Trial teams need to do everything possible to make their trial relevant to the people for whom the results are intended to apply, particularly for groups who are under-served by research (see NIHR INCLUDE project, which aims to improve trial delivery for under-served groups).
The INCLUDE Impaired Capacity to Consent Framework aims to help trial teams think specifically about whether adults with impaired capacity to consent should be included in their trial for its results to be widely applicable, and what challenges there may be to making this possible. Having identified potential challenges, the team can then consider ways to reduce those challenges. For this to work, the Framework should be used at the trial design stage before funding is in place if possible and revisited when later developing the trial.
A brief overview of the Framework is below. The full Framework and many other resources linked to capacity to consent in research are available at:
This work is led by Dr Vicky Shepherd at Cardiff University. More resources linked to to support researchers doing research with adults who have impaired capacity to consent are available at https://www.capacityconsentresearch.com.
Funders and others signposting researchers to INCLUDE
NIHR signposts grant applicants to INCLUDE and the Ethnicity Framework in its Stage 2 Standard Guidance for Applicants when applying for Health Technology Assessment funding.
The Wellcome Trust signposts applicants to INCLUDE (and therefore to the Ethnicity Framework) in its Clinical Trials Policy guidance.
The Belgian Health Care Knowledge Centre, KCE, signposts applicants to INCLUDE and the INCLUDE Ethnicity Framework in its Useful links & resources for investigators.
The NHS Research and Development Forum includes the INCLUDE Ethnicity Framework in its resources to support health care research in the UK.
The Chief Scientist Office, Scotland, points grant applicants to the INCLUDE Ethnicity Framework for both its Health Improvement, Protection and Services Research Committee and its Translational Clinical Studies Research Committee.