I first became interested in how decisions are made for those who are unable to make their own decisions during my clinical role as a critical care nurse. In an environment where extremely sick patients are unconscious and reliant on technology to support them through their critical illness, other people are required to make decisions about their care and treatment. These decisions can be about which course of treatment would be most effective for the person, but sadly sometimes these are very challenging decisions about recognising that treatment is no longer effective, and whether the focus should change towards providing palliative care.
In my later role as a researcher in the Centre for Trials Research, I encountered similar decision-making processes for people who were unable to provide their own consent to take part in clinical trials and other types of research. Most of this experience was with older people living in care homes, some of whom have impaired mental capacity due to dementia, or stroke, but also with people who have intellectual disabilities, or experiencing sudden events such as post-partum haemorrhage.
The importance of wide consultation
While decisions made about medical treatment and care are very different from those made about taking part in a research study, they both require information about the options available, and a careful weighing up of the relevant factors. Both also require consultation with a range of people who all bring expert knowledge – either about the risks and benefits of each option, or expert knowledge about the person themselves and what their wishes and feelings would be about the choices available. Families and friends making a decision on behalf of another person are known as surrogates or proxies.
My interest led me to recently studying medical law and ethics at Swansea University, and in particular examining how the ethical and legal requirements can be balanced in order to ensure that the rights and well-being of the person are protected, whilst respecting their wishes. This interest in law and ethics has formed the background to my work over the last couple of years, and culminated in now being awarded a Fellowship to undertake my own research in this area.
The National Institute for Health Research (NIHR) offer a number of personal awards at different levels and accessible by different professional backgrounds. These prestigious awards offer an incredible opportunity to undertake a fully-funded research project, alongside a tailored training and development programme, intended to develop leading researchers of the future. I have been fortunate to have been awarded a Doctoral Research Fellowship which also enables me to undertake my research project as part of a doctoral (PhD) programme. As I am based in a HEI in Wales, my Fellowship is funded by Health and Care Research Wales.
The Fellowship means that I will be exploring how decisions are made about research participation for those unable to provide their own consent, for the next three years, and is co-located between the Centre and the Division of Population Medicine, both in Cardiff University. The experience, skills, and evidence generated through this doctoral research should enable me to pursue further funding and fellowship opportunities to continue the work, as well as benefitting patients and public in the future.
My research focus
I am undertaking a number of studies as part of the project as a whole. I am conducting a systematic review (framework synthesis) of the empirical evidence on the ethical issues involved in proxy decision-making for research, alongside a review of the literature that analyses the ethical and legal basis. This will help to understand how decisions are made, and ought to be made. I will also be examining what information is currently provided to friends and families about their role, and will be interviewing people with experience of making these decisions to explore their views and experiences. I am also carrying out a survey of health and social care professionals who provide care for people who lack capacity to explore their knowledge and understanding of decision-making for research.
These will contribute to the overall aim of the project which is to develop a decision support tool to help family and friends make informed decisions about research on behalf of someone else. A range of stakeholders will be involved in developing and testing the tool to make sure it is practical and feasible to use.
After the Fellowship, I would like to carry out further research to evaluate if the tool is effective in supporting decision-making, and also other projects to improve the opportunity for people with cognitive impairments to take part in research. The aim is to move towards more inclusion and opportunity for individuals to participate in research, whilst maintaining their well-being, and the safeguards that the legal and ethical frameworks provide.
As a researcher with an interest in research involving people who lack mental capacity, I was invited to contribute to the recent Mental Capacity – Action in Research conference in Cardiff, which was a great opportunity to meet and share with others who are also working towards this aim.