DECISION

Family members’ experiences of informed consent and proxy decision making for research involving adults lacking capacity.

Decision study findings

Background

Around two million people in the UK have significantly impaired mental capacity due to neurodegenerative conditions such as dementia, acute medical emergencies such as stroke, or associated with learning or intellectual disabilities. Research involving people who have impaired decision-making capacity raises ethical and practical challenges, including the need for others to be involved in the informed consent process. Relatives and friends are often asked to act as a ‘proxy’ or ‘surrogate’ for the person, but making decisions on behalf of another can be difficult and can be experienced as a burden.

Qualitative interview study

The DECISION Study is a qualitative interview study exploring family members/friends' experiences of being involved in decisions about research, made on behalf of an adult who has impaired decision-making capacity. We will be interviewing 20-25 people in England and Wales who have been involved in such decisions (in the last year) about their experiences. This will include relatives or close friends of those with dementia or other similar conditions, profound learning or intellectual disabilities, or other conditions that affect the ability to make decisions either temporarily or for the longer term.

Proxy decisions

These semi-structured interviews aim to find out how ‘proxy’ decisions are made and what information is helpful for family members and friends when making decisions about research participation. Interviews will be audio-recorded with permission. Thematic analysis will be used to identify key themes and allow an in-depth understanding of family members/friends’ experiences, in order to develop a theoretical (ethical) framework, and develop and tailor future supportive interventions.

Decision support instrument

The DECISION Study forms part of an NIHR Doctoral Research Fellowship funded by the Welsh Government through Health and Care Research Wales. The ultimate aim of the project is to develop a decision support instrument (DSI) which is a tool used to help people make choices by providing information about the options and outcomes that are important to the person. This could be used by people acting as proxies in the future when deciding about whether a person lacking capacity should take part in a research study, in order to support informed decision making.

Results

What did we do?

When someone’s ability to make decisions for themselves is affected by a condition such as dementia, a family member may be asked to make decisions on their behalf. This might be a decision about their care or treatment. Sometimes it can be a decision about taking part in a research study. We interviewed 17 family members who had considered whether the person they care for should take part in a research study or not. We wanted to hear about their experiences and views, and understand how they made a decision on the person’s behalf.

What did we find?

Making a decision about research on behalf of another person can be complicated as a lot of different factors are balanced. We found that most family members considered whether it was the best thing for their loved one to take part, and also whether they would have wanted to do so. They thought about whether the person they care for would have been interested in research or science, and also considered whether they would have wanted to help others, or would generally volunteer for things. They considered the impact on the person’s health and well-being, and whether the study would overall have a positive or negative impact on them. Some family members worried about whether it was the ‘right’ decision.

Families thought deciding about research was part of their role as carer, and also because they were the one who knew the person best and felt trusted by them. Some family members had ‘Power of Attorney’ for the person they cared for. This meant they were used to making decisions about their health and finances. We found that many families thought that it covered decisions about research or thought it should do.

We also found that decisions about research can be difficult to make as some people were worried about making the ‘wrong’ decision, or how to know what was best. Family members said they might benefit from guidance about how to make decisions about research on behalf of the person they care for.

What does this mean?

While decision-making about research on behalf of someone else can be straightforward for some family members, some may benefit from support when making decisions. The next step of the project is to develop a tool to help support family members through the decision-making process. Further research may be needed into whether the current Power of Attorney process should be extended to include decisions about research. This might enable people to say who should make a decision on their behalf. It might also encourage people to discuss their future preferences about research.

We would like to thank all those who generously gave up their time to take part in the interviews.