Evaluating consent processes for interventional donor research
Research type
Research Study
Full title
Evaluation of consent processes for interventional donor research in the context of deemed consent
IRAS ID
300678
Contact name
Jessie Cooper
Contact email
Sponsor organisation
City, University of London
Clinicaltrials.gov Identifier
Registration with the Open Science Framework, https://osf.io/buhs2/
Duration of Study in the UK
1 years, 6 months, 20 days
Research summary
In recent years, research in transplant medicine has focused on developing ‘interventional donor research’, defined as research in which: “[the] intervention is administered while the organ is still in the deceased donor […] before it is transplanted into the recipient” (Childress et al., 2017). Whilst this form of research holds the promise of improving the quality and quantity of transplantable organs, it is understood to be hampered by ethical and legal issues, particularly in relation to consent. In the case of donor relatives asked to provide consent for this type of research, commentators have drawn attention to how they may be faced with two difficult consent decisions - donation and research - at a time of great emotional distress. In response to these debates, a limited number of guidelines have been developed which recommend the importance of gaining specific (rather than generic) consent for interventional donor research. However, guidance on obtaining consent for these research innovations are being led by expert opinion, rather than demonstrable evidence (Cooper, Harvey & Gardiner, 2020). Confusion persists around the practicalities and context of consent in interventional donor research, not least with the introduction of Deemed (opt out) consent for organ donation in Wales (2013), England (2019) and Scotland (2019).
This study seeks to redress this gap by interviewing specialist nurses and donor relatives who were approached about consenting their family member into the UK SIGNET Trial, which is trialling the use of statin medication in brain stem dead donors to improve transplant outcomes. The study aims to: 1) understand experiences and processes around informed consent for interventional donor research in the SIGNET Trial; 2) identify and interpret how deemed consent may influence consent for interventional donor research; 3) use the findings to make recommendations to improve training/procedures around consent for UK interventional donor research.
REC name
London - Stanmore Research Ethics Committee
REC reference
21/LO/0801
Date of REC Opinion
5 Jan 2022
REC opinion
Further Information Favourable Opinion