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...

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 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 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)

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)

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)

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)

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)

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)

Background: Financial conflict of interest in clinical research is an area of active debate. While data exist on the perspectives and roles of academic institutions, investigators, industry sponsors, and scientific journals, little is known about the perspectives of potential research participants.Methods: The authors surveyed potential research participants over the internet, using the Harris Interactive Chronic Illness Database. A potential research participant was defined by: self report of diagnosis by a health care professional and willingness to participate in clinical trials. Email (...) invitations were sent to 20 205 persons with coronary artery disease, breast cancer, or depression; a total of 6363 persons were screened; of these, 86% or 5478 met inclusion criteria and completed the survey. The outcome measures were respondents’ ratings on: importance of knowing conflict of interest information, whether its disclosure ought to be required, and its effect on willingness to participate—across seven widely discussed scenarios of financial conflicts of interest .Results: Majority responded that knowing conflict of interest information was “extremely” or “very” important; a larger majority felt financial conflicts of interest should be disclosed as part of informed consent . In all seven scenarios, a majority was still willing to participate but in some scenarios a sizable minority would be wary of participation. Respondents were more wary of individual than institutional conflicts of interest. Illness group and sociodemographic factors had modest effects and did not affect the main trends.Conclusions: The prevailing practice of non-disclosure of financial conflicts of interest in clinical research appears contrary to the values of potential research participants. (shrink)

It is shown that the jet mechanism derivable from the Lorentz deformation picture leads to a nearly constant average jet transverse momentum. It is pointed out that this is consistent with the high-energy experimental data. It is pointed out further that this result strengthens the physical basis for the minimal time-energy uncertainty combined covariantly with Heisenberg's space-momentum uncertainty relation.

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)

Objective: To determine whether a moral reasoning exercise can improve response quality to surveys of healthcare priorities Methods: A randomised internet survey focussing on patient age in healthcare allocation was repeated twice. From 2574 internet panel members from the USA and Canada, 2020 (79%) completed the baseline survey and 1247 (62%) completed the follow-up. We elicited respondent preferences for age via five allocation scenarios. In each scenario, a hypothetical health planner made a decision to fund one of two programmes identical (...) except for average patient age (35 vs 65 years). Half of the respondents (intervention group) were randomly assigned to receive an additional moral reasoning exercise. Responses were elicited again 7 weeks later. Numerical scores ranging from –5 (strongest preference for younger patients) to +5 (strongest preference for older patients); 0 indicates no age preference. Response quality was assessed by propensity to choose extreme or neutral values, internal consistency, temporal stability and appeal to prejudicial factors. Results: With the exception of a scenario offering palliative care, respondents preferred offering scarce resources to younger patients in all clinical contexts. This preference for younger patients was weaker in the intervention group. Indicators of response quality favoured the intervention group. Conclusions: Although people generally prefer allocating scarce resources to young patients over older ones, these preferences are significantly reduced when participants are encouraged to reflect carefully on a wide range of moral principles. A moral reasoning exercise is a promising strategy to improve response quality to surveys of healthcare priorities. (shrink)

It is shown that the Lorentz-deformation property discussed in previous papers is consistent with the hadronic jet phenomenon in high-energy production processes.

Ample research links mothers’ postpartum depression (PPD) to adverse interactions with their infants. However, most studies relied on general population samples, whereas a substantial number of women are at elevated depression risk. The purpose of this study was to describe mothers’ interactions with their 6- and 12-month-old infants among women at elevated risk, although with a range of symptom severity. We also identified higher-order factors that best characterized the interactions and tested longitudinal consistency of these factors from 6 to 12 (...) months of infant age. We leveraged data from eight projects across the United States (n = 647), using standardized depression measures and an adaptation of the NICHD Mother-Infant Interaction Scales. Overall, these depression-vulnerable mothers showed high levels of sensitivity and positive regard and low levels of intrusiveness, detachment, and negative regard with their infants. Factor analyses of maternal behaviors identified two overarching factors—“positive engagement” and “negative intrusiveness” that were comparable at 6 and 12 months of infant age. Mothers’ ability to regulate depressed mood was a key behavior that defined “positive engagement” in factor loadings. An exceptionally strong loading of intrusiveness on the second factor suggested its central importance for women at elevated depression risk. Mothers with severe depressive symptoms had significantly more “negative intrusiveness” and less “positive engagement” with their 6-month-old infants than women with moderate or fewer depressive symptoms, suggesting a potential tipping point at which symptoms may interfere with the quality of care. Results provide the foundation for further research into predictors and moderators of women’s interactions with their infant among women at elevated risk for PPD. They also indicate a need for evidence-based interventions that can support more severely depressed women in providing optimal care. (shrink)

Background The use of lengthy, detailed, and complex informed consent forms is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in (...) biomedical research. Methods This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 to 5. Results Of the 2484 questionnaires distributed, 2113 were returned. The majority of respondents considered most elements required in the ICF to be ‘moderately important’ to ‘very important’ for their decision making. Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF. Conclusions Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF. (shrink)

When is it that two objects compose a whole? Or, put another way, if Z is an object composed of X and Y, then what must be done to bring it about that X and Y both exist and Z does not exist? The author defends an answer to what is now know as the Special Composition Question.

Emotion regulation (i.e. either up- or down-regulating affective responses to emotional stimuli) has been shown to modulate long-term emotional memory formation. Further, research has demonstrated that the emotional aspects of scenes are preferentially remembered relative to neutral aspects (known as the emotional memory trade-off effect). This trade-off is often enhanced when sleep follows learning, compared to an equivalent period of time spent awake. However, the interactive effects of sleep and emotion regulation on emotional memory are poorly understood. We presented 87 (...) participants with pictures of neutral or negative objects on neutral backgrounds paired with instructions to either increase or decrease their emotional response by altering personal relevance, or to passively view the stimuli. Following a 12 h period of sleep or wakefulness, participants were tested for their memory of objects and backgrounds separately. Although we replicated the emotional memory trade-off effect, no differences in the magnitude of the trade-off effect were observed between regulation conditions. Sleep improved all aspects of memory, but it did not preferentially benefit memory for emotional components of scenes. Irrespective of a period of sleep or wake following encoding, findings suggest emotion regulation during encoding did not influence memory for emotional items at a 12-hour delay. (shrink)