People with mental illness are treated, in research, as a ‘class’ or category who are vulnerable, without always being clear why they should be treated as such, not why an individual, rather than the class, is vulnerable. The two main reasons given are lack of competence and power imbalance. Competence issues include incapacity and legislation, assessment and the impact of the illness in decisions. Power issues cover the role of mental health legislation, coercion, protectiveness and paternalism, stigma and discrimination and (...) the ‘well’ and ‘ill’ self. These are examined within a framework of risk assessment, both to the patient and to others. Over-concern to protect the vulnerable can lead to gate-keepers preventing their inclusion in studies at various stages of the research. This denies such groups a voice in the research process.It is suggested that ethical scrutiny of research is not only to prevent harm to the vulnerable, but also to provide a framework to empower such people to take part in research. To do otherwise is to further stigmatize and marginalize them. One way forward is to look at the risk presented by different types of research, from clinical intervention trials to non-therapeutic, qualitative studies and to modify capacity and access requirements in the light of the risks presented. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

There is always a debate around consent in the context of research. Given the expansion of different approaches to qualitative research within dementia care, there is increasing consideration around consent in this context; particularly in research concerning the experiences of living with dementia and the care of persons with dementia. Specifically there is a drive to directly involve persons with dementia as they offer specific expertise concerning living with dementia. Additionally, capacity legislation strengthens the case for ensuring that persons with (...) dementia are actively enabled to make their own decisions for as long as possible. This paper discusses an approach and method that can enable more persons who are living with dementia to participate in some types of research should they want to. Currently, most researchers rely on an extension of the traditional competency-based informed consent method and/or proxy consent or assent. However, related to the development of so-called person-centred and participatory research in dementia, there are now a number of academic publications on approaches and practical methods of ‘inclusionary’ consent. This paper considers the broader contextual influences on inclusionary consent and outlines the key aspects of such approaches based on the development of one specific method for including persons with dementia in consent processes. The method is based on the premise that, for persons with a dementia, informed consent becomes increasingly redundant and consequently exclusionary to them as persons. And even where capacity is said to no longer exist, persons with dementia are often able to make choices and make known their preferences about participating in research where the consent process is made specifically dementia-sensitive. Ethics committees can facilitate researchers both by supporting them when they need to and want to include persons with dementia in gerontological research and by challenging them to ensure that participation is genuine and starts with process consent. (shrink)

Objectives: To analyse and compare the surveys on German doctors and judges on end of life decision making regarding their attitudes on the advance directive and on the dying process.Design: The respondents were to indicate their agreement or disagreement to eight statements on the advance directive and to specify their personal view on the beginning of the dying process.Participants: 727 doctors in three federal states and 469 judges dealing with guardianship matters all over Germany.Main measurements: Comparisons of means, analyses of (...) variance, pivot tables and factor analyses .Results: Three attitude groups on advance directive were disclosed by the analysis: the decision model, which emphasises the binding character of a situational advance directive; the deliberation model, which puts more emphasis on the communicative aspect; and the delegation model, which regards the advance directive as a legal instrument. The answers regarding the beginning of the dying process were broadly distributed, but no marked difference was observed between the responding professions. The dying process was assumed by most participants to begin with a life expectancy of only a few days.Conclusions: A high degree of valuation for advance directive was seen in both German doctors and judges; most agreed to the binding character of the situational directive. Regarding the different individual concepts of the dying process, a cross-professional discourse on the contents of this term seems to be overdue. (shrink)

This paper explores the use of advance directives in clinical dementia research. The focus is on advance consent to participation of demented patients in non-therapeutic research involving more than minimal risks and/or burdens. First, morally relevant differences between advance directives for treatment and care, and advance directives for dementia research are discussed. Then attention is paid to the philosophical issue of dementia and personal identity, and the implications for the moral authority of research advance directives. Thirdly, a number of practical (...) shortcomings of advance directives for non-therapeutic dementia research are explored and attention is paid to the role of proxies. It is concluded that upon a closer look the initial attractiveness of advance directives for dementia research is lessened, and that it is doubtful whether these instruments can compensate for the lack of subject consent in case of non-therapeutic dementia research involving more than minimal risks and/or burdens for the incompetent demented subject. (shrink)