While some lament the slide of Western culture into relativism and nihilism and others celebrate the trend as a liberating sort of progress, Charles Taylor calls on us to face the moral and political crises of our time, and to make the most ...

Society is failing in its moral obligation to improve the standard of healthcare provided to vulnerable populations, such as people who lack decision making capacity, by a misguided paternalism that seeks to protect them by excluding them from medical research. Uncertainties surround the basis on which decisions about research participation is made under dual regulatory regimes, which adds further complexity. Vulnerable individuals’ exclusion from research as a result of such regulation risks condemning such populations to poor quality care as a (...) result of ‘evidence biased’ medicine. This paper explores the research regulation provisions for proxy decision making for those unable to provide informed consent for themselves, and the subsequent legal and practical difficulties for decision-makers. There are two separate regulatory regimes governing research involving adults who lack capacity to consent in England and Wales. The Mental Capacity Act 2005 governs how incapacitated adults can be involved in research, however clinical trials of medicinal products are separately regulated by the Medicines for Human Use Regulations 2004. There are significant differences under these dual regimes in the provisions for those lacking capacity to participate in medical research. The level of risk permitted differs, with a greater requirement for justification for participation in a clinical trial than other types of research. Who acts as proxy decision maker, how much information is provided to the person lacking capacity, and whether they retain the power of veto also significantly differs. The development of two separate regulatory regimes has resulted in significant differences between the provisions for clinical trials and other forms of research, and from usual medical practice. The resulting uncertainty has reinforced the tendency of those approving and conducting research to exclude adults lacking capacity to avoid difficult decisions about seeking consent for their participation. Future developments, such as the incoming EU Regulations, may address some of these differences, however the justification and level of risk permitted requires review to ensure that requirements are appropriate and proportionate to the burdens and risks for the individual, and also to the benefits for the wider population represented. (shrink)

Background: Research involving adults lacking mental capacity relies on the involvement of a proxy or surrogate, although this raises a number of ethical concerns. Empirical studies have examined attitudes towards proxy decision-making, proxies’ authority as decision-makers, decision accuracy, and other relevant factors. However, a comprehensive evidence-based account of proxy decision-making is lacking. This systematic review provides a synthesis of the empirical data reporting the ethical issues surrounding decisions made by research proxies, and the development of a conceptual framework of proxy (...) decision-making for research. Methods: A systematic review was conducted according to PRISMA guidelines. Databases including MEDLINE, EMBASE, and CINAHL were searched using a combination of search terms, and empirical data from eligible studies were retrieved. The review followed the framework synthesis approach to refine and develop a conceptual framework. Results: Thirty-four studies were included in the review. Two dimensions of proxy decision-making emerged. The ethical framing criteria of decision-making used by proxies: use of a substituted judgement, use of a best interests approach, combination of substituted judgement and best interests, and ‘something else’, and the active elements of proxy decision-making: ‘knowing the person’, patient-proxy relationship, accuracy of the decision, and balancing risks, benefits and burdens, and attitudes towards proxy decision-making. Interactions between the framing criteria and the elements of decision-making are complex and contextually-situated. Conclusions: The findings from this systematic review challenge the accepted reductionist account of proxy decision-making. Decision-making by research proxies is highly contextualized and multifactorial in nature. The choice of proxy and the relational features of decision-making play a fundamental role: both in providing the proxy’s authority as decision-maker, and guiding the decision-making process. The conceptual framework describes the relationship between the framing criteria used by the proxy, and the active elements of decision-making. Further work to develop, and empirically test the proposed framework is needed. (shrink)

Research involving adults who lack capacity to consent relies on proxy (or surrogate) decision making. Proxy decisions about participation are ethically complex, with a disparity between normative accounts and empirical evidence. Concerns about the accuracy of proxies’ decisions arise, in part, from the lack of an ethical framework which takes account of the complex and morally pluralistic world in which proxy decisions are situated. This qualitative study explored the experiences of family members who have acted as a research proxy in (...) order to develop an understanding of the ethical concepts involved, and the interactions between those concepts. Proxies described a complex process of respecting the wishes and preferences of the person they represented, whist integrating preferences with what they viewed as being in the interests of the person. They aimed to make a decision that was ‘best’ for the person and protected them from harm; they also aimed to make the ‘right’ decision, viewed as being authentic to the person’s values and life. Decisions were underpinned by the relationship between the person and their proxy, in which both trust and trustworthiness were key. Proxies’ decisions, based both on respect for the person and the need to protect their interests, arose out of their dual role as both proxy and carer. The findings raise questions about accounts which rely on existing normative assumptions with a focus on accuracy and discrepancy, and which fail to take account of the requirement for proxies to make authentic decisions that arise out of their caring obligations. (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)

Background:Protecting the dignity of elderly residents of facilities and providing dignified care can be difficult. Although attempts have been made from several aspects, dignity is considered an area in which less real impact has been made in both theory and practice.Objective:The objective of this study is to characterize the concept of dignity in care for elderly subjects in residential facilities from a practical perspective through concept synthesis.Research design:This study includes in-depth interviews with residents of elderly facilities and a literature review.Participants (...) and research context:A total of 12 residents of seven facilities in three prefectures in Japan were recruited via purposive sampling, and 27 interviews were conducted. Each digitally recorded interview was transcribed verbatim. The interview data were analyzed based on hermeneutic phenomenological research. The literature was searched using PubMed, CINAHL, and Web of Science with combinations of terms such as dignity, elderly, and residential facilities and then selected according to the predefined inclusion criteria. The descriptions about dignity in the included studies were divided into codes and compared with the results of the interviews.Ethical considerations:This study was approved by the institutional review board of Nagoya University’s Graduate School of Medicine.Findings and discussion:There were 1728 data codes for the interviews from which four themes were generated. In the literature review, 3716 titles were searched, and 28 articles were selected. Combining these results, five following themes and a conceptual matrix were obtained: individual dignity not affected by others; dignified care in a narrow sense; elements of the staff side; dignity in relation to family members, friends, society, and other residents; and dignity in relation to nursing care facilities and the nursing care system.Conclusion:According to the established matrix, we must consider the role of the care system, facility, family, and society in providing care with dignity and the individual dignity to residents and dignity in daily care. (shrink)

Surrogate (proxy) decision makers must make research decisions for people with dementia who lack decision-making capacity. Proxies’ decision-making processes are minimally understood. We randomly assigned 82 proxies of AD patients to informed consent for one of three hypothetical protocols with differing levels of risk and benefit. Proxies answered questions about potential benefits of the described research to the patient and society, as well as about whether they would enroll their relative and why or why not. Proxies interested in enrolling their (...) relative cited the potential for direct benefit to their relative, altruism, and trust in researchers. Those declining cited risks, inconvenience, and stage of illness. Proxies weighed numerous factors, incorporating both substituted judgment and best interests standards in their decision-making processes. Although further empirical work is needed to understand the influences on and adequacy of proxies’ decision making regarding research, these findings can help inform policy regarding surrogate consent. (shrink)

Many studies claim to measure decision-making under risk by employing the Domain-Specific Risk-Taking (DOSPERT) scale, a self-report measure, or the Balloon Analogue Risk Task (BART), a behavioural task. However, these tasks do not measure decision-making under risk but decision-making under uncertainty, a related but distinct concept. The present commentary discusses both the theoretical and empirical basis of the distinction between uncertainty and risk from the viewpoint of several scientific disciplines and reports how many studies wrongfully employ the DOSPERT scale and (...) BART as risk-taking measures. Importantly, we call for proper distinguishing between (tasks measuring) decision-making under uncertainty and decision-making under risk in psychology and related fields. We believe this is vital as research has shown that people’s attitudes, behaviour, and brain activity differ between both concepts, indicating that confusing the concepts may lead researchers to erroneous conclusions. (shrink)

Hastings Center Report, Volume 52, Issue 1, Page 32-41, January/February 2022.

In current American medical practice, autonomy is assumed to be more valuable than human life: if a patient autonomously refuses lifesaving treatment, the doctors are supposed to let him die. In this paper we discuss two values that might be at stake in such clinical contexts. Usually, we hear only of autonomy and best interests. However, here, autonomy is ambiguous between two concepts—concepts that are tied to different values and to different philosophical traditions. In some cases, the two values (that (...) of agency and that of authenticity) entail different outcomes. We argue that the comparative value of these values needs to be assessed. (shrink)

This essay lays the groundwork for a novel conception of autonomy that may be called “effective autonomy”—a conception designed to be genuinely action guiding in bioethics. As empirical psychology research on the heuristics and biases approach shows, decision making commonly fails to correspond to people’s desires because of the biases arising from bounded cognition. People who are classified as autonomous on contemporary philosophical accounts may fail to be effectively autonomous because their decisions are uncoupled from their autonomous desires. Accordingly, continuing (...) attempts to value patient autonomy must go beyond existing philosophical conceptions of autonomy to consider the background conditions of human decision making. (shrink)

Uncertainty and affect are fundamental and interrelated aspects of the human condition. Uncertainty is often associated with negative affect, but in some circumstances it is associated with positive affect. In this paper, we review different explanations for the varying relationship between uncertainty and affect. We identify “mental simulation” as a key process that links uncertainty to affective states. We suggest that people have a propensity to simulate negative outcomes, which results in a propensity towards negative affective responses to uncertainty. We (...) also propose the existence of several important moderators of this process, including context and individual differences such as uncertainty tolerance, as well as emotion regulation strategies. Finally, we highlight important knowledge gaps and promising areas for future research, both empirical and conceptual, to further elucidate the relationship between uncertainty and affect. (shrink)

This book is the most comprehensive treatment available of one of the most urgent - and yet in some respects most neglected - problems in bioethics: decision-making for incompetents. Part I develops a general theory for making treatment and care decisions for patients who are not competent to decide for themselves. It provides an in-depth analysis of competence, articulates and defends a coherent set of principles to specify suitable surrogate decisionmakers and to guide their choices, examines the value of advance (...) directives, and investigates the role that considerations of cost ought to play in decisions concerning incompetents. Part II applies this theoretical framework to the distinctive problems of three important classes of individuals, many of whom are incompetent: minors, the elderly and psychiatric patients. The authors' approach combines a probing analysis of fundamental issues in ethical theory with a sensitive awareness of the concrete realities of health care institutions and the highly personal and individual character of difficult practical problems. Its broad scope will appeal to health professionals, moral philosophers and lawyers alike. (shrink)

For all masters or doctoral courses on nursing theory or related to framework development for practice or research. For beginning graduate students in nursing and related disciplines, this text offers the clearest, most useful introduction to methods of theory development. It places nursing theory development in context, with a rich historical view that traces the field from its from its mid-20th century beginnings through contemporary and emerging issues. Present-day coverage includes both domain- and population-focused theories designed to specifically address the (...) needs of clients served by nurses. Important additions in this edition include short reflections and critical thinking projects, as well as a new chapter on using knowledge development and theory to inform practice. (shrink)