Three standard psychometric tests were administered to parents who volunteered their children for a randomised, double-blind placebo-controlled trial of a new asthma drug and to a control group of parents whose children were eligible for the trial but had declined the invitation. The trial took place at a children's hospital in Australia. The subjects comprised 68 parents who had volunteered their children and 42 who had not, a participation rate of 94 per cent and 70 per cent, respectively. The responses (...) of these parents to the Gordon Survey of Interpersonal Values Questionnaire, the Coopersmith Self-Esteem Inventory and the Cattell Sixteen Personality Factor Questionnaire were analysed by computer. There was a marked difference between the psychological profiles of the two groups of parents. Volunteering parents put more value on benevolence while non-volunteering parents were more concerned with power and prestige. The self-esteem of volunteering parents was much lower than that of non-volunteering parents. Finally, volunteering parents were more introverted, exhibited greater anxiety and low supergo, while non-volunteering parents appeared to have greater social confidence and emotional stability. Since an individual's values, self-esteem and personality may be important antecedents of behaviour, these findings suggest that parents who volunteer their children for clinical research are not only socially disadvantaged and emotionally vulnerable, but may also be psychologically predisposed to volunteering. Furthermore, these findings provide evidence for the existence of a psychosocial 'filter' effect of the informed consent procedure, which may be discouraging the better educated, more privileged and psychologically resilient members of society from participation as research subjects. (shrink)

The issue of aftercare for participants in clinical research was explored in the context of an asthma drug trial. Although there may be financial constraints and practical difficulties with implementation, the results show that it may be feasible for clinical investigators and commercial sponsors to take on some limited responsibility for the medical care of research subjects after clinical trials. However, the ethical implications for this practice remain unclear. On the one hand, society may have a moral obligation to compensate (...) and reward some of its members who assume the risk of research subjects for the benefit of society as a whole. On the other hand, the promise of aftercare may provide an inducement to volunteers which, under certain conditions may be considered morally wrong and scientifically unsound. (shrink)

Three standard psychometric tests were administered to parents who volunteered their children for a randomised, double-blind placebo-controlled trial of a new asthma drug and to a control group of parents whose children were eligible for the trial but had declined the invitation. The trial took place at a children's hospital in Australia. The subjects comprised 68 parents who had volunteered their children and 42 who had not, a participation rate of 94 per cent and 70 per cent, respectively. The responses (...) of these parents to the Gordon Survey of Interpersonal Values Questionnaire, the Coopersmith Self-Esteem Inventory and the Cattell Sixteen Personality Factor Questionnaire were analysed by computer. There was a marked difference between the psychological profiles of the two groups of parents. Volunteering parents put more value on benevolence while non-volunteering parents were more concerned with power and prestige. The self-esteem of volunteering parents was much lower than that of non-volunteering parents. Finally, volunteering parents were more introverted, exhibited greater anxiety and low supergo, while non-volunteering parents appeared to have greater social confidence and emotional stability. Since an individual's values, self-esteem and personality may be important antecedents of behaviour, these findings suggest that parents who volunteer their children for clinical research are not only socially disadvantaged and emotionally vulnerable, but may also be psychologically predisposed to volunteering. Furthermore, these findings provide evidence for the existence of a psychosocial 'filter' effect of the informed consent procedure, which may be discouraging the better educated, more privileged and psychologically resilient members of society from participation as research subjects. (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...

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...

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)

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 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 determination of the place of life in nature has been a major philosophic issue. Some, in their attempt to show the continuity of nature, have resorted to the reductive method and have argued that the living differ in no significant sense from the non-living, unless it be in their complexity; others, in their desire to emphasize the qualitatively varied aspects of nature, have drifted to disjunctive method and have claimed that there is an unbridgeable gap between the living and (...) the non-living. Yet life in its natural setting presents both continuity with the physical world and a distinctive difference from it. One need neither sunder the continuity in nature nor deny the empirically observable qualitative differences. It is this principle that will guide the present discussion of life. (shrink)

Meanings have an empirical genesis and status. This simple claim has often been denied or ignored. Some metaphysicians in their exaltation of the eternal have regarded meanings as essences, or eternal objects, or neutral entities, in a subsistential or supernatural realm that is changeless and has no roots in nature. Some logicians in their zest to manipulate meanings isolate them so completely as forms of reason, or as syntactical symbols that at no point is their connection with natural events made (...) intelligible. Yet meanings, all meanings, have relation to mind. It is this empirical, psychological aspect of meaning that I shall analyze. The larger philosophic question as to what the relation of the psychological aspect is to the metaphysical or the logical will not concern us except indirectly. (shrink)

All these activities of living beings, and the functioning of their organs, and the functioning of instruments demand a teleological explanation. Why do human beings toil? Why do living beings try to maintain the activities of the organism? What are the functions of specific organs or instruments? Intelligible answers can be given in teleological terms. Of course, one could ask many questions about these situations that would not require the teleological explanation; for example, questions concerning the mechanical structure of living (...) beings or of instruments. Yet this fact would not eliminate the legitimacy nor the utility of the teleological category. (shrink)

If a hereditary predisposition to colorectal cancer or breast cancer is diagnosed, most guidelines state that clinical geneticists should request index patients to inform their at-risk relatives about the existence of this condition in their family, thus enabling them to consider presymptomatic genetic testing. Those identified as mutation carriers can undertake strategies to reduce their risk of developing the disease or to facilitate early diagnosis. This procedure of informing relatives through the index patient has been criticised, as it results in (...) relatively few requests for genetic testing, conceivably because a certain number of relatives remain uninformed. This pilot study explored attitudes toward informing family members and relevant practices among clinical geneticists. In general, clinical geneticists consider it to be in the interests of family members to be informed and acknowledge that this goal is not accomplished by current procedures. The reasons given for maintaining present practices despite this include clinical ‘mores’, uncertainty about the legal right of doctors to inform family members themselves, and, importantly, a lack of resources. We discuss these reasons from an ethical point of view and conclude that they are partly uninformed and inconsistent. If informing relatives is considered to be in their best interests, clinical geneticists should consider informing relatives themselves. In the common situation in which index patients do not object to informing relatives, no legal obstacles prevent geneticists from doing so. An evaluation of these findings among professionals may lead to a more active approach in clinical practice. (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)

Maran ha-g. R. A. Y. L. Shṭinman z. ts. ṿe-ḳ.l. -- Rabotenu meʼore ha-dor -- Ḳiyum ha-ʻolam ʻa. y. Torah be-mishnat rabotenu -- Maran Rabi Gedalyah Aizman z. ts. ṿe-ḳ.l.