Parents' and children's consent to heart surgery
Research type
Research Study
Full title
Parents' and children's informed and voluntary consent to heart surgery
IRAS ID
248332
Contact name
Katy Sutcliffe
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2018/8/56, Data protection number
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
The study will explore the views and experiences of 60 children referred for heart surgery. The purposive sample will include children aged 6 to 15 years. With their consent, they and their parents will be observed before and after surgery and interviewed after surgery. Forty clinical staff will be interviewed, and selected discussions between staff and families will be recorded. Interviews will also be audio-recorded and transcribed.
The main questions are: How far do children want to be informed and involved in decisions about the treatment? How can parents and clinical staff helpfully inform, prepare, support, protect and respect the young patients? When are children old enough to be competent to give informed and voluntary consent to heart surgery? What do families most value in the ways they have been informed and supported? Do they think the information and care might be improved?
The replies will be thematically analysed, and reported in papers for academic and professional journals and for patients groups.
In a survey of young people and staff about heart surgery,* none of the reported questions or open replies mentioned consent. This research aims to provide information about this under-researched area for the practical use in future by staff, patients and parents/carers. Besides the great need to respect everyone who is observed or interviewed, to respect their feelings and privacy and avoid distressing them, there is also the need to know more about how children are informed and involved in making decisions about heart surgery, and support they find helpful or less helpful. The research will be informed by previous similar work in paediatric cardiology, orthopaedic and diabetes centres.* Harris, T. (2015) Confidential Report of a Survey conducted in preparation to write a book about heart surgery for teenagers. London: British Heart Foundation.
REC name
London - Hampstead Research Ethics Committee
REC reference
19/LO/0073
Date of REC Opinion
18 Feb 2019
REC opinion
Further Information Favourable Opinion