To examine one model of research advance directive as a possible way to reduce the mismatch between patient and proxy choices and also to learn more about how patients with mild to moderate dementia may want to keep decision making or cede it to their proxies in the future.
Separate interviews were conducted with 149 dyads of dementia patients and family proxies about future enrollment in five types of research. Subsequent joint interviews were conducted with 69 of those dyads to discuss their separately articulated decisions and ask whether the patient prefers future enrollment decisions to be made as he or she directs today or as the proxy deems best in the future.
Patients chose to cede future decision making to their proxies in 82.9% of the trials. Patients ceded decisions to their proxies in 80.7% of those trials about which the dyad had given opposite answers (n = 74, 49.7%). Patients who had expressed discomfort about the prospect of the proxy making an enrollment decision in a trial (n = 49, 32.9%) ceded decision making to their proxies in 45.7% of those trials.
Both patients and proxies were willing to discuss future research enrollment in the context of an advance directive for research. Such a document may be helpful to proxies and researchers in the future to judge the types of research and associated risks patients are willing to enroll in. Although most patients willingly cede future decisions to their proxies, a sizeable minority do not wish to do so.
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"Interestingly, a majority of dementia patients would leave their legal representative (some) leeway to make decisions for them in the future that differ from their own preferences, if the legal representative would get access to better or more information (Kim et al. 2013). However, a minority would not be comfortable with legal representatives making decisions against their own preferences (Kim et al. 2013; Stocking et al. 2006), these persons would want their legal representatives to give voice to their own preferences and wishes. "
[Show abstract][Hide abstract] ABSTRACT: 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 (ARD). 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.
Full-text · Article · Oct 2015 · Monash bioethics review
"That is, many individuals endorse their surrogates making the decision that seems best to the surrogate at the time, independent of the extent to which it is consistent with the individual's previously expressed wishes. Unfortunately, the same studies find that many others are not willing to give their surrogates leeway (Karlawish et al., 2009; Kim et al., 2009; Wendler et al., 2002; Stocking et al., 2006). One study found that 17–26% of older Americans would allow their surrogates complete leeway, 38–41% would allow some leeway, and 33–45% would allow no leeway at all (Kim et al., 2009). "
[Show abstract][Hide abstract] ABSTRACT: Current practice relies on surrogates to enroll incapacitated adults in research. Yet, it is unclear to what extent this practice protects adults who have lost the ability to consent for themselves. To address this question, we conducted two literature searches to identify articles which report empirical data on three issues central to protecting adults who have lost the ability to consent: (1) adults' willingness to participate in research should they lose the ability to consent; (2) adults' willingness to allow a surrogate to make research decisions for them; and (3) the extent to which surrogates' enrollment decisions are consistent with their charges' preferences and values. These searches identified 21 articles, representing 20 distinct datasets. The data indicate that many adults are willing to participate in research should they lose the ability to consent, and many are willing to allow their family members to make research decisions for them if they become incapacitated. The data also raise concern that surrogates may be making research enrollment decisions that, in some cases, are inconsistent with their charges' preferences and values. These findings suggest that modifications to current practice should be considered to better protect adults who have lost the ability to consent. One option would be to require, in addition to surrogate permission and subject assent, sufficient evidence that enrollment is consistent with the individual's preferences and values.
Full-text · Article · Apr 2012 · Journal of Empirical Research on Human Research Ethics
"However, communication with carers of people with dementia suggests that they are often surprised at the choices their relatives make with regard to diet or participation in activities, compared to the past, so it is difficult to ensure that other values and preferences remain the same with the experience of dementia. Several studies have highlighted the potential conflict that can exist between people with dementia and their proxies when consenting to research (Buchanan & Brock 1990, Sachs et al. 1994, Stocking et al. 2006). Being a proxy decision maker can also be a burdensome activity for some care givers (Sugarman et al. 2001), and Bartlett and Martin (2002) draw attention to the lack of practical guidance on the best way to involve carers in the process. "
[Show abstract][Hide abstract] ABSTRACT: This paper aims to: • Consider the major challenges to involving people with dementia in qualitative research. • Critique a process consent framework. • Demonstrate the need for nurses and researchers to explore these issues in research and practice with people with dementia. • Consider the impact of the Mental Capacity Act 2005 on research with people with dementia. To achieve its aims, the authors will draw on current literature and use examples which explores the use of life story work with people with dementia by taking a qualitative approach.
There is acceptance that researchers should consider ways of actively involving people with dementia in research as participants where appropriate to answering specific research questions. Process consent methods have been advocated as an ethical way forward in recruiting and gaining consent for people with dementia, the Mental Capacity Act offers guidance to both practitioners and researchers.
This paper does not seek to be a comprehensive review of the current literature but is a discussion paper appraising a process consent framework against current literature and drawing on the lead author's PhD study, exploring life story work with older people with dementia.
The Mental Capacity Act and process consent frameworks compliment one another, and their use should be considered when researching issues affecting older people with dementia. Researchers and practitioners should work more closely to ensure that the principles of process consent are achieved. Process consent models can equally be applied to everyday nursing practice.
Process consent models can provide an ethical and practical framework to ensure that consent is continually assessed in people with dementia with all clinical interventions. The paper also draws on literature exploring practical ways of involving people with dementia in evaluating service delivery.