The INCLUDE Impaired Capacity to Consent Framework

SCOPE

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.

What is impaired capacity to consent?

Capacity means the ability to use and understand information to make a decision, and communicate any decision made. A person lacks capacity if their mind is impaired or disturbed in some way, which means they are unable to make a decision at this time (e.g., by mental health conditions, dementia, severe learning disabilities, brain damage etc.). These groups are frequently excluded from trials and designing trials to include these groups can be challenging.

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.