‘He would probably want to help people if he could’: making decisions about research on behalf of people living with dementia

Victoria Shepherd is a Research Associate at the School of Medicine at Cardiff University. She currently holds an NIHR Doctoral Research Fellowship exploring the ethical, legal, and practical issues surrounding research involving adults who lack capacity to consent. She tweets @VickyLShepherd and @DECISION_Study

The latest NICE guidelines recommend that opportunities to participate in research should be available to people living with dementia at all stages of the condition. Providing accessible information about research studies that takes account of dementia-related cognitive and communication needs, and ensuring support is available to make decisions about participation, is essential. However, there has been little attention paid to how decisions are made about the participation of people with dementia if they are unable to decide for themselves.

When someone lacks capacity to consent to take part in research, relatives or close friends are usually approached to be involved in the decision about their participation. As part of a project exploring the involvement of people with impaired decision-making capacity in research, we wanted to find out how family members make decisions about research on behalf of someone living with a condition such as dementia.  Understanding how families in the UK make decisions about research, and what information and support they might need, is a new area for research and so we conducted the DECISION Study to explore this for the first time.

For our study, published in Age and Ageing, we interviewed family members of someone who lacked capacity to consent and who had been involved in deciding whether they should or should not participate in a research study. We found that family members had rarely discussed future preferences about research with the person they cared for and so didn’t know their exact wishes, but family members sought to make a decision they thought was authentic to the person they represented and the values that were important to them. However, for some family members it was a difficult decision to make, and some experienced an emotional and decisional burden as a result. Additionally, some families described the challenges of broaching the question of participating in dementia research with their relatives when they had impaired insight into their condition, which in some cases led to a denial of their dementia diagnosis.

The families we interviewed thought that support for family members making decisions about research on behalf of someone living with dementia might benefit families in the future. Supported decision-making could reduce the impact felt by family members and make their decisions more informed and representative of the wishes and preferences of the person they care for, and so continue to provide an opportunity to participate in research in the later stages of dementia.

Our previous research has shown that information about research studies given to families making decisions rarely provides enough information about how they should approach making such decisions, or their role in the process. We have also found that health and social care professionals working with people with impaired capacity do not have a good understanding about the legal frameworks governing their inclusion in research, which may affect their confidence in recruiting participants who lack capacity and inadequately supporting family members. This has led us to develop a tool that could help both family members approached to make a decision about research and the clinicians and practitioners who approach them. The tool (a decision aid) would supplement the study-specific information. In the future, we will be piloting the decision support tool ahead of testing to see whether it does support family members to make informed decisions about research for others.

Other recommendations from our study include encouraging people living with dementia and similar conditions to have early conversations about their future research (as well as care) preferences, and for health and social care professionals to receive greater training in involving populations who lack capacity to consent in research and to provide opportunities to include them in research at all stages of the condition.

A short animation of the DECISION Study findings can be found here