief Investigator for the FEED1 trial, supported by JD who conceived the idea and led the funding proposal. CG, MJJ and WMcG are all clinical co-investigators who support FEED1 sites. All authors have reviewed the manuscript for important intellectual content and approved the final version.

    • Funding The FEED1 trial is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (project reference 17/94/31).

    • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funder had no role in the design of this study and will have no role in the analysis, interpretation of data or decision to submit results in the future.

    • Competing interests The authors declare receiving grant funding to conduct the FEED1 trial. CG declares receiving funding via the MRC for a Clinician Scientist Fellowship, which supported his salary over the time spent on this work.

    • Patient and public involvement statement The FEED1 Trial team includes a parent co-investigator, a representative from Bliss charity and a parent and public involvement group. Parents' views have been included since the conception of the study.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.