Informed consent and proxy decision making in research involving adults lacking capacity: development of an intervention to support proxy informed decision making, set within ethical and legal frameworks. (PhD Studentship)
Principal / Lead Investigator
- Victoria Shepherd (SEWTU, Cardiff University)
- Prof Fiona Wood (Lead supervisor - PRIME, Cardiff University)
- Prof Kerry Hood (Co-Supervisor - PRIME, Cardiff University)
- Dr Mark Sheehan (Co-Supervisor, University of Oxford)
- Mr Richard Griffiths (Co-Supervisor, Swansea University)
Type of study
NIHR Doctoral Research Fellowship
Who is the study sponsor?
Research studies are needed in order for improvements to be made to health and social care for all members of society. Informed consent is an essential part of ethical medical research. However, some people may be unable to decide for themselves about whether or not to take part in a research study due to reduced cognitive function. This may be because of sudden and severe illness, a condition such as dementia, or because of a profound learning or intellectual disability. Currently, patients with conditions like these are more likely to be excluded from research. But with increasing numbers of adults living longer, leading to more people with conditions like dementia, it is important that these groups are included in research. Friends and families who care for adults unable to make their own decisions are often asked to act as a ‘proxy’ to make such decisions on their behalf. However these decisions are complicated, and involve challenging legal and ethical issues.
Laws covering medical research have sections covering decisions about research for adults who lack decision making capacity. They state that decisions should be based on whether the person would have wanted to take part, if they were capable of deciding. However, little is known about how proxy decisions are actually made in everyday situations, and whether the ethical and legal requirements are being met. Currently there is no information or support available for proxy decision makers. Greater understanding about how decisions about research are made, and how friends and families can be supported when making such decisions, is urgently required.
Aims of the research
The aim of this project is to develop a tool to support informed decision making for adults lacking decision making capacity to take part in research.
This will be achieved through:
- Exploring the ethical and legal factors involved
- Deciding what factors and information must be included in the support tool
- Developing a support tool that is suitable to be used by families and friends when making decisions for adults lacking capacity.
Public / patient involvement
Active public and patient involvement in this research proposal has been secured through collaboration with Health and Care Research Wales Involving People network. Two members of the Involving People network were recruited to form an expert lay advisory panel. They have contributed to the refining and design of the research proposal through providing alternative perspectives on proxy decision making as a result of their own experiences.
Since the study was funded, a third member of the Involving People network has been recruited to join the lay advisory panel. The role of the panel will be to discuss the research project at regular six monthly face to face meetings with the research team, and to provide feedback about the progress and conduct of the project.
How could this research potentially benefit patients?
Concerns about the ethical and legal issues of including adults who lack decision-making capacity in medical research have been identified as barriers to them being involved in research. This includes people with neurodegenerative diseases such as dementia, profound learning disabilities, stroke, and critical illness.
The findings from this study will support families and carers who are involved in making decisions on behalf of others, and healthcare professionals involved in their care, when considering taking part in research or not.
This study aims to promote future health and social care improvements across a wide range of NHS settings and services, by enabling and supporting research with traditionally under-researched and hard to reach members of society.
NIHR: Doctoral Fellowship Award
Total grant value
Further info (e.g. related web link)
Outputs generated (Reports / Publications)
Shepherd, V.et al. 2019. Research involving adults lacking capacity to consent: a content analysis of participant information sheets for consultees and legal representatives in England and Wales. Trials 20, article number: 233. (10.1186/s13063-019-3340-5)
Shepherd, V.et al. 2018. Ethical understandings of proxy decision-making for research involving adults lacking capacity: a systematic review (framework synthesis) of empirical research. American Journal of Bioethics 9(4), pp. 267-286.
Jordan, A.et al. 2018. What adolescents living with long-term conditions say about being involved in decision-making about their healthcare: A systematic review and narrative synthesis of preferences and experiences. Patient Education and Counseling 101(10), pp. 1725-1735.
Shepherd, V.et al. 2018. Healthcare professionals' understanding of the legislation governing research involving adults lacking mental capacity in England and Wales: a national survey. Journal of Medical Ethics 44(9), pp. 632-637. (10.1136/medethics-2017-104722)
Shepherd, V., Wood, F. and Hood, K. 2017. Establishing a set of research priorities in care homes for older people in the UK: a modified Delphi consensus study with care home staff. Age and Ageing 46(2), pp. 284-290. (10.1093/ageing/afw204)
Shepherd, V. 2016. Research involving adults lacking capacity to consent: the impact of research regulation on 'evidence biased' medicine. BMC Medical Ethics 17(1), article number: 55. (10.1186/s12910-016-0138-9)