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Dear editors, We read with interest the recent article regarding the lack of inclusion of people who lack capacity in trials: ‘Protection by exclusion? The (lack of) inclusion of adults who lack capacity to consent in clinical trials in the UK’ [1]. As the authors so eloquently spotlight, those without capacity in many population groups are those who are likely to be most vulnerable to frailty, comorbidities and isolation. Their exclusion from research significantly limits the specific evidence base for their care. As a research team developing and evaluating a Dementia Support Worker intervention based in primary care, we appreciate the challenges of including people in complex dementia interventions research who are most likely to benefit from the intervention. We are mindful of one of five ‘Dementia statements’, developed by people living with dementia and grounded in Human Rights law: ‘We have a right to know about and decide if we want to be involved in research that looks at cause, cure and care for dementia and be supported to take part’ [1]. We wished to develop an ethical recruitment process that enabled us to involve and understand the barriers to involvement of hard-to-reach groups of people with dementia: those who lack capacity but also those who lack support networks and experience frailty and emotional difficulties. We have developed a person-centred flexible recruitment pathway in consultation with our Patient and Public Involvement (PPI) group (including people with dementia and carers). The approach involves the practice team, Clinical Research Network (CRN), staff, and the research team working seamlessly together. The approach is pro-active, using a combination of letters, phone calls, invites to clinics and a home visit as appropriate and depending on the response at each stage. Many people with dementia do not necessarily read or understand letters, so we cannot assume that no response means engagement in decision-making about involvement. At the same time, we aim to avoid unwelcome pursuit; declining to take part results in no further contact, and involvement requires actively opting in. A key principle of the Mental Capacity Act [3] is that individuals must be supported to understand information relevant to a decision, retain information, weigh up that information and communicate a decision by any means possible. Where people lack capacity, a personal consultee can be involved in decision-making based on prior knowledge of the person’s preferences and values. The Department of Health [2] provides guidance on nominating a consultee. This is not without challenges. Capacity can fluctuate over time. Also, a person’s personality, preferences and values may change as the dementia progresses. Those who may have been willing to engage in research may become more suspicious and unwilling, for instance. These dilemmas will need to be addressed on a case-by-case basis, but even if a consultee is involved, the role of verbal and non-verbal signs of assent from the person with dementia should not be ignored. In order to try to address some of these challenges, our recruitment pathway allows ongoing assessment of the nature of family support and barriers to involvement, over time and prior to consent. Judgements about capacity and about who might reasonably act as consultee will result from this ongoing process and from developing an understanding of an individual’s communication abilities and needs, rather than relying on a test

Letter on “Protection by exclusion? The (lack of) inclusion of adults who lack capacity to consent to research in clinical trials in the UK”