The fourth amendment to the German Medicinal Products Act (Arzneimittelgesetz) states that nontherapeutic research in incompetent populations is permissible under the condition that potential research participants expressly declare their wish to participate in scientific research in an advance research directive. This article explores the implementation of advance research directives in Germany against the background of the international legal and ethical framework for biomedical research. In particular, it addresses a practical problem that arises from the disclosure requirement for advance research directives. (...) We show that, if the disclosure standard for advance research directives is set at a token level, nontherapeutic research in incompetent populations becomes practically impossible. To resolve this issue, we suggest the disclosure standard be set at a type level. (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)

Background Advances in artificial intelligence, robotics and wearable computing are creating novel technological opportunities for mitigating the global burden of population ageing and improving the quality of care for older adults with dementia and/or age-related disability. Intelligent assistive technology is the umbrella term defining this ever-evolving spectrum of intelligent applications for the older and disabled population. However, the implementation of IATs has been observed to be sub-optimal due to a number of barriers in the translation of novel applications from the (...) designing labs to the bedside. Furthermore, since these technologies are designed to be used by vulnerable individuals with age- and multi-morbidity-related frailty and cognitive disability, they are perceived to raise important ethical challenges, especially when they involve machine intelligence, collect sensitive data or operate in close proximity to the human body. Thus, the goal of this paper is to explore and assess the ethical issues that professional stakeholders perceive in the development and use of IATs in elderly and dementia care. Methods We conducted a multi-site study involving semi-structured qualitative interviews with researchers and health professionals. We analyzed the interview data using a descriptive thematic analysis to inductively explore relevant ethical challenges. Results Our findings indicate that professional stakeholders find issues of patient autonomy and informed consent, quality of data management, distributive justice and human contact as ethical priorities. Divergences emerged in relation to how these ethical issues are interpreted, how conflicts between different ethical principles are resolved and what solutions should be implemented to overcome current challenges. Conclusions Our findings indicate a general agreement among professional stakeholders on the ethical promises and challenges raised by the use of IATs among older and disabled users. Yet, notable divergences persist regarding how these ethical challenges can be overcome and what strategies should be implemented for the safe and effective implementation of IATs. These findings provide technology developers with useful information about unmet ethical needs. Study results may guide policy makers with firsthand information from relevant stakeholders about possible solutions for ethically-aligned technology governance. (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)

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)

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)

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)