Title: Family attitudes, actions, decisions and experiences following implementation of deemed consent and the Human Transplantation Act (Wales)
Funder: Health and Care Research Wales (Welsh Government)

Abstract: The focus of the study is on deceased organ donation in Wales under the new soft opt out system that comes fully into force on 1st December 2015, and family/patient representative’s perspectives, thereafter referred to as ‘family’. The aim is to explore the impact of the Human Transplantation (Wales) Act 2013 (a prudent healthcare policy) on family views and attitudes to organ donation registration and deemed consent, and their experiences and decisions when a family member is a potential deceased organ donor.1-2 Prudent health 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? Objectives 1. To ascertain a broad overview of anonymised recorded family statements, actions and outcomes to organ donation requests in Wales for an 18 month period. 2. To explore in greater depth the perspectives and experiences of families who were involved in a donation request. 3. To explore the perspectives of specialist nurses for organ donation covering Wales to contextualise potential donor family views, experiences and decisions. 4. To contextualise findings with publicly available quarterly activity reports on organ donor registration and organ donation in Wales. 5. To further develop research capacity and capability in NHS Blood and Transplant and PPI in Wales. Statement of the proposed research The Human Transplantation Act (Wales) 2013 introduces a ‘soft opt out’ system of organ donation that is a prudent health policy. In a poll conducted in 2014 in Wales, 90% of people said they supported organ donation, and 33% of the eligible population were on the NHS organ donor register.3 The purpose of the Act is to make it easier for people to donate their organs to benefit patients. The Act constitutes one of the biggest changes to the partnership and social contract between the Welsh Government and the people of Wales. Under the current ‘opt in’ system if a person has not made the decision themselves to consent to organ donation before their death, families are required to give consent after the death. When an individual has registered their decision to donate on the organ donor register families are more likely to agree to donation proceeding.3-4 In the 2011/12 UK audit of donor activity, 125 families however overruled the individual's intention recorded on the NHS organ donor register.3 If the decision to donate is unknown then families are less likely to agree and as such not give consent. Overall, 57% of families refuse consent to deceased donation in Wales. In contrast the family refusal rate in Spain is less than 20%.4-6 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’ for adults over 18 years, resident for 12 months or more in Wales, who have not made an express decision regarding organ donation and are competent to understand the notion of deemed consent; individuals also have to die in Wales. 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 the criteria above. The donation request conversation with the family would be a presumptive one getting the family to accept that by not expressing a decision that the deceased person's consent to donation would be deemed to have been given. The family would be required to produce clear evidence that the person did not want to be an organ donor for consent not to be deemed. The evidence could be a witnessed conversation or a document signed and dated. The law allows for consent to be deemed in certain circumstances however, it does not mandate that organ donation goes ahead in such cases. If someone has registered a decision or informed someone that they did not want to donate organs (opt out) prior to their death, their decision will be respected unless the family is able to produce clear evidence that the individual had changed their mind. The Act is however controversial and not everyone consulted agreed with the soft opt out system and its principle of deemed consent.3 Potential donor families are identified as being most affected by the Act as unlike the old ‘opt in’ system, their role in the ‘soft opt out’ system remains essential but changed by deemed consent. The proposed study is designed to address a critical gap in understanding by exploring if the Act has changed the views and decisions of families.7 Understanding how and why people in reality respond to the soft opt out will be vital to contextualising the impact of this prudent health policy in achieving its aims.


Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE