Background Anticipatory planning in the UK focuses on supporting people who anticipate periods of impaired capacity to express their wishes about future care through processes such as advance care planning. Other countries have extended anticipatory planning to include processes for people to prospectively express their preferences about research participation. Advance research planning (ARP) is thought to extend autonomy and ensure that ‘proxy’ decisions about research are based on their wishes and preferences. Methods A cross-sectional survey was conducted with two stakeholder (...) groups (members of the public including people living with capacity-affecting conditions and family members; researchers and other professionals) who were recruited via research registries and other routes. Online questionnaires were used to capture the perspectives of the two groups. Responses were analysed using descriptive statistics and content analysis. Results A total of 327 participants (members of the public n = 277, professionals n = 50) completed the survey (November 2022 - March 2023). ARP was supported by 97% of public contributors and 94% of professionals. Participants thought that ARP should include the person’s general wishes about research, specific types of studies, and who should make decisions on their behalf. They identified a number of challenges, including how ARP could take account of changes in individuals’ preferences or circumstances whilst protecting their rights and interests. Implementation barriers included the potential time, complexity, and cost involved. These could be addressed by embedding ARP in existing anticipatory planning pathways and aligning it with other research enrolment activities. Relationships and trust played a key role, including underpinning who should support the delivery of ARP, how they are trained, and when it is undertaken. Conclusions There were high levels of support for introducing ARP in the UK. Further research should explore practical barriers and stakeholder concerns and identify any unintended consequences. Future activities should include developing ARP interventions alongside training and other resources, and also focus on public awareness campaigns, and engaging policymakers and other stakeholders. (shrink)

People with dementia have commonly been excluded from research. The adverse impacts of this exclusion are now being recognized and research literature, position statements, and ethics guidelines increasingly call for inclusion of people with dementia in research. However, few published studies investigate the views of potential participants on taking part in research should they experience dementia-related cognitive impairment. This cross-sectional survey examined the views of people aged sixty and older attending hospital outpatient clinics about clinical research participation if they had (...) dementia and impaired decision-making ability. Over 90 percent of respondents were agreeable to participating in a wide range of research activities, such as cognitive testing, physical measurements, imaging procedures, and blood draws. For drug studies, however, agreement dropped to 60 percent. Altruism was a strong motivator for research participation. In regard to who should be involved in decisions about their participation in research during periods of incapacity, respondents mostly preferred the person they appoint as their substitute decision-maker for healthcare matters or a doctor or health professional on the research team. Over three-quarters expressed interest in making an advance research directive. The study findings are discussed in relation to law reforms in Australia that aim to strengthen respect and inclusion for people with impaired decision-making capacity, especially by providing frameworks for advance planning for research participation. (shrink)

Alzheimer’s disease is a very common, progressive and still incurable disease. Future possibilities for its cure lie in the promotion of research that will increase our knowledge of the disorder’s causes and lead to the discovery of effective remedies. Such research will necessarily involve individuals suffering from Alzheimer’s disease. This raises the controversial issue of whether patients with Alzheimer’s disease are competent to give their consent for research participation.

Ethical guidelines protecting medical research participants have been criticized for stripping the sociocultural contexts of research. This critique is urgent considering ongoing calls to account for participant diversity in recruitment and inclusion procedures. Our intersectional analysis of illness narratives explores how sociostructural factors might play a role in participants’ exposure to research-related harm in clinical trials. Although widening participation does respond to generalizability concerns, we argue that gendered, classed, and ableist processes of self-silencing could simultaneously enhance risk of harm for (...) participants with multiple oppressed identities. To prevent this, researchers might actively involve participants when designing trials. (shrink)

ObjectivesTo investigate which of two sources of information about an older adult’s wishes—choices made in an advance directive or proxy’s opinion—provides better insight into the older adult’s preferences measured in hypothetical clinical situations involving decisional incapacity.MethodsSecondary analyses of data collected from 157 community-dwelling, decisionally competent adults aged 70 years and over who attended a group information session on advance directives with their proxy. Older adults were invited to complete a directive introduced during the session, designed to express healthcare preferences. An (...) average of 3 months later, older adults were asked during an interview whether they would want to receive each of four medical interventions and what their goals of care would be should they develop one of three sudden health events, assuming that they had severe dementia. Proxies were asked to guess the older adult’s answers in each of the seven scenarios.ResultsEighty per cent of the older adults completed the directive. Choices they made in the directive were more in line with the preferences they stated during the interview than were their proxies’ guesses at their answers. However, concordance was relatively low, with percentages of agreement ranging from 43% to 83% across scenarios.ConclusionsFindings suggest that a directive might provide better insight into a person’s wishes than the person’s proxy, although neither source is perfect. A multifaceted decision-making model that includes both sources of information might better serve the interests of older adults who have lost the capacity to make decisions on their own.Trial registration numberISRCTN89993391; Post-results. (shrink)