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Children’s views on research without prior consent in emergency situations: a UK qualitative study
  1. Louise Roper1,
  2. Frances C Sherratt1,
  3. Bridget Young1,
  4. Paul McNamara2,
  5. Angus Dawson3,
  6. Richard Appleton4,
  7. Esther Crawley5,
  8. Lucy Frith1,
  9. Carrol Gamble6,
  10. Kerry Woolfall1
  1. 1 Institute of Psychology Health and Society, University of Liverpool, Liverpool, UK
  2. 2 Department of Child Health, Institute of Translational Medicine, University of Liverpool, Liverpool, UK
  3. 3 School of Public Health, University of Sydney, Sydney, New South Wales, Australia
  4. 4 Neurology Department, Alder Hey Children’s Hospital, Liverpool, UK
  5. 5 Bristol Medical School, University of Bristol, Bristol, UK
  6. 6 Clinical Trials Research Centre (CTRC), University of Liverpool, Liverpool, UK
  1. Correspondence to Dr Kerry Woolfall; K.Woolfall{at}liverpool.ac.uk

Abstract

Objectives We explored children’s views on research without prior consent (RWPC) and sought to identify ways of involving children in research discussions.

Design Qualitative interview study.

Setting Participants were recruited through a UK children’s hospital and online advertising.

Participants 16 children aged 7–15 years with a diagnosis of asthma (n=14) or anaphylaxis (n=2) with recent (<12 months) experience of emergency care.

Results Children were keen to be included in medical research and viewed RWPC as acceptable in emergency situations if trial interventions were judged safe. Children trusted that doctors would know about their trial participation and act in their best interests. All felt that children should be informed about the research following their recovery and involved in discussions with a clinician or their parent(s) about the use of data already collected as well as continued participation in the trial (if applicable). Participants suggested methods to inform children about their trial participation including an animation.

Conclusions Children supported, and were keen to be involved in, clinical trials in emergency situations. We present guidance and an animation that practitioners and parents might use to involve children in trial discussions following their recovery.

  • medical ethics
  • qualitative research
  • consent

This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

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Footnotes

  • Contributors KW conceived the study. KW, BY, LR and FCS designed the study. PM, LR and FCS recruited children to the study. LR conducted the interviews. LR, FCS and KW analysed the data. KW and LR drafted the paper. KW, LR, FCS, BY, PM, AD, RA, EC, LF and CG contributed to revisions and approved the final draft. KW takes responsibility for the paper as a whole.

  • Funding The study was funded by the MRC Hubs for Trials Methodology Research (project R42) and supported by Wellcome Trust ISSF award.

  • Disclaimer The lead author affirms that the manuscript is an honest, accurate and transparent account of the study being reported; that no important aspects of the study have been omitted and that any discrepancy from the study as originally planned has been explained. The report is independent research supported by the National Institute for Health research (Senior Research Fellowship, Prof Esther Crawley, SRF-2013-06-013). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the National institute for Health Research or the Department of Health.

  • Competing interests None declared.

  • Patient consent Not required.

  • Ethics approval A National Health Service Research Ethics Committee (15/NW/0915) provided ethical approval.

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

  • Data sharing statement No additional data are available.

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