The involvement of children in non-beneficial clinical research is extremely important for improving pediatric care, but its ethical acceptability is still disputed. Therefore, various pro-research justifications have been proposed throughout the years. The present essay aims at contributing to the on-going discussion surrounding children’s participation in non-beneficial clinical research. Building on Wendler’s ‘contribution to a valuable project’ justification, but going beyond a risk/benefit analysis, it articulates a pro-research argument which appeals to a phenomenological view on the body and vulnerability. It (...) is claimed that children’s bodies are not mere physical objects, but body-subjects due to which children, as persons, can contribute to research that may hold no direct clinical benefit to them even before they can give informed consent. (shrink)

These CQ Sources were compiled by Bette Anton.

One of the common domains in health care in which the concept of vulnerability is used is end-of-life care, including euthanasia and assisted suicide (EAS). Since different uses and implications of the notion have been recognised in the literature on EAS, this paper aims to analyse them and reflect on who is the most vulnerable in the context of EAS. A prior exploratory review of the literature has served as a starting point for the discussion. We concluded that vulnerability is (...) a complex, multi-perspective and multi-layered concept, which implies the vulnerability of different stakeholders involved in EAS practices and vulnerability in different aspects of being human (i.e., physical, mental, moral, social and spiritual). A comprehensive understanding of the notion of vulnerability, which balances as well as complements the concept of autonomy, seems to be an indispensable element of the discourse on EAS. (shrink)

Despite the role of public health interventions in controlling disease transmission and protecting the public during the COVID-19 emergency, the implementation of quarantine restrictions has raised serious ethical concerns, especially in relation to the well-being of vulnerable populations. Drawing on the lived experiences of rural Chinese migrants who are subject to pandemic control, the authors highlight their inadequate capacities to manage the risks associated with the pandemic and adjust to quarantine restrictions. Informed by an ethical discourse of vulnerability, we show (...) that underpinning this group’s deficient coping strategies is a range of detrimental social structures and institutions that have developed under the persistent rural–urban divide in China. These structural constraints and pathologies expose rural migrants to serious risks and uncertainties while depriving them of the means and resources necessary to protect their own interests in the process of complying with quarantine restrictions. Understanding the plight of rural Chinese migrants as a structural problem also has implications for the global response to the COVID-19 pandemic. We further suggest a need for state intervention to mitigate structural deficiencies and empower the vulnerable during the COVID-19 era. (shrink)

Background:In China, the conventional family-based ageing care model is under pressure from social transitions, raising the question of whether and to what extent families are still capable of dealing with the care of the aged.Objective:This article examines the vulnerability and inadequacy of families to bear responsibility for the care of the aged against a backdrop of socioeconomic transformation and diminishing institutional support in rural China.Research design:This article adopts an empirical ethical approach that integrates empirical investigation with ethical inquiry.Participants and research (...) context:The empirical component of this article focuses on the lived experiences of caring for a wife and mother with dementia in one rural Chinese family, collected from a 6-month fieldwork study conducted at one primary hospital.Ethical considerations:Approval was obtained from the university ethics committee.Findings:The empirical study highlights a conflicted family process of managing and negotiating care that indicates the inadequacies and limited ability of families to deal with aged care tasks. In addition, inadequate structures and institutional deficiencies exacerbate the vulnerability of rural families and their inability to offer adequate care.Conclusion:Acknowledging the vulnerability of families as ageing care providers, this article calls for a socially supported family care model for rural older people in China and also proposes policy recommendations. (shrink)

Emotionally-related live organ donation is different from almost all other medical treatments in that a family member or, in some countries, a friend contributes with an organ or parts of an organ to the recipient. Furthermore, there is a long-acknowledged but not well-understood gender-imbalance in emotionally-related live kidney donation. This article argues for the benefit of the concept of just love as an analytic tool in the analysis of emotionally-related live organ donation where the potential donor(s) and the recipient are (...) engaged in a love relation. The concept of just love is helpful in the analysis of these live organ donations even if no statistical gender-imbalance prevails. It is particularly helpful, however, in the analysis of the gender-imbalance in live kidney donations if these donations are seen as a specific kind of care-work, if care-work is experienced as a labour one should perform out of love and if women still experience stronger pressures to engage in care-work than do men. The aim of the article is to present arguments for the need of just love as an analytic tool in the analysis of emotionally-related live organ donation where the potential donor(s) and the recipient are engaged in a love relation. The aim is also to elaborate two criteria that need to be met in order for love to qualify as just and to highlight certain clinical implications. (shrink)

By their very nature, overseas medical missions (and even domestic medical charities such as free clinics ) are designed to serve vulnerable populations. If these groups were capable of protecting their own interests, they would not need the help of medical volunteers: their medical needs would be met through existing government health programs or by utilizing their own resources. Medical volunteerism thus seems like an unfettered good: a charitable activity provided by well-meaning doctors and nurses who want to give of (...) their time, skills, and resources to help those who would not otherwise be able to take care of their medical needs. In this article, I argue that if medical volunteerism is to be good, however, it must always meet certain basic ethical requirements. These requirements may be (and perhaps often are) overlooked in the rush to organize and carry out short-term medical missions. I illustrate my point with special reference to short-term medical missions designed to provide surgical repair of obstetric vesico-vaginal fistula, a condition in which the tissues that normally separate the bladder from the vagina are destroyed by obstetric trauma, leading to continuous and unremitting incontinence in the affected woman. (shrink)

The visible condition of a person in bodily pain or of a person who has lost autonomy, social status or self–representation, reveals to some degree an invisible reality which is present in every human being. Assuming the validity of this premise, my primary purpose in the following paper is first to reflect upon social and cultural attitudes that consider disability and vulnerability as a boundary and a threat; and secondly, to propose an alternative in transgressing the differences of socio - (...) anthropological boundaries in order to enable dynamic communication with fellow human beings, and ultimately, to bring about the true human flourishing. The structure of my argument is threefold. In a first part my focus is stressed upon concerns of those living with a physical condition of disability and a mainstream socio–cultural attitudes towards it. In the second part, my attention will be on the meaning of vulnerability associated with, but distinct from the notion of disability. Thirdly, I will elucidate my argument with concrete examples from the L´Arche community - where people with and without disabilities are living together in mutual interdependency and cooperation. (shrink)

Vulnerability has become a popular though controversial topic in bioethics, notably since 2000. As a result, a common body of knowledge has emerged distinguishing between different types of vulnerability, criticizing the categorization of populations as vulnerable, and questioning the practical implications. It is argued that two perspectives on vulnerability, i.e., the philosophical and political, pose challenges to contemporary bioethics discourse: they re-examine the significance of human agency, the primacy of the individual person, and the negativity of vulnerability. As a phenomenon (...) of globalization, vulnerability can only be properly addressed in a global bioethics that takes the social dimension of human existence seriously. (shrink)

Some have characterized patients living with intractable pain as a vulnerable population in both clinical and research settings. Labeling the population as vulnerable, however, does not provide clarity regarding the potential risks that they face when they participate in research. Instead, research vulnerability for patients in pain is a function of an interaction between their pain conditions and elements of the research enterprise. Therefore, the identification of potential risks requires consideration not only of characteristics of patients with chronic pain, but (...) also consideration of features of researchers, the quality of institutional oversight, and the medical/social environment within which the research is conducted. This paper provides an analysis of those risks and provides some suggestions as to how the risks might be better managed. (shrink)

The concept of vulnerability has been the topic of considerable discussion in research bioethics, largely because of dissatisfaction with early constructions of the concept that were based on subpopulations of research subjects. These subpopulations have attributes likely to undermine their capacity to provide autonomous informed consent: persons who are relatively or absolutely incapable of protecting their own interests through negotiations for informed consent. Several subpopulations were seen as requiring special protections, including children, pregnant women, prisoners, racial minorities, the economically disadvantaged, (...) the very sick, and the institutionalized. Recent years have witnessed the identification of other subpopulations with attributes that could render them vulnerable, as well. For example, the Council for the International Organization of Medical Societies has named such potentially vulnerable groups as the homeless, nursing home residents, patients with incurable diseases, patients in the emergency department, employees, students, and members of communities who are unfamiliar with modern medicine. (shrink)

Background Although it is the moral duty of physicians to protect vulnerable patients, there are no data on how vulnerability is perceived in clinical practice. This study explores how physicians classify someone as “vulnerable”. Method Thirty-three physicians were initially questioned about resource allocation problems in their work. The results of these interviews were examined with qualitative study software to identify characteristics associated with vulnerability in patients. Data were conceptualized, classified and cross-linked to highlight the major determinants of vulnerability. The findings (...) revealed the principal factors that make patients vulnerable in clinical practice, according to our definition of vulnerability: the likelihood of having one’s interests unjustly considered. Results Vulnerability can arise as a result of a mismatch between the characteristics of patients and physicians, the healthcare system, the treatment, or the communication between physicians and patients. Vulnerability appears as a gap between a patient’s needs and the means intended to meet them. Vulnerability can further be the result of doing too little or too much for patients. This result suggests that structures provided by healthcare systems are not as differentiated as they should be to cover all situations. Our initial definition of vulnerability was illustrated and supported by our results, showing that it encompasses all factors involved, not solely personal characteristics, indicating the need for a more pragmatic approach for use in clinical practice. Conclusion Vulnerability is not due to a single factor but appears under certain circumstances when there is a discrepancy between a patient’s interests and the care provided, despite existing compensation systems. (shrink)

The introduction of and the commitment to evidence-based nursing in all care settings have led to a rapid increase of intervention and outcome-based research programs. Yet, the topics of nursing research are not only affected by interventions and outcomes but also affected by the concept of caring derived from humanistic philosophy. Considering this twofold orientation of nursing science, nuanced ethical regulations for nursing research programs are called for. In addition to the different research approaches, further arguments for ethical regulations are (...) as follows: first, the different degrees of contextualization and the variety of participation models regarding the target groups; second, the capacities and opportunities of participants; and third, the caring relationship between nurses and research subjects. To capture these special features of nursing science, four approaches to fill the gaps in existing ethical regulations for nursing research are proposed: (a) process orientation, (b) community orientation, (c) context orientation, and (d) relation orientation. (shrink)

The notion that exploitation consists in taking wrongful advantage of another’s vulnerability is widespread in the philosophical literature. Considering the popularity of this view, it is disappointing to find that very few authors attempt to provide substantive accounts of characteristics they consider relevant vulnerabilities (i.e., those pertinent to exploitation), as well as of relevant features which make taking advantage of those vulnerabilities wrongful. In this paper, I analyze the few approaches (notably those presented by Ruth Sample and Robert Goodin) that (...) in fact provide such accounts, and I examine whether and how they pertain to exploitation in general, as well as to exploitation in more personal/intimate relationships. I conclude that these vulnerability-based accounts of exploitation are either too vague or too restrictive, since they tend to leave out many instances of exploitation (especially those within personal and intimate relationships), and are as such inadequate. (shrink)

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

The so-called European principles of bioethicsare a welcome enrichment of principlistbioethics. Nevertheless, vulnerability, dignityand integrity can perhaps be moreaccurately understood as anthropologicaldescriptions of the human condition. Theymay inspire a normative language, but they donot contain it primarily lest a naturalisticfallacy be committed. These anthropologicalfeatures strongly suggest the need todevelop deontic arguments in support of theprotection such essential attributes ofhumanity require. Protection is to beuniversalized, since all human beings sharevulnerability, integrity and dignity, thusfundamenting a mandate requiring justice andrespect for fundamental human (...) rights.Being a feature of all humanity, vulnerabilityis improperly extended to designatedestitute individuals and populations. Rather,they are in a state of fallen vulnerability,for they already are harmed in some way, andhave become deprived of their range ofcapabilities. These individuals are destituteand are no longer in command of theirfundamental human rights. They have lost thestatus of unharmed vulnerability;identifying them as susceptible – vulnerated andno longer only vulnerable – stresses thepoint that bioethics demands specific socialaction to palliate or remove their distress.When harm does occur – in the form of disease,for example –, individuals are no longervulnerable – for they have ceased to be intact–, they become susceptible to additionaldeprivations and sickness; integrity isdemeaned and dignity is offended, leading tostates of dysfunction that require specificremedial social practices, aimed at treatingand removing injuries.The main point this paper addresses is thatvulnerability – as well as dignity and integrity – are descriptive characteristics ofhuman beings qua humans, which are not normative in themselves, but fundamental enoughto inspire bioethical requirements of protection and respect for human rights in thewake of social justice. A clear distinction must be made in regard to human beings who areinjured by poverty, sickness, discriminating deprivations or suffer otherdestitutions, having ceased to be only vulnerable for they are no longer intact. Theseindividuals and populations require more than protection, their needs must be met byspecific care and remedial measures to be identified and instigated by bioethics quaapplied ethics. (shrink)

This article discusses the prioritization of scarce and in-demand influenza vaccines during a pandemic. The mass vaccination campaign in Canada against H1N1 influenza in 2009 illustrated that some groups considered vulnerable may also be stigmatized. In 2009, prisoners and people with severe obesity were given priority of H1N1 vaccination in some Canadian jurisdictions. Assigning priority for vaccination to such groups may be socially unpopular. This article examines a number of possible arguments that might motivate opposition to prioritizing stigmatized groups. We (...) find these arguments flawed. They rely on a suspect ‘social worth’ rationale for the prioritization of scarce resources. Furthermore, human rights concerns support the prioritization of vulnerable but stigmatized groups for vaccination during a pandemic. We also argue that it is necessary to prioritize vulnerable but stigmatized groups to promote the common good in its various forms. The article concludes with an analysis of an objection that no vulnerable groups—stigmatized or otherwise—should be given priority for influenza vaccination in a pandemic. We argue that the objection is based on a confusion. (shrink)

Despite broad agreement that the vulnerable have a claim to special protection, defining vulnerable persons or populations has proved more difficult than we would like. This is a theoretical as well as a practical problem, as it hinders both convincing justifications for this claim and the practical application of required protections. In this paper, I review consent-based, harm-based, and comprehensive definitions of vulnerability in healthcare and research with human subjects. Although current definitions are subject to critique, their underlying assumptions may (...) be complementary. I propose that we should define vulnerability in research and healthcare as an identifiably increased likelihood of incurring additional or greater wrong. In order to identify the vulnerable, as well as the type of protection that they need, this definition requires that we start from the sorts of wrongs likely to occur and from identifiable increments in the likelihood, or to the likely degree, that these wrongs will occur. It is limited but appropriately so, as it only applies to special protection, not to any protection to which we have a valid claim. Using this definition would clarify that the normative force of claims for special protection does not rest with vulnerability itself, but with pre-existing claims when these are more likely to be denied. Such a clarification could help those who carry responsibility for the protection of vulnerable populations, such as Institutional Review Boards, to define the sort of protection required in a more targeted and effective manner. (shrink)

How can social institutions complicate and worsen vulnerabilities of particular individuals or groups? We begin by explicating how certain diagnoses within mental health and medicine operate as interactive kinds of labels and how such labels can create institutional barriers that hinder one's capacity to achieve wellbeing. Interactive-kind modeling is a conceptual tool that elucidates the ways in which labeling can signal to others how the labeled person ought to be treated, how such labeling comes about and is perceived, and how (...) it compounds vulnerabilities. We argue that this shift in standpoint helps us recognize and mitigate compounded vulnerabilities. (shrink)

Institutional review boards, tasked with facilitating ethical research, are often pulled in competing directions. In what we call the protection-inclusion dilemma, we acknowledge the tensions IRBs face in aiming to both protect potential research participants from harm and include under-represented populations in research. In this manuscript, we examine the history of protectionism that has dominated research ethics oversight in the United States, as well as two responses to such protectionism: inclusion initiatives and critiques of the term vulnerability. We look at (...) what we know about IRB decision-making in relation to protecting and including “vulnerable” groups in research and examine the lack of regulatory guidance related to this dilemma, which encourages protection over inclusion within IRB practice. Finally, we offer recommendations related to how IRBs might strike a better balance between inclusion and protection in research ethics oversight. (shrink)

Background Notwithstanding the need to produce evidence-based knowledge on medications for pregnant women, they remain underrepresented in clinical research. Sometimes they are excluded because of their supposed vulnerability, but there are no universally accepted criteria for considering pregnant women as vulnerable. Our aim was to explore whether and if so to what extent pregnant women are vulnerable as research subjects. Method We performed a conceptual and empirical analysis of vulnerability applied to pregnant women. Analysis A conceptual analysis supports Hurst's definition (...) of vulnerability. Consequently, we argue that pregnant women are vulnerable if they encounter an identifiably increased likelihood of incurring additional or greater wrong. According to the literature, this increased likelihood could exist of four alleged features for pregnant women's vulnerability: informed consent, susceptibility to coercion, higher exposure to risk due to lack of knowledge, vulnerability of the fetus. Discussion Testing the features against Hurst's definition demonstrates that they all concern the same issue: pregnant women are only vulnerable because a higher exposure to risk due to lack of scientific knowledge comprises an increased wrong. Research Ethics Committees have a responsibility to protect the vulnerable, but a higher exposure to risk due to lack of scientific knowledge is a much broader issue and also needs to be addressed by other stakeholders. Conclusions The only reason why pregnant women are potentially vulnerable is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge. Accordingly, the discussion can advance to the development of practical strategies to promote fair inclusion of pregnant women in clinical research. (shrink)

Does the fact that humans are vulnerable, needy and dependent beings play an important role in Kantian ethics? It is sometimes claimed that it cannot and does not. I argue that it can and does. I distinguish between broad (all persons are vulnerable) and narrow (only some persons are vulnerable) senses of vulnerability, and explain the role of vulnerability in both senses in Kantian ethics. The basis of this argument is to show that the core normative focus of Kantian ethics (...) is on the dignity that human beings have in virtue of their capacity for rational agency. This implies that the empirical conditions under which human beings can acquire, sustain, exercise, and develop their rational capacities are of core moral importance in Kantian ethics. This explains why human vulnerabilities, including the vulnerability of human bodies, are important in Kantian ethics, since rational capacities in human agents (and the bodies those rational capacities depend upon) are highly vulnerable in all persons (vulnerability in the broad sense) and especially vulnerable in some sub-groups of persons (vulnerability in the narrow sense). (shrink)

The Health Services are under a dialectic tension between two directives: the collective control of risks and individual care, whose needs are shaped by social determinants of health. The surveillance, as a service, centers on the biopolitical governing of collective risks and focusses on a certain population, living in a specific area, defined as a social space, where the health needs are evident, demanding healthcare. The responses depend on the surveillance data taken from the societal processes that make up the (...) risks. The central ethical problem is if these data cause facilitate emancipation or perpetuate the risks. (shrink)