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Centre for Trials Research

INCLUDE Impaired Capacity to Consent Framework

INCLUDE Impaired Capacity to Consent Framework

INCLUDE Impaired Capacity to Consent Framework: supporting researchers to design more inclusive trials

Trials must be designed to ensure those taking part reflect the population who will receive the intervention. However, some populations do not have equitable access to trials, including people who are not able to provide their consent to take part and who are often excluded. This might include people living with conditions such as dementia, people with learning disabilities, or people who have had a medical emergency or are critically ill.

In our CONSULT-ENABLE study, researchers told us that this is partly because research teams are unfamiliar with the legal and ethical frameworks that govern these types of trials and they don’t always have the necessary expertise. Researchers identified a need for tools to help them to design more inclusive trials.

The National Institute for Health and Care Research (NIHR) led the INCLUDE initiative which was a nationwide project to improve the inclusion of under-served groups in research. Following on from this, CTR led the development of the INCLUDE Impaired Capacity to Consent Framework which helps researchers to design trials that are more inclusive of people who may not be able to provide their consent.

Overview of the project

Working with researchers and people affected by capacity-affecting conditions and their carers, we developed the Framework over five phases:

  1. we adapted the INCLUDE Ethnicity Framework for this population
  2. we asked researchers to pilot it in a range of trials
  3. we consulted people living with impairing conditions and their carers to explore their views on the Framework
  4. we finalised the Framework ready for launching at a webinar in November 2022
  5. we developed a toolkit of resources to support researchers in using the Framework

Supporting inclusion in trials

The framework has four key questions to help researchers identify who should be included in their trial, and whether particular aspects of their condition, the intervention being tested, or the way the trial has been designed might affect their ability to take part.  For each question, there are worksheets to help the researchers identify what actions and resources are needed, with signposting to information and resources on capacity and consent. This includes summaries of the ethical and legal frameworks, alongside practical guidance such as how to assess capacity and create accessible information sheets.

We developed a multi-media toolkit of resources to help implement the Framework, which includes infographics and animations, a library of completed frameworks, and facilitated workshops for researchers.

We also worked with an expert in inclusive communication and design to co-produce an Easy Read guide to support public involvement when research teams are designing a trial that involves people with capacity-affecting conditions and disabilities.

Access the framework and resources

The framework, resources, webinar recording, and toolkit can all be found on the CONSULT website. The framework and resources are also signposted to by funders such as the NIHR, and the Health Research Authority, and as part of the Clinical Trials Toolkit route map.

The next stage of this project is to develop online training for researchers on how to design and conduct trials involving people with impaired capacity to consent as they told us that this is important to help them to design more inclusive trials.

Further information can also be found on the INCLUDE Impaired Capacity to Consent Framework for researchers.