Implementation of the ‘INCLUDE Impaired Capacity to Consent Framework’ for researchers

Working with organisations who design and conduct trials to develop a toolkit to help researchers to implement the framework in their work and so design more inclusive trials in the future.

Using the INCLUDE impaired capacity to consent framework.

Background

Randomised controlled trials are the gold standard for testing which medical treatments or ways of providing care are effective. But if some populations are routinely excluded from trials, we don’t know which treatments work best for them. We need to design trials better so that they are more inclusive of groups who are under-served by research. The National Institute for Health and Care Research (NIHR) defines under-served groups as being:

‘A group that is less well represented in research than would be desirable from population prevalence and healthcare burden’

The NIHR’s recent INCLUDE initiative recognised that the definition of under-served is highly context-specific as it depends on the particular population involved, the condition being investigated, the research question, and the intervention being tested. Examples include people with particular demographic characteristics such as age or ethnicity, social or economic factors, or health-related factors such as people with disabilities.

Inclusion of people with impaired capacity to consent

One under-served group is people who have cognitive impairment and are unable to provide consent to take part in a trial. This may be due to a condition such as dementia, an acute illness such as a stroke, or a learning disability. Our previous research found that researchers struggle to design and conduct trials involving people with a cognitive impairment due a lack of knowledge and support. Researchers identified a need for more guidance.

Building on the work of INCLUDE and the previous development of the Ethnicity Framework to help trial teams think about which ethnic groups should be included in their trial and how to enable their participation, we have developed the INCLUDE Impaired Capacity to Consent Framework. The framework is intended to help trial teams to identify which people with particular conditions or disabilities should be included in their trial and how to ensure the trial is designed to be inclusive of them. It was developed with researchers and people affected by these conditions and has two parts: four key questions and a series of worksheets to help answer the questions, along with links to more information and resources. We now need to develop tools to help researchers to use the framework in practice.

Implementing the framework

In this project we will work with organisations who design and conduct trials to develop a toolkit to help researchers to implement the framework in their work and so design more inclusive trials in the future. The toolkit will include multi-media resources such as videos and infographics to raise awareness with researchers (and lay research partners) about the issues around inclusivity and the purpose of the framework, and more focused workshop materials to give concrete pointers on how research teams can work through the framework and address any barriers to the inclusion of people with impaired capacity. It will also include the development of ‘easy read’ materials to ensure that the framework is accessible to research partners with additional communication needs.

Involving the public and patients

Members of the public with experience of a condition or disability that affects their memory or understanding, and carers, are part of the lay advisory group supporting the project and are also involved in developing the accessible materials. By involving people with personal experience, we aim to ensure that the framework and toolkit are relevant to all those involved.