In this paper I get clearer on the considerations that ought to inform the evaluation and development of medico-legal competency criteria—where this is taken to be a question regarding the abilities that ought to be needed for a patient to be found competent in medico-legal contexts. In the “Decisional Competency in Medico-Legal Contexts” section I explore how the question regarding the abilities that ought to be needed for decisional competence is to be interpreted. I begin by considering (...) an interpretation that takes the question to be asking about the abilities needed to satisfy an idealized view of competent decision-making, according to which decisional competency is a matter of possessing those abilities or attributes that are needed to engage in good or effective or, perhaps, substantially autonomous or rational decision-making. The view has some plausibility—it accords with the way decisional competency is understood in a number of everyday contexts—but fails as an interpretation of the question regarding the abilities that should be needed for decisional competence in medico-legal contexts. Nevertheless, consideration of why it is mistaken suggests a more accurate interpretation and points the way in which the question regarding the evaluation of medico-legal competency criteria is to be answered. Building on other scholarly work in the area, I outline in the “Primary and Secondary Requirements” section several requirements that decisional competence criteria ought to satisfy. Then, in the “Applying the Framework” section, I say something about the extent to which medico-legal competency criteria, as well as some models of decisional competency proposed in the academic literature, fulfil those requirements. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Ought We to Require Emotional Capacity as Part of Decisional Competence?Paul S. Appelbaum* (bio)AbstractThe preceding commentary by Louis Charland suggests that traditional cognitive views of decision-making competence err in not taking into account patients’ emotional capacities. Examined closely, however, Charland’s argument fails to escape the cognitive bias that he condemns. However, there may be stronger arguments for broadening the focus of competence assessment to include (...) emotional capacities, centering on the ways in which emotions aid humans in processing information. Before emotional capacities are added to the list of functions essential for decisional competence, though, the feasibility and utility of such a reorientation must be demonstrated.To what extent ought persons’ capacities to experience emotion be taken into account when determining whether they should be deemed competent to make their own decisions? In the previous article, Louis Charland (1998) argues that traditional models of decision-making competence—of which the MacArthur Competence Treatment Study is a typical example—are mistaken in focusing narrowly on persons’ cognitive abilities to the neglect of emotional factors. In contrast, he suggests, constructs of competence ought explicitly to require a capacity to experience emotions, which he believes is central to meaningful decision making, before deeming persons competent.Charland, as he acknowledges, is not the first to suggest that the presence of some degree of emotional capacity is a necessary element of competence, but his argument is among the most elaborate to date and is certainly worth closer examination. Looked at carefully, however, Charland’s argument does not make quite the case for the determination of emotional capacity in competence assessment that he claims for it. Indeed, as I demonstrate below, Charland may share the same “pernicious [End Page 377] cognitive bias” that he ascribes to more traditional approaches. However, despite what I identify as the problems in Charland’s argument, others have raised more disturbing questions about the lack of attention to emotional issues in competence assessment. Thus, I am not ready to reject entirely the possibility that determinations of decisional competence ought to consider emotional factors. I conclude by outlining the questions that remain to be answered to identify more clearly the potential benefits of such an approach.The Construct of Decision-Making CompetenceSome preliminary comments about the nature of the dominant construct of decision-making competence may provide a useful frame for my response to Charland’s paper. Contemporary ideas of competence are tied inextricably to the ideal of self-determination in modern Western societies. Such societies are committed to respect for individual choice, both as a good in its own right and on the grounds that each person knows best what choices will maximize his or her own welfare. In general, therefore, states will not intervene to prevent persons from acting on their decisions, even when the choices they make—like the decision to smoke or to refuse potentially life-saving medical care—may objectively be thought to be detrimental to them.In some cases, however, the presumption that people will act in their own interests, as well as the notion that there is something intrinsically valuable in respecting their choices, fails (Buchanan and Brock 1989). When people’s minds are so disordered that they cannot be said to be making meaningful choices, other values come into play. Such people are called “incompetent.” When persons reach that point, the state’s interest in protecting its citizens becomes primary and someone else must make decisions on their behalf. Note that the size of this group must be sharply limited, lest a liberal society’s commitment to self-determination be undermined: There is no more profound infringement of the rights of citizens than the determination that they are incompetent. Thus, the criteria for incompetence must be selected in a deliberately narrow fashion—alternately, one might say that the standards for competence are made intentionally broad—so that all but a tiny percentage of citizens will be permitted to make decisions on their own.In the Anglo-American world, the process of formulating criteria of competence by and large has been left to the common law courts. Over the course of centuries they have identified the capacities that are, in... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Appreciating Anorexia:Decisional Capacity and the Role of ValuesThomas Grisso (bio) and Paul S. Appelbaum (bio)Keywordscompetence, consent, anorexia, appreciation, decision makingTan and her colleagues (2006) reported that persons with anorexia nervosa typically manifest no difficulty satisfying the criteria for abilities associated with competence to consent to or refuse treatment. Their results led them to conclude that these patients generally had no problem grasping the nature of anorexia and (...) its possible consequences (understanding), typically did not have difficulty processing information when making treatment decisions (reasoning), and usually neither denied that they had a disorder nor manifested distorted beliefs about the potential consequences of treatment for the disorder.Nevertheless, these authors found, some anorexia patients said that they knew they might die and that they would rather die than suffer the alternative consequences (e.g., loss of identity, feeling of being disgusting). They point out that these beliefs, suggesting questionable competence, were not identified by the usual criteria for competence to consent to treatment. Therefore, they propose that we should consider a modification of the criteria for competence to consent to treatment. They argue for inclusion of "pathological values" as the basis for a finding of incompetence. Their notion of a pathological value (as we summarize it based on their Discussion) includes (a) a personal value (b) on which treatment refusal is based, that (c) is not authentic, and (d) is due to a mental disorder.Second, Tan and colleagues were concerned that the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), currently used widely to assess competence to consent to treatment, did not seem to take values into account when examining deficits related to lack of appreciation or reasoning. They point out that most patients with anorexia nervosa in their study had "pathological values" that influenced their thinking about treatment, yet they did not obtain poor scores on the instrument's appreciation scale, which assesses whether patients deny that they have the illness or offer reasons for accepting or refusing treatment that are based on delusional premises or a serious distortion of reality. Moreover, almost all of the anorexia patients in the study obtained adequate scores on reasoning, which examines the ability to process options and consequences when weighing a treatment decision. [End Page 293]Reasons for Caution in Altering Criteria for CompetenceA fundamental step in considering Tan and her co-worker's proposal is to examine whether it is necessary to add a concept of "pathological values" to the legal construct of competence to consent to treatment. Modifying the legal doctrine of consent is important if that is needed to improve its validity or reliability. But modifications of the doctrine would have considerable costs, including a long process of producing logical and empirical evidence for its necessity, developing methods to assess the new concept, and then a process of debate, persuasion, and education to change laws, ethical guidelines, and medical training. Moreover, principles of theory building urge parsimony. A theory should employ no more concepts or assumptions than are required to account for the phenomena that the theory seeks to organize or explain. So one must be sure that modifications are truly necessary before adding complexity to the theory of decisional competence.In addition, there is an inherent danger in altering a concept like competence to consent to treatment on the basis of the study of any one mental disorder. It is not at all clear how the modification might influence findings of competence when applied to other disorders. Using a study of patients with anorexia nervosa as the impetus for changing the competence concept runs this risk. For example, anorexia is one of a class of mental disorders that is characterized by a failure to abstain from behavior (here, limiting food intake and other behaviors designed to reduce weight) that has negative consequences for the person. Other conditions in this category might include substance abuse disorders and impulse control disorders (e.g., pathological gambling). Even if one concludes that revised criteria for competence would reduce false-positive findings of competence in this group of disorders, one would have to consider carefully its impact on the full range of disabling mental conditions.Moreover, the sensitivity... (shrink)

Despite substantial research on overall decision-making capacity levels in schizophrenia, the factors that cause individuals to make errors when making decisions regarding research participation or treatment are relatively unknown. We examined the responses of 84 individuals, middle-aged or older, with schizophrenia or schizoaffective disorder. We used a structured decision-making capacity measure, the MacArthur Competence Assessment Tool for Clinical Research, to determine the frequency and apparent cause of participants’ errors. We found that most errors were due to difficulty recalling the (...) disclosed information, particularly the study’s procedures, potential risks, and purpose. Errors attributable to concrete thinking, psychotic symptoms, or perceived coercion were rarer. These results suggest that informed consent procedures for this population might be improved by providing information in a way that facilitates learning and memory, such as iterative disclosure of the information, corrective feedback, and emphasis of key points of the study—for instance, its purpose, procedures, and potential risks. (shrink)

Informed consent represents a specific protocol for obtaining consent from a fully informed human subject to take part in clinical research. Still, informed consent is not only required for clinical trials but it also represents a critical precondition before enrolment in standard everyday medical procedures. Relevant fundamental criteria for obtaining informed consent must be followed, and that is that patient must have the decisional capacity to reach autonomous decision. The patient must be adequately informed and not coerced. Evaluating (...) class='Hi'>decisional capacity is crucial to providing the required level of care. The decision of which decisional capacity tool to use can be challenging because of various dissimilarities among the instruments. In this paper, four widely documented instruments have been evaluated, namely, the MacArthur Competence Assessment Tool for Treatment (MacCAT-T), the Hopkins Competency Assessment Test (HCAT), the Structured Interview for Competency/Incompetency Assessment Testing, Ranking Inventory (SICIATRI), and the Capacity Assessment Tool (CAT). Some of them include a fully structured interview; semi-structured forms characterise others. Most of them are adaptable for different scenarios, and yet, some are tailored for specific treatment decisions. Some evaluate all four components of decisional capacity, while others do not. Although a broad range of capacity assessment tools is available, it has been shown that they notably improve the accuracy of capacity evaluations. Given that many pathological conditions could result in impaired decisional capacity, physicians must be able to correctly and consistently assess the capacity for which education and previous experience are pivotal. (shrink)

Although treating the elderly occasion the same kinds of ethical issues as treating other patients, specific problems do arise when making decisions for persons, once competent, who no longer can express their values. I examine the problem of decisional incapacity and offer a critique of the principles, such as substituted judgment, and the instruments, such as advance directives, living wills, other instructional directives, as well as surrogate decision-makers.

Limits to paternalism are, in the liberal democracies, partially defined by the concepts of decision-making capacity/incapacity (mental competence/incompetence). The paper is a response to Ian Wilkss (1997) recent attempt to defend the idea that the standards for decisional capacity ought to vary with the degree of risk incurred by certain choices. Wilkss defense is based on a direct appeal to the logical features of examples and analogies, thus attempting to by-pass earlier criticisms (e.g., Culver Gert, 1990) of risk-based (...) standards. Wilkss argument is found wanting on the grounds that he misconstrues the logic of such capacity, especially in accounting for conceptual and pragmatic ties with issues of decisional authority. A diagnosis is offered as to the source of Wilkss error (the assumption that mental competence is a species of wider genus of competence), and an alternative way of accounting for risk within the predominant contemporary legal framework is sketched. (shrink)

Developmentally, adolescence sits in transition between childhood and adulthood. Involving adolescents in their medical decision-making prompts important and complex ethical questions. Originating in the UK, the concept of Gillick competence is a dominant framework for navigating adolescent medical decision-making from legal, ethical and clinical perspectives and is commonly treated as comprehensive. In this paper, we argue that its utility is far more limited, and hence over-reliance on Gillick risks undermining rather than promoting ethically appropriate adolescent involvement. We demonstrate that (...) Gillick only provides guidance in the limited range of cases where legal decisional authority needs to be clarified. The range of cases where use of Gillick actually promotes adolescent involvement is narrower still, because several features must be present for Gillick to be enacted. Each of these features can, and do, act as barriers to adolescent involvement. Within these limited situations, we argue that Gillick is not specific or strong enough and is reliant on ethically contestable principles. Moreover, in most situations in adolescent healthcare, Gillick is silent on the ethical questions around involving adolescents. This is because it focuses on decisional authority—having the final say in decision-making—which is one small subset of the many ways adolescents could be involved in decision-making. The implication of our analysis is that use of Gillick competence tends to limit or undermine adolescent involvement opportunities. We propose that those working with adolescents should be judicious in seeking Gillick’s guidance, instead drawing on and developing alternative frameworks that provide a comprehensive model for adolescent involvement. (shrink)

According to Pickering, Newton-Howes, and Young, the harmfulness of decisions does, and should, factor into determining patients' decisional competence. As they claim, decision-making proces...

Patient competence, defined as the ability to reason, appreciate, understand, and express a choice is rarely discussed in patients with obsessive compulsive disorder, and coercive measures are seldom used. Nevertheless, a psychiatrist of psychologist may doubt whether OCD patients who refuse treatment understand their disease and the consequences of not being treated, which could result in tension between respecting the patient’s autonomy and beneficence. The purpose of this article is to develop a notion of competence that is grounded (...) in clinical practice and corresponds with the experiences of patients with obsessions and/or compulsions. We present a naturalistic case study giving both the patient’s and the therapist’s perspective based on in-depth interviews and a narrative analysis. The case study shows that competence is not merely an assessment by a therapist, but also a co-constructed reality shaped by the experiences and stories of patient and therapist. The patient, a medical student, initially told her story in a restitution narrative, focusing on cognitive rationality. Reconstructing the history of her disease, her story changed into a quest narrative where there was room for emotions, values and moral learning. This fitted well with the therapist’s approach, who used motivational interventions with a view to appealing to the patient’s responsibility to deal with her condition. We conclude that in practice both the patient and therapist used a quest narrative, approaching competence as the potential for practical reasoning to incorporate values and emotions. (shrink)

Decisional capacity evaluations (DCEs) occur in clinical settings where it is unclear whether a consumer of medical services has the capacity to make an informed decision about the relevant medical options. DCEs are localized interventions, not the global loss of competence, that assign a surrogate decision maker to make the decision on behalf of the medical consumer. We maintain that one important necessary condition for a DCE to be morally justified, in cases of medical necessity, is that the (...) health care consumer under evaluation is incapable of expressing a preference for a certain outcome. (shrink)

How does one scientifically verify a psychometric instrument designed to assess the mental competence of medical patients who are asked to consent to medical treatment? Aside from satisfying technical requirements like statistical reliability, results yielded by such a test must conform to at least some accepted pretheoretical desiderata; for example, determinations of competence, as measured by the test, must capture a minimal core of accepted basic intuitions about what competence means and what a theory of competence (...) is supposed to do. The concepts of “face validity” and “content validity” are both important here. Face validity “indicates that an instrument appears to test what it is supposed to and that it is a plausible method for doing so” (Portney and Watkins 2000, 82). Content validity “means that the test contains all the elements that reflect the variable being studied” (Portney and.. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Anorexia and the MacCAT-T Test for Mental Competence:Validity, Value, and EmotionLouis C. Charland (bio)Keywordsmental competence, decisional capacity, anorexia, value, emotionValidity of the MacCAT-THow does one scientifically verify a psychometric instrument designed to assess the mental competence of medical patients who are asked to consent to medical treatment? Aside from satisfying technical requirements like statistical reliability, results yielded by such a test must conform to at (...) least some accepted pretheoretical desiderata; for example, determinations of competence, as measured by the test, must capture a minimal core of accepted basic intuitions about what competence means and what a theory of competence is supposed to do. The concepts of "face validity" and "content validity" are both important here. Face validity "indicates that an instrument appears to test what it is supposed to and that it is a plausible method for doing so" (Portney and Watkins 2000, 82). Content validity "means that the test contains all the elements that reflect the variable being studied" (Portney and Watkins 2000, 83). An adequate instrument for measuring mental competence must at minimum satisfy both of these requirements.What Tan and her colleagues (2006) have shown is that the MacArthur Competence Assessment Tool—Treatment (MacCAT-T) test for mental competence may not be an empirically valid measure of mental competence for some cases of anorexia. The data they report show that "competence," as measured by the MacCAT-T, does not conform sufficiently well with what is wanted of a clinical medical theory of competence. More specifically, the MacCAT-T is deficient in both face and content validity. This result is extremely significant; previous challenges to the validity of the MacCAT-T have often been largely theoretical in nature. My own objection that the MacCAT is inadequate because it omits the influence of emotion is based on a combination of empirical theory (Charland 1998a) and philosophical argument (Charland 1998b). However, it is entirely theoretical in nature. So is my argument that in ignoring emotion the MacCAT misses a crucial contributing ingredient in competence, namely, value (Charland 2001, see especially 136 note 2). Tan's study provides valuable empirical evidence for the second of these challenges, which deals more specifically with value. On the one hand, the study clearly demonstrates that patients sometimes do [End Page 283] base their treatment decisions on reasons derived from values. And on the other hand, it also nicely illustrates the centrality of values—"utilities" or "preferences"—in the decision-making process generally; a basic assumption of standard decision theory for which, paradoxically, there appears to be no satisfactory counterpart in the MacCAT-T model of reasoning and decision making.Thus, values figure among the reasons that patients actually use in reasoning when they weigh the risks and benefits of proposed treatment options. The MacCAT-T must be amended to incorporate this fact if it is to be a satisfactory clinical medical tool. Without such a correction, the concept of mental competence it measures is empirically invalid. At the root of the problem is a clash of intuitions. Tan's data provide convincing evidence that some of the patients who are deemed to be mentally competent by MacCAT-T standards should not in fact be considered competent. Note that the language in which this clash is expressed—"should not in fact"—involves a combination of descriptive and prescriptive elements, reminding us that the concept of competence is dual in nature: it is both prescriptive and descriptive (Freedman 1981). These problems underscore the need for greater clarity about what pretheoretically we want a clinical theory and test of competence to capture. It is of course reasonable to say that such a test must be consistent with major tenets of the relevant case law (Appelbaum 1998). But a legally valid concept of competence of this sort is too thin and arbitrary a foundation on which to build a clinical medical theory of competence. An empirically valid theory and test of the latter sort must incorporate the role of values if it is be truly helpful in medical practice.Value and the MacCAT-TI agree with Tan and her colleagues that some notion of "pathological value" needs to be... (shrink)

We study the uncertain dichotomous choice model. In this model a set of decision makers is required to select one of two alternatives, say ‘support’ or ‘reject’ a certain proposal. Applications of this model are relevant to many areas, such as political science, economics, business and management. The purpose of this paper is to estimate and compare the probabilities that different decision rules may be optimal. We consider the expert rule, the majority rule and a few in-between rules. The information (...) on the decisional skills is incomplete, and these skills arise from an exponential distribution. It turns out that the probability that the expert rule is optimal far exceeds the probability that the majority rule is optimal, especially as the number of the decision makers becomes large. (shrink)

In euthanasia and/or assisted suicide of persons with dementia, the controversy has mostly focused on decisionally incapable persons with very advanced dementia for whom the procedure must be based on a written advance euthanasia directive. This focus on advance euthanasia directive-based EAS has been accompanied by scant attention to the issue of decision-making capacity assessment of persons with dementia who are being evaluated for concurrent request EAS. We build on a previous analysis of concurrent request EAS cases from the Netherlands, (...) which showed that many such cases involve persons with significant cognitive impairment. We use illustrative cases to describe the difficulty of determining decisional capacity in persons whose stage of dementia falls between severely impaired and mildly impaired. We show that the Dutch practice of capacity assessment in such dementia cases is difficult to reconcile with the widely accepted functional model of capacity—a model explicitly endorsed by the Dutch euthanasia review committees. We discuss why such deviations from the standard functional model might be occurring, as well as their ethical implications for dementia EAS policy and practice. (shrink)

Ethics consultation has become an integral part of the fabric of U.S. health care delivery. This article summarizes the second edition of the Core Competencies for Health Care Ethics Consultation report of the American Society for Bioethics and Humanities. The core knowledge and skills competencies identified in the first edition of Core Competencies have been adopted by various ethics consultation services and education programs, providing evidence of their endorsement as health care ethics consultation (HCEC) standards. This revised report was prompted (...) by thinking in the field that has evolved since the original report. Patients, family members, and health care providers who encounter ethical questions or concerns that ethics consultants could help address deserve access to efficient, effective, and accountable HCEC services. All individuals providing such services should be held to the standards of competence and quality described in the revised report. (shrink)

A ‘Ulysses arrangement’ (UA) is an agreement where a patient may arrange for psychiatric treatment or non-treatment to occur at a later stage when she expects to change her mind. In this article, I focus on ‘competence-insensitive’ UAs, which raise the question of the permissibility of overriding the patient’s subsequent decisionally competent change of mind on the authority of the patient’s own prior agreement. In “The Ethical Justification for Ulysses Arrangements”, I consider sceptical and supportive arguments concerning competence-insensitive (...) UAs, and argue that there are compelling reasons to give such UAs serious consideration. In “Decisional Competence and Legal Capacity in UAs”, I examine the nature of decisional competence and legal capacity as they arise in UAs, an issue neglected by previous research. Using the distinctions which emerge, I then identify the legal structure of a competence-insensitive UA in terms of the types of legal capacity it embodies and go on to explain how types of legal capacity might be shared between the patient and a trusted other to offer support to the patient in the creation and implementation of a competence-insensitive UA. This is significant because it suggests possibilities for building patient support mechanisms into models of legal UAs, which has not addressed in the literature to date. Drawing on this, in “Using Insights from the Competence/Capacity Distinction to Enhance Patient Support in UAs”, I offer two possible models to operationalize competence-insensitive UAs in law that allow for varying degrees of patient support through the involvement of a trusted other. Finally, I outline some potential obstacles implementing these models would face and highlight areas for further research. (shrink)

ObjectivesTo investigate which of two sources of information about an older adult’s wishes—choices made in an advance directive or proxy’s opinion—provides better insight into the older adult’s preferences measured in hypothetical clinical situations involving decisional incapacity.MethodsSecondary analyses of data collected from 157 community-dwelling, decisionally competent adults aged 70 years and over who attended a group information session on advance directives with their proxy. Older adults were invited to complete a directive introduced during the session, designed to express healthcare preferences. (...) An average of 3 months later, older adults were asked during an interview whether they would want to receive each of four medical interventions and what their goals of care would be should they develop one of three sudden health events, assuming that they had severe dementia. Proxies were asked to guess the older adult’s answers in each of the seven scenarios.ResultsEighty per cent of the older adults completed the directive. Choices they made in the directive were more in line with the preferences they stated during the interview than were their proxies’ guesses at their answers. However, concordance was relatively low, with percentages of agreement ranging from 43% to 83% across scenarios.ConclusionsFindings suggest that a directive might provide better insight into a person’s wishes than the person’s proxy, although neither source is perfect. A multifaceted decision-making model that includes both sources of information might better serve the interests of older adults who have lost the capacity to make decisions on their own.Trial registration numberISRCTN89993391; Post-results. (shrink)

End-of-life decision-making in patients with dementia is a complex topic. Belgium and the Netherlands have been at the forefront of legislative advancement and progressive societal changes concerning the perspectives toward physician-assisted death (PAD). Careful consideration of clinical and social aspects is essential during the end-of-life decision-making process in patients with dementia. Geriatric assent provides the physician, the patient and his family the opportunity to end life with dignity. Unbearable suffering, decisional competence, and awareness of memory deficits are among (...) the clinical considerations that physicians should incorporate during the end-of-life decision-making process. However, as other societies introduce legislature granting the right of PAD, new social determinants should be considered; Mexico City is an example. Current perspectives regarding advance euthanasia directives (AED) and PAD in patients with dementia are evolving. A new perspective that hinges on the role of the family and geriatric assent should help culturally heterogeneous societies in the transition of their public health care policies regarding end-of-life choices. (shrink)

Decision-Making Capacity First published Tue Jan 15, 2008; substantive revision Fri Aug 14, 2020 In many Western jurisdictions the law presumes that adult persons, and sometimes children that meet certain criteria, are capable of making their own medical decisions; for example, consenting to a particular medical treatment, or consenting to participate in a research trial. But what exactly does it mean to say that a subject has or lacks the requisite capacity to decide? This question has to do with what (...) is commonly called “decisional capacity”, a central concept in health care law and ethics, and increasingly an independent topic of philosophical inquiry. -/- Decisional capacity can be defined as the ability of subjects to make their own medical decisions. Somewhat similar questions of capacity arise in other contexts, such as capacity to stand trial in a court of law and the ability to make decisions that relate to personal care and finances. However, the history behind the more general legal notions of capacity to stand trial and capacity to manage one’s life is different and operates somewhat differently in law (Roth, Meisel, & Litz 1977; Zapf & Roesch 2005). For the purposes of this discussion the notion of decisional capacity will be limited to medical contexts only; most notably, those where decisions to consent or to refuse treatment or participation in clinical research are concerned. (shrink)

BackgroundInformed consent is a key element of ethical clinical research. Addicted population may be at risk for impaired consent capacity. However, very little research has focused on their comprehension of consent forms. The aim of this study is to assess the capacity of addicted individuals to provide consent to research.Methods53 subjects with DSM-5 diagnoses of a Substance Use Disorder and 50 non psychiatric comparison subjects participated in the survey from December 2014 to March 2015. This cross-sectional study was carried out (...) at a community-based Outpatient Treatment Center and at an urban-located Health Centre in Spain. A binary judgment of capacity/incapacity was made guided by the MacArthur Competence Assessment Tool for Clinical Research and a clinical interview. Demographics and clinical characteristics were assessed by cases notes and the Mini-Mental State Examination, the Global Assessment Functional Scale and the Clinical Global Impression Scale.ResultsNPCs performed the best on the MacCAT–CR, and patients with SUD had the worst performance, particularly on the Understanding and Appreciation subscales. 32.7 % SUD people lacked research-related decisional capacity. There were no statistically significant differences between the groups in terms of capacity to consent to research.ConclusionsThe findings of our study provide evidence that a large proportion of individuals with SUD had decisional capacity for consent to research. It is therefore inappropriate to draw conclusions about capacity to make research decisions on the basis of a SUD diagnosis. In the absence of advanced cognitive impairment, acute withdrawal or intoxication, we should assume that addicted persons possess decision-making capacity. Thus, the view that people with SUD would ipso facto lose decision-making power for research consent is flawed and stigmatizing. (shrink)

There are reasons to believe that decision‐making capacity (mental competence) of women in labor may be compromised in relation to giving informed consent to epidural analgesia. Not only severe labor pain, but also stress, anxiety, and premedication of analgesics such as opioids, may influence women’s decisional capacity. Decision‐making capacity is a complex construct involving cognitive and emotional components which cannot be reduced to ‘understanding’ alone. A systematic literature search identified a total of 20 empirical studies focused on women’s (...) decision‐making about epidural analgesia for labor pain. Our review of these studies suggests that empirical evidence to date is insufficient to determine whether women undergoing labor are capable of consenting to epidural analgesia. Given such uncertainties, sufficient information about pain management should be provided as part of prenatal education and the consent process must be carefully conducted to enhance women’s autonomy. To fill in the significant gap in clinical knowledge about laboring women’s decision‐making capacity, well‐designed prospective and retrospective studies may be required. (shrink)

Defends an alternative to danger to self or others as a basis for involuntary treatment. Involuntary hospitalization for treatment should hinge on a patient's competence to refuse treatment.

There is an important gap in philosophical, clinical and bioethical conceptions of decision-making capacity. These fields recognize that when traumatic life circumstances occur, people not only feel afraid and demoralized, but may develop catastrophic thinking and other beliefs that can lead to poor judgment. Yet there has been no articulation of the ways in which such beliefs may actually derail decision-making capacity. In particular, certain emotionally grounded beliefs are systematically unresponsive to evidence, and this can block the ability to deliberate (...) about alternatives. People who meet medico-legal criteria for decision-making capacity can react to health and personal crises with such capacity-derailing reactions. One aspect of this is that a person who is otherwise cognitively intact may be unable to appreciate her own future quality of life while in this complex state of mind. This raises troubling ethical challenges. We cannot rely on the current standard assessment of cognition to determine decisional rights in medical and other settings. We need to understand better how emotionally grounded beliefs interfere with decision-making capacity, in order to identify when caregivers have an obligation to intervene. (shrink)

The nurse's moral competences in the management of situations which present ethical implications are less investigated in literature than other ethical problems related to clinical nursing. Phenomenology affirms that emotional warmth is the first fundamental attitude as well as the premise of any ethical reasoning. Nevertheless, it is not clear how and when this could be confirmed in situations where the effect of emotions on the nurse's decisional process is undiscovered. To explore the processes through which situations of moral (...) distress are determined for the nurses involved in nursing situations, a phenomenological–hermeneutic analysis of a nurse's report of an experience lived by her as a moral distress situation has been conducted. Nursing emerges as a relational doctrine that requires the nurse to have different degrees of personal involvement, the integration between logical–formal thinking and narrative thinking, the perception of the salience of the given situation also through the interpretation and management of one's own emotions, and the capacity to undergo a process of co‐construction of shared meanings that the others might consider adequate for the resolution of her problem. Moral action requires the nurse to think constantly about the important things that are happening in a nursing situation. Commitment towards practical situations is directed to training in order to promote the nurse's reflective ability towards finding salience in nursing situations, but it is also directed to the management of nursing assistance and human resources for the initial impact that this reflexive ability has on patients' and their families' lives and on their need to be heard and assisted. The only case analysed does not allow generalizations. Further research is needed to investigate how feelings generated by emotional acceptance influence ethical decision making and moral distress in nursing situations. (shrink)

Respect for patient autonomy is paramount in resolving ethical tensions in end-of-life care. The concept of relational autonomy has contributed to this debate; however, scholars often use this concept in a fragmented manner. This leads to partial answers on ascertaining patients’ true wishes, meaningfully engaging patients’ significant others, balancing interests among patients and significant others, and determining clinicians’ obligations to change patients’ unconventional convictions to enhance patient autonomy. A satisfactory solution based on relational autonomy must incorporate patients’ competence (apart (...) from decisional capacity), authenticity (their true desires or beliefs) and the involvement level of their significant others. To that end, we argue that John Christman’s procedural approach to relational autonomy provides critical insights, such as the diachronic or socio-historical personhood, sustained critical reflection and his recent explication of the nature of asymmetrical relationships and helpful interlocutors. This study reviews Christman’s account, proposes minor modifications and advocates for an integrated three-dimensional model for medical decision-making. Clarifying the relationship among the three elements promotes an ethical framework with a coherent understanding of relational autonomy. This model not only provides a descriptive and normative framework for end-of-life care practice but also reconsiders the nature of the clinician–patient relationship and its normative implications. We further present a case study to illustrate the merits of our proposed model. Altogether, our proposal will help navigate complex medical decision-making, foster trust and negotiate shared values between patients and their significant others, particularly in end-of-life care. (shrink)

Uncertainty is inherent in new and unexpected viral outbreaks such as the current COVID-19 pandemic. It imposes challenges for health officials in soliciting cooperative behavioural changes based on incomplete information. In this paper, we use evolving mask recommendations in the United States as an example to analyse the ethical importance and practical demonstration of trustworthiness in pandemic messaging and decision-making. We argue that responsible public health interventions in the time of uncertainties requires explicit intersecting ethical considerations both in action and (...) in communication to promote trustworthiness. First, as public health decisions have to be made in the face of incomplete and evolving data, health officials need to exhibit competence while committing to epistemic humility. They can explain the methods used in making and updating mask recommendations as well as explicitly acknowledge the need to incorporate sociocultural and other contextual considerations in translating scientific data into mask recommendations. Second, officials and agencies must uphold and communicate decisional transparency as part of their effort to demonstrate accountability and promote the public’s understanding of the evolving pandemic. Third, especially since both the pandemic and mask recommendations may have disparate impact on different populations, officials should start with the fair implementation of the least restrictive measures that can help reduce harm. (shrink)

In order to make strategic decisions and improve their firm’s performance, top management teams must have information on the competitive context in general, and the firm’s competitors in particular. During the decision-making process, top managers can have access to “privileged information”—i.e., information of a confidential and potentially strategic nature that could ultimately confer a decisional advantage over competing parties. However, obtaining and using privileged information in a business context is often illegal—and if not, is usually deemed unethical or “against (...) the rules.” Using a quasi-experimental design, this study explores the reasons why an individual might engage in such unethical behavior. We assess the extent to which managers use privileged information with respect to perceived team cohesion and peers’ ethicality. More specifically, our results show that the use of privileged information is predicted by the decision-maker’s perceptions of their team cohesion and their peers’ ethicality. Moreover, we find that team performance, as a group-level nonself-reported factor, moderates the relationship between cohesion and the use of privileged information. The relationship between cohesion, ethical behavior, and team performance is also discussed. We draw on these findings to make some practical suggestions on how to incorporate practices that could better prevent the unethical use of privileged information in strategic decision-making processes. (shrink)

Reports of children participating in hunger strikes while detained in offshore detention centres raise interrelated ethical issues and recognizable challenges for the medical decision-makers at these sites. A composite case study, informed by reports in the public domain, is employed to explore the unique challenges of consent and decision-making in these circumstances and the perennial issues inherent in adolescents’ developing capacity and autonomy. We present an amalgamated case of a fourteen-year-old adolescent who refused to consent to medical reversal of her (...) hunger strike protest. The medical team became the final arbiter when her parents, who were also in detention, could not agree with each other even after mediation. The case explores the complexity of evaluating the adolescent’s capacity to provide informed consent while influenced by the opinions of co-detainees in this extreme setting. We argue that the parents and the child had compromised decisional capacity due to the effects of detention. The challenges to the medical team are recognized and discussed. The team members faced a difficult dilemma and considered the competing values of the multiple cultural and ethical factors. Each team member integrated his or her own roles, duties, and discipline-specific professional guidelines with the primary goal of mitigating potential harms. (shrink)

BackgroundFollowing several landmark rulings and increasing public support for physician-assisted death, in 2016, Canada became one of a handful of countries legalising medical assistance in dying (MAiD) with Bill C-14. However, the revised Bill C-7 proposes the specific exclusion of MAiD where a mental disorder is the sole underlying medical condition (MAiD MD-SUMC).AimThis review explores how some persons with serious and persistent mental illness (SPMI) could meet sensible and just criteria for MAiD under the Canadian legislative framework.MethodsWe review the proposed (...) Bill C-7 criteria (capacity, voluntariness, irremediability and suffering) as well as the nuances involved in separating a well-reasoned request for assisted suicide from what might be solely a manifestation of a SPMI.FindingsIn this paper, we argue against the absolute exclusion of patients with SPMIs from accessing MAiD. Instead, we propose that in some circumstances, MAiD MD-SUMC may be justifiable while remaining the last resort. Conducting MAiD eligibility assessments removes the need to introduce diagnosis-specific language into MAiD legislation. Competent psychiatric patients who request MAiD should not be treated any differently from other eligible candidates. Many individuals with psychiatric disorders will be incapable of consenting to MAiD. The only ethical option is to assess eligibility for MAiD on an individual basis and include as legitimate candidates those who suffer solely from psychiatric illness who have the decisional capacity to consent to MAiD. (shrink)

Based on extensive questionnaire data, this paper focuses on parents’ views about children’s right to decide about participation in research. The data originates from 4000 families participating in a longitudinal prospective screening as 1997. Although current regulations and recommendations underline that children should have influence over their participation, many parents in this study disagree. Most (66%) were positive providing information to the child about relevant aspects of the study. However, responding parents were split about whether or not children should at (...) some point be allowed decisional authority when participating in research: 41.6% of the parents reported being against or unsure. Those who responded positively believed that children should be allowed to decide about blood-sampling procedures (70%), but to a less extent about participation (48.5%), analyses of samples (19.7%) and biological bank storage (15.4%). That as many as possible should remain in the study, and that children do not have the competence to understand the consequences for research was strongly stressed by respondents who do not think children should have a right to decide. When asked what interests they consider most important in paediatric research, child autonomy and decision-making was ranked lowest. We discuss the implications of these findings. (shrink)

Context Informed consent is crucial in daily clinical practice and research in medicine and psychiatry. A recent neuroethical investigation explored the psychological factors that are crucial in determining whether or not subjects give consent. While cognitive functions have been shown to play a central role, the impact of empathy and emotions on subjects' decisions in informed consent remains unclear. Objective To evaluate the impact of empathy and emotions on subjects' decision in informed consent in an exploratory study. Design Decisional (...) capacity and informed consent to a subsequent imaging study were evaluated with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR). Empathy and emotion recognition were measured with the Multifaceted Empathy Test (MET) and the Florida Affect Battery (FAB). Setting Psychiatric subjects were recruited from a general psychiatric hospital and a forensic state hospital. Patients A mixed group of 98 healthy men and forensic and non-forensic psychiatric subjects were investigated. Results Both empathy (MET) and emotion recognition (FAB) correlated with MacCAT-CR scores. Higher cognitive empathy and good emotion recognition (compared with low empathy and emotion recognition) were associated with increased decisional capacity and higher rates of refusal to give informed consent. Conclusions This study shows an empirical relationship between decision-making and informed consent, on the one hand, and emotions and empathy on the other. While this study is exploratory and preliminary, the findings of a relationship between informed consent, emotions and empathy raise important neuroethical questions with regard to an emotional-social concept of informed consent and potential clinical implications for testing informed consent. (shrink)

Richard Thaler and Cass Sunstein define a nudge as “any aspect of the choice architecture that alters people's behavior in a predictable way without forbidding any options or significantly changing their economic incentives.” Much has been written about the ethics of nudging competent adult patients. Less has been written about the ethics of nudging surrogates’ decision‐making and how the ethical considerations and arguments in that context might differ. Even less has been written about nudging surrogate decision‐making in the context of (...) pediatrics, despite fundamental differences that exist between the pediatric and adult contexts. Yet, as the field of behavioral economics matures and its insights become more established and well‐known, nudges will become more crafted, sophisticated, intentional, and targeted. Thus, the time is now for reflection and ethical analysis regarding the appropriateness of nudges in pediatrics. We argue that there is an even stronger ethical justification for nudging in parental decision‐making than with competent adult patients deciding for themselves. We give three main reasons in support of this: (1) child patients do not have autonomy that can be violated (a concern with some nudges), and nudging need not violate parental decision‐making authority; (2) nudging can help fulfill pediatric clinicians’ obligations to ensure parental decisions are in the child's interests, particularly in contexts where there is high certainty that a recommended intervention is low risk and of high benefit; and (3) nudging can relieve parents’ decisional burden regarding what is best for their child, particularly with decisions that have implications for public health. (shrink)

Over the past decade or so, the predominant patient-centered ethos in American bioethics has come under attack by critics who claim that it is morally deficient in certain respects, particularly when viewed in the context of acute-care decisionmaking. One line of criticism has been that the current ethic of patient autonomy gives an individual competent patient far too much decisional authority over the terms of his own treatment so that the patient is at complete liberty to neglect the ways (...) in which his medical decisions can drastically and negatively affect the lives of other family members. Given that family members must help shoulder the financial, emotional, and rehabilitative burdens involved in the patient's care, it has been argued that they too have a legitimate interest in choosing what sort of medical treatment the patient eventually receives. Another closely related line of criticism is that the prevailing focus on patient autonomy gives short shrift to the moral significance of the family as a genuine community. Echoing a view of the person advanced by most communitarian political theorists, some commentators have argued that the patient comes to the clinic so thoroughly embedded in a complex web of familial relationships and obligations that it does not make sense to identify him as the only person in the family to make decisions about treatment. (shrink)

Privacy and technology clash in the courts. I elaborate the example of Puttaswamy v Union of India (2017), an example from the High Court of India, whose sweeping and inclusive jurisprudential style raises starkly the question of the influence that academic philosophers and other scholars have over how legitimate societal interests in exploiting information technology and protecting personal privacy are “balanced” by the courts. Philosophers will be satisfied to see that their theories are acknowledged in a landmark national decision finding (...) that India’s 1.3 billion people have a constitutional, fundamental right to privacy that constrains a challenged government biometric identification system. Some scholars will appreciate the inclusive definition of privacy, which included decisional privacy, combined with the treatment of privacy as a paramount human good meriting the protection of fundamental rights. But some academic philosophers are potentially disappointed that the Court synthesizes rather than differentiates among their competing theories, concepts, and definitions, and, in the end, relies upon liberal Enlightenment ideals that some scholars have argued are singularly ill-suited for the twenty-first century. (shrink)

This chapter explores whether it is possible to treat incompetent persons paternalistically. What is often seen to be wrong about acting paternalistically towards others is that one is treating these others as if they cannot make their own decisions about their own good. So how should one think about situations where one must make decisions on behalf of people who indeed cannot make their own decisions about their own good – especially if these people are still to some extent capable (...) of expressing their desires and concerns about what happens to them? This is often the case in the medical setting, when a patient has lost decisional capacity or has not developed such a capacity in the first place. Focusing on the medical setting, this chapter argues that insofar as someone has the component elements of agency, they can be the target of unjustified paternalism. The chapter first explores the ways in which patients may lack decisional capacity and whether such patients nevertheless retain a sense of agency that can be disrespected. It then examines whether, on some plausible accounts of paternalism, what constitutes disrespect towards the competent constitutes a similar disrespect to the agential capacities of the incompetent. (shrink)

Gaining informed consent among marginalized groups that include decisionally incapacitated individuals and those outside of the researcher's own geo-social and ethnic background still challenges many researchers. We suggest that there is a need for consideration of a different approach to research ethics in international settings. Based on extensive field work in West Africa on medical knowledge transfers and patient–healer relationships, this paper will discuss the challenges posed in obtaining informed individual consent in international settings. It is argued that while being (...) on the whole convincing, the top-down approach of the proposed solutions, which clearly dominates the participative approach, fails in building sustainable capacity, decision-making competency, and empowerment in the communities in which the research is conducted. Using appropriate decision aids can help resolve these issues. (shrink)

Evidence shows that during birth women frequently experience unconsented care, coercion, and a loss of autonomy. For many countries, this contradicts both the law and medical ethics guidelines, which emphasize that competent and fully informed women’s autonomy must always be respected. To better understand this discordance, we empirically describe perinatal maternity care providers’ and women’s moral deliberation surrounding coercive measures during birth. Data were obtained from 1-on-1 interviews with providers (N = 15) and women (N = 14), and a survey (...) of women (N = 118). Analyses focused on an in-depth exploration of responses to a question on the permissibility of coercion in birth whose wording was borrowed from a Swiss medical-ethical guideline. Reasons for and against a principle permissibility of coercive measures in birth were grouped into clusters of reasons to build a coherent explanatory framework. Factors considered morally relevant when deliberating on coercion included women’s decisional capacity, beneficence/non-maleficence, authority through knowledge on the part of providers, flaws of the medical system, or the imperative to protect the most vulnerable. Also, we identified various misconceptions, such as the conviction that a pathological birth can justify coercion or that fetal rights can justifiably infringe on women’s autonomy. Information and education on the issue of coercion in birth are urgently needed to enable women to fully exercise their reproductive autonomy, to prevent long-term adverse health outcomes of women and children, and to reconcile the medical vigilance which has lead to a reduction of perinatal morbidity and mortality with women’s enfranchisement in their own care. (shrink)

When mature minors face a decision with important consequences, such as whether to undergo a risky but potentially life-saving medical procedure, who should decide? Relying on liberal political theory’s account of the importance of decisional autonomy for adults, and given the scalar nature of the capacities needed to exercise decisional autonomy, I argue that mature minors with the requisite capacities and commitments have a right to decisional autonomy though they are not yet 18. I argue for this (...) right using a ‘balancing of interest’ account of rights: the interest mature minors have in decisional autonomy outweighs their parents’ interest in shaping their children as a means of ‘creative self-extension’. But I propose two limitations on this right: requests for waivers of the rule that one must be at least 18 to decide cannot be so numerous as to make adjudication impractical; and though a competent adult’s voluntary decision to refuse medical treatment should generally be respected, the state may reject a mature minor’s decision upon review by an indifferent judge of the minor’s capacities and reasons. The judge reviews not the substantive merits or prudence of the decision, but whether the decision promotes the interest in decisional autonomy, by asking among other things whether the decision is the minor’s own, is tethered to core commitments rather than based on arbitrary preferences, and could be regarded as reasonable to the minor’s ‘future self’. (shrink)