The NIHR INCLUDE Impaired Capacity to Consent Framework is a tool for researchers to ensure that their trial is designed to be inclusive of people with impaired capacity to consent, as well as improving the quality of the trial design and funding application. It should preferably be used at the earliest stage when designing a trial (for example, it might be used when developing an NIHR Stage 2 application), however it can also inform later stages of developing the trial such as when drafting the protocol and ethics application. The framework is intended to be used with all populations who may experience impaired capacity, although the issues raised will differ between populations and trial contexts..
The INCLUDE Impaired Capacity to Consent Framework has four key questions, each of which is intended to prompt trial teams to think about who should be included in the trial, and how to facilitate their involvement as much as possible. These questions should be considered by trial teams in partnership with patient and public partners.
Answering the key questions can be tricky. To help with this we have developed some worksheets that give pointers to the sort of things to think about when answering the questions. Not all questions/sections will be relevant and can be left out if they are not helpful. It is intended to be used for trials, but it may be useful for designing other types of studies – especially question 4 about whether the study design will affect inclusion.