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Including people who lack capacity to consent in trials: testing a new tool

Can you help with the development of the INCLUDE Impaired Capacity to Consent Framework by piloting the framework and sharing feedback about how it can be used in practice?

Trials involving adults who lack capacity to consent can be challenging. Following on from the NIHR INCLUDE guidance to improve the inclusion of under-served groups in research, and the development of the Ethnicity Framework, members of the inclusivity sub-group of the Trial Methodology Research Partnership (TMRP) Trial Conduct Working Group are now leading the development of a framework to help researchers to design trials to be inclusive of adults with impaired capacity to consent.

We are asking researchers involved in the design and conduct of trials which may include adults with impaired capacity to consent to pilot the framework using a research proposal (this could be a real or hypothetical trial) and provide feedback. You can contribute as an individual or within a small team, and the activity is anticipated to take 2-3 hours. With your permission, your contribution will be acknowledged by name in the framework documents.

We will be piloting the tool during September 2021. Please feel free to share the details with your networks!

If you are interested in contributing, or would like more information, please contact:

Dr Victoria Shepherd, Centre for Trials Research, Cardiff University ShepherdVL1@cardiff.ac.uk

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