Table 7 Instructions for using the INCLUDE Impaired Capacity to Consent Framework

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.