PhD in Population Medicine - Increasing inclusivity in trials: supporting decision-making about involving adults and young people with profound and multiple learning disabilities in research

Adults and young people with profound and multiple learning disabilities (PMLD) frequently have complex medical conditions which can be life limiting and require specialist care and support. PMLD may experience problems with communication and decision-making which may affect their ability to make a decision about participation in research - even with supported decision-making. Populations with impaired capacity to consent, including PMLD, are frequently excluded from research, with over 90% of randomised controlled trials (RCTs) being designed to exclude people with a learning disability. This is primarily due to the complex ethical and legal issues surrounding the inclusion of people unable to provide informed consent, and the practical challenges of involving alternative ‘proxy’ decision-makers on their behalf. Interventions to enable trials to be more inclusive of under-represented groups has been highlighted as a priority area for further research in order to ensure that trials are generalisable and that the benefits of research are distributed equitably across all population groups.

Previous research has explored how families are involved in making decisions about research for people who have lost capacity due to conditions such as dementia. This found that research decisions are complex, with proxies using the biographical narrative of the person they represent to make a decision they think is authentic to their values and wishes. However, there is a dearth of research exploring how decisions are made for PMLD who may have had life-long impaired capacity and may not have formed or expressed wishes and feelings which could guide proxy decisions about research participation. There may be additional issues around proxy decision-making for children and young people’s continued inclusion in research when they reach the age of majority and legal capacity, but do not have mental capacity to make decisions about continued participation. In these situations, family members’ role will change from providing parental consent to acting as consultee or legal representative for their adult child.

This project aims to explore how decisions about research are made by family members and professionals caring for adults and young people with profound and multiple learning disabilities, to identify ways of conducting trials more inclusively and ethically for PMLD as an under-represented group, and the development of interventions to support those involved in the design and conduct of trials involving PMLD.

This mixed-methods project will be conducted in three stages.

1) Existing evidence will be reviewed to explore the range of ethical, legal, and practical issues surrounding the inclusion of adults and young people with profound and multiple learning disabilities (PMLD) in research.

2) Qualitative interviews and focus groups will be conducted with a range of stakeholders to explore the attitudes and experiences of those involved in caring for, and conducting research with, PMLD. This will include healthcare professionals (GPs, LD nurses and other community LD team members), social care practitioners (support workers from community and residential settings) and social workers involved in supporting PMLD. The topic guides for the interviews and focus groups will be informed by the findings from the literature review.

3) The final stage will be to develop an intervention to support the ethical inclusion of PMLD in trials using established intervention development frameworks (e.g MRC guidance for developing complex interventions) and in conjunction with the relevant stakeholder groups. It may take the form of an educational intervention for health and/or social care professionals who care for PMLD, or a decision support intervention for family members or health/social care professionals acting as a consultee or legal representative for PMLD.
The outcomes from the project will include improving our understanding about how decisions about research are made by family members and professionals caring for adults and young people with profound and multiple learning disabilities, to identify ways of conducting trials more inclusively and ethically for PMLD as an under-represented group, and the development of an intervention to support those involved in the design and conduct of trials involving PMLD.

Training will include systematic/critical review of evidence, qualitative research methods, and intervention development. A broad range of trials methodology research training and internship opportunities are also available.