The overall aim of this article is to discuss the organization of limit setting in healthcare in terms of legitimacy. We argue there is a strong ethical demand that such processes should be arranged to provide adversely affected people well-justified reasons to confer legitimacy to the processes despite favouring a different decision-making outcome. Two increasingly popular approaches, Accountability for Reasonableness (A4R) and Multi-Criteria Decision Analysis (MCDA), can both be applied to support legitimate decision-making processes. However, the role played (...) by ‘fair-minded people’ in the A4R framework can be shown to undermine an adequate conceptualization of legitimacy according to the ethical demand. We discuss and specify conditions enabling A4R to meet this ethical demand when being implemented in a real-world setting without having to renounce the aim of striving for ‘reasonableness’ and impartiality. The methodological approach MCDA describes how to arrange for transparent resource allocation. This approach does not encompass any normative guidance on how to shape limit settings in terms of ‘reasonableness’; it basically promotes ‘rational’ decisions. We discuss how this practical methodology can be integrated with the theoretical A4R framework to meet the ethical demand while at the same time promoting politically required impartiality of healthcare limit setting. (shrink)

Norman Daniels’ theory of justice and health faces a serious practical problem: his theory can ground the special moral importance of health and allows distinguishing just from unjust health inequalities, but it provides little practical guidance for allocating resources when they are especially scarce. Daniels’ solution to this problem is a fair process that he specifies as "accountability for reasonableness". Daniels claims that accountability for reasonableness makes limit-setting decisions in healthcare not only legitimate, but also fair. This paper (...) assesses the latter claim. Does accountability for reasonableness result in fair limit-setting decisions? It is argued that the answer to this question is not a clear yes. Daniels is remarkably unclear about the criterion of fairness that accountability for reasonableness satisfies. The paper discusses different options for resolving this lack of clarity and examines how they apply to Daniels’ accountability for reasonableness framework. It is concluded, first, that accountability for reasonableness is not a paradigm case of any of the classic notions of procedural justice; second, that what might be called "constrained pure procedural justice" best reflects how accountability for reasonableness results in fair limit-setting decisions; and third, that the procedural conditions of accountability for reasonableness must be further specified and amended to better achieve a fair process, and hence fair limit-setting decisions. (shrink)

Lower respiratory tract infections are a leading cause of paediatric morbidity and mortality worldwide. Children in low-income countries are disproportionately affected. This is in large part due to limitations in healthcare resources and medical technologies. Mechanical ventilation can be a life-saving therapy for many children with acute respiratory failure. The scarcity of functioning ventilators in low-income countries results in countless preventable deaths. Some hospitals have attempted to adapt to this scarcity by using hand-bag ventilation, as either a bridge to a (...) mechanical ventilator, or until clinical improvement occurs rendering mechanical ventilation no longer necessary. In instances of hand-bag ventilation, an endotracheal tube is first placed. Family members are then asked to play the role of a ventilator, manually compressing a bag repeatedly to inflate the child’s lungs. This approach is fraught with numerous ethical challenges. A careful examination of the data and a nuanced approach to the ethical considerations are imperative. Ethical arguments in support of and in opposition to allowing parental hand-bag ventilation are explored, including the best interests of the child, the child’s right to an open future, beneficence and parental protection, legitimising substandard care, and finally, contextual concerns. An algorithmic, potentially ethically permissible approach to parental participation in manual ventilation is proposed. (shrink)

BackgroundRespecting patients’ confidentiality is an ethical and legal responsibility for health professionals and the cornerstone of care excellence. This study aims to assess health professionals’ knowledge, attitudes, and associated factors towards patients’ confidentiality in a resource-limited setting.MethodsInstitutional based cross-sectional study was conducted among 423 health professionals. Stratified sampling methods were used to select the participants, and a structured self-administer questionnaire was used for data collection. The data was entered using Epi-data version 4.6 and analyzed using SPSS, version 25. Bi-variable (...) and multivariable binary logistic regression analyses were used to measure the association between the dependent and independent variables. Odds ratio with 95% confidence intervals and P value was calculated to determine the strength of association and to evaluate statistical significance.ResultOut of 410 participants, about 59.8% with [95% CI (54.8–68.8%)] and 49.5% with [95% CI (44.5–54.5%)] had good knowledge and favorable attitude towards patents confidentiality respectively. Being male (AOR = 1.63, 95% CI [1.03–2.59]), taking training on medical ethics (AOR = 1.73, 95% CI = [1.11–2.70]), facing ethical dilemmas (AOR = 3.07, 95% CI [1.07–8.79]) were significantly associated factors for health professional knowledge towards patients’ confidentiality. Likewise, taking training on medical ethics (AOR = 2.30, 95% CI [1.42–3.72]), having direct contact with the patients (AOR = 3.06, 95% CI [1.12–8.34]), visiting more patient (AOR = 4.38, 95% CI [2.46–7.80]), and facing ethical dilemma (AOR = 3.56, 95% CI [1.23–10.26]) were significant factors associated with attitude of health professionals towards patient confidentiality.ConclusionThe findings of this study revealed that health professionals have a limited attitude towards patient confidentiality but have relatively good knowledge. Providing a continuing medical ethics training package for health workers before joining the hospital and in between the working time could be recommended to enhance health professionals’ knowledge and attitude towards patient confidentiality. (shrink)

The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University.

Background. Responsible clinical research drives the advancement of healthcare. Despite tremendous improvements in the globalresearch and development environment since the 1950s, low- and middle-income countries (LMICs) are often left behind. There are several reasons for this. Firstly, operational, social, ethical and regulatory challenges in LMICs make it difficult for researchers to conduct clinical studies in those settings in line with international requirements. Secondly, many people living in low-resource settings distrust research because some past studies have not benefited the participants or (...) the communities involved.Objectives. To present the consensus recommendations by a Council for International Organizations of Medical Sciences (CIOMS) Working Group on how to advance good-quality, ethical clinical research in resource-limited settings.Methods. CIOMS convened a Working Group of senior scientists from drug regulatory authorities, the pharmaceutical industry, publicprivate partnerships for product development, and academia.Results. This article summarises the Working Group’s report.Conclusion. The report recommendations can foster the creation of a more enabling ecosystem for clinical research and promotecollaboration between policymakers, regulators, researchers and funders. (shrink)

A paediatric clinical trial conducted in a developing country is likely to encounter conditions or illnesses in participants unrelated to the study. Since local healthcare resources may be inadequate to meet these needs, research clinicians may face the dilemma of deciding when to provide ancillary care and to what extent. The authors propose a model for identifying ancillary care obligations that draws on assessments of urgency, the capacity of the local healthcare infrastructure and the capacity of the research infrastructure. The (...) model lends itself to a decision tree that can be adapted to the local context and resources so as to provide procedural guidance. This approach can help in planning and establishing organisational policies that govern the provision of ancillary care. (shrink)

ABSTRACTThe quality of medicines is generally adequately assured by manufacturers and regulatory authorities for well-resourced settings, while the implementation of existing quality standards is challenged in many low- and middle-income countries. This situation of multiple pharmaceutical standards raises the question whether it could ever be ethically justified to compromise on the quality assurance of medicines depending on what individuals, communities, or societies can afford. In this paper, we contend that ethically, any unjustified exceptions to medicines’ quality assurance represents a violation (...) of the principles of beneficence and non-maleficence. Exceptions are only acceptable in exceptional and temporary circumstances, if based on a meaningful quality risk assessment, guided by a rigorous ethical framework built on the principles of independence, technical competence, transparency, and accountability. We also discuss how such exceptional and temporary circumstances should be defined/justified.... (shrink)

The concept of legitimacy is often used and emphasized in the context of setting limits in health care, but rarely described is what is actually meant by its use. Moreover, it is seldom explicitly stated how health-care workers can contribute to the matter, nor what weight should be apportioned to their viewpoints. Instead the discussion has focused on whether they should take on the role of the patients’ advocate or that of gatekeeper to the society’s resources. In this article, (...) we shed light on the role of health-care workers in limit setting and how their conferred legitimacy may support subordinators’ (i.e. citizens’) conferred legitimacy. We argue that health-care workers have an important role to play as both moral and political agents in limit setting, and delineate normative conditions that justify and facilitate health-care workers in conferring legitimacy on this kind of decision. Their role and potential impact on political limit setting does not—theoretically—affect the idea of democratic legitimacy negatively. Rather, as we suggest, by designing for limit-setting policymaking accordingly, health-care workers, as well as citizens, are more justified in conferring democratic legitimacy to health-care limit-setting decisions than if these concerns were not addressed. (shrink)

State Medicaid programs have proposed closed formularies to limit spending on drugs. Closed formularies can be justified when they enable spending on other socially valuable aims. However, it is still necessary to justify guidelines informing formulary design, which can be done through a process of decision making that includes the public. This article examines criticisms that Medicaid closed formularies limit deliberation about decisions that affect drug access and unfairly disadvantage poor patients. Although unfairness to poor patients is a (...) risk, it is not a problem unique to Medicaid, since private insurance programs have also implemented closed formularies. (shrink)

In Setting Limits, Daniel Callahan advances the provocative thesis that age be a limiting factor in decisions to allocate certain kinds of health services to the elderly. However, when one looks at available data, one discovers that there are many more elderly women than there are elderly men, and these older women are poorer, more apt to live alone, and less likely to have informal social and personal supports than their male counterparts. Older women, therefore, will make the heaviest (...) demand on health care resources. If age were to become a limiting factor, as Dr. Callahan suggests it should, the limits that will be set are limits that will affect women more drastically than they affect men. This review essay examines the implications of Callahan's thesis for elderly women. (shrink)

In resource-limited settings where healthcare services are limited and poverty is common, it is difficult to ethically conduct clinical research without providing patient-care. Therefore, integration of patient-care with clinical research appears as an attractive way of conducting research while providing patient-care. In this article, we discuss the ethical implications of such approach with perspectives from Papua New Guinea.

Background: The process of obtaining informed consent continues to be a contentious issue in clinical and public health research carried out in resource-limited settings. We sought to evaluate this process among human research participants in randomly selected active research studies approved by the School of Medicine Research and Ethics Committee at the College of Health Sciences, Makerere University. Methods: Data were collected using semi-structured interviewer-administered questionnaires on clinic days after initial or repeat informed consent procedures for the respective clinical studies (...) had been administered to each study participant. Results: Of the 600 participants interviewed, two thirds (64.2 %, 385/600) were female. Overall mean age of study participants was 37.6 (SD = 7.7) years. Amongst all participants, less than a tenth (5.9 %, 35/598) reported that they were not given enough information before making a decision to participate. A similar proportion (5.7 %, 34/597) reported that they had not signed a consent form prior to making a decision to participate in the study. A third (33.7 %, 201/596) of the participants were not aware that they could, at any time, voluntarily withdraw participation from these studies. Participants in clinical trials were 50 % less likely than those in observational studies [clinical trial vs. observational; (odds ratio, OR = 0.5; 95 % CI: 0.35-0.78)] to perceive that refusal to participate in the parent research project would affect their regular medical care. Conclusions: Most of the participants signed informed consent forms and a vast majority felt that they received enough information before deciding to participate. On the contrary, several were not aware that they could voluntarily withdraw their participation. Participants in observational studies were more likely than those in clinical trials to perceive that refusal to participate in the parent study would affect their regular medical care. (shrink)

Resource constraints in developing countries compel policy makers to ration the provision of healthcare services. This article examines one such set of Guidelines: A patient dialysing in the state sector in South Africa may not refuse renal transplantation when a kidney becomes available. Refusal of transplantation can lead to exclusion from the state-funded dialysis programme. This Guideline is legally acceptable as related to Constitutional stipulations which allow for rationing healthcare resources in South Africa. Evaluating the ethical merit of the Guideline, (...) and exploring the ethical dilemma it poses, proves a more complex task. We examine the actions of healthcare professionals as constrained by the Guideline. From a best interests framework, we argue that in these circumstances directing patient decision making is not necessarily unethical or unacceptably paternalistic. We then scrutinise the guideline itself through several different ethical ‘lenses’. Here, we argue that bioethics does not provide a definitive answer as to the moral merit of rationing dialysis under these circumstances, however it can be considered just in this context. We conclude by examining a potential pitfall of the Guideline: Unwilling transplant recipients may not comply with immunosuppressive medication, which raises questions for policies based on resource management and rationing. (shrink)

Background Compensating participants of biomedical research is a common practice. However, its proximity with ethical concerns of coercion, undue influence, and exploitation, demand that participant compensation be regulated. The objective of this paper is to discuss the current regulations for compensation of research participants in Malawi and how they can be improved in relation to ethical concerns of coercion, undue influence, and exploitation. Main text In Malawi, national regulations recommend that research subjects be compensated with a stipend of US$10 per (...) study visit. However, no guidance is provided on how this figure was determined and how it should be implemented. While necessary to prevent exploitation, the stipend may expose the very poor to undue influence. The stipend may also raise the cost of doing research disadvantaging local researchers and may have implications on studies where income stipend is the intervention under investigation. We recommend that development and implementation of guidelines of this importance involve interested parties such as the research community and patient groups. Conclusion Compensating human research subjects is important but can also act as a barrier to voluntary participation and good research efforts. Deliberate measures need to be put in place to ensure fair compensation of research participants, avoid their exploitation and level the field for locally funded research. (shrink)

In Setting Limits, Daniel Callahan advances the provocative thesis that age be a limiting factor in decisions to allocate certain kinds of health services to the elderly. However, when one looks at available data, one discovers that there are many more elderly women than there are elderly men, and these older women are poorer, more apt to live alone, and less likely to have informal social and personal supports than their male counterparts. Older women, therefore, will make the heaviest (...) demand on health care resources. If age were to become a limiting factor, as Dr. Callahan suggests it should, the limits that will be set are limits that will affect women more drastically than they affect men. This review essay examines the implications of Callahan's thesis for elderly women. (shrink)

This is an introduction to set theory and logic that starts completely from scratch. The text is accompanied by many methodological remarks and explanations.

This volume presents the philosophical and heuristic framework Cantor developed and explores its lasting effect on modern mathematics. "Establishes a new plateau for historical comprehension of Cantor's monumental contribution to mathematics." --The American Mathematical Monthly.

In Setting Limits, Daniel Callahan advances the provocative thesis that age be a limiting factor in decisions to allocate certain kinds of health services to the elderly. However, when one looks at available data, one discovers that there are many more elderly women than there are elderly men, and these older women are poorer, more apt to live alone, and less likely to have informal social and personal supports than their male counterparts. Older women, therefore, will make the heaviest (...) demand on health care resources. If age were to become a limiting factor, as Dr. Callahan sug-gests it should, the limits that will be set are limits that will affect women more dras” tically than they affect men. This review essay examines the implications of Callahan's thesis for elderly women. (shrink)

This is a book review of Cantorian set theory and limitations of size by Michael Hallett.

Computable limits and colimits are “recursive counterparts” of the suitable classical concepts from category theory. We present mainly some interesting problems related to computable products. Moreover, some “computable counterparts” of well-known classical facts from category theory are given. MSC: 03D45, 18A30.

Critical-care decision making is highly complex, given the need for health care providers and organizations to consider, and constructively respond to, the diverse interests and perspectives of a variety of legitimate stakeholders. Insights derived from an identified set of ethics-related considerations have the potential to meaningfully inform inclusive and deliberative policy development that aims to optimally balance the competing obligations that arise in this challenging, clinical decision-making domain. A potential, constructive outcome of such policy engagement is the collaborative development of (...) an as-fair-as-possible dispute resolution process that incorporates an appropriated-justified, defensible critical-care obligation threshold. (shrink)

The usual objections to infinite numbers, and classes, and series, and the notion that the infinite as such is self-contradictory, may... be dismissed as groundless. There remains, however, a very grave difficulty, connected with the contradiction [of the class of all classes not members of themselves]. This difficulty does not concern the infinite as such, but only certain very large infinite classes.

This essay defends the following two claims: (1) liraitation-of-size reasoning yields enough sets to meet the needs of most mathematicians; (2) set formation and mereological fusion share enough logical features to justify placing both in the genus composition (even when the components of a set are taken to be its members rather than its subsets).

Work in the setting of the recursively enumerable sets and their Turing degrees. A set X is low if X', its Turning jump, is recursive in $\varnothing'$ and high if X' computes $\varnothing''$ . Attempting to find a property between being low and being recursive, Bickford and Mills produced the following definition. W is deep, if for each recursively enumerable set A, the jump of $A \bigoplus W$ is recursive in the jump of A. We prove that there are (...) no deep degrees other than the recursive one. Given a set W, we enumerate a set A and approximate its jump. The construction of A is governed by strategies, indexed by the Turning functionals Φ. Simplifying the situation, a typical strategy converts a failure to recursively compute W into a constraint on the enumeration of A, so that $(W \bigoplus A)'$ is forced to disagree with Φ(-; A'). The conversion has some ambiguity; in particular, A cannot be found uniformly from W. We also show that there is a "moderately" deep degree: There is a low nonzero degree whose join with any other low degree is not high. (shrink)

In When Clinical Trials Compete: Prioritizing Study Recruitment, Gelinas et al tackle an important issue—study non-completion—and draw conclusions with which we largely agree. Most importantly, we accept that setting priorities among competing research studies is necessary and should be informed by ethical analysis. We disagree with the conclusion of Gelinas et al that this priority setting should take place at the level of the individual research institution. At a minimum, they should consider other actors who might be better (...) suited for this role instead of—or alongside—the institutions that host research. Our view is motivated by three main considerations. First, research institutions have significant latitude to promote their own interests, and there is reason to suspect that their interests do not closely align with the interests of the public. Thus, asking research institutions to set research priorities may result in the selection of studies with suboptimal social value. Second, a large proportion of clinical trials recruits participants at multiple institutions.1 If each institution sets its own priorities, we can expect discrepancies between the priorities set by partner institutions. These discrepancies may delay and discourage collaborative research projects. Finally, we suspect that a great deal of recruitment competition occurs between, rather than within, research institutions. Setting priorities only at …. (shrink)

The Clinical ethics centre in Paris offers its services equally to doctors and patients/proxies. Its primary goal is to re-equilibrate doctor–patient roles through giving greater voice to patients individually in medical decisions. Patients are present at virtually all levels, initiating consults, providing their point of view and receiving feedback. The implications of patients' involvement are threefold. At an operational level, decision-making is facilitated by repositioning the debate on ethical grounds and introducing a dynamic of decisional partnership, although contact with patients (...) can make it difficult to deny their demands and set the limits of our role. Ethically, it reinforces patients' autonomy and grants them a place of veritable ethics ‘actors’, with the danger that this may become excessively autonomy oriented. Finally, at a collective level, the programme fulfils its political purpose in promoting patients' rights and the ideal of démocratie sanitaire, but complicates balancing individual demands with collective values. (shrink)

Assisted suicide is a tragic issue, one of those for which the tools of mere logic are inadequate and in which the power of the individual case is compelling and seductive but not necessarily clarifying. Meaningful dialogue is difficult. Persuasion is limited because the resolution of the issue, on a moral level, must be founded upon fundamental notions of what it means to be human, especially in the midst of suffering or disability or at the point of death.

According to a tradition going back to Socrates, one should thoroughly examine the grounds of one’s judgments before settling on what one has reason to do or believe. According to contemporary metaethical constructivism, assumed in this essay, reflective scrutiny is also central to assessing a judgment’s claim to justification. This essay argues against the injunctions to thoroughly examine oneself and seek ultimate reasons for one’s normative judgments. In other words, the essay argues against the ideal of the philosophical way of (...) life. It shows that in most cases one does not have reason to question the practical conclusion of one’s initial deliberation. It is only under very limited conditions, specified in the essay, that one is justified in engaging in further reflection. Furthermore, the essay argues that if one does go for full self-examination, the consequences are most likely to be bad for oneself, given one’s practical interests. (shrink)

According to a tradition going back to Socrates, one should thoroughly examine the grounds of one’s judgments before settling on what one has reason to do or believe. According to contemporary metaethical constructivism, assumed in this essay, reflective scrutiny is also central to assessing a judgment’s claim to justification. This essay argues against the injunctions to thoroughly examine oneself and seek ultimate reasons for one’s normative judgments. In other words, the essay argues against the ideal of the philosophical way of (...) life. It shows that in most cases one does not have reason to question the practical conclusion of one’s initial deliberation. It is only under very limited conditions, specified in the essay, that one is justified in engaging in further reflection. Furthermore, the essay argues that if one does go for full self‐examination, the consequences are most likely to be bad for oneself, given one’s practical interests. (shrink)

In recent years the question of whether adding the limited principle of omniscience, LPO, to constructive Zermelo–Fraenkel set theory, CZF, increases its strength has arisen several times. As the addition of excluded middle for atomic formulae to CZF results in a rather strong theory, i.e. much stronger than classical Zermelo set theory, it is not obvious that its augmentation by LPO would be proof-theoretically benign. The purpose of this paper is to show that CZF+RDC+LPO has indeed the same strength as (...) CZF, where RDC stands for relativized dependent choice. In particular, these theories prove the same Π02 theorems of arithmetic. (shrink)

In Setting Limits, Daniel Callahan advances the provocative thesis that age be a limiting factor in decisions to allocate certain kinds of health services to the elderly. However, when one looks at available data, one discovers that there are many more elderly women than there are elderly men, and these older women are poorer, more apt to live alone, and less likely to have informal social and personal supports than their male counterparts. Older women, therefore, will make the heaviest (...) demand on health care resources. If age were to become a limiting factor, as Dr. Callahan suggests it should, the limits that will be set are limits that will affect women more drastically than they affect men. This review essay examines the implications of Callahan's thesis for elderly women. (shrink)

Hastings Center Report, Volume 52, Issue 3, Page 34-36, May–June 2022.