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How experience makes a difference: practitioners’ views on the use of deferred consent in paediatric and neonatal emergency care trials
BACKGROUND: In 2008 UK legislation was amended to enable the use of deferred consent for paediatric emergency care (EC) trials in recognition of the practical and ethical difficulties of obtaining prospective consent in an emergency situation. However, ambiguity about how to make deferred consent ac...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2013
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4228267/ https://www.ncbi.nlm.nih.gov/pubmed/24195717 http://dx.doi.org/10.1186/1472-6939-14-45 |
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author | Woolfall, Kerry Frith, Lucy Gamble, Carrol Young, Bridget |
author_facet | Woolfall, Kerry Frith, Lucy Gamble, Carrol Young, Bridget |
author_sort | Woolfall, Kerry |
collection | PubMed |
description | BACKGROUND: In 2008 UK legislation was amended to enable the use of deferred consent for paediatric emergency care (EC) trials in recognition of the practical and ethical difficulties of obtaining prospective consent in an emergency situation. However, ambiguity about how to make deferred consent acceptable to parents, children and practitioners remains. In particular, little is known about practitioners’ views and experiences of seeking deferred consent in this setting. METHODS: As part of a wider study investigating consent methods in paediatric emergency care trials (called CONNECT), a 20 item online questionnaire was sent by email inviting practitioners (doctors and nurses) who were involved in talking with families about children’s and young people’s (aged 0–16 years) participation in UK EC trials. To ensure those with and without experience of deferred consent were included, practitioners were sampled using a combination of purposive and snowball sampling methods. Simple descriptive statistics were used to analyse the quantitative data, whilst the constant comparative method was used to analyse qualitative data. Elements of a symbiotic empirical ethics approach was used to integrate empirical evidence and bioethical literature to explore the data and draw practice orientated conclusions. RESULTS: Views on deferred consent differed depending upon whether or not practitioners were experienced in this consent method. Practitioners who had no experience of deferred consent reported negative perceptions of this consent method; these practitioners were concerned about the impact that deferred consent would have upon the parent-practitioner relationship. In contrast, practitioners experienced in deferred consent described how families had been receptive to the consent method, if conducted sensitively and in a time appropriate manner. Experienced practitioners also described how deferred consent had improved recruitment, parental decision-making capacity and parent-practitioner relationships in the emergency care setting. CONCLUSIONS: The views of practitioners with first-hand experience of deferred consent should be considered in the design and ethical review of future paediatric EC trials; the design and ethical review of such trials should not solely be informed by the beliefs of those without experience of using deferred consent. Further research involving parents and children is required to inform practitioner training and normative guidance on the use and appropriateness of deferred consent in emergency settings. |
format | Online Article Text |
id | pubmed-4228267 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2013 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-42282672014-11-13 How experience makes a difference: practitioners’ views on the use of deferred consent in paediatric and neonatal emergency care trials Woolfall, Kerry Frith, Lucy Gamble, Carrol Young, Bridget BMC Med Ethics Research Article BACKGROUND: In 2008 UK legislation was amended to enable the use of deferred consent for paediatric emergency care (EC) trials in recognition of the practical and ethical difficulties of obtaining prospective consent in an emergency situation. However, ambiguity about how to make deferred consent acceptable to parents, children and practitioners remains. In particular, little is known about practitioners’ views and experiences of seeking deferred consent in this setting. METHODS: As part of a wider study investigating consent methods in paediatric emergency care trials (called CONNECT), a 20 item online questionnaire was sent by email inviting practitioners (doctors and nurses) who were involved in talking with families about children’s and young people’s (aged 0–16 years) participation in UK EC trials. To ensure those with and without experience of deferred consent were included, practitioners were sampled using a combination of purposive and snowball sampling methods. Simple descriptive statistics were used to analyse the quantitative data, whilst the constant comparative method was used to analyse qualitative data. Elements of a symbiotic empirical ethics approach was used to integrate empirical evidence and bioethical literature to explore the data and draw practice orientated conclusions. RESULTS: Views on deferred consent differed depending upon whether or not practitioners were experienced in this consent method. Practitioners who had no experience of deferred consent reported negative perceptions of this consent method; these practitioners were concerned about the impact that deferred consent would have upon the parent-practitioner relationship. In contrast, practitioners experienced in deferred consent described how families had been receptive to the consent method, if conducted sensitively and in a time appropriate manner. Experienced practitioners also described how deferred consent had improved recruitment, parental decision-making capacity and parent-practitioner relationships in the emergency care setting. CONCLUSIONS: The views of practitioners with first-hand experience of deferred consent should be considered in the design and ethical review of future paediatric EC trials; the design and ethical review of such trials should not solely be informed by the beliefs of those without experience of using deferred consent. Further research involving parents and children is required to inform practitioner training and normative guidance on the use and appropriateness of deferred consent in emergency settings. BioMed Central 2013-11-06 /pmc/articles/PMC4228267/ /pubmed/24195717 http://dx.doi.org/10.1186/1472-6939-14-45 Text en Copyright © 2013 Woolfall et al.; licensee BioMed Central Ltd. http://creativecommons.org/licenses/by/2.0 This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Research Article Woolfall, Kerry Frith, Lucy Gamble, Carrol Young, Bridget How experience makes a difference: practitioners’ views on the use of deferred consent in paediatric and neonatal emergency care trials |
title | How experience makes a difference: practitioners’ views on the use of deferred consent in paediatric and neonatal emergency care trials |
title_full | How experience makes a difference: practitioners’ views on the use of deferred consent in paediatric and neonatal emergency care trials |
title_fullStr | How experience makes a difference: practitioners’ views on the use of deferred consent in paediatric and neonatal emergency care trials |
title_full_unstemmed | How experience makes a difference: practitioners’ views on the use of deferred consent in paediatric and neonatal emergency care trials |
title_short | How experience makes a difference: practitioners’ views on the use of deferred consent in paediatric and neonatal emergency care trials |
title_sort | how experience makes a difference: practitioners’ views on the use of deferred consent in paediatric and neonatal emergency care trials |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4228267/ https://www.ncbi.nlm.nih.gov/pubmed/24195717 http://dx.doi.org/10.1186/1472-6939-14-45 |
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