This is an impressionistic and informal essay written near the end of a novelist’s Australia Research Council funded research project: ‘Developing narratives from language and stories indigenous to the south coast of Western Australia’, and informed by how that research project morphed into an emphasis on revitalization of Noongar language, and the attempt to restore connections between a particular Creation Story and landscape in an area regarded as ‘massacre territory’. A sympathetic reader might think of the topic as ‘The Wirlomin (...) Noongar Language and Stories Project meets The Barren Ranges’. (shrink)

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

Florijn’s helpful discussion of the Heringa case illustrates the difficulties in drawing a boundary on eligibility conditions for EAS. In Heringa, the Dutch Supreme Court reaffirmed...

We analyse the tensions in a hybrid collaboration and how these are mitigated using boundary-spanning community impact, leading to compatibility between distinctive institutional logics. Our qualitative longitudinal study undertaken during 2011–2016 involved reviewing literature and archival data, key informant interviews, workshop and focus groups. We analysed common themes within the data, relating to our two research questions concerning how and why hybrids collaborate, and how resulting tensions are mitigated. The findings suggest a viable model of service delivery termed hybridized collaboration (...) in which the inherent tensions from different institutional logics do not prevent success. Paradoxically, multiple logics are a basis for the partnership’s existence, but the ability to achieve different and occasionally conflicting aims simultaneously can be difficult, resulting in tensions. We offer two novel insights. First, we highlight how social enterprise hybrids collaborate locally and in multi-organizational relationships. We found that the initial opportunity to collaborate was catalysed by the existence of shared objectives. Pre-existing relationships between organizations, and the existence of synergistic capabilities also influence the choice of partners. Secondly, we identify how tensions arise, and are mitigated via several factors including the pre-existing relationships, allowing for regular “spaces of negotiation” between collaborators, the shared social mission, community social impact, the resulting public relations, and shared resources and knowledge. (shrink)

The COVID-19 pandemic put a large burden on many healthcare systems, causing fears about resource scarcity and triage. Several COVID-19 guidelines included age as an explicit factor and practices of both triage and ‘anticipatory triage’ likely limited access to hospital care for elderly patients, especially those in care homes. To ensure the legitimacy of triage guidelines, which affect the public, it is important to engage the public’s moral intuitions. Our study aimed to explore general public views in the UK on (...) the role of age, and related factors like frailty and quality of life, in triage during the COVID-19 pandemic. We held online deliberative workshops with members of the general public. Participants were guided through a deliberative process to maximise eliciting informed and considered preferences. Participants generally accepted the need for triage but strongly rejected ‘fair innings’ and ‘life projects’ principles as justifications for age-based allocation. They were also wary of the ‘maximise life-years’ principle, preferring to maximise the number of lives rather than life years saved. Although they did not arrive at a unified recommendation of one principle, a concern for three core principles and values eventually emerged: equality, efficiency and vulnerability. While these remain difficult to fully respect at once, they captured a considered, multifaceted consensus: utilitarian considerations of efficiency should be tempered with a concern for equality and vulnerability. This ‘triad’ of ethical principles may be a useful structure to guide ethical deliberation as societies negotiate the conflicting ethical demands of triage. (shrink)

Subjects enrolled in studies testing high risk interventions for incurable or progressive brain diseases may be vulnerable to deficiencies in informed consent, such as the therapeutic misconception. However, the definition and measurement of the therapeutic misconception is a subject of continuing debate. Our qualitative pilot study of persons enrolled in a phase I trial of gene transfer for Parkinson disease suggests potential avenues for both measuring and preventing the therapeutic misconception. Building on earlier literature on the topic, we developed and (...) tested an interview guide that focuses on how the subjects decided to participate, emphasizing the integration of subjects’ various statements that are relevant to assessing the therapeutic misconception, rather than evaluating them as isolated statements. The results indicate that a subject’s understanding of the purpose of research is best explored in juxtaposition to the subject’s motivation for participating. (shrink)

Should the assessment of decision‐making capacity (DMC) be risk sensitive, that is, should the threshold for DMC vary with risk? The debate over this question is now nearly five decades old. To many, the idea that DMC assessments should be risk sensitive is intuitive and commonsense. To others, the idea is paternalistic or incoherent, or both; they argue that the riskiness of a given decision should increase the epistemic scrutiny in the evaluation of DMC, not increase the threshold for DMC. (...) We respond to the critics’ main concerns by providing a comprehensive account of how risk‐sensitive DMC is coherent, avoids paternalism, and best fulfills the epistemic goal of DMC evaluations. (shrink)

By the time this essay is published, it will be a matter of weeks before doctors and nurse practitioners in Canada can legally end the lives (by medical assistance in dying, or MAID) of non-dying p...

Shavelson et al. (2023) raise the familiar question of parity or fairness in the assisted dying1 debate: if we legally permit the practice for one person, should we not permit everyone similarly si...

The Patient Preference Predictor (PPP) proposal places a high priority on the accuracy of predicting patients’ preferences and finds the performance of surrogates inadequate. However, the quest to develop a highly accurate, individualized statistical model has significant obstacles. First, it will be impossible to validate the PPP beyond the limit imposed by 60%–80% reliability of people’s preferences for future medical decisions—a figure no better than the known average accuracy of surrogates. Second, evidence supports the view that a sizable minority of (...) persons may not even have preferences to predict. Third, many, perhaps most, people express their autonomy just as much by entrusting their loved ones to exercise their judgment than by desiring to specifically control future decisions. Surrogate decision making faces none of these issues and, in fact, it may be more efficient, accurate, and authoritative than is commonly assumed. (shrink)

Volume 19, Issue 10, October 2019, Page 3-7.

Most jurisdictions require that a mental capacity assessment be conducted using a functional model whose definition includes several abilities. In England and Wales and in increasing number of countries, the law requires a person be able to understand, to retain, to use or weigh relevant information and to communicate one’s decision. But interpreting and applying broad and vague criteria, such as the ability ‘to use or weigh’ to a diverse range of presentations is challenging. By examining actual court judgements of (...) capacity, we previously developed a descriptive typology of justifications used in the application of the Mental Capacity Act criteria. We here critically optimise this typology by showing how clear definitions—and thus boundaries—between the criteria can be achieved if the ‘understanding’ criterion is used narrowly and the multiple rationales that fall under the ability to ‘use or weigh’ are specifically enumerated in practice. Such a typology-aided practice, in theory, could make functional capacity assessments more transparent, accountable, reliable and valid. It may also help to create targeted supports for decision making by the vulnerable. We also discuss how the typology could evolve legally and scientifically, and how it lays the groundwork for clinical research on the abilities enumerated by the MCA. No data are available. This paper does not report any original data. (shrink)

We are grateful to Jongsma et al 1 for their interest in our article analysing the case of ‘Mrs A’, a Dutch woman with Alzheimer’s disease who received euthanasia based on her advance euthanasia directive.2 Their commentary criticises two elements of our analysis. First, the authors believe our reasons for doubting that Mrs A had the capacity to write and revise an AED rely on ‘partial’ empirical data and rest on normative errors. Second, they use two of our statements to (...) suggest we must endorse some implausible claims, for example, that ‘… in all situations and for all people, current well-being should always take precedence over all other values’. Jongsma et al assert: ‘Miller et al argue that people with dementia are impaired to make decisions.’ This casts our probabilistic claim about Mrs A’s capacity as an absolute claim about persons with dementia in general. It also implies we are using an outdated diagnosis-based view of capacity. The accusation then becomes explicit : > … several empirical studies have shown that patients with dementia are able to actively participate in qualitative studies and can respond to open questions in a meaningful way,[2-8] as well that they are able to complete an advance directive in the early phases of dementia.[9, 10] One can therefore not simply conclude on the basis of the diagnosis of dementia …. (shrink)

Bioethicists have long been concerned that seriously ill patients entering early phase (‘phase I’) treatment trials are motivated by therapeutic benefit even though the likelihood of benefit is low. In spite of these concerns, consent forms for phase I studies involving seriously ill patients generally employ indeterminate benefit statements rather than unambiguous statements of unlikely benefit. This seeming mismatch between attitudes and actions suggests a need to better understand research ethics committee members’ attitudes toward communication of potential benefits and risks (...) of early phase studies to potential subjects. We surveyed the members of two U.S. research ethics committees using a phase I gene transfer study scenario, and compared the results to a previous survey of potential subjects’ perceptions and attitudes toward benefit and risk for the same protocol. The results show that there is indeed a gap between the subjects’ perceptions and the committee members’ views on what is appropriate to be communicated to research subjects. This discrepancy is the product of both the commonly assumed optimism of the subjects and to a “protective pessimism” of the research ethics committee members. We discuss this discrepancy using “frameworks of trust” and demonstrate the need to incorporate these frameworks into the existing model of informed consent. (shrink)

The aims of this book are to “explain the concept of an inalienable right,” “show why it is morally justifiable to ascribe inalienability to some legal rights,” and “examine in more detail some selected rights”. Inalienability of rights is said to be particularly pertinent in bioethics since, for example, if the right to life is inalienable, it would seem that euthanasia and assisted suicide would be impermissible. I will limit my comments to McConnell’s discussions of the first two aims and (...) his discussions on euthanasia and assisted suicide. Given the highly contentious nature of the debate over euthanasia and assisted suicide, the possibility of illuminating that debate through a study of inalienable rights is quite attractive. (shrink)

The routine practice of clinical research involving patient-subjects without informed consent prior to 1966 unquestionably was unethical. Does it follow that all clinical research involving competent adult patient-subjects is unethical without informed consent?In his landmark 1966 paper, Henry Beecher noted that of the 50 example studies he had originally compiled in preparation for that paper, only two even mentioned consent, and he observed further that mention of consent is “meaningless unless one knows how fully the patient was informed”. Some of (...) the studies in Beecher’s paper, such as one comparing sulfadiazine with no treatment to assess the complications of streptococcal pharyngitis (when the... (shrink)

The “learning health care system” is being heralded as offering great potential for improving the quality and cost-worthiness of medical care by closely integrating the care of patients with the accumulation of aggregate data that can guide evidence-based medicine. By using electronic medical records, routine patient care and administrative data will be available for systematic observational studies. With the aid of these electronic medical records, quality-improvement studies of institutional practices and pragmatic, comparative effectiveness randomized trials of individual treatments could become (...) standard features of the medical care environment in the LHS. In this.. (shrink)

The modern legal and ethical movement against traditional welfare paternalism in medical decision-making extends to how decisions are made for patients lacking decisional capacity, prioritising surrogates’ judgment about what patients would have decided over even their best interests. In England and Wales, the Mental Capacity Act 2005 follows this trend of prioritising the patient’s prior wishes, values and beliefs but the dominant interpretation in life-sustaining treatment cases does so by in effect calling those values the ‘best interests’ of the patient (...) and focusing nearly exclusively on the ‘subjective’ viewpoint of the patient. In this article, we examine the recent Court of Protection judgment inBarnsley Hospitals NHS Foundation Trust v MSP[2020] EWCOP 26, which adhered closely to this approach, to suggest that it could have unexpected negative consequences. These include insufficient information gathering about and attention to patients’ objective medical interests, inadequacy of the evidentiary standard used for the substituted decision-making and, in some cases, even prioritising a surrogate’s current substituted judgment over the potential for an actual judgment by the patient. (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)

Authorising euthanasia and assisted suicide with advance euthanasia directives is permitted, yet debated, in the Netherlands. We focus on a recent controversial case in which a Dutch woman with Alzheimer’s disease was euthanised based on her AED. A Dutch euthanasia review committee found that the physician performing the euthanasia failed to follow due care requirements for euthanasia and assisted suicide. This case is notable because it is the first case to trigger a criminal investigation since the 2002 Dutch euthanasia law (...) was enacted. Thus far, only brief descriptions of the case have been reported in English language journals and media. We provide a detailed description of the case, review the main challenges of preparing and applying AEDs for persons with dementia and briefly assess the adequacy of the current oversight system governing AEDs. (shrink)

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

Donors to biobanks are typically asked to give blanket consent, allowing their donation to be used in any research authorized by the biobank. This type of consent ignores the evidence that some donors have moral, religious, or cultural concerns about the future uses of their donations – concerns we call “non-welfare interests”. The nature of non-welfare interests and their effect on willingness to donate to a biobank is not well understood. In order to better undersand the influence of non-welfare interests, (...) we surveyed a national sample of the US population using a probability-based internet panel. Logistic regression models assessed the demographic and attitudinal characteristics associated with participants’ willingness to give consent for unspecified future uses of their donation when presented with 7 research scenarios that raised possible non-welfare interest concerns. Most people had non-welfare interests that significantly affect their willingness to donate to a biobank using blanket consent. Some non-welfare interests are associated with subgroups but others are not. A positive attitude toward biomedical research in general was associated with increased willingness to donate, while concerns about privacy and being African American were associated with decreased willingness. Non-welfare interests matter and can diminish willingness to donate to a biobank. Our data suggest that trust in research promotes willingness to donate. Ignoring non-welfare interests could erode this trust. Donors’ non-welfare interests could be accommodated through greater transparency and easier access to information about the uses of donations. (shrink)

A growing number of clinical trials use invasive research procedures to obtain tissue for disease screening and to monitor the effects of drugs. These procedures can be ethically contentious because they often have neither therapeutic nor diagnostic value, and because research participants may not realize this, which could compromise the validity of their consent to the procedure. In the first section of this paper, we describe the burdens, risks, and benefits associated with certain common invasive, nondiagnostic research procedures. We next (...) offer a series of arguments about the general properties of a valid consent for such procedures, and we close by examining what is currently known about consent quality for invasive research procedures when measured against the standards laid out in the second section. We conclude that there is little evidence to either confirm or dispel concerns about participants’ consent quality for protocols involving invasive, nondiagnostic research procedures. (shrink)

All contemporary frameworks of mental capacity stipulate that we must begin from the presumption that an adult has capacity. This presumption is crucial, as it manifests respect for autonomy and guards against prejudice and paternalism on the part of the evaluator.Given its ubiquity, we might presume that we all understand the presumption’s meaning and application in the same way. Evidence demonstrates that this is not the case and that this has led to harm in vulnerable persons. There is thus strong (...) reason to question our presumptions about the presumption of capacity.We distinguish between two main ways of understanding and applying the presumption of capacity, and advocate for the one that we argue mitigates risk of harm. Our proposed interpretation offers many advantages in that it is consonant with actual practice of capacity evaluations, precludes confused and abusive avoidance of needed evaluations, and preserves the respect for autonomy motivating the presumption in the first place. (shrink)

Background Most jurisdictions that allow euthanasia and assisted suicide (AS) regulate it through the medical profession. However, the extent and nature of how medicine should be involved are debated. Swiss AS practice is unusual in that it is managed by lay AS organizations that rely on a law that permits AS when done for nonselfish reasons. Physicians are not mentioned in the law but are usually called upon to prescribe the lethal medications and perform capacity evaluations.Methods We analyzed in-depth interviews (...) of 23 Swiss AS experts including ethicists, lawyers, medical practitioners, and senior officials of AS organizations for their views on AS.Results Although there was agreement on some issues (e.g., need for better end-of-life care), the interviewees’ preferred model for AS, and the nature of preferred medical involvement, varied, which we categorized into five types: preference for AS practice as it occurred prior to lay AS organizations; preference for the current lay model; preference for a modified lay model to increase autonomy protections while limiting medical AS normalization; preference for various types of more medicalized models of AS; and, ambivalence about any specific model of medical involvement. The rationales given for each type of model reflected varying opinions on how medicine’s role would likely impact AS practice and demonstrated the experts’ attitudes toward those impacts.Conclusion The dynamics within the Swiss AS regime, as reflected in the varying views of Swiss AS experts, shed light on the dilemmas inherent to medical scope and involvement in AS, which may have implications for debates in other jurisdictions. (shrink)

Current treatments for chronic pain have limited benefit. We describe a resilience intervention for individuals with chronic pain which is based on a model of viewing chronic pain as dysregulated homeostasis and which seeks to restore homeostatic self-regulation using strategies exemplified by survivors of extreme environments. The intervention is expected to have broad effects on well-being and positive emotional health, to improve cognitive functions, and to reduce pain symptoms thus helping to transform the suffering of pain into self-growth. A total (...) of 88 Veterans completed the pre-assessment and were randomly assigned to either the treatment intervention or control. Fifty-eight Veterans completed pre- and post-testing. The intervention covered resilience strengths organized into four modules: engagement, social relatedness, transformation of pain and building a good life. A broad set of standardized, well validated measures were used to assess three domains of functioning: health and well-being, symptoms, and cognitive functions. Two-way Analysis of Variance was used to detect group and time differences. Broadly, results indicated significant intervention and time effects across multiple domains: Pain decreased in present severity [F = 5.02, p < 0.05, η2p = 0.08], total pain over six domains [F = 14.52, p < 0.01, η2p = 0.21], and pain interference [F = 6.82, p < 0.05, η2p = 0.11]; Affect improved in pain-related negative affect [F = 7.44, p < 0.01, η2p = 0.12], fear [F = 7.70, p < 0.01, η2p = 0.12], and distress [F = 10.87, p < 0.01, η2p = 0.16]; Well-being increased in pain mobility [F = 5.45, p < 0.05, η2p = 0.09], vitality [F = 4.54, p < 0.05, η2p = 0.07], and emotional well-being [F = 5.53, p < 0.05, η2p = 0.09] Mental health symptoms and the cognitive functioning domain did not reveal significant effects. This resilience intervention based on homeostatic self-regulation and survival strategies of survivors of extreme external environments may provide additional sociopsychobiological tools for treating individuals with chronic pain that may extend beyond treating pain symptoms to improving emotional well-being and self-growth.Clinical Trial Registration: Registered with ClinicalTrials.gov. (shrink)

BackgroundResearchers worry that patients in early-phase research experience unrealistic optimism about benefits and risks of participation. The standard measure of unrealistic optimism is the Comparative Risk/Benefit Assessment questionnaire, which asks people to estimate their chances of an outcome relative to others in similar situations. Such a comparative framework may not be a natural way for research participants to think about their chances.ObjectiveTo examine how people interpret questions measuring unrealistic optimism and how their interpretations are associated with their responses.MethodsUsing an early-phase (...) cancer trial vignette, we administered the CRBA to 297 adults from the general public. They estimated their comparative chances of risk and benefit, then provided rationales for their estimates.ResultsFor both CRBA benefit and risk questions, about 50% of respondents chose 0, and 50% chose a non-0 response. Respondents’ rationales for their estimates showed that overall only about 40%–44% gave comparative rationales, indicating that they interpreted the CRBA as intended. 68.7% of respondents who gave the ‘correct’ 0 rating gave comparative rationales, whereas only 11.6% of respondents who gave non-0 ratings did so. A similar trend was seen for chances of risk.ConclusionResearch participants may not understand comparative benefit and risk questions as intended; attributions of unrealistic optimism may require additional evidence that the respondents’ estimates are intended to be comparative. (shrink)

Introduction -- Direct realism. An introduction to direct realism : the views of D.M. Armstrong -- The representationalism of Dretske, Tye, and Lycan -- Searle's naturalism and the prospects for knowledge -- Philosophy as science : neuroscience, neurophilosophy, and naturalized epistemology. Cognitive science, philosophy, and our knowledge of reality, pt. 1. The views of David Papineau -- Cognitive science, philosophy, and our knowledge of reality, pt. 2. The views of Daniel Dennett -- Can the Churchlands' neurocomputational theory cognition ground a (...) viable epistemology? (by Errin Clark) -- Other alternatives, and naturalism's future. Other proposals : Pollock's internalism, Kim's functionalism (with Peggy Burke), and more externalist considerations -- The future directions of naturalism -- A positive case for our knowledge of reality -- Methodological naturalism and the scientific method, and other implications. (shrink)