Table 8 Recommendations for research teams using the INCLUDE Impaired Capacity to Consent Framework

Introduction

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General background

• Review the legal frameworks governing research involving adults lacking capacity in the UK* before considering the framework questions as the justification for including adults lacking capacity will need to be clearly articulated when seeking approvals etc. Consider whether the study is connected with an impairing condition affecting participants who are unable to consent, or with the treatment of the condition. Could it be carried out as effectively (i.e. meet the research objectives) if it was confined to research participants able to give?

• If the trial will involve different jurisdictions, familiarise yourself with the relevant legal frameworks — particularly if it is emergency research as the arrangements will vary considerably. Bear in mind that dual ethical approvals may be required

• Public involvement (including families and carers where appropriate) is essential throughout

Q1. Who should my trial results apply to?

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People with particular types or severity of conditions or disabilities that may impair their capacity to consent

• The framework will not help you to answer Q1 — you will need to explore the evidence about who makes up the target population. Consider who would be likely to receive the intervention if it is implemented into routine care. For example, who could benefit from the intervention if effective, or not having it if found to be ineffective? Are they likely to have conditions or disabilities that may impair their capacity to consent? What types or severity of conditions/disabilities are particularly relevant to consider?

• Bear in mind that the capacity-affecting condition/disability may be long-term (e.g. learning disabilities), progressive in nature (e.g. dementia), be associated with an acute event (e.g. stroke, cardiac arrest) – or it may be a combination of these (e.g. a hip fracture in someone living with dementia) in which case multiple perspectives may need to be considered

• Consider whether routine care pathways, clinician equipoise, or other factors may be different for these particular populations

Q2. Are they likely to respond to the intervention in a different way?

Worksheet A

Factors relating to the impairing condition/disability, plus other relevant factors such as ethnicity

• Q2 will be relevant to some trials more than others depending on the nature of the intervention/comparator

• Consider whether participants’ ability to respond to or engage with an intervention will affect how effective the intervention will be. For example, people with cognitive impairment may find it difficult to engage with a self-management intervention

• Consider whether the nature of impaired capacity (e.g. an acute event, progressive) may affect their ability to respond or engage. Might capacity to consent change over time (e.g. loss of capacity, regaining capacity)? What impact might that have?

• In addition to cognitive disabilities, consider whether other disabilities that affect communication (e.g. aphasia, hearing or visual impairments) may affect participants’ ability to respond to the intervention, and consider how the trial design should take account of this

• Consider whether other relevant factors or characteristics may affect participants’ ability to respond to the intervention, e.g. any cultural or language-related factors

Q3. Will my intervention make it harder for them to respond?

Worksheet B

Factors relating to the intervention/comparator (including what the intervention/comparator is and where, when and who will be delivering it)

• Q3 will be relevant to some trials more than others depending on the nature of the intervention/comparator

• Consider whether participants’ ability to respond to or engage with an intervention will affect how effective the intervention will be. For example, an exercise intervention that requires participants to attend a programme of activities at an unfamiliar venue may be difficult to access for people with cognitive impairment

• Depending on the nature of the intervention, prior work to explore whether the intervention is feasible for people with cognitive impairment may be needed

Q4. Will the trial design make it harder for them to take part in, or remain in, the trial?

Worksheet C

Eligibility and recruitment (including consent)

• Q4 will be relevant to all trials — and to many other types of research studies. Working through worksheets C–F will provide a systematic approach to working through the design of your trial

• Consider whether eligibility criteria should focus on (in)capacity to consent or participants’ ability to engage with the intervention

• If the trial will involve people who lack capacity to consent, familiarise yourself with the relevant legal frameworks* including assessing capacity, involving personal consultees and legal representatives (and nominated consultees and professional legal representatives where needed), and the additional documents that will be required

• Consider how people with cognitive impairment might be given the opportunity to participate. For example, if an expression of interest is required via a website or return of a letter how might people be supported to do so?

• Consider how participant information could be developed in ways that will enable people with cognitive impairment to receive and access it. Could this be in alternative formats? Who should be involved and how would this be resourced?

• Consider whether participants’ ability to consent might change during the trial — what processes for re-assessing capacity and involving others might be needed? Consider which additional documents will be required. For example, someone enrolled without prior consent following a cardiac arrest may regain capacity to provide their own consent to continue in the trial. Someone living with dementia who provided consent at the outset may lose capacity during a trial and require the involvement of a consultee or legal representative

Worksheet D

Data collection (what, who, how and where will data be collected)

• Worksheet D will depend on the nature of the data being collected. For example, whether any patient-reported outcome measures (PROMs) are being used and how they will be completed

• Depending on the methods of data collection, prior work to explore whether it is feasible for people with cognitive impairment may be needed. For example, are proxy-completed versions required (and are there validated versions)? What happens about the continued use of data if a participant enrolled without prior consent dies before consent has been obtained?

• Consider whether enabling a participant to nominate a study partner may be helpful in supporting participation and data collection

Worksheet E

Analysis

• Consider how processes for reporting adverse events will include people who may be unable to self-report

• Consider whether there may be any variation between groups who are able to consent and those who may not be able to consent. If there is a combination of self-reported and proxy-reported data how will these be analysed? Should there be planned subgroup or interim analyses, or any stopping triggers?

Worksheet F

Reporting and dissemination

• Consider how and where trial results can be shared in ways that will enable people with cognitive impairment to receive and access them. Could this be in alternative formats? Who should be involved and how would this be resourced?

Summary of actions and resources needed

Worksheet G

Key factors identified and the actions and costs/resources needed

• This is your opportunity to recap on issues identified through the key questions and worksheets, outline the proposed actions or considerations to address them, and consider what costs or resources are required (if any)

• Complete this worksheet as you go through the framework to form a summary of the discussions and decisions

• Use this summary to justify the costs being requested in a funding application