CONSULT Training will develop training for researchers on how to design and conduct trials involving people with impaired decision-making.
Around 2 million people in the UK have significantly impaired decision-making. Over the coming decades, this number is likely to grow considerably due to an ageing population and a rise in conditions such as dementia. Research is essential in order to improve evidence -based care for these populations who often have the most complex care needs. However, research involving people with conditions that affect their ability to understand information and make decisions may present challenges. People with these conditions may be unable to provide their own consent to take part in research, and this raises a number of ethical, legal, and practical issues that researchers need to address.
In order to include people in research who are unable to provide their own consent to participate, someone close to them is approached to help make a decision on their behalf. This is usually a family member or close friend, but it might be a person who cares for them in a professional capacity if it is not possible to involve family members or friends. They are asked to act as a ‘consultee’ or ‘legal representative’ and to decide whether the person they are representing should participate in the study or not based on what, in their opinion, the person’s wishes and feelings would be about taking part.
We have previously developed tools to support researchers, such as the INCLUDE Impaired Capacity to Consent Framework. Researchers have told us that they find tools like the Framework useful when designing and conducting trials involving these groups, but they do not always have the knowledge and skills they need. They felt that they would benefit from better training in this area.
In this project we will be developing training for researchers on how to design and conduct trials involving people with impaired decision-making. We will conduct an online survey with researchers to ask them what training and information would be useful to them to help them to design and conduct trials involving people who have impaired decision-making. We will also ask them for examples about challenges they have encountered when designing and conducting research with these groups, and for any examples they can share.
We will use the information to develop training for researchers that will help them to design and conduct trials that are better designed and more inclusive of people with impaired decision-making.
Medical Research Council Impact Acceleration Account
|1 Oct 2023
|30 Sep 2024