Background On December 2017 the Italian Parliament approved law n. 219/2017 “Provisions for informed consent and advance directives” regarding challenging legal and bioethical issues related to healthcare decisions and end-of life choices. The law promotes the person’s autonomy as a right and provides for the centrality of the individual in every scenario of health care by mean of three tools: informed consent, shared care planning and advance directives. Few years after the approval of the law, we (...) conducted a survey among physicians working in four health care facilities specific for the care of people suffering from psychiatric disorders, cognitive disorders and dementia located in the North of Italy aiming to investigate their perceived knowledge and training need, attitudes regarding law n. 219/2017 provisions, and practices of implementation of the law. Methods A semi-structured questionnaire was developed on an online platform. The invitation to participate in the survey was sent by email to the potential participants. Information was collected by means of the online platform (Google Forms) which allows to export data in a spreadsheet (Windows Excel) to perform basic statistical analysis (frequency distributions, bar chart representation). Results Twenty-five out of sixty physicians participated in the survey. None of the respondents value their knowledge of the law as very good, 10 good, 13 neither poor nor good, 1 poor and 1 very poor. All the respondents want to learn more about the law (21 yes and 4 absolutely yes). The majority of respondents agrees with the content of the law as a whole (3 absolutely agree, 13 agree), and on each provision. The question on the clarity of the concept of capacity in the law received mixed answers and this impacted on the physicians’ opinion regarding the legitimacy in principle for our groups of patients to realize shared care planning and write advance directives. Thirteen physicians neither introduced the theme of shared care planning nor arranged for shared care planning and the main reason for this was that no patient was in a clinical situation to require it. When shared care planning is realized, a variability in terms of type and number of meetings, mode of tracking and communication is registered. Conclusions Our survey results indicate a need for more clarity regarding the interpretation and implementation of the law in the patient groups under study. There are in particular two related areas that deserve further discussion: (1) the question of whether these patient groups are in principle legitimized by the law to realize shared care planning or write advance directives; (2) the notion of capacity required by the law and how this notion can be declined in real-life situations. (shrink)

In order to discover an effective treatment for dementia it is necessary to include dementia patients in clinical research trials. Dementia patients face an increased risk to lose the capacity to consent to research participation, and research possibilities with incompetent participants are legally strictly limited. One solution is for patients to consent to research through an advance research directive whilst still competent. In order to explore whether such a directive would be useful and valuable in practice (...) we conducted a qualitative study. We explored the opinions and arguments of researchers in the field of dementia, aiming to map the possibilities and constraints of ARDs. It was argued that a positive ARD could be valuable to discuss research participation with proxies, and patients with a negative ARD will be excluded from research trials. However, it is argued that an ARD cannot replace the informed consent procedure, and in practice proxy dissent will overrule written consent. The practical use of these directives is thus limited, as most researchers will not comply with positive directives. (shrink)

BackgroundEverybody has the right to decide whether to receive specific medical treatment or not and to provide their free, prior and informed consent to do so. As dementia progresses, people with Alzheimer’s dementia (PwAD) can lose their capacity to provide informed consent to complex medical treatment. When the capacity to consent is lost, the autonomy of the affected person can only be guaranteed when an interpretable and valid advance directive exists. Advance directives are not (...) yet common in Germany, and their validity is often questionable. Once the dementia diagnosis has been made, it is assumed to be too late to write an advance directive. One approach used to support the completion of advance directives is ‘Respecting Choices’®—an internationally recognised, evidence-based model of Advance Care Planning (ACP), which, until now, has not been evaluated for the target group of PwAD. This study’s aims include (a) to investigate the proportion of valid advance directives in a memory clinic population of persons with suspected AD, (b) to determine the predictors of valid advance directives, and (c) to examine whether the offer of ACP can increase the proportion of valid advance directives in PwAD.MethodWe intend to recruit at leastN = 250 participants from two memory clinics in 50 consecutive weeks. Of these, the first 25 weeks constitute the baseline phase (no offer of ACP), the following 25 weeks constitute the intervention phase (offer of ACP). The existence and validity of an advance directive will be assessed twice (before and after the memory clinic appointment). Moreover, potential predictors of valid advance directives are assessed.DiscussionThe results of this study will enhance the development of consent procedures for advance directives of PwAD based on the ACP/Respecting Choices (R) approach. Therefore, this project contributes towards increasing the autonomy and inclusion of PwAD and the widespread acceptance of valid advance directives in PwAD.Trial RegistrationDRKS, DRKS00026691, registered 15th of October 2021,https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00026691. (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)

In December 2017, Law 219/2017, ‘Provisions for informed consent and advance directives’, was approved in Italy. The law is the culmination of a year-long process and the subject of heated debate throughout Italian society. Contentious issues are addressed in the law. What emerges clearly are concepts such as quality of life, autonomy, and the right to accept or refuse any medical treatment – concepts that should be part of an optimal relationship between the patient and healthcare professionals. The (...) law maximizes the value of the patient’s time to decide. Every patient is allowed to make choices for the present as well as for the future, conceived as a continuation of the present, and to decide what comes next, based on what he/she already knows. The law identifies three distinct but converging paths towards the affirmation of a care relationship based on reciprocal trust and respect: the possibility to consent to or refuse treatment, the shared care planning, and advance directives. The fundamental point to emerge from the new Italian law is that consensus is an essential connotation of the treatment relationship. Consensus is not limited to the acceptance/rejection of medical treatment but is ongoing. It is projected into the future through shared care planning and advance directives which act as tools for self-determination and the manifestation of the beliefs and preferences of persons unable to express their will. These principles are in line with the idea of appropriate care as evaluated from two different perspectives, one of scientific adequacy and the other commensurate with the individual’s resources, fragility, values, and beliefs. Surely, however, the new law is not the end of the matter on issues such as conscientious objection, which is deeply rooted within the Italian cultural and political debate. In this regard, healthcare institutions and policymakers will be called upon to develop and implement organizational policies aimed at the management of foreseeable conscientious objection in this field. (shrink)

Ronald Dworkin argued that Advance Directives informed by a principle of autonomy ought to guide decisions in relation to the treatment of those in care for dementia. The principle of autonomy in play presupposes a form of competence that is tied to the individual person making the Directive. This paper challenges this individualist assumption. It does so by pointing out that the competence of a patient is inherently relational, and the key illustrative case to make this point (...) is the case of music therapy. In music therapy, a relatively recent treatment modality in aged care, patients previously thought to be permanently unresponsive are shown on the contrary to be capable of significant levels of social agency. The conclusion to draw is that Advance Directives that fail to acknowledge the real possibility of such relational competence are misapplied. (shrink)

The aim of the paper is that of investigating the concept of “person” in the context of Italian law on informed consent and advance healthcare directives. The following paper will first consider the importance of the concept of “person” within bioethics; secondly it will exhibit how there are different levels of bioethics, and that on the discussion level of laws and regulations, concepts worthy of metaphysical and value references cannot be used, because they must be shared by everyone (...) in a pluralistic society. I’ll then move on to discuss the law on informed consent and advance healthcare directives; first I’ll discuss the references to the Italian Constitution, showing that the implied concept of “person” is closely linked to the concepts of “equality” and “autonomy”, and finally I’ll discuss the particular case of minors and the protection that the law provides them. (shrink)

We agree with Emily Walsh (2020) that the current preferences of patients with dementia should sometimes supersede those patients’ advance directives. We also agree that consensus clinical ethics guidance does a poor job of explaining the moral value of such patients’ preferences. Furthermore, Walsh correctly notes that clinicians are often averse to treating patients with dementia over their objections, and that this aversion reflects clinical wisdom that can inform revisions to clinical ethics guidance. But Walsh’s account of (...) the moral value of the preferences of patients with dementia suffers from three major problems: (1) it does not engage the actual practices of clinical ethics; (2) it provides an inadequate account of why these patients’ preferences matter; and (3) it offers a poor explanation of clinicians’ intuitions in these cases. Her arguments engage a philosophical debate that is largely irrelevant to clinical practice and she therefore leaves pressing real-world clinical ethics questions unaddressed. After underscoring some of Walsh’s main points, we will discuss each of these shortcomings. (shrink)

This Element examines three related topics in the field of bioethics that arise frequently both in clinical care and in medico-legal settings: capacity, informed consent, and third-party decision-making. All three of these subjects have been shaped significantly by the shift from the paternalistic models of care that dominated medicine in the United States, Canada, and Great Britain prior to the 1960s to the present models that privilege patient autonomy. Each section traces the history of one of these topics and (...) then explores the major ethics issues that arise as these issues are addressed in contemporary clinical practice, paying particular attention to the role that structural factors such as bias and social capital play in their use. In addition, the volume also discusses recent innovations and proposals for reform that may shape these subjects in the future in response both to technological advances and changes in societal priorities. (shrink)

Alzheimer’s disease is the most common form of dementia which is estimated to impact 350,000 people over 65 years of age in Canada. The lack of effective treatment and the growing number of people who are expected to be diagnosed with Alzheimer’s disease in the near future are compelling reasons why continued research is in this area is necessary. With additional research, there needs to be greater recognition of the complexity of seeking ongoing informed consent from those with (...) Alzheimer’s disease. This complexity is because the impairment of memory and cognitive ability does not diminish in a linear manner, but rather fluctuates between periods of impairment and relatively normal cognitive lucidness. There is limited discussion in the guidelines of those progressing from early stages of Alzheimer’s disease who have intermittent cognitive function. Guidelines to research and Research Ethics Boards require further development to facilitate researcher including those with Alzheimer’s disease while protecting this growing pool of potential participants. (shrink)

Dementia is a growing issue at the end of life that presents unique challenges for advance care planning. Advance directives are a useful and important component of end-of-life planning, but standard advance directives have less utility in cases of loss of capacity due to dementia. An advance directive designed to specifically address end-of-life issues in the setting of dementia can provide patients with increased autonomy and caregivers with improved information about the desires of (...) the individual in question. The Dartmouth Dementia Directive is a dementia-specific advance directive, available online, that seeks to address common concerns of individuals who are planning for dementia-related end-of-life care. This directive was piloted in a community-based workshop, which provided important details and perspective on the best use of dementia-specific advance directives in the greater population. (shrink)

Research represents an avenue through which patients can contribute to the knowledge base surrounding their condition. However, persons with dementia cannot legally consent to participation in most scientific research. One possible avenue to preserve patient autonomy in the sphere of research is through an advance planning document. Scholars of medicine, ethics, and law have largely approached this topic from a theoretical angle, compelling the authors to develop and implement a tangible research-specific advance planning tool. In order to (...) inform the creation of this novel legal instrument, the present study leveraged semistructured telephone interviews with cognitively intact older adults in the Upper Connecticut River Valley region of New Hampshire. Participants were prompted to reflect on their attitudes toward participation in scientific research, should they develop dementia. They were also asked to consider the possibility of incorporating research into their advance planning regime, their preferred format for a research-specific advance planning tool, and the potential relationship between an advance planning tool and their surrogate decision maker in the context of research participation. Qualitative analysis was employed to extract themes from interview responses, revealing a pervasive desire for an advance planning tool that embraces specificity, flexibility, practicality, and the integral role of the surrogate decision maker. Ultimately, through collaboration with physicians and an elder law attorney in the region, these findings were translated into a research-specific advance planning component within the Dartmouth Dementia Directive. (shrink)

Although the patient’s right to decide what they want for themselves, which is encompassed in the notion of ‘patient-centred medicine’ and ‘informed consent’, is widely recognised and emphasised in Japan, there remain grave problems when it comes to respecting the wishes of the no-longer-competent when death is imminent. In general, it is believed that the concepts above do not include the right to refuse treatment when treatment withdrawal inevitably results in death, even when the patient previously expressed the wish (...) to exercise this right when competent. In this paper, I first explain the current social and legal situation in Japan, where the lack of legal clarity regarding the right to reject treatment tends to result in doctors adopting the interpretation of patients’ words that is least conducive to treatment withdrawal. I then argue that the right to refuse treatment should be taken seriously, even when the patient is no longer competent, or the treatment refusal will result in death. I suggest that the concept of relational autonomy might have some practical and valuable implications in a country where individual autonomy is considered incompatible with societal values. Finally, I answer possible objections to relational autonomy and address the widespread societal concern about sliding down the slippery slope from allowing the right to refuse treatment to the obligation to die. (shrink)

Advance directives (ADs), which are also sometimes referred to as ‘living wills’, are statements made by a person that indicate what treatment she should not be given in the event that she is not competent to consent or refuse at the future moment in question. As such, ADs provide a way for patients to make decisions in advance about what treatments they do not want to receive, without doctors having to find proxy decision-makers or having recourse to the (...) doctrine of necessity. While patients can request particular treatments in an AD, only refusals are binding. This paper will examine whether ADs safeguard the autonomy and best interests of the incompetent patient, and whether legislating for the use of ADs is justified, using the specific context of the legal situation in the United Kingdom to illustrate the debate. The issue of whether the law should permit ADs is itself dependent on the issue of whether ADs are ethically justified; thus we must answer a normative question in order to answer the legislative one. It emerges that ADs suffer from two major problems, one related to autonomy and one to consent. First, ADs’ emphasis on precedent autonomy effectively sentences some people who want to live to death. Second, many ADs might not meet the standard criteria for informed refusal of treatment, because they fail on the crucial criterion of sufficient information. Ultimately, it transpires that ADs are typically only appropriate for patients who temporarily lose physical or mental capacity. (shrink)

This article explores universal normative bases that could help to shape a workable legal construct that would facilitate a global use of advance directives. Although I believe that advance directives are of universal character, my primary aim in approaching this issue is to remain realistic. I will make three claims. First, I will argue that the principles of autonomy, dignity and informed consent, embodied in the Oviedo Convention and the UNESCO Declaration on Bioethics and Human Rights, could (...) arguably be regarded as universal bases for the global use of advance directives. Second, I will demonstrate that, despite the apparent consensus of ethical authorities in support of their global use, it is unlikely, for the time being, that such consensus could lead to unqualified legal recognition of advance directives, because of different understandings of the nature of the international rules, meanings of autonomy and dignity which are context‐specific and culture‐specific, and existing imperfections that make advance directives either unworkable or hardly applicable in practice. The third claim suggests that the fact that the concept of the advance directive is not universally shared does not mean that it should not become so, but never as the only option in managing incompetent patients. A way to proceed is to prioritize work on developing higher standards in managing incompetent patients and on progressing towards the realization of universal human rights in the sphere of bioethics, by advocating a universal, legally binding international convention that would outlaw human rights violations in end‐of‐life decision‐making. (shrink)

By providing an interdisciplinary reading of advance directives regulation in international, European and domestic law, this book offers new insights into the most controversial legal issues surrounding the debate over dignity and autonomy ...

OBJECTIVES: The subject of patient self-determination in health care has gained broad interest because of the increasing number of incompetent patients. In an attempt to solve the problems related to doctors' decision making in such circumstances, advance directives have been developed. The purpose of this study was to examine relationships between public attitudes towards patient autonomy and advance directives. SUBJECTS AND MAIN OUTCOME MEASURES: A stratified random sample of 600 adults in northern Sweden was surveyed by a questionnaire (...) with a response rate of 78.2%. The subjects were asked about their wish for control of their health care, their concerns about health care, their treatment preferences in a life-threatening situation (both reversible and irreversible), and their attitudes towards the application of advance directives. RESULTS: Numerous relationships between various aspects of self-determination in health care (desire for control, fears of over-treatment, and choice of treatment level) in general and advance directives, in particular, were found. Those who wanted to have a say in their health care (about 94%) also mainly supported the use of an advance directive. CONCLUSIONS: The fact that almost 30% of the respondents were undecided concerning their personal use of advance directives points to a lack of knowledge and to the necessity of education of the public on these issues. (shrink)

Background: Advance care planning gives patients and their family members the possibility to consider and make decisions regarding future care and medical procedures. Aim: To explore the view of people in the early stage of dementia on planning for future care. Research design: The study is a qualitative interview study with a semistructured interview guide. The data were analyzed according to the Qualitative Analysis Guide of Leuven. Participants and research context: Dementia nurses assisted in the recruiting of (...) people with dementia for participation in the study. Study information was mailed to 95 people with early stage dementia. Ten people with dementia and eight caregiver spouses participated in the study. Ethical considerations: People with dementia belong to a vulnerable patient group, and care was taken in the areas of informed consent and accessible information. Findings: The views of people with dementia are characterized by a complex storyline involving tensions and movement within the themes of wants, beliefs, and levels of insight. Participants wanted to think about the future but also wanted to live in the here and now. Discussion: High demands are placed on the advance care planning process for people with dementia and their family caregivers. A dignity-enhancing approach in dementia care emphasizes the dignity of and respect for this vulnerable and care-dependent patient group. Conclusion: The process of advance care planning in dementia care needs to go beyond person-centered care to a relationship-centered process. The illness trajectory and the impact on autonomy need to be taken into consideration. (shrink)

This article explores universal normative bases that could help to shape a workable legal construct that would facilitate a global use of advance directives. Although I believe that advance directives are of universal character, my primary aim in approaching this issue is to remain realistic. I will make three claims. First, I will argue that the principles of autonomy, dignity and informed consent, embodied in the Oviedo Convention and the UNESCO Declaration on Bioethics and Human Rights, could (...) arguably be regarded as universal bases for the global use of advance directives. Second, I will demonstrate that, despite the apparent consensus of ethical authorities in support of their global use, it is unlikely, for the time being, that such consensus could lead to unqualified legal recognition of advance directives, because of different understandings of the nature of the international rules, meanings of autonomy and dignity which are context-specific and culture-specific, and existing imperfections that make advance directives either unworkable or hardly applicable in practice. The third claim suggests that the fact that the concept of the advance directive is not universally shared does not mean that it should not become so, but never as the only option in managing incompetent patients. A way to proceed is to prioritize work on developing higher standards in managing incompetent patients and on progressing towards the realization of universal human rights in the sphere of bioethics, by advocating a universal, legally binding international convention that would outlaw human rights violations in end-of-life decision-making. (shrink)

Background Stroke is a worldwide problem with a limited number of approved treatments. Obtaining informed consent for acute stroke therapy is complicated by the breadth of information that must be communicated in a short period of time, the hectic nature of the emergency environment, the possible lack of understanding by the patient and/or family, and the critically time-sensitive nature of treatment for stroke. Complicating matters even further, patients are often unable to consent for themselves, placing the burden on surrogates (...) to infer patients’ wishes regarding treatment, and potentially limiting acute treatment by practitioners. Innovation An advance directive for acute stroke therapy was created, entitled COAST (Coordinating Options for Acute Stroke Therapy). This clinical initiative is being piloted at a large comprehensive stroke center, including the development of the advance directive form, integration of the form with electronic medical records, training healthcare providers, and outreach to patients. Conclusions COAST is an advance directive for stroke designed to make stroke care more efficient, optimize patients’ autonomy, improve the quality of healthcare, and streamline the ethical management of complex care decisions in acute stroke. The inherent benefit of COAST is in providing patients and their families with more information regarding stroke and its treatment options, allowing them to take a more active role in their care. (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)

The paper examines the ethical and legal challenges of making decisions for previously competent patients and the role of advance directives and legal representatives in light of the Oviedo Convention. The paper identifies gaps in the Convention that result in conflicting instructions in cases of a disagreement between the expressed prior wishes of a patient, and the legal representative. The authors also examine the legal and moral status of informally expressed prior wishes of patients unable to consent. The authors (...) argue that positivist legal reasoning is insufficient for a consistent interpretation of the relevant provisions of the Convention and argue that ethical argumentation is needed to provide guidance in such cases. Based on the ethical arguments, the authors propose a way of reconciling the apparent inconsistencies in the Oviedo Convention. They advance a culturally sensitive approach to the application of the Convention at the national level. This approach understands autonomy as a broader, relational consent and emphasizes the social and cultural embeddedness of the individual. Based on their approach, the authors argue that there exists a moral obligation to respect the prior wishes of the patient even in countries without advance directives. Yet it should be left to the national legislations to determine the extent of this obligation and its concrete forms. (shrink)

Advance directives (ADs) have for some time been championed by ethicists and patient associations alike as a tool that people newly diagnosed with dementia, or prior to onset, may use to ensure that their future care and treatment are organized in accordance with their interests. The idea is that autonomous people, not yet neurologically affected by dementia, can design directives for their future care that caregivers are morally obligated to respect because they have been designed by autonomous (...) individuals. In this paper, we first criticize the idea that ADs can retain moral authority in severe dementia by arguing that it is paradoxical. Second, we consider two arguments that initially seem to refute this critique of ADs, but we eventually dismiss them. The first argument states that ADs retain moral authority in severe dementia because autonomously formed interests, for example, ADs, can only be appropriately discarded by autonomous persons. This we term the historical autonomy argument. We dismiss it by demonstrating how we, in analog cases, are not obligated to continue to respect autonomously formed interests even though they have been discarded under nonappropriate conditions. The second argument is that ADs can be justified by what we term external interests. While we agree that people with severe dementia plausible can be said to have external interests, we show that ADs cannot express such interests and hence cannot be justified by them. We conclude that none of the discussed arguments support the use of ADs and because of this, the idea of ADs should be reassigned. (shrink)

Currently, in the United States, there is no legal obligation for medical professionals or civil courts to uphold patients’ Advance Directives (ADs) regarding end-of-life care. The applicability and standing of ADs prepared by Alzheimer’s patients is a persistent issue in bioethics. Those who argue against giving ADs full status take two main approaches: (1) appealing to beneficence on behalf of the Alzheimer’s patient and (2) claiming that there is no longer any personal equivalence between the AD’s creator and the (...) subject of the AD. In this paper, I present profound arguments against both approaches. Firstly, I argue that the principle of beneficence cannot apply in the case of Alzheimer’s patients, and, secondly, that the moral and legal authority of the AD need not depend on strict equivalence of personal identity. I conclude by arguing that valid ADs protect the dignity and autonomy of Alzheimer’s patients and that, therefore, there are moral obligations to uphold ADs which should be reflected in public policy and legislation. (shrink)

Aid‐in‐dying laws in the United States have two important restrictions. First, only patients who are terminally ill, defined as having a prognosis of six months or less to live, qualify. Second, at the time the patients take the lethal medication, they must be competent to make medical decisions. This means that an advance directive requesting aid in dying for a later time when the patient lacks decision‐making capacity would be invalid. However, many people are more concerned about avoiding living (...) into severe dementia for years—a time when they will lack decision‐making capacity—than they are about preventing suffering or the loss of dignity or autonomy for a few months at the end of life.Gillian Bennett is an example of someone determined not to live into severe dementia. She opted for preemptive suicide in 2014, explaining why in a letter she posted online: “Every day I lose bits of myself, and it’s obvious that I am heading toward the state that all dementia patients eventually get to: not knowing who I am and requiring full‐time care.”A major problem with Bennett’s solution, however, is that the individual is likely thereby to be giving up some “good time.” A legal alternative to preemptive suicide is to create an advance directive stating the circumstances under which one wants not to receive any lifesaving or life‐sustaining treatment, even the most basic and noninvasive. This option is our focus in this paper: how to create effective advance directives to avoid living into severe dementia. To be relevant to progressive dementia, the directive would need to state what kinds of care should be withheld and when. At the same time, advance directives for severe dementia face serious challenges. Before addressing these, we review the normative force of directives themselves. (shrink)

In a recent article Thomas May has argued that the use of advance directives (ADs) to respect a no longer competent patient's autonomy is a failed strategy. Respect for patient autonomy is clearly one of the guiding moral principles of modern medicine, and its importance is reflected in medical emphasis on informed consent. Prima facie, at least, ADs seem likewise to respect patient autonomy by allowing patients to make decisions about treatment in advance of situations in which (...) the patient may no longer be able to specify the form of treatment desired. So a claim that ADs do not extend patient autonomy to these situations of diminished competence represents a serious criticism of our understanding not only of advance directives, but of autonomy as well. (shrink)

Rapid advancement of technologies continues to revolutionize healthcare foundations and outlook. Technological progress in medicine are not only continuing to improve quality of individual life but also generally improving quality of healthcare services. As a matter of fact, the most significant change in healthcare systems was the shift from standardized, patronizing and rigid physician–patient relationship to more patient-focused, personalized and participatory practice. With this shift came increased attention to the assurance of patient’s right to autonomy. Therefore, this article aims to (...) discuss principal problematic aspects of patient’s right to autonomy hereby the patient’s role in the context of technologies and innovation. It is argued, that one of the effective ways to ensure patient’s right to autonomy is implementation of legal instruments, such as informed consent, advance directives and Ulysses contracts. However, this article also proposes, that with a potential of new technologies and artificial intelligence, these legal instruments need to be reconsidered and transformed in more efficient and eligible model, presenting information in more individualized, appealing and convenient manner. (shrink)

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 (...) class='Hi'>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)

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)

The advent of new genetic and genomic technologies may cause friction with the principle of respect for autonomy and demands a rethinking of traditional interpretations of the concept of informed consent. Technologies such as whole‐genome sequencing and micro‐array based analysis enable genome‐wide testing for many heterogeneous abnormalities and predispositions simultaneously. This may challenge the feasibility of providing adequate pre‐test information and achieving autonomous decision‐making. At a symposium held at the 11th World Congress of Bioethics in June 2012 (Rotterdam), organized (...) by the International Association of Bioethics, these challenges were presented for three different areas in which these so‐called ‘new genetics’ technologies are increasingly being applied: newborn screening, prenatal screening strategies and commercial personal genome testing. In this article, we build upon the existing ethical framework for a responsible set‐up of testing and screening offers and reinterpret some of its criteria in the light of the new genetics. As we will argue, the scope of a responsible testing or screening offer should align with the purpose(s) of testing and with the principle of respect for autonomy for all stakeholders involved, including (future) children. Informed consent is a prerequisite but requires a new approach. We present preliminary and general directions for an individualized or differentiated set‐up of the testing offer and for the informed consent process. With this article we wish to contribute to the formation of new ideas on how to tackle the issues of autonomy and informed consent for (public) healthcare and direct‐to‐consumer applications of the new genetics. (shrink)

Advance directives are critically important for capable individuals who wish to avoid the burdens of life-prolonging interventions in the advanced stages of dementia. However, this paper will argue that advance directives should have less application to questions about feeding patients during the clinical course of dementia than often has been presumed. The argument will be framed within the debate between Ronald Dworkin and Rebecca Dresser regarding the moral authority of precedent autonomy to determine an individual’s future (...) end-of-life care plan. We will use a brief analysis of the positions taken in two important papers that come out of the Dworkin/Dresser debate and a hypothetical patient, John, who will be followed from diagnosis of dementia to death, to show how advance directives should apply to key points in the progression of his disease, particularly in relation to food and nutrition. (shrink)

My contention is that considering a person to be co-located with an organism, or one of its\nspatial or temporal parts, gives rise to a host of problems as a result of there then being too many\nthinkers. These problems, which Olson has emphasized, can be mitigated (somewhat) by a\nNoonan-style pronoun revisionism. But doing so will have very unwelcome consequences for\nbioethics as autonomy, informed consent, advance directives and substituted judgment will be\nimpossible for the human animal. I count it as a (...) point in favor of Olson’s answer to the\nmetaphysical question “What are we?” that it avoids such ethical quandaries. But his animalism -\nwith its Parfit-inspired claim that it is not identity that matters in survival but the continuation of\nour psychology even if someone else is its subject - appears to be at odds with our self-conception\nand practical concerns. And if the only argument for this thesis is the fission scenario, then the\nthesis is further undermined as Parfit’s account of fission runs afoul of Wiggins’s Only a and b\nrule. What I will very tentatively suggest is that we explore two (incompatible) accounts of\nanimalism which deny that being identical to a future being is only of derivative importance to us. (shrink)

Advance directives are intended to extend patient autonomy by enabling patients to prospectively direct the care of their future incapacitated selves. There has been much discussion about issues such as whether the future incompetent self is identical to the agent who issues the advance directives or whether advance directives can legitimately secure patient autonomy. However, there is another important question to ask: to what extent and in what conditions is it ethically appropriate for one to limit the (...) liberty or agency of one’s future incompetent self by issuing an advance directive? -/- In this paper, I use a virtue-ethical approach to explore this question, focusing on the case of an advance directive for the future self with moderate dementia. First, I examine virtuous attitudes with regard to autonomy and argue that one can manifest vices or ethically undesirable character traits in trying to intervene in the future self’s life. In particular, I argue that this case can manifest vices such as disdainfulness, intellectual arrogance, and self-dictatorship, which is the vice of trying to control one’s life to an excessive degree, and that a self-dictator fails to give due moral consideration to the future self’s liberty or agency. I then introduce the Daoist idea of wu-wei, which recommends embracement of what happens in one’s life, as one of the possible remedies for the overemphasis on the value of autonomy and control. (shrink)

Background Genetic databases are becoming increasingly common as a means of determining the relationship between lifestyle, environmental exposures and genetic diseases. These databases rely on large numbers of research subjects contributing their genetic material to successfully explore the genetic basis of disease. However, as all possible research questions that can be posed of the data are unknown, an unresolved ethical issue is the status of informed consent for future research uses of genetic material. Discussion In this paper, we discuss (...) the difficulties of an informed consent model for future ineffable uses of genetic data. We argue that variations on consent, such as presumed consent, blanket consent or constructed consent fail to meet the standards required by current informed consent doctrine and are distortions of the original concept. In this paper, we propose the concept of an authorization model whereby participants in genetic data banks are able to exercise a certain amount of control over future uses of genetic data. We argue this preserves the autonomy of individuals at the same time as allowing them to give permission and discretion to researchers for certain types of research. Summary The authorization model represents a step forward in the debate about informed consent in genetic databases. The move towards an authorization model would require changes in the regulatory and legislative environments. Additionally, empirical support of the utility and acceptability of authorization is required. (shrink)

Anticipation of future decisions can be important for individuals at risk for diseases to maintain autonomy over time. For future treatment and care decisions, advance care planning is accepted as a useful anticipation tool. As research with persons with dementia seems imperative to develop disease-modifying interventions, and with changing regulations regarding research participation in Germany, advance research directives (ARDs) are considered a solution to include persons with dementia in research in an ethically sound manner. However, little (...) is known about what affected people deem anticipatable.This contribution provides a critical reflection of the literature on anticipation and of a qualitative study on the assessment of ARDs with persons with cognitive impairment in Germany. It combines theoretical and empirical reflections to inform the ethical-legal discourse.Anticipation involves the conceptual separation of the past, the present, and the future. Including dimensions such as preparedness, injunction, and optimization helps in establishing a framework for anticipatory decision-making. While dementia may offer a window of time to consider future decisions, individual beliefs about dementia including fears about stigma, loss of personhood, and solitude strongly impact anticipating sentiments. Concepts of anticipation can be useful for the examination of uncertainty, changing values, needs, and preferences interconnected with the dementia trajectory and can serve as a means to make an uncertain future more concrete. However, fears of losing one’s autonomy in the process of dementia also apply to possibilities of anticipation as these require cognitive assessment and reassessment of an imagined future with dementia. (shrink)

The advent of new genetic and genomic technologies may cause friction with the principle of respect for autonomy and demands a rethinking of traditional interpretations of the concept of informed consent. Technologies such as whole-genome sequencing and micro-array based analysis enable genome-wide testing for many heterogeneous abnormalities and predispositions simultaneously. This may challenge the feasibility of providing adequate pre-test information and achieving autonomous decision-making. At a symposium held at the 11th World Congress of Bioethics in June 2012 (Rotterdam), organized (...) by the International Association of Bioethics, these challenges were presented for three different areas in which these so-called ‘new genetics’ technologies are increasingly being applied: newborn screening, prenatal screening strategies and commercial personal genome testing. In this article, we build upon the existing ethical framework for a responsible set-up of testing and screening offers and reinterpret some of its criteria in the light of the new genetics. As we will argue, the scope of a responsible testing or screening offer should align with the purpose(s) of testing and with the principle of respect for autonomy for all stakeholders involved, including (future) children. Informed consent is a prerequisite but requires a new approach. We present preliminary and general directions for an individualized or differentiated set-up of the testing offer and for the informed consent process. With this article we wish to contribute to the formation of new ideas on how to tackle the issues of autonomy and informed consent for (public) healthcare and direct-to-consumer applications of the new genetics. (shrink)

The dilemma of whether and how to disclose a diagnosis of cancer or of any other terminal illness continues to be a subject of worldwide interest. We present the case of a 62-year-old Japanese woman afflicted with advanced gall bladder cancer who had previously expressed a preference not to be told a diagnosis of cancer. The treating physician revealed the diagnosis to the family first, and then told the patient: "You don't have any cancer yet, but if we don't treat (...) you, it will progress to a cancer". In our analysis, we examine the role of family consent, communication patterns (including ambiguous disclosure), and advance directives for cancer disclosure in Japan. Finally, we explore the implications for Edmund Pellegrino's proposal of "something close to autonomy" as a universal good. (shrink)

The world population aged significantly over the twentieth century, leading to an increase in the number of individuals presenting progressive, incapacitating, incurable chronic-degenerative diseases. Advances in medicine to prolong life prompted the establishment of instruments to ensure their self-determination, namely the living will, which allows for an informed person to refuse a type of treatment considered unacceptable according to their set of values. From the knowledge on the progression of Alzheimer disease, it is possible to plan the medical care, (...) even though there is still no treatment available. Irreversible cognitive incapacity underlines the unrelenting loss of autonomy of the demented individual. Such a loss requires the provision of specific and permanent care. Major ethical issues are at stake in the physician–patient–family relationship, even when dementia is still at an early stage. The authors suggest that for an adequate health care planning in Alzheimer disease the living will can be presented to the patient in the early days of their geriatric care, as soon as the clinical, metabolic or even genetic diagnosis is accomplished. They also suggest that the appointment of a health care proxy should be done when the person is still in full enjoyment of his cognitive ability, and that the existence and scope of advance directives should be conveyed to any patient in the early stages of the disease. It follows that ethical guidelines should exist so that neurologists as well as other physicians that deal with these patients should discuss these issues as soon as possible after a diagnosis is reached. (shrink)

BackgroundEvaluation of decision-making capacity to consent to medical treatment has proved to be difficult in patients with dementia. Studies showed that physicians are often insufficiently trained in the evaluation of decision-making capacity. In this study, we present findings from a secondary analysis of a qualitative interviews with physicians. These interviews were initially used to assess usability of an instrument for the evaluation of decision-making capacity. By looking at difficult cases of decision-making capacity evaluation in patients with dementia, we (...) provide recommendations for such evaluations in clinical practice.MethodsWe used thematic coding to analyse physicians’ narratives of problematic decision-making capacity evaluations in patients with dementia to uncover challenging issues of decision-making capacity evaluation.ResultsIn this study, decision-making capacity evaluations in patients with dementia were mainly perceived as challenging when they pertained to treatment refusals and treatment unrelated circumstances, such as psychiatric consultation, advance directives, and new living arrangements. Furthermore, the physicians reported training needs regarding situation-independent challenges with decision-making capacity evaluation.ConclusionsUpon further examining self-reported training needs and challenging cases, we have developed recommendations to improve decision-making capacity evaluations in clinical practice. In these recommendations, we argue that being able to evaluate decision-making capacity is an integral part of the informed consent process. (shrink)

Several ethicists have argued that research trials and treatment programs that involve the provision of drugs to addicts are prima facie unethical, because addicts can’t refuse the offer of drugs and therefore can’t give informed consent to participation. In response, several people have pointed out that addiction does not cause a compulsion to use drugs. However, since we know that addiction impairs autonomy, this response is inadequate. In this paper, I advance a stronger defense of the capacity of (...) addicts to participate in the programs envisaged. I argue that it is only in certain circumstances that addicts find themselves choosing in ways that conflict with their genuine preferences. Research and treatment programs have none of the features that characterize choices in these autonomy-undermining circumstances, and there is therefore no reason to think that addicts lack the capacity to give informed consent to these programs. (shrink)

When people lose capacity to make a medical decision, the standard is to assess what their preferences would have been and try to honor their wishes. Dementia raises a special case in such situations, given its long, progressive trajectory during which others must make substituted judgments. The question of how to help surrogates make better‐informed decisions has led to the development of dementia‐specific advance directives, in which people are given tools to help them communicate what their (...) preferences are while they are still able. Such directives allow the perspective of the person to play a clearer role in guiding decisions about their care. Dementia directives can never serve as rigid algorithms. Rather, they can be used to help inform conversations, to help surrogates make decisions that are better aligned with the preferences the person would have had. This essay lays out the proposed utility of dementia‐specific directives and addresses some of the criticisms raised about them. (shrink)

As the prevalence of dementia rises, it is increasingly important to determine how to best respect incapable individuals' autonomy during end‐of‐life decisions. Many philosophers advocate for the use of advance directives in these situations to allow capable individuals to outline preferences for their future incapable selves. In this paper, however, I consider whether advance directives lack moral authority in instances of dementia. First, I introduce several scholars who have argued that changes in peoplewith dementia's values (...) throughout disease progression reduce the validity of their advanced wishes. I then outline Karin Jongsma's rejection of this claim, which she calls the “losing and choosing” distinction. Jongsma argues that changes in people with dementia's values should not be respected, because they are unchosen and dictated by the disease. I critique her claim that the process of value change is morally relevant when determining which values we respect. I argue that if individuals with dementia are capable of valuing, their contemporary values should be respected, even when they conflict with past preferences outlined in an advance directive. As such, situations of value change diminish the moral authority of advance directives for individuals with dementia. (shrink)

This article reviews the Dutch societal debate on euthanasia/assisted suicide in dementia cases, specifically Alzheimer's disease. It discusses the ethical and practical dilemmas created by euthanasia requests in advance directives and the related inconsistencies in the Dutch legal regulations regarding euthanasia/assisted suicide. After an initial focus on euthanasia in advanced dementia, the actual debate concentrates on making euthanasia/assisted suicide possible in the very early stages of dementia. A review of the few known cases of assisted suicide (...) of people with so-called early dementia raises the question why requests for euthanasia/assisted suicide from patients in the early stage of Alzheimer's disease are virtually non-existent. In response to this question two explanations are offered. It is concluded that, in addition to a moral discussion on the limits of anticipatory choices, there is an urgent need to develop research into the patient's perspective with regard to medical treatment and care-giving in dementia, including end-of-life care. (shrink)

The use of four-point physical restraints has long been controversial in psychiatry. But the most common objections against these restraints hinges on the idea that they would be imposed against patients. In light of the trend towards giving patients access to Advance Directives, why not allow patients to use such legal documents to arrange for restraints being used against them? Patients might do this if they feared an inability to make competent decisions in the future. Proper oversight over the (...) requests and the restraint-use would help psychiatric patients plan for their own care. Clearly, not all patients would qualify for such an expansion of their autonomy. Many would be unable to give adequately informed consent. Still, for the patients who could consent, being able to draw up such a “Ulysses Contract” could provide an improved balance of risks and benefits. (shrink)

People in extraordinary situations are vulnerable. As research participants, they are additionally threatened by abuse or exploitation and the possibility of harm through research. To protect people against these threats, informed consent as an instrument of self-determination has been introduced. Self-determination requires autonomous persons, who voluntarily make decisions based on their values and morals. However, in nursing research, this requirement cannot always be met. Advanced age, chronic illness, co-morbidity and frailty are reasons for dependencies. These in turn lead to (...) limited abilities or opportunities for decision-making and self-determination. Exclusion of vulnerable people from research projects would disadvantage them by not covering their needs, which would violate the ethical principles of justice and beneficence. Commonly, vulnerability is attributed to social groups. The consequence for individuals, attributed as belonging to such a vulnerable group, is that the principles of respect for autonomy, justice and beneficence are subordinated to the principle of non-maleficence, understood as avoiding the risk to cause more harm than good. In addition, group-specific attribution could lead to stigmatizing because labelling a person as deviation from a norm violates integrity. For clinical nursing research, the question arises how the protection of vulnerable people could be granted without compromising ethical principles. The concept of relational ethics provides a possible approach. It defines vulnerability as the relation between a person’s health status and the extent to which this person is dependent on the researcher and the research context. Vulnerability is not attributed solely to a person but to a situation, meaning the person is viewed in context. By combining vulnerability as a context-related and situational concept with existing approaches of informed consent, the different ethical principles can be balanced and preserved at every step of the research process. (shrink)

Volume 20, Issue 8, August 2020, Page 104-106.

Background A psychosocial problem faced by people with early-stage dementia (PwESD) is the perception of threats to personal dignity. Insights into its dynamics are important for understanding how it changes as dementia advances and to develop suitable interventions. However, longitudinal studies on this change in PwESD are lacking. Aims To determine how perceptions of dignity and selected clinical and social factors change over 1 year in home-dwelling PwESD and the predictors associated with changes in perceptions of dignity over (...) 1 year. Research design and methods A longitudinal study was conducted. The sample included 258 home-dwelling Czech PwESD. Data were collected using the Patient Dignity Inventory (PDI-CZ), Mini-Mental State Examination, Bristol Activities of Daily Living Scale, Geriatric Depression Scale and items related to social involvement. Questionnaires were completed by the PwESD at baseline and after 1 year. Ethical considerations The study was approved by the ethics committee and informed consent was provided by the participants. Results People with Early-Stage Dementia rated the threat to dignity as mild and the ratings did not change significantly after 1 year. Cognitive function, self-sufficiency, vision, and hearing worsened, and more PwESD lived with others rather than with a partner after 1 year. Worsened depression was the only predictor of change in perceived personal dignity after 1 year, both overall and in each of the PDI-CZ domains. Predictors of self-sufficiency and pain affected only some PDI-CZ domains. Conclusions Perceptions of threat to dignity were mild in PwESD after 1 year, although worsened clinical factors represented a potential threat to dignity. Our findings lead us to hypothesise that perceived threats to personal dignity are not directly influenced by health condition, but rather by the social context. (shrink)

Advance patient directives are various forms of anticipatory medical directives made by competent individuals for the eventuality of future incompetence. They are therefore appropriate instruments for competent patients in the early stage of Alzheimer's disease to document their self-determined will in the advanced stages of dementia. Theoretical objections have been expressed against the concept of advance patient directives (problems of authenticity and identity) which, however, cannot negate the fundamental moral authority of advance patient directives. Therefore, patients, (...) family members, and physicians should make use of the appropriate form of advance directive as part of common treatment and care planning. Advance directives, when utilized intelligently, represent appropriate instruments for shared decision-making by patient, family members and physician. They should be utilized to a greater extent, particularly for the treatment planning of demented patients. (shrink)