Organ Donation Version 1.
Research type
Research Study
Full title
Family attitudes, actions, decisions and experiences following implementation of deemed consent and the Human Transplantation Act (Wales)
IRAS ID
190066
Contact name
Jane Noyes
Contact email
Clinicaltrials.gov Identifier
BangorREC5 15/wa/0414 , Research Ethics Committee code
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Background:
The Human Transplantation Act (Wales) 2013 introduces a ‘soft opt out’ system of organ donation. The new Act changes the fundamental principles of consent to deceased organ donation from one ‘of opt in’ consent to a so called ‘soft opt out’. Under the opt-in system, in 2012 125 families overruled the individual's intention recorded on the NHS organ donor register. After 1st December 2015, under the new ‘soft opt out’ system people can choose to do nothing as the law allows for their consent to be ‘deemed' to have been given if they fulfil predetermined criteria. The donation request conversation with the family would be a presumptive one getting the family to accept that by not expressing a decision that their consent to donation would be deemed to have been given. Potential donor families are identified as being most affected by the Act.Aims:
To explore the impact of the Human Transplantation (Wales) Act 2013 from the perspective of people involved in the donation conversation. A secondary aim is to further enable key staff in NHS Blood and Transplant and patient and public representatives to engage in research.Research questions:
1. What impact and changes has the Act and media campaign had on the views and decisions of families of organ donors in Wales?
2. What are the views of families of the deceased person on the shift in relationship with the Government and healthcare services, organ donor registration, deemed consent, and their changed role in decision-making in a soft opt out system?Study Methods:
Phase 1 – Gaining an initial understanding of the impact of the Act on all potential donor families for 18 months from 1st Dec 2015.
Specialist Nurses for Organ Donation (SNODs) will complete an anonymised 1 page questionnaire that will be filled out as soon as possible after the SNOD has disengaged from talking with the potential donor family. SNODs will complete questionnaires with information gathered from their routine conversations with potential donor families.
Phase 2: Undertaking research (questionnaires/interviews) with potential deceased donor families/patient representatives and close friends to gain a deeper understanding of their thoughts, experiences and responses to the Act.
Phase 3 – Undertaking small group and 1:1 interviews with NHS Blood and Transplant team members to understand their perspectives.
Phase 4: Phases 1-3 will be analysed and combined and compared with routinely collected anonymised information on organ donor registration figures, opt outs, and organ donor figures in Wales to better understand the big picture.
REC name
Wales REC 5
REC reference
15/WA/0414
Date of REC Opinion
24 Nov 2015
REC opinion
Further Information Favourable Opinion