Table 3 Summary of responses to questions about piloting the framework

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.