While some trust theorists have adverted to the vulnerabilities involved in trust, especially vulnerability to betrayal, the literature on trust has not engaged with recent work on the ethics of vulnerability. This paper initiates a dialogue between these literatures, and in doing so begins to explore the complex interrelations between vulnerability and trust. More specifically, it aims to show how trust can both mitigate and compound vulnerability. Through a discussion of two examples drawn from literary sources, the paper also investigates (...) the effects of pathogenic vulnerability on the psychic economies of trust and distrust. (shrink)

Healthcare is permeated by phenomena of vulnerability and their ethical significance. Nonetheless, application of this concept in healthcare ethics today is largely confined to clinical research. Approaches that further elaborate the concept in order to make it suitable for healthcare as a whole thus deserve renewed attention. Conceptual analysis. Taking up the task to make the concept of vulnerability suitable for healthcare ethics as a whole involves two challenges. Firstly, starting from the concept as it used in research ethics, a (...) more detailed characterization and systematization of the different realms of human abilities and the various ways in which these realms contain vulnerability is to be established. Secondly, at the same time, the sought-after concept of vulnerability should avoid picturing the relation between healthcare recipient and provider as a relation between a dependent individual in need and another individual capable of providing all the help necessary. An adequate concept of vulnerability should enable one to understand when and in which respects care providers may be vulnerable as well. Philosophical accounts of vulnerability can help to meet both of these challenges. Philosophical accounts of vulnerability can help to make the concept of vulnerability suitable for healthcare ethics as a whole. They come with a price, though. While the ethical role of vulnerability in medical ethics usually is to signify states of affairs that are to be diminished or overcome, philosophical accounts introduce forms of vulnerability that are regarded as valuable. Further analyzing and systematizing forms and degrees of vulnerability thus comprises the task to distinguish between amounts and types of vulnerability that can count as valuable, and amounts and types of vulnerability that are to be alleviated. (shrink)

Concern for human vulnerability seems to be at the heart of bioethical inquiry, but the concept of vulnerability is under-theorized in the bioethical literature. The aim of this article is to show why bioethics needs an adequately theorized and nuanced conception of vulnerability. We first review approaches to vulnerability in research ethics and public health ethics, and show that the bioethical literature associates vulnerability with risk of harm and exploitation, and limited capacity for autonomy. We identify some of the challenges (...) emerging from this literature: in particular, how to reconcile universal human vulnerability with a context-sensitive analysis of specific kinds and sources of vulnerability; and how to reconcile obligations to protect vulnerable persons with obligations to respect autonomy. We then briefly survey some of the theoretical resources available within the philosophical literature to address these challenges, and to assist in understanding the conceptual connections between vulnerability and related concepts such as harm, exploitation, needs, and autonomy. We also sketch out a taxonomy of sources and kinds of vulnerability. Finally, we consider the implications for policy evaluation of making vulnerability an explicit and central focus of bioethics. Our investigation is in the form of a broad survey motivating a research agenda rather than a detailed analysis. (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)

Subpart B of 45 Code of Federal Regulations Part 46 (CFR) identifies the criteria according to which research involving pregnant women, human fetuses, and neonates can be conducted ethically in the United States. As such, pregnant women and fetuses fall into a category requiring “additional protections,” often referred to as “vulnerable populations.” The CFR does not define vulnerability, but merely gives examples of vulnerable groups by pointing to different categories of potential research subjects needing additional protections. In this paper, I (...) assess critically the role of this categorization of pregnant women involved in research as “vulnerable,” both as separate entities and in combination with the fetuses they carry. In particular, I do three things: (1) demonstrate that pregnant women qua pregnancy are either not “vulnerable” according to any meaningful definition of that term or that such vulnerability is irrelevant to her status as a research participant; (2) argue that while a fetus may be vulnerable in terms of dependency, this categorization does not equate to the vulnerability of the pregnant woman; and (3) suggest that any vulnerability that appends to women is precisely the result of federal regulations and dubious public perceptions about pregnant women. I conclude by demonstrating how this erroneous characterization of pregnant women as “vulnerable” and its associated protections have not only impeded vital research for pregnant women and their fetuses, but have also negatively affected the inclusion of all women in clinical research. (shrink)

Imagine you are walking down a city street. It is windy and raining. Amidst the bustle you see a young woman. She sits under a railway bridge, hardly protected from the rain and holds a woolen hat containing a small number of coins. You can see that she trembles from the cold. Or imagine seeing an old woman walking in the street at dusk, clutching her bag with one hand and a walking stick with the other. A group of male (...) youths walk behind her without overtaking, drunk and in the mood for mischief. It doesn't need an academic to say what vulnerability is. We can all see it, much more often than we care to. (shrink)

A compilation of 16 papers selected from two UNESCO Bangkok Bioethics Roundtables, with research and policy dialogues from different countries in the region. It includes papers on informed consent, ethics committees, communication, organ transplants, traditional medicines and sex selection.

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)

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)

ABSTRACTThe concept of ‘vulnerability’ is well established within the realm of research ethics and most ethical guidelines include a section on ‘vulnerable populations’. However, the term ‘vulnerability’, used within a human research context, has received a lot of negative publicity recently and has been described as being simultaneously ‘too broad’ and ‘too narrow’.1 The aim of the paper is to explore the concept of research vulnerability by using a detailed case study – that of mineworkers in post‐apartheid South Africa. In (...) particular, the usefulness of Kipnis’s taxonomy of research vulnerability will be examined.2In recent years the volume of clinical research on human subjects in South Africa has increased significantly. The HIV and TB pandemics have contributed to this increase. These epidemics have impacted negatively on the mining industry; and mining companies have become increasingly interested in research initiatives that address these problems. This case study explores the potential research vulnerability of mineworkers in the context of the South African mining industry and examines measures that can reduce this vulnerability. (shrink)

Emergency care research sometimes involves incapacitated adults as research participants. The ethical principle of respect for autonomy may not necessarily apply to an incapacitated person unable to act in an autonomous manner, although it can be argued that researchers still have a duty of respect towards such people because they have moral status despite being incapacitated. Sharing some common ground with theories of moral status based on ‘humanness’ and the ability for rational thought is the notion of human dignity, which (...) features in arguments regarding researcher conduct with incapacitated patients. However, human dignity premised upon the unique ability of humans for rational thought and moral self-regulation is contingent upon these capabilities – a limitation that possibly makes dignity a less useful framework for research conduct in emergency care research. In this article, I will discuss the different conceptions of human dignity – as equality, status and virtue – and then draw on more recent literature that explains human dignity as a social constraint and as a factor influencing the conduct of healthcare professionals and researchers. I will address questions of whether dignity as a principle ought to apply only to those who have the ability to think rationally, or to all humans regardless of their condition or mental status. I will argue that, in relation to offering protection to research participants in emergency conditions, it is immaterial which view is taken. (shrink)

Vulnerability has emerged as a fruitful concept in recent political discourse. Although care theorists have sometimes framed care ethics in terms of vulnerability, they have most often oriented it around dependency. This article discusses the differences between dependency and vulnerability and argues for a reconceptualization of care ethics in terms of vulnerability. By reframing care ethics around vulnerability, care theorists can not only broaden the scope of issues that care ethics can address and clarify ambiguities in the theory but also (...) strengthen the justification for a responsibility to care. (shrink)

Most of the literature on phase one trials has focused on ethical and safety issues in research on patients with advanced cancer, but this article focuses on healthy, adult subjects. The article makes six specific recommendations for protecting the rights and welfare of healthy subjects in phase one trials: 1) because phase one trials are short in duaration (usually 1 to 3 months), researchers should gather more data on the short-term and long-term risks of participation in phase one studies by (...) healthy subjects; 2) researchers should develop strict inclusion/exclusion criteria that exclude unhealthy or vulnerable subjects, such as decisionally impaired people, in phase one studies; 3) subjects should not participate in more than one phase one study at the same time and should wait at least 30 days between participating in different studies; 4) researchers should develop a database to keep track of phase one participants; 5) subjects should be guaranteed a minimum wage equivalent to the equivalent type of unskilled labor, but there should be no upper limits on wages; and 6) subjects should be allowed to engage in collective bargaining with research sponsors. *Disclaimer: The ideas and opinions expressed in this article are the authors' personal views and do not represent the views of the National Institute of Environmental Health Sciences, the National Institutes of Health, or the United States government. (shrink)

BackgroundThe issue of stigma is very important in the battle against HIV/aids in Africa since it may affect patient attendance at healthcare centres for obtaining antiretroviral medications and regular medical check-ups. Stigmatization creates an unnecessary culture of secrecy and silence based on ignorance and fear of victimization. This study was designed to determine if there is external stigmatization of people living with HIV and AIDS by health care workers at a tertiary hospital in KwaZulu-Natal province, South Africa. The study investigated (...) the impact of knowledge of HIV/aids by HCWs on treatment of patients, as well as the comfort level and attitude of HCWs when rendering care to PLWHA.MethodsA descriptive cross sectional study was designed to collect data using an anonymous self-administered structured questionnaire from 334 HCWs. The study was conducted in clinical departments of a large multidisciplinary 922-bed tertiary care teaching hospital in Durban, KZN.ResultsOverall HCWs had an above average knowledge about HIV/aids although some gaps in knowledge were identified. Tests of statistical significance showed that there was association between level of education and knowledge of HIV/aids ; occupation and knowledge of HIV/aids ; and gender and knowledge of HIV/aids. Test for comfort level was only significant for gender, with males showing more comfort and empathy when dealing with PLWHA. The study also revealed that patients were sometimes tested for HIV without informed consent before surgery, due to fear of being infected, and there was some gossiping about patients' HIV status by HCWs, thereby compromising patient confidentiality. The majority of HCWs showed a willingness to report incidents of stigmatization and discrimination to higher authorities, for better monitoring and control.ConclusionsAlthough knowledge, attitude and comfort level of HCWs taking care of PLWHA was above average, enforcement of existing antidiscrimination laws and continuing education in medical ethics and healthcare law, would greatly improve the performance of HCWs taking care of PLWHAs. More psychological support and counselling should be provided to HCWs, to further reduce the impact of stigmatization and discrimination against PLWHA. (shrink)

These CQ Sources were compiled by Bette Anton.

The use of prisoners as research participants is controversial. Efforts to protect them in response to past exploitation and abuse have led to strict regulations and reluctance to involve them as participants. Hence, prisoners are routinely denied the opportunity to participate in research. In the absence of comprehensive information regarding prisoners’ current involvement in research, we examined UK prisoners’ involvement through review of research applications to the UK National Research Ethics Service. We found that prisoners have extremely limited access to (...) research participation. This analysis was augmented by a survey of those involved in research and research governance (UK researchers and Research Ethics Committee members). Our results suggest that pragmatic concerns regarding the perceived burden of including prisoners are far more prominent in motivating their exclusion than ethical concerns or knowledge of regulations. While prisoners may remain a vulnerable research population due to constraints upon their liberty and autonomy and the coercive nature of the prison environment, routine exclusion from participation may be disadvantageous. Rigorous ethical oversight and the shift in the prevailing attitude towards the risks and benefits of participation suggest that it may be time for research to be more accessible to prisoners in line with the principle of equivalence in prison healthcare. We suggest the necessary first step in this process is a re-examination of current guidance in the UK and other countries with exclusions. (shrink)

This paper analyses the way in which being in possession of an adequate range of options is an essential component of autonomy. I discuss the way in which the conceptualisation of options in terms of basic rights might assist this argument, and apply these ideas to HIV/AIDS clinical research in the developing world. Finally, I suggest that mechanisms should be put in place through which vulnerable research participants can express their views about the relationship between the research in which they (...) are involved, and needs of a worthwhile life. (shrink)

Background A morally sound framework for benefit-sharing is crucial to minimize research exploitation for research conducted in developing countries. However, in practice, it remains uncertain which stakeholders should be involved in the decision-making process regarding benefit-sharing and what the implications might be. Therefore the study aimed to empirically propose a framework for benefit-sharing negotiations in research by taking HIV vaccine trials as a case. Methods The study was conducted in Tanzania using a case study design and qualitative approaches. Data were (...) collected using in-depth interviews (IDI) and focus group discussions (FGD). A total of 37 study participants were selected purposively comprising institutional review board (IRB) members, researchers, community advisory board (CAB) members, a policymaker, and HIV/AIDS advocates. Deductive and inductive thematic analysis approaches were deployed to analyze collected data with the aid of MAXQDA version 20.4.0 software. Results The findings indicate a triangular relationship between the research community, researched community and intermediaries. However, the relationship ought to take into consideration the timing of negotiations, the level of understanding between parties and the phase of the clinical trial. The proposed framework operationalize partnership interactions in community-based participatory research. Conclusion In the context of this study, the suggested framework incorporates the research community, the community being researched, and intermediary parties. The framework would guarantee well-informed and inclusive decision-making regarding benefit-sharing in HIV vaccine trials and other health-related research conducted in resource-limited settings. (shrink)

Most of the literature on phase one trials has focused on ethical and safety issues in research on patients with advanced cancer, but this article focuses on healthy, adult subjects. The article makes six specific recommendations for protecting the rights and welfare of healthy subjects in phase one trials: 1) because phase one trials are short in duaration (usually 1 to 3 months), researchers should gather more data on the short-term and long-term risks of participation in phase one studies by (...) healthy subjects; 2) researchers should develop strict inclusion/exclusion criteria that exclude unhealthy or vulnerable subjects, such as decisionally impaired people, in phase one studies; 3) subjects should not participate in more than one phase one study at the same time and should wait at least 30 days between participating in different studies; 4) researchers should develop a database to keep track of phase one participants; 5) subjects should be guaranteed a minimum wage equivalent to the equivalent type of unskilled labor, but there should be no upper limits on wages; and 6) subjects should be allowed to engage in collective bargaining with research sponsors. *Disclaimer: The ideas and opinions expressed in this article are the authors' personal views and do not represent the views of the National Institute of Environmental Health Sciences, the National Institutes of Health, or the United States government. (shrink)

The death of multiculturalism has been pronounced many times. In spite of this, this political program has proven resilient and the fact of cultural diversity remains inescapable in most liberal democracies. Still, with the rise of the far right, the migrant crises in the United States and Europe and with social movements pushing the boundaries of multicultural theory, it is high time to review multiculturalism, a movement of the late 20th century, and see where it is headed in the 21st (...) century. This article has two objectives. First, after reviewing three debates—anti‐essentialists versus multiculturalism, interculturalism versus multiculturalism and multiculturalism versus the welfare state—I argue that the normative core of multiculturalism is still viable. Second, I argue that multiculturalism remains unable to contribute to some of the most pressing issues of the 21st century and point to a novel approach to the justification of multicultural policies. This justification relies on the concept of vulnerability, a concept that plays an important but undertheorized role in current multicultural theories. (shrink)

The exportation of unethical practices to low- and middle-income countries has been conceived as a prevalent practice which needs to be examined more closely. Such a practice might point towards the exploitation of vulnerable population groups. We conducted a survey among Mexican research ethics committee members to explore the issue of ethics dumping in Mexico by understanding how its existence and contributing factors and norms are perceived by these ethics committee members. We designed an exploratory survey based on a five-point (...) Likert scale, following an established, validated and published methodology. The questionnaire included both open close-ended questions. The aspects covered in the questionnaire were introductory questions on the existence of ethical issues; general perception on ethics dumping in Mexico; lack of voluntariness, undue inducement, and therapeutic misconception as exploitation risks; existence of exploitative practices; norms facilitating ethics dumping; acceptable levels of benefit to Mexico; boundaries of ethics dumping. The survey was administered to a sample of research ethics committee members from public and private Mexican hospitals in 2016. Most of the ethics committee members believed clinical trials are generally ethically sound, though almost a majority think that ethics dumping is a common occurrence and that it is a serious issue. Most agree that ethics dumping needs to be addressed. They also identified other issues such as ethical issues related to patient participation and ethics committees. Further, most committee members agree that undue inducement and therapeutic misconception affect voluntariness, and that both individuals and communities receive appropriate benefits. From the perspective of Mexican research ethics committee members, ethics dumping commonly exists in Mexican clinical trials, as well as several related issues such as ethical issues on patient participation and ethics committees, as well as voluntariness issues. Further, most members believed these issues need to be addressed. However, most were also of the opinion that clinical trials are generally ethically compliant. This points to the need for further studies on the reasons for these perspectives. (shrink)

Dieser Beitrag untersucht die Frage, ob erwachsene Kinder ihren Eltern als deren Kinder etwas schulden. Ich argumentiere, dass sich entsprechende filiale Pflichten nicht begründen lassen, und zwar weder i.) mit Verweis auf Güter, die Kinder im Laufe ihrer Kindheit von ihren Eltern erhalten haben, noch ii.) vor dem Hintergrund der aktuellen Beziehung zwischen Eltern und ihren erwachsenen Kindern, noch iii.) mit Blick auf das positive Potential dieses Verhältnisses für Eltern wie Kinder. Zwar haben Kinder also keine filialen Pflichten, doch sind (...) sie iv.) dennoch in ihrer filialen Freiheit eingeschränkt. Diese Einschränkung ergibt sich aus der speziellen relationalen Vulnerabilität, welche die Eltern-Kind-Beziehung prägt und die Kindern Grund gibt, sich in ihrem Verhalten ihren eigenen Eltern gegenüber von dieser Verletzlichkeit leiten zu lassen und auf sie Rücksicht zu nehmen. (shrink)

Background: Empirical ethics inquiry works from the notion that stakeholder perspectives are necessary for gauging the ethical acceptability of human studies and assuring that research aligns with societal expectations. Although common, studies involving different populations often entail comparisons of trends that problematize the interpretation of results. Using graphical model selection—a technique aimed at transcending limitations of conventional methods—this report presents data on the ethics of clinical research with two objectives: (1) to display the patterns of views held by ill and (...) healthy individuals in clinical research as a test of the study's original hypothesis and (2) to introduce graphical model selection as a key analytic tool for ethics research. Methods: In this institutional review board (IRB)-approved, National Institutes of Health-funded project, data were collected from 60 mentally ill and 43 physically ill clinical research protocol volunteers, 47 healthy protocol-consented participants, and 29 healthy individuals without research protocol experience. Respondents were queried on the ethical acceptability of research involving people with mental and physical illness (i.e., cancer, HIV, depression, schizophrenia, and posttraumatic stress disorder) and non-illness-related sources of vulnerability (e.g., age, class, gender, ethnicity). Using a statistical algorithm, we selected graphical models to display interrelationships among responses to questions. Results: Both mentally and physically ill protocol volunteers revealed a high degree of connectivity among ethically salient perspectives. Healthy participants, irrespective of research protocol experience, revealed patterns of views that were not highly connected. Conclusions: Between ill and healthy protocol participants, the pattern of views was vastly different. Experience with illness was tied to dense connectivity, whereas healthy individuals expressed views with sparse connections. In offering a nuanced perspective on the interrelation of ethically relevant responses, graphical model selection has the potential to bring new insights to the field of ethics. (shrink)

It has been almost 20 years since the field of bioethics was galvanized by a controversial series of multinational AZT trials employing placebo controls on pregnant HIV-positive women in the developing world even though a standard of care existed in the sponsor countries. The trove of ethical investigations that followed was thoughtful and challenging, yet an important and problematic methodological assumption was left unexplored. In this article, I revisit the famous “double standard of care” case study in order to offer (...) novel consideration of the placebo orthodoxy that underlies much of the ethical debate. This majority view found in medical research is that placebo-controlled trials are methodologically superior to comparative trials that use active controls. I challenge this orthodoxy and argue that lives were unnecessarily lost in these trials as a result. Furthermore, current HIV research on vaccines and microbicides is now poised to repeat the error of subscribing to the placebo orthodoxy. (shrink)

International codes of ethics play an important role in guiding professional practice in developing countries. In the occupational health setting, codes developing by international agencies have substantial import on protecting working populations from harm. This is particularly so under globalisation which has transformed processes of production in fundamental ways across the globe. As part of the process of revising the Ethical Code of the International Commission on Occupational Health, an African Working Group addressed key challenges for the relevance and cogency (...) of an ethical code in occupational health for an African context through an iterative consultative process. (shrink)

African researchers and their collaborators have been making significant contributions to useful research findings and discoveries in Africa. Despite evidence of scientific misconduct even in heavily regulated research environments, there is little documented information that supports prevalence of research misconduct in Africa. Available literature on research misconduct has focused on the developed world, where credible research integrity systems are already in place. Public attention to research misconduct has lately increased, calling for attention to weaknesses in current research policies and regulatory (...) frameworks. Africa needs policies, structural and governance systems that promote responsible conduct of research. To begin to offset this relative lack of documented evidence of research misconduct, contributors working in various research institutions from nine African countries agreed to share their experiences to highlight problems and explore the need to identify strategies to promote research integrity in the African continent. The experiences shared include anecdotal but reliable accounts of previously undocumented research misconduct, including some ‘normal misbehavior’ of frontline staff in those countries. Two broad approaches to foster greater research integrity are proposed including promotion of institutional and individual capacity building to instil a culture of responsible research conduct in existing and upcoming research scientist and developing deterrent and corrective policies to minimize research misconduct and other questionable research practices. By sharing these experiences and through the strategies proposed, the authors hope to limit the level of research misconduct and promote research integrity in Africa. (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)

This article explores solidarity as an ethical concept underpinning rules in the global health context. First, it considers the theoretical conceptualisation of the value and some specific duties it supports (ie: its expression in the broadest sense and its derivative action-guiding duties). Second, it considers the manifestation of solidarity in two international regulatory instruments. It concludes that, although solidarity is represented in these instruments, it is often incidental. This fact, their emphasis on other values and their internal weaknesses diminishes the (...) action-guiding impact of the solidarity rules. The global health and human subject research scene needs a completely new instrument specifically directed at means by which solidarity can be achieved, and a reformed infrastructure dedicated to realising that value. (shrink)

BackgroundVulnerability is a key concept in traditional and contemporary bioethics. In the philosophical literature, vulnerability is understood not only to be an ontological condition of humanity, but also to be a consequence of contingent factors. Within bioethics debates, vulnerable populations are defined in relation to compromised capacity to consent, increased susceptibility to harm, and/or exploitation. Although vulnerability has historically been associated with older adults, to date, no comprehensive or systematic work exists on the meaning of their vulnerability. To fill this (...) gap, we analysed the literature on aged care for the meaning, foundations, and uses of vulnerability as an ethical concept.MethodsUsing PRISMA guidelines, we conducted a systematic review of argument-based ethics literature in four major databases: PubMed, Embase®, Web of Science™, and Philosopher’s Index. These covered biomedical, philosophy, bioethical, and anthropological literature. Titles, abstracts, and full texts of identified papers were screened for relevance. The snowball technique and citation tracking were used to identify relevant publications. Data analysis and synthesis followed the preparatory steps of the coding process detailed in the QUAGOL methodology.ResultsThirty-eight publications met our criteria and were included. Publication dates ranged from 1984 to 2020, with 17 publications appearing between 2015 and 2020. Publications originated from all five major continents, as indicated by the affiliation of the first author. Our analyses revealed that the concept of vulnerability could be distinguished in terms of basic human and situational vulnerability. Six dimensions of older adults’ vulnerability were identified: physical; psychological; relational/interpersonal; moral; sociocultural, political, and economic; and existential/spiritual. This analysis suggested three ways to relate to older adults’ vulnerability: understanding older adults’ vulnerability, taking care of vulnerable older adults, and intervening through socio-political-economic measures.ConclusionsThe way in which vulnerability was conceptualised in the included publications overlaps with distinctions used within contemporary bioethics literature. Dimensions of aged care vulnerability map onto defining features of humans, giving weight to the claim that vulnerability represents an inherent characteristic of humans. Vulnerability is mostly a value-laden concept, endowed with positive and negative connotations. Most publications focused on and promoted aged care, strengthening the idea that care is a defining practice of being human. (shrink)

The concept of vulnerability has long played a central role in discussions of research ethics. In addition to its rhetorical use, vulnerability has become a term of art in U.S. and international research regulations and guidelines, many of which contain specific provisions applicable to research with vulnerable subjects. Yet, despite the frequency with which the term vulnerability is used, little consensus exists on what it actually means in the context of human subject protection or, more importantly, on how a finding (...) of vulnerability should affect the process of research ethics review.The Common Rule, the centerpiece of the U.S. human subject protection regulations, uses the word vulnerable three times. First, it provides that institutional review boards that regularly review research involving a vulnerable category of subjects should consider including one or more individuals who are knowledgeable about and experienced in working with these subjects. (shrink)

The participation of vulnerable patients in clinical research poses apparent ethical dilemmas. Depending on the nature of the vulnerability, their participation may challenge the ethical principles of autonomy, non-maleficence, or justice. On the other hand, non-participation may preclude the building of a knowledge base that is a prerequisite for defining the optimal clinical management of vulnerable patients. Such clinical uncertainty may also incur substantial economic costs. We present the participation of pre-menopausal women with atrial fibrillation in trials of novel oral (...) anticoagulant drugs as a case study. Due to their non-participation in pivotal trials, it is uncertain whether for them, the risks that are associated with these drugs are outweighed by the advantages compared with conventional treatment. We addressed the question whether research of this new class of drugs in this subgroup would be appropriate from both, an ethical as well an economic perspective. We used the method of specifying norms as a wider framework to resolve the apparent ethical dilemma, while incorporating the question whether research of oral anticoagulants in premenopausal women with atrial fibrillation can be justified on economic grounds. For the latter, the results of a value-of-information analysis were used. Further clinical research on NOACs in premenopausal women with atrial fibrillation can be justified on both, ethical and economic grounds. Addressing apparent ethical dilemmas by invoking a method such as specifying norms can improve the quality of public practical reasoning. As such, the method should also prove valuable to committees that have formally been granted the authority to review trial protocols and proposals for scientific research. (shrink)

Human rights have increasingly been put forward as an important framework for bioethics. In this paper, it is argued that human rights offer a potentially fruitful approach to understanding the notion of Respect for Persons in bioethics. The idea that we are owed a certain kind of respect as persons is relatively common, but also quite often understood in terms of respecting people’s autonomous choices. Such accounts do however risk being too narrow, reducing some human beings to a second-class moral (...) status. This paper puts forward a political approach to our standing as persons and a strongly pluralistic account of human rights that lays the ground for a more broadly applicable conception of Respect for Persons. It is further argued that this model also provides an example of a more general approach to philosophical ethics, an approach which is here called taxonomical pluralism. When it comes to Respect for Persons specifically, this principle is developed in terms of five distinct core concerns. (shrink)

Human infection challenge studies (HCS) involve intentionally infecting research participants with pathogens (or other micro-organisms). There have been recent calls for more HCS to be conducted in low-income and middle-income countries (LMICs), where many relevant diseases are endemic. HCS in general, and HCS in LMICs in particular, raise numerous ethical issues. This paper summarises the findings of a project that explored ethical and regulatory issues related to LMIC HCS via (i) a review of relevant literature and (ii) 45 qualitative interviews (...) with scientists and ethicists. Among other areas of consensus, we found that there was widespread agreement that LMIC HCS can be ethically acceptable, provided that they have a sound scientific rationale, are accepted by local communities and meet usual research ethics requirements. Unresolved issues include those related to (i) acceptable approaches to trade-offs between the scientific aim to produce generalisable results and the protection of participants, (iii) the sharing of benefits with LMIC populations, (iii) the acceptable limits to risks and burdens for participants, (iv) the potential for third-party risk and whether the degree of acceptable third-party risk is different in endemic settings, (v) the conditions under which (if any) it would be appropriate to recruit children for disease-causing HCS, (v) appropriate levels of payment to participants and (vi) appropriate governance of (LMIC) HCS. This paper provides preliminary analyses of these ethical considerations in order to (i) inform scientists and policymakers involved in the planning, conduct and/or governance of LMIC HCS and (ii) highlight areas warranting future research. Insofar as this article focuses on HCS in (endemic) settings where diseases are present and/or widespread, much of the analysis provided is relevant to HCS (in HICs or LMICs) involving pandemic diseases including COVID19. (shrink)

Australia's policy of mandatory indefinite detention of those seeking asylum and arriving without valid documents has led to terrible human rights abuses and cumulative deterioration in health for those incarcerated. We argue that there is an imperative to research and document the plight of those who have suffered at the hands of the Australian government and its agents. However, the normal tools available to those engaged in health research may further erode the rights and well being of this population, requiring (...) a rethink of existing research ethics paradigms to approaches that foster advocacy research and drawing on the voices of those directly affected, including those bestowed with duty of care for this population. (shrink)

In this paper, following the taxonomy developed by Mackenzie, Rogers and Dodds of different sources and states of vulnerability, I claim that wild animals are inherently and situationally vulnerable. This is because they can experience suffering as a response to certain internal and external states and have a high exposure to, and a low capacity to cope with, harmful natural processes. From this it follows that we have a moral obligation to support and assist individuals who are occurrently vulnerable and (...) to reduce the risk of dispositional vulnerabilities becoming occurrent in the future, by endorsing some form of what I call ‘environmental enhancement’. Finally, I pay critical attention to how to prevent interventions aimed at ameliorating vulnerability from paradoxically generating pathogenic vulnerabilities. (shrink)

Background: Individual, comprehensive, and written informed consent is broadly considered an ethical obligation in research involving the sampling of human material. In developing countries, however, local conditions, such as widespread illiteracy, low levels of education, and hierarchical social structures, complicate compliance with these standards. As a result, researchers may modify the consent process to secure participation. To evaluate the ethical status of such modified consent strategies it is necessary to assess the extent to which local practices accord with the values (...) underlying informed consent. Methods: Over a 2-week period in April 2014 we conducted semistructured interviews with researchers from a genetic research institute in rural Pakistan and families who had given blood samples for their research. Interviews with researchers focused on the institute’s requirements for consent, and the researchers’ strategies for and experiences with obtaining consent in the field. Interviews with donors focused on their motivation for donating samples, their experience of consent and donation, and what factors were central in their decisions to give consent. Results: Researchers often reported modifications to consent procedures suited to the local context, standardly employing oral and elder consent, and tailoring information to the social education level of donor families. Central themes in donors’ accounts of their decision to consent were the hope of getting something out of their participation and their remarkably high levels of trust in the researchers. Several donor accounts indicated a degree of confusion about participation and diagnosis, resulting in misconceived expectations of therapeutic benefits. Conclusions: We argue that while building and maintaining trusting relationships in research is important—not least in developing countries—strategies that serve this endeavor should be supplemented with efforts to ensure proper provision and understanding of relevant information, specifically about the nature of research and measures for individual consent and opt-out. (shrink)

As much as we can be squeamish and angry over what was being done in these studies, they force us to consider how we tell these stories and the policy we make now, as so much of our research is global and the risks and benefits of experimentation always in need of recalibration.Susan M. ReverbyA growing distrust exists among Latin American populations as past abuses in medical research have rightly been publicized, and as researchers continue to intentionally and unintentionally circumvent (...) the systems of regulation and oversight. Beyond the cultural gaps between researcher and subject, the Latin American people have their own perspectives about responsible conduct of research formed by sociopolitical thought and familial and community identity, which may be overlooked or ignored by the U.S. and other foreign nations. Just as the Havasupai Tribe in Arizona have challenged us to think about the role of culture and the need for improved regulations and practices in conducting research within the United States, through past abuses in human experimentation and the emergence of discourse between our Latin American neighbors, similar challenges confront us. (shrink)

Vulnerability in research is often understood as a diminished ability to protect one's own interests, manifested by a compromised capacity to give informed or voluntary consent. Certain groups of people are thought to be more vulnerable than others and therefore are at risk of being exploited or mistreated in research. Accordingly, the federal regulations call for additional safeguards to protect vulnerable groups.There remains some ambiguity and contradiction, however, regarding what groups are vulnerable in research and why,3 since the available codes (...) of research ethics and regulations describe many groups as vulnerable. When so many groups are considered vulnerable, but no specification is offered as to how they are vulnerable or what particular protections are appropriate, the possibility of meaningful safeguards is diminished. In addition, current concepts of vulnerability are usually applied to whole groups of people, without distinguishing between individuals in a group who might truly have a compromised capacity to protect their own interests from those who do not. (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)

Refugees and asylum seekers may experience challenges related to pre-arrival experiences, structural disadvantage after migration and during resettlement requiring the need for special protection when participating in research. The aim was to review if and how people with refugee and asylum seeker backgrounds have had their need for special protection addressed in national and international research ethics guidelines. A systematic search of grey literature was undertaken. The search yielded 2187 documents of which fourteen met the inclusion criteria. Few guidelines addressed (...) specific ethical considerations for vulnerable groups much less people with refugee and asylum seeker backgrounds. One guideline explicitly addressed vulnerability for refugees and asylums seekers. To ensure members of ethics committees and researchers consider the potential challenges of conducting research with these groups, guidelines may need to be supplemented with a refugee and asylum seeker specific research ethics framework. Such a framework may be necessary to optimally protect people with refugee and asylum seeker backgrounds in research. (shrink)

The psycho-social day-to-day experience of COVID-19 pandemic has shone some light on the wider scope of health vulnerability and has correspondingly enlarged the ethical debate surrounding the social implications of health and healthcare. This emerging paradigm is neither a single-handed problem of biomedical scientists nor of social analysts. It instead needs a strategically oriented collaborative and interdisciplinary preventive effort. To that effect, this article presents some socio-ethical reflections underscoring the judicious use of the insight from care ethics as an asset (...) in minimizing the possible propagation of the COVID-19 virus and the escalation of its vulnerability in the day-to-day human interaction. It further emphasizes that if this insight is overlooked, the effects of the diverse facets of the “shadow pandemics” of COVID-19—fallouts on both the affected and the infected—may equally be deadly. (shrink)

Background: International codes of ethics play an important role in guiding professional practice in developing countries. In the occupational health setting, codes developed by international agencies have substantial import on protecting working populations from harm. This is particularly so under globalisation which has transformed processes of production in fundamental ways across the globe. As part of the process of revising the Ethical Code of the International Commission on Occupational Health, an Africa Working Group addressed key challenges for the relevance and (...) cogency of an ethical code in occupational health for an African context through an iterative consultative process. Discussion: Firstly, even in the absence of strong legal systems of enforcement, and notwithstanding the value of legal institutionalisation of ethical codes, guidelines alone may offer advantageous routes to enhancing ethical practice in occupational health. Secondly, globalisation has particularly impacted on health and safety at workplaces in Africa, challenging occupational health professionals to be sensitive to, and actively redress imbalance of power. Thirdly, the different ways in which vulnerability is exemplified in the workplace in Africa often places the occupational health professional in invidious positions of Dual Loyalty. Fourth, the particular cultural emphasis in traditional African societies on collective responsibilities within the community impacts directly on how consent should be sought in occupational health practice, and how stigma should be dealt with, balancing individual autonomy with ideas of personhood that are more collective as in the African philosophy of ubuntu. To address stigma, practitioners need to be additionally sensitive to how power imbalances at the workplace intersect with traditional cultural norms related to solidarity. Lastly, particularly in the African context, the inseparability of workplace and community means that efforts to address workplace hazards demand that actions for occupational health extend beyond just the workplace. Summary: A stronger articulation of occupational health practice with advocacy for prevention should be an ethical norm. Ethical codes should ideally harmonize and balance individual and community needs so as to provide stronger moral authority guidelines. There is a need to consider an African Charter on Bioethics as complementary and strengthening of existing codes for the region. (shrink)

The article analyses the three terms autonomy, dignity and vulnerability. The relevance and practical application of the terms is tested in two spheres. First, as guiding principles in the area of ethics of medicines and science. Second, as human rights principles, serving to guide the conduct of public policies for an effective realization of human rights. The article argues that all human beings have the same dignity, but that the autonomy—and therefore vulnerability—differs considerably. Simply said, with reduced autonomy comes increased (...) vulnerability, implying extra attention to the protective dimensions. The article finds that the three terms approach the protection of human beings in different ways and that all are relevant and applicable in both spheres, but that an isolated notion of autonomy and a ‘group-based’ notion of vulnerability are not adequate. (shrink)