Research is crucial to advancing knowledge about dementia, yet the burden of the disease currently outpaces research activity. Research often excludes people with dementia and other cognitive impairments because researchers and ethics committees are concerned about issues related to capacity, consent, and substitute decision-making. In Australia, participation in research by people with cognitive impairment is governed by a national ethics statement and a patchwork of state and territorial laws that have widely varying rules. We contend that this legislative variation precludes (...) a consistent approach to research governance and participation and hinders research that seeks to include people with impaired capacity. In this paper, we present key ethical principles, provide a comprehensive review of applicable legal rules in Australian states and territories, and highlight significant differences and ambiguities. Our analysis includes recommendations for reform to improve clarity and consistency in the law and reduce barriers that may exclude persons with dementia from participating in ethically approved research. Our recommendations seek to advance the national decision-making principles recommended by the Australian Law Reform Commission, which emphasize the rights of all adults to make their own decisions and for those with impaired capacity to have access to appropriate supports to help them make decisions that affect their lives. (shrink)

The proposal of the new criteria for the diagnosis of Alzheimer’s disease based on biomarker data is making possible a diagnosis of AD at the mild cognitive impairment or predementia/prodromal– stage. Given the present lack of effective treatments for AD, the opportunity for the individuals to personally take relevant decisions and plan for their future before and if cognitive deterioration occurs is one the main advantages of an early diagnosis. Advance directives are largely seen as an effective tool for planning (...) medical care in the event the subject becomes incompetent. Nevertheless, their value has been questioned with regard to people with dementia by scholars who refer to the arguments of personal identity and of patient’s changing interests before and after the onset of dementia. In this paper, I discuss the value of advance directives in Alzheimer’s disease and other kind of dementia. Despite critics, I argue that advance directives are especially advisable in dementia and provide reasons in favor of their promotion at an early stage of the disease as a valuable tool to respect patients’ values and preferences on medical treatment, including participation in research and end of life decisions. I mainly support advance directives that include both decisions regarding health care and the appointment of an attorney in fact. I conclude that patients with AD at a prodromal or early stage should be offered the opportunity to execute an advance directive, and that not to honor a demented individual’s directive would be an unacceptable form of discrimination towards those patients. (shrink)

Dementia is highly prevalent and incurable. The participation of dementia patients in clinical research is indispensable if we want to find an effective treatment for dementia. However, one of the primary challenges in dementia research is the patients’ gradual loss of the capacity to consent. Patients with dementia are characterized by the fact that, at an earlier stage of their life, they were able to give their consent to participation in research. Therefore, the phase when patients are still competent to (...) decide offers a valuable opportunity to authorize research, by using an advance research directive. Yet, the use of ARDs as an authorization for research participation remains controversial. In this paper we discuss the role of autonomous decision-making and the protection of incompetent research subjects. We will show why ARDs are a morally defensible basis for the inclusion of this population in biomedical research and that the use of ARDs is compatible with the protection of incompetent research subjects. (shrink)

BackgroundAdvance research directives (ARD) have been suggested as a means by which to facilitate research with incapacitated subjects, in particular in the context of dementia research. However, established disclosure requirements for study participation raise an ethical problem for the application of ARDs: While regular consent procedures call for detailed information on a specific study (“token disclosure”), ARDs can typically only include generic information (“type disclosure”). The introduction of ARDs could thus establish a double standard in the sense that within the (...) context of ARDs, type disclosure would be considered sufficient, while beyond this context, token disclosure would remain necessary.Main bodyThis paper provides an ethical analysis of ARDs, taking into account the results of numerous empirical studies that have been performed so far. It will be argued that a revised understanding of informed consent can allow for context-sensitive disclosure standards. As a consequence, ARDs that include type disclosure can be acceptable under suitable circumstances. Such an approach raises a number of objections. A thorough examination shows, however, that they are not sufficient to justify a rejection of the approach.ConclusionThe approach presented in this paper avoids introducing a double standard. It is, therefore, more suitable for the implementation of ARDs than established approaches. (shrink)

Six people were interviewed about the possibility of becoming posthumous body donors. Interview transcripts were analyzed using interpretative phenomenological analysis. Individual-level analysis suggested a common interest in Personhood Concerns and a common commitment to Enlightenment Values. Investigations of these possible themes across participants resulted in identification of two sample-level themes, each with two subthemes: Autonomy, with subthemes of agency and consent, and Rationality, with subthemes of knowledge/epistemology and materialism/ontology. This paper concentrates on the former. Consent for posthumous body donation was (...) felt to sometimes fall short of adequately identifying donors’ preferences about what happened after consent was given, even with respect to actions for which consent established permission. In turn, paucity of information about donors’ preferences limited others’ ability to act as proxy agents to facilitate donors’ posthumous autonomy. Thus, while consent may curtail violations of people’s autonomy by authorizing actions for which permission has been established, it may fall short of facilitating their autonomy in ways that might be possible with greater knowledge of those people’s desires. Alternative methods of establishing consent are explored that might better-determine people’s desires and thereby improve others’ ability to act as proxy agents for them to facilitate their subsequent (even posthumous) autonomy. (shrink)