Trials involving adults with impaired capacity to consent can be challenging to conduct, resulting in this underserved group often being excluded, or trials that do include them being difficult to implement. Building on the NIHR INCLUDE project and the Ethnicity Framework, we have developed the INCLUDE Impaired Capacity to Consent Framework to support researchers design trials to be more inclusive of this population. The framework was developed by a team from the MRC-NIHR TMRP Trial Conduct Working Group and is intended for trials involving all populations where there may be issues around capacity to consent.
The framework consists of 4 key questions for researchers to consider. Including which groups of people with capacity-affecting conditions or disabilities their trial results should apply to (and therefore include), and whether particular aspects of their condition/disability, the intervention being tested, or the way the trial has been designed will affect their ability to take part. Worksheets then help researchers identify what actions and resources are needed, with links to supporting information and resources.
At this webinar we will discuss the importance of inclusivity in trials and the NIHR’s Equality, Diversity and Inclusion (EDI) Strategy, and introduce the framework outlining when and how it should be used, and what the benefits might be for stakeholders including researchers, funders, ethics committees, and people living with capacity-affecting conditions and disabilities. We will share the toolkit of materials developed by the Centre for Trials Research to help researchers to use the framework, and signpost where the framework and accompanying resources can be found.
- Prof Shaun Treweek, Trial Forge / University of Aberdeen
- Prof Paul Dark, Deputy Medical Director, NIHR Clinical Research Network Centre
- Dr Victoria Shepherd, Centre for Trials Research, Cardiff University