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Consent and assent in paediatric practice: it’s the conversation that matters
  1. Hugh T Davies1,
  2. Jenny Preston2,
  3. Bob Phillips3
  1. 1 Oxford 'A' National Health Service Research Ethics Committee, Oxford, UK
  2. 2 Senior Patient and Public Involvement Manager, NIHR Alder Hey Clinical Research Facility, Liverpool, UK
  3. 3 Centre for Reviews and Dissemination, University of York Alcuin College, York, UK
  1. Correspondence to Dr Hugh T Davies; hughtdavies{at}gmail.com

https://doi.org/10.1136/archdischild-2023-326454

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    In paediatric medical research, across jurisdictions, parental consent and the assent of their child will usually come from a shared conversation between the researcher and family. This is how a study is introduced, information delivered, uncertainties addressed and understanding confirmed. Evidence indicates the crucial importance of the dialogue1 yet it currently goes unguided, undocumented, and often unchecked as review and research design continue to focus on the Participant Information Sheets (PIS).2 We propose that it’s time to move our focus on to this conversation to help families make their decision and in this viewpoint we suggest how this can be realised working within the constraints that researchers face. We address consent to research, but would contend that this idea has equal applicability in clinical practice.

    An assent and consent information decision aid

    Recognising the importance of this dialogue, the UK Oxford ‘A’ Research Ethics Committee has developed and published a framework for consent and a summary information decision aid with input from researchers and patient representatives.3 We propose that this could be adapted for paediatric practice to make a shared template for the conversation between researchers and families when they discuss a research study (see online supplemental file 1).

    Supplemental material

    [archdischild-2023-326454supp001.pdf]

    We would envisage this should be no more than four sides of A4 as a longer document would be unwieldy and difficult to use within a consultation. Detailed material would be provided in links, including the full PIS. We propose this simple document would provide a shared …

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    Footnotes

    • X @drbobphillips

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • 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.