Background
Exclusion of adults with impaired capacity to consent
Improving inclusion of this under-served group
Methods
Development of the INCLUDE Impaired Capacity to Consent Framework
Phase 1: establishing the scope and content of the framework
1) What are your views about the usefulness of a framework for designing trials to include adults with impaired capacity? Are there any types of trials or particular populations or settings you think it would be more, or less, useful for? | |
2) What are your views about the current format (4 key questions, worksheets for Q2–3 and a worksheet to identify measures needed)? | |
3) What are your views about the contents? Is anything included that shouldn't be, is anything missing that should be added? | |
4) What are your views about the supporting information (background document, appendix on legal frameworks, links to resources)? Is anything included that should not be, is anything missing that should be added? |
Phase 2: ‘proof of concept’ scoping and piloting the framework
Study characteristic | No. studies/contexts |
---|---|
Population/condition | |
Dementia | 1 |
Learning disabilities | 1 |
Genetic disorders | 1 |
Older adults in community | 1 |
Trauma | 2 |
Critical care | 1 |
Aphasia | 1 |
Stroke | 1 |
Combination of populations | 2 |
Trial type | |
Interventional/non-CTIMP | 5 |
CTIMP | 1 |
Surgical | 2 |
Non-trial (genotyping data only) | 1 |
Not specified/generic | 2 |
What are your views about the current format (four key questions, worksheets, appendix)? | |
• Length — researchers were supportive of the use of the questions and worksheets. However, the document was considered quite long, and they felt it was important that any duplication and redundancy was removed (e.g. being able to indicate ‘not applicable’ in worksheet sections) to ensure the framework is explicit and directive. Changes to formatting could reduce some overlap and length of the document. • Layout — the layout was generally considered to be clear. However, some suggested changes to the flow or order of the document, such as having a header on each page or having each worksheet directly after the corresponding question (rather than having all four questions first. It was also thought useful to have an area to note down any actions or considerations alongside each section rather than only at the end of the framework, these could then be collated together. | |
What are your views about the contents? Is anything included that shouldn't be, is anything missing that should be added? | |
• Instructions for use — there was some confusion about the reference to the INCLUDE Ethnicity Framework and therefore which groups the framework was intended to focus on. It was suggested that general guidance be included about how long the framework may take to complete, how to best utilise it, who should be involved, and when it should be used. • Content — greater signposting to resources and examples were thought to be useful through the worksheets rather than just at the end. It was also suggested that more could be asked about retention/completion of follow-up, particularly in relation to long term follow-up. Earlier signposting to the appendix containing the legal summary would be particularly helpful. | |
Are there any types of trials or particular populations or settings you think it would be more, or less, useful for? | |
• Populations — as anticipated, there were mixed views about how the framework might apply to different populations. Researchers who were developing studies involving people with a variety of diagnoses and co-morbidities or where the majority of participants would lack the capacity to consent encountered difficulties answering some of the questions (e.g. those asking about ‘the’ population or how the severity or prevalence may differ between groups. Others who were developing studies involving older people found the framework useful even though there was a range of capacity-affecting conditions to consider. • Context surrounding loss of capacity — it was suggested that having two versions of the framework could be considered, such as one for studies with people with acute loss of capacity (e.g. trauma, cardiac arrest) and those whose loss of capacity is longer-term (e.g. dementia, learning disabilities). In part, this was because whilst the underlying legislation is the same, the beliefs and experiences of the people involved (and their family’s involvement) are likely to be very different. • Study types — There were questions about whether the framework was applicable to all types of studies. It was considered particularly useful for interventional trials rather than those not involving the recruitment of individual participants, although it (or some elements of it) may be useful across a wider range of studies including observational studies. One team wondered whether there could be different worksheets for different study designs, or a filter question, or whether it could be clearer that some questions may not be applicable to all study designs. • Timing — it was viewed as a very useful tool during the early stages of design and grant application. Plus, when developing finer details. One team reported that whilst many of the aspects included in the framework had already been discussed at the grant application stage, when developing the protocol, it had proved useful to help consider additional aspects that hadn’t been considered at the earlier stage. • Ongoing use — one team thought that it would be helpful to have as a live document throughout the course of the study, from grant application, protocol development, ethics through to recruitment and beyond. Others suggested that the worksheets relating to question 4 would act as a reminder/checklist when developing trial processes and documentation, in particular the protocol, or could act as a record for decisions made about inclusion and so be a useful accountability mechanism to monitor in trial management groups and so help keep the inclusion of under-served groups near the top of the agenda. | |
Any other comments | |
• Positive framing — it was suggested that centring the ethical dimensions of fairness and justice and a stronger emphasis on inclusion and ensuring participation (rather than exclusion) would be useful. The framework could potentially include a statement about why this population needs to be considered with some examples of cases where it would be unethical not to include them. • Decision-specific nature of capacity — teams reported that having a reminder about the time- and decision-specific nature of capacity was considered very helpful to foreground answering the questions. It was suggested that this could be more prominent or upfront in the framework. • Time and workload involved — one team reported that completing the framework had taken longer than the 2-h group meeting they had planned. They suggested that completing particular sub-sections with smaller groups or people with particular roles might be helpful, and then collating the sections. Another noted that it may be too big a task for junior research team members to complete alone and that training and support might be needed from the lead investigator. • Need for additional resources — there was a suggestion that, as it relies on some prior understanding about research involving adults lacking capacity, some researchers may be so unfamiliar with the context they may be unable to work through barriers to participation. An additional resource such as a slide set or a video could support engagement with the framework. It was also suggested that worked examples would be helpful. |
Phase 3: stakeholder consultation
Public stakeholder consultation during development of the framework
Public stakeholder consultation during the development of the implementation toolkit
Co-production of an easy read guide to the framework
Phase 4: refining and finalising the framework
Phase 5: implementation project
Stakeholder analysis and development of an impact plan
Development of a logic model
NPT analysis for implementing the framework
NPT components | Questions to consider within the NPT framework | INCLUDE Impaired Capacity to Consent Framework |
---|---|---|
Coherence (i.e. meaning and sense making by participants) | Is the intervention easy to describe? | The intervention is easy to describe. |
Is it clearly distinct from other interventions? | The intervention is distinguishable from other tools such as the INCLUDE Ethnicity Framework. | |
Does it have a clear purpose for all relevant participants? | It has a clear purpose, although the purpose may be unclear to some, for example it could be confused with a tool to help assess capacity to consent. To be strengthened through additional messaging such as via an explainer video and infographics. | |
Do participants have a shared sense of its purpose? | The development of the framework originated in the MRC-NIHR TMRP Trial Conduct Working Group which, together with engagement with specialty leads and researchers, has provided a shared sense of purpose. To be strengthened through stakeholder consultation. | |
What benefits will the intervention bring and to whom? | The framework is expected to improve the ability of researchers to design trials to include adults with impaired capacity. It will also benefit funders, research ethics committees (RECs) and other organisations through providing assurance about the quality/appropriateness of the trial design. Longer term, it will benefit people with impaired capacity through improving access to trials and generating evidence to underpin their care. | |
Are these benefits likely to be valued by potential participants? | During public involvement activities and stakeholder consultations, researchers and patients/carers have stated that they value the potential benefits of the framework. Funders, RECs and other organisations have valued similar tools such as the INCLUDE Ethnicity Framework. | |
Will it fit with the overall goals and activity of the organisation? | Developing research that is more inclusive of under-served populations is a high priority for both policy (e.g. Department of Health and Social Care) and organisations (e.g. National Institute of Health and Care Research, Health Research Authority). The framework supports these strategic priorities to improve equality, diversity and inclusivity in research. | |
Cognitive participation (i.e. commitment and engagement by participants) | Are target user groups likely to think the intervention is a good idea? | Based on previous experience with the INCLUDE Ethnicity Framework, researchers and other stakeholders are likely to think the framework is a good idea. |
Will they see the point easily? | Researchers and other stakeholders will see the point of the framework, but this may depend on the level of their own knowledge, ability and confidence. To be strengthened through additional messaging such as via an explainer video and infographics. | |
Will they be prepared to invest time, energy and work in it? | Time-constraints and the framework length and format may impact on researchers’ willingness to invest time and energy in it. Additional messaging (e.g. via an explainer video and infographics), maximising the usability of the framework (e.g. refining the format and content) and facilitating its use (e.g. through the development of workshop materials) will be key. | |
Collective action (i.e. the work participants do to make the intervention function) | How will the intervention affect the work of user groups? | The framework will increase time and work at the initial trial design phase, but that may be recouped when the framework is revisited to inform the protocol design and REC submission stages. |
Will it promote or impede their work? | The additional time required to fully consider issues during the trial design stage may be viewed as impeding the process of developing funding application, but it may enhance the quality (and therefore its competitiveness) of the application. If the trial is funded, it may facilitate later stages, e.g. protocol design and application for ethical approval. | |
What effect will it have on processes? | The framework will encourage conversation, consideration, and collaboration during trial design decisions. The actions and resources needed to improve inclusion may appear to make the trial more complex and time and resource-intensive (i.e. less ‘efficient’) as economic benefits are typically easier to measure than social/wider health benefits. However, these should be viewed as ‘missing’ costs and challenge ideas around current efficiencies as ‘doing the wrong things righter’ which needs to change. To be strengthened through additional messaging, e.g. via an explainer video and infographics. | |
Will staff require extensive training before they can use it? | Most researchers will not need extensive skills and knowledge to use the framework, but they will require support to maximise their use of the framework and signposting to information and resources in order to ensure appropriate actions and resources are planned. | |
How compatible is it with existing work practices? | Establishing an additional (optional) step into the process of developing a trial for a funding application is compatible with existing work practices. However, it may increase the burden on researchers at an already busy time. The impact of this will need to be monitored. This could be explored as part of a future evaluation. | |
What impact will it have on division of labour, resources, power, and responsibility between different professional groups? | The framework is intended to be used collaboratively across the co-applicants, wider research team, and public contributors. It is not intended to be the work of one person. However, it may disproportionately increase the burden on some team members. The impact of this will need to be monitored. This could be explored as part of a future evaluation. | |
Reflexive monitoring (i.e. participants reflect on or appraise the intervention) | How are users likely to perceive the intervention once it has been in use for a while? | Use of this framework (and other similar frameworks) may be perceived as an important and necessary step when developing a trial, or an additional burden/hurdle to overcome as a ‘tick-box’ exercise. This will need to be monitored and could be explored as part of a future evaluation. |
Will it be clear what effects the intervention has had? | The aim is for adults with impaired capacity to have better access to trials. The effect will need to be monitored, such as assessing the number/proportion of trials appropriately designed to include this group. This could be explored as part of a future evaluation. | |
Can users/staff contribute feedback about the intervention once it is in use? | Individuals and organisations will be encouraged to have ‘ownership’ of the framework through stakeholder consultations and subsequent engagement. Feedback will be sought following the facilitated workshops and via informal contact with researchers and organisations. | |
Can the intervention be adapted/improved on the basis of experience? | Further work is needed to address issues around intersecting factors, and the relationship between the frameworks for different under-served groups. |
Stakeholder consultation survey
Area of interest | Academic researcher n (%) | Clinician n (%) | Clinical researcher n (%) | PPI group member n (%) | REC member n (%) |
---|---|---|---|---|---|
Dementia/ care home/older adults | 10 (40) | 1 (4) | |||
Emergency medicine | 1 (4) | 2 (8) | |||
Intellectual disability | 1 (4) | ||||
Intensive/critical care | 2 (8) | ||||
Primary care | 1 (4) | ||||
Clinical psychology | 1 (4) | ||||
Trauma | 2 (8) | ||||
Not specified | 2 (12) | 1 (4) | |||
Total n=25 | 19 (76) | 1 (4) | 2 (8) | 2 (8) | 1 (4) |
What are your views about using the framework (e.g. its value and whether you would feel capable/confident to use it)? | |
• Views about using the framework were provided by 96% (n=24) of respondents • Positive viewsa — n=13 (52%) expressed only positive comments about the framework, including generic comments (e.g. describing it as excellent) and more specific comments about the framework’s clarity, useability, and usefulness • Need for more information — other responses included questions about how it applied to particular trial populations (e.g. critically ill patients), types of research (e.g. only clinical trials of interventions) and specific issues (e.g. surrogate decision-makers) • Other responses — included one comment that the framework was difficult to understand | |
What would be the potential barriers to you using the framework? | |
• A number of potential barriers to using the framework were reported by respondents (96%, n=24). Only one reported there being no potential barriers to using the framework • Lack of understanding about the framework — this was reported as a general barrier by some respondents (20%, n=5), including not understanding the target audience, the purpose of the framework, or its use and application, or a lack of understanding and knowledge about who is to be considered as having impaired capacity • Lack of time — this was a common potential barrier to using the framework, reported by 6 (24%) of respondents, was the time required to work through it. One respondent suggested giving an indication of how long each worksheet might take to complete. Another response included the potential difficulty in “persuading others in study team that it is something worth putting time and effort into” • Lack of support from influential stakeholders — this was also cited as a potential barrier by respondents (12%, n=3). For example, whether the framework is considered, or accepted, by funders, Research Ethics Committees (RECs), or members of the public • Other potential barriers to using the framework — these included whether it would help identify practical solutions to the issues raised, ease of access to the worksheets, or a lack of support and guidance to use the framework | |
Which of these implementation toolkit items would be likely to help you to use the framework? | |
• Implementation toolkit items in order of importanceb: - Worked examples of the framework (n=22, 88%) - Links to resources to help with any actions identified (n=19, 76%) - Infographic with key messages (n=17, 68%) - Accessible information with key messages (n=14, 56%) - Short explainer video (n=12, 48%) - Interactive workshop materials (n=10, 40%) - Other (n=6, 24%), e.g. having a range of tools available • Materials for different stakeholder groups — suggestions were made about other ways respondents felt would help them use the framework such as producing materials for funding bodies, research design service teams, and research ethics committees • Signposting by funders — it was suggested that funders should either signpost applicants to the framework or embed it in their guidance for applicants • Access to expertise — another suggestion was that having someone in their organisation being an expert user of the framework and toolkit |
Development of an implementation toolkit to support the use of the framework
Online webinar to introduce the framework
Workshop activities to support researchers to implement the framework effectively
Results
Who should use the framework | |
1. Trial teams should use the framework as part of a collaborative process — the framework is intended to be used by trial teams in partnership with patient and public partners (and other stakeholders) to ensure that the involvement of adults with a condition or disability that may impair their capacity to consent is considered at the trial design stage. 2. The framework should be used by experienced and less experienced teams — while the framework may cover issues that some trial teams had already considered, the worksheets will help to highlight issues consistently across trials and for all trial teams regardless of their experience through raising issues that teams have often not previously considered. | |
Which trials and populations should the framework be used with | |
3. The framework should be used for all populations who experience impaired capacity — impaired capacity may be due to the condition or disability that is the focus of the trial or may be co-existing with the condition or disability that the trial is focused on. The impairment may be long-term, a temporary or acute impairment where the intervention being tested cannot wait for the person to recover capacity, or the person’s capacity may fluctuate. While the worksheets ask trial teams to think about possible differences between groups who may experience impaired capacity, it is important to remember that no group is homogenous so there are also ‘within group’ differences, and there will be intersectionality between these and other factors or personal characteristics. 4. Regardless of the focus of the trial — the framework should be used when developing trials where the capacity-affecting condition/disability is the focus of the trial (e.g. dementia care), trials where the focus is another condition but cognitive impairment is highly prevalent in the population of interest (e.g. management of infections in care home residents), or where it may affect a small but important proportion of the overall population (e.g. diabetes prevention in high-risk populations which includes people with a learning disability). 5. The framework may be useful for different types of research — the framework is intended to be used for clinical trials, but it may also be useful for designing other types of studies and questions/sections that are not relevant can be left out. Some questions/sections will require interpretation to apply to the particular trial context, for example there are specific legal frameworks governing research involving adults who lack the capacity to consent which vary depending on the type of research (i.e if it is a clinical trial of a medicine or not, whether it is classed as emergency or nonemergency research) and where the trial is being conducted [39]. 6. To identify any issues and the resources needed to address them — throughout worksheets A–F, there are areas to note where any actions the trial teams may need to take in order to address the issues they identify. The final worksheet G provides a space to summarise these actions and any resources/costs needed to enable the participation of adults with impaired capacity to consent. For example, actions may include using tools such as the Consent Support Tool [40] to assess potential participants’ communication and support needs, creating accessible information about the trial, and ensuring research nurses or others provide tailored support to help meet individuals’ information and decision support needs and maximise their ability to contribute to decisions about participation. However, there are resource implications for purchasing the tool, time for developing accessible information, and ensuring research nurses have the time and skills to support people to participate in consent decisions. Ensuring adequate resources will require planning and justification at the funding application stage. | |
When the framework should be used | |
7. The framework should be used at the earliest opportunity — while it is intended to be used during early stages of trial design such as during funding applications, the framework can be completed iteratively. The questions posed in the framework can form the basis of discussions about the trial design, with the framework document being used to record the outcome of the discussions and actions required. The completed framework can be updated or referred back to at any point. 8. Once the legal arrangements have been reviewed — researchers should review the legal arrangements that will apply to their trial prior to completing the framework by reviewing the appendix which provides more information on the legal definition of capacity and the legal arrangements for including adults with impaired capacity to consent in research. 9. Revisited during the design and conduct of a study — it can be revisited during further trial development and will be particularly helpful when drafting the protocol, designing site training, and developing the application for ethical approval which is often seen as a challenge in studies involving adults who lack capacity to consent [17]. For example, question 1 which explores who should be included in the trial can help to justify why the trial should include adults lacking capacity and cannot be solely conducted with adults who are able to provide their own consent. 10. Prior to ethics review — exploring the processes for assessing capacity (including ensuring the personnel involved are appropriately skilled and experienced to do so) and identifying and approaching consultees and legal representatives (covered in worksheet C) will reassure ethics committees that the trial has been appropriately designed to include these populations. | |
Time and resources involved | |
11. Time should be set aside to address inclusivity — it may take a few hours to complete but this can be done over several occasions and not all sections may be relevant. Although it may increase time and work at the initial trial design phase, the framework supports researchers to fully consider issues and collaborate on solutions, which will enhance the quality of the funding application and can facilitate later stages such as when seeking ethical approval. 12. Any associated costs can be included and justified in the funding application — it may also increase the overall costs being requested [17] but will also help to justify how the inclusion of these otherwise ‘missing costs’ will ensure that the inclusive design is appropriately resourced. Using the framework will help ensure that inclusion is appropriately resourced, and funders are supportive of the use of the INCLUDE frameworks. |
Key questions | Worksheets | Topic or area of interest | Recommendations for research teams |
---|---|---|---|
Introduction | - | 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? | - | 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 |