This paper examines the concept of vulnerability in the context of social research ethics. An ambiguity is noted in use of this term: it may refer to an incapacity to provide informed consent to participate in a research project, or it may imply heightened susceptibility to the risk of harm. It is pointed out that vulnerability is a matter of degree, and that there are different sources and types of harm, which must be taken into account in any judgment about (...) whether additional precautions are required to protect particular categories of research participants. Furthermore, such judgments must be sensitive to the particular context in which research is taking place. This is one of several considerations that raise questions about the desirability of the sort of pre-emptive ethical regulation that has become institutionalized in many countries over the past few decades, a form that is more appropriate to medical rather than to social research. However, this is not to deny that a concern with the vulnerability of research participants is necessary on the part of social researchers. Furthermore, it must be recognized that researchers themselves may be vulnerable to harm in the research process. Finally, some discussion is provided of the way in which a concern with vulnerability can conflict with other considerations that researchers need to take into account in doing their work. The key point is that vulnerability is a complex and controversial concept, and it requires careful handling in thinking about social research ethics. (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)

The 2015 UK Supreme Court judgment in Montgomery v Lanarkshire reinforces the importance of informed consent to medical treatment. This paper suggests that Montgomery recognises the challenge faced by vulnerable individuals in choosing between treatment options and making decisions with appreciation of information about material risks. The judgment endorses a form of weak paternalism to safeguard such persons, which is not disrespectful of the aggregate principles of the Mental Capacity Act 2005. But ethical practice requires professionals to tread carefully between (...) weak and hard paternalism in the context of therapeutic interactions with vulnerable patients, while ensuring their awareness of material risks. (shrink)

International migration has a female face in the beginning of the twenty-first century; since at least 1990, a total of 49 percent of international migrants have been women (UN 2008).1 Many women relocate in pursuit of goals that they can’t realize in their countries of origin, and many women move on their own to developed countries as caregivers to the very old or the very young, as nurses to attend to the sick in hospitals, and as domestic workers.2 How should (...) we regard their decisions to do so? One way of thinking about such moves is to deplore the fact that women have to move in order to attain certain goals in their lives; it would be more desirable to live in a world that would not make such moves necessary... (shrink)

The 1992 Convention on Biological Diversity (CBD) and its 2010 Nagoya Protocol brought about a breakthrough in global policy making. They combined a concern for the environment with a commitment to resolving longstanding human injustices regarding access to, and use of biological resources. In particular, the traditional knowledge of indigenous communities was no longer going to be exploited without fair benefit sharing. Yet, for 25 years after the adoption of the CBD, there were no major benefit sharing agreements that led (...) to significant funding streams for indigenous communities. This changed with the signing of the Rooibos Benefit Sharing Agreement in South Africa, described in this paper. As the authors report, the Rooibos Agreement is a superlative in two respects. It is the biggest benefit sharing agreement between industry and indigenous peoples to date. It is also the first industry-wide agreement to be formed in accordance with biodiversity legislation. This article is a co-production between traditional knowledge holders, the lawyer who represented their interests, the Co-Chair of the Nagoya Protocol negotiations, and an ethicist who analyzed the major challenges of this historic agreement. With no precedent in the benefit sharing world, the agreement stands as a concrete example of the ‘art of the possible.’ Although the rooibos case is unique in a number of aspects, the experience offers many transferable insights, including: patience; incrementalism; honesty; trust; genuine dialogue; strong legal support; a shared recognition that a fair, win-win deal is possible; government leadership; and unity amongst indigenous peoples. Such ingredients of success can apply well beyond southern Africa. (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)

Both living donor transplantation and human subjects research expose one set of individuals to clinical risks for the clinical benefits of others. In the Belmont Report, the National Commission for the Protection of Human Subjects of Biomedical and Behavior Research articulated three principles to serve as the basis for a research ethics framework: respect for persons, beneficence and justice. In contrast, living donor transplantation lacks a framework. In this manuscript, we adapt the three principles articulated in the Belmont Report to (...) serve as the foundation for an ethics framework for living donor transplantation which we supplement with the principles of vulnerability and responsibility. The National Commission supported additional protections for vulnerable groups of potential research participants. In 2001, Kenneth Kipnis effectively argued that the concept of vulnerable groups failed to explore in what ways particular groups of people were vulnerable, thereby risking unnecessary protections for some and inadequate protections for others. He proposed a taxonomy that explored different types of vulnerabilities that all research participants may experience to provide a more robust framework for human subjects protections, which we adapt to living donors. Robert Goodin claims that health professionals, who stand in special relationship with patients, are responsible for promoting and protecting their well-being. In living donor transplantation, the donor transplant team is responsible for empowering prospective donors to address their vulnerabilities and/or for protecting those who cannot by disqualifying them from donation. (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)

Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers seek to test the efficacy of another vaccine for the same pathogen in clinical trials involving human subjects. On the one hand, there are compelling reasons why it would be unethical to trial a novel vaccine when an effective product exists already. First, (...) it is a firm principle of medical ethics that an effective treatment or vaccine should not be withheld from patients if their life may depend on it. Second, since epidemic outbreaks often emerge in settings with less-resourced health systems, there is a pronounced risk that any trial withholding an effective vaccine would disproportionately affect the vulnerable populations that historically have been exploited for biomedical research. Third, clinical trials for novel vaccines may be at odds with efforts to control active outbreaks. On the other hand, it may be justified to conduct a trial for a candidate vaccine if it is expected to have certain advantages compared with the existing product. This essay discusses key factors for comparing vaccines against epidemic pathogens, including immunological, logistical and economic considerations. Alongside a case study of the development of vaccines for Ebola, the essay seeks to establish a general framework that should be expanded and populated by immunologists, epidemiologists, economists and bioethicists, and ultimately could be applied to the case of COVID-19 vaccines. (shrink)

Research Ethics, Volume 18, Issue 4, Page 265-280, October 2022. Concerns around comprehension and recall of consent information by research participants have typically been associated with low health and research literacy levels. In genomics research, this concern is heightened as the scientific and ethical complexities of genetics research, such as biobanking, genetic susceptibility, data sharing, and incidental findings may be more difficult for potential research participants to understand. However, challenges to research participants’ comprehension of consent information may be compounded by (...) factors beyond health and research literacy levels. To identify factors that may impact research participants’ understanding and recall of consent information, we designed a qualitative study to explore whether participants enrolled in a tuberculosis genetics study in Cameroon understood the objectives of the study, the risks and benefits and certain key aspects of the study such as biobanking and data sharing. The results showed that research participants had limited understanding and/or recall of the TBGEN-Africa study goals and methods. Some participants were of the opinion that TBGEN-Africa was not a genetics study because tuberculosis is not an inheritable condition. Factors that may have hindered understanding and/or recall of study information are diagnostic misconception, and information overload and situational vulnerability. There is a need for improved practices to support research participants’ understanding of consent information in genetics studies including designing the consent process in ways that minimize psychological distress and diagnostic/therapeutic misconception. (shrink)

How are we to understand hunger strikes and episodes of lip-sewing in immigration detention? Are they simply cases of self-destruction or bare life, as is often claimed, or is there scope to view these embodied acts of self-harm as having a political dimension and to see those engaged in them as resistant subjects exercising political agency? To explore these issues, I draw on recent feminist theoretical work on vulnerability. Received wisdom suggests that vulnerability is an impediment to political action. Rejecting (...) the idea that vulnerability equates exclusively to injurability and passivity, I contend, by contrast, that corporeal vulnerability can potentially prompt action, serve as a resource for collective acts of resistance, and enable the politicization of certain spaces. Since context matters to how vulnerability and resistance intersect, I illustrate my argument by exploring, in particular, the protests that took place at Woomera immigration detention centre in Australia in 2002. (shrink)

While the need to protect vulnerable research participants is universal, conceptual challenges with the notion of vulnerability may result in the under or over-protection of participants. Ethics review bodies making assumptions about who is vulnerable and in what circumstance can be viewed as paternalistic if they do not consider participant viewpoints. Our study focuses on participant vulnerability in Scholarship of Teaching and Learning (SoTL) research. We aim to illuminate students’ views on participant vulnerability to contribute to critical analysis of the (...) role and processes of ethics review. Additionally, we aim to highlight the importance of seeking the views of participant communities, especially in research environments beyond ethics review’s medical origins. Thirty-four students from a health-related faculty at a university in Aotearoa New Zealand, participated in five focus groups. Participants discussed factors affecting their potential participation in research drawing upon a series of vignettes based on examples of published SoTL projects. Themes, generated using reflexive thematic analysis, built a participant-informed picture of vulnerability. Findings indicate that students do not generally consider themselves vulnerable and instead consider participation in SoTL research through an agentic lens. Students expect that participation will be voluntary, not negatively impact their grades, and not single them out so that others could judge them. Our study also highlights the value students place on relationships with one another and teaching staff and the implications these have for SoTL research participation and future professional practice. This research challenges research ethics committees to think further about vulnerability in the context of SoTL whilst highlighting the importance of providing opportunities for research participants more broadly to explore and vocalize their views as members of participant communities. (shrink)

Neurodiversity has remained a controversial concept over the last decade. In its broadest sense the concept of neurodiversity regards atypical neurological development as a normal human difference. The neurodiversity claim contains at least two different aspects. The first aspect is that autism, among other neurological conditions, is first and foremost a natural variation. The other aspect is about conferring rights and in particular value to the neurodiversity condition, demanding recognition and acceptance. Autism can be seen as a natural variation on (...) par with for example homosexuality. The broad version of the neurodiversity claim, covering low-functioning as well as high-functioning autism, is problematic. Only a narrow conception of neurodiversity, referring exclusively to high-functioning autists, is reasonable. We will discuss the effects of DSM categorization and the medical model for high functioning autists. After a discussion of autism as a culture we will analyze various possible strategies for the neurodiversity movement to claim extra resources for autists as members of an underprivileged culture without being labelled disabled or as having a disorder. We will discuss their vulnerable status as a group and what obligation that confers on the majority of neurotypicals. (shrink)

The current ban on certain performance enhancing substances in sport such as erythropoietin faces a line-drawing problem: what is the moral difference between taking an EPO injection to incre...

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)

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 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)

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)

There is a long history of women being underrepresented in biomedical and health research. Specific women’s health needs have been, and in some cases still are, comparatively neglected areas of study. Concerns about the health and social impacts of such bias and exclusion have resulted in inclusion policies from governments, research funders, and the scientific establishment since the 1990s. Contemporary understandings of foregrounding sex and gender issues within biomedical research range from women’s rights to inclusion, to links between human rights, (...) women’s health and sustainable development, and the increasing scientific and funding expectation for studies to consider the sex and gender implications of research design, results and impact. However, there are also exploitation issues to consider when foregrounding the inclusion of women as research participants, especially for research ethics committees and institutional review boards. A hidden risk is that exploitative research designs and practices may be missed, particularly by reviewers who may not have a nuanced understanding of gender-based harm. Utilizing contemporary case studies of ethics dumping, this paper highlights some of the concerns, and makes recommendations for IRBs/research ethics reviewers to help ensure that essential research is undertaken to the highest ethical standards. (shrink)

It might become possible to build artificial minds with the capacity for experience. This raises a plethora of ethical issues, explored, among others, in the context of whole brain emulations (WBE). In this paper, I will take up the problem of vulnerability – given, for various reasons, less attention in the literature – that the conscious emulations will likely exhibit. Specifically, I will examine the role that vulnerability plays in generating ethical issues that may arise when dealing with WBEs. I (...) will argue that concerns about vulnerability are more matters of institutional design than individual ethics, both when it comes to creating humanlike brain emulations, and when animal-like emulations are concerned. Consequently, the article contains reflection on some institutional measures that can be taken to protect the sims' interests. It concludes that an institutional framework more likely to succeed in this task is competitive and poly-centric, rather than monopolistic and centralized. (shrink)

State-sponsored breastfeeding promotion campaigns have become increasingly common in developed countries. In this article, by using the tools of liberal political theory, as well as public health and health promotion ethics, we argue that such campaigns are not justified. They ignore important costs for women, including undermining autonomy, fail to distribute burdens fairly, cannot be justified neutrally and fail a basic efficacy test. Moreover, our argument demonstrates that breastfeeding campaigns are a rare case that bridges the fields of public health (...) ethics and the ethics of health promotion campaigns. This demonstrates the need to consider the ethics of state promotion of both voluntary and coercive behavioural change that benefits third parties. (shrink)

This paper discusses the need to focus on the dignity of human participants as a legal and ethical basis for providing post-trial access to healthcare. Debate about post-trial benefits has mostly focused on access to products or interventions proven to be effective in clinical trials. However, such access may be modelled on a broad fair benefits framework that emphasises both collateral benefits and interventional products of research, instead of prescribed post-trial access alone. The wording of the current version of the (...) Declaration of Helsinki could in fact be interpreted to broaden the scope to include other collateral benefits by applying such a broad fair benefits framework. We argue that this possibility should be utilised by low and middle income countries’ health research ethics committees in order to ensure that research participants who enrol in clinical trials so as to receive medical care continue to access care after the trial is concluded, as befits their dignity. Although each LMIC has unique concerns, nonetheless there are common challenges based especially on emerging issues, such as post-trial access to healthcare. Accordingly, the South African perspective is used to draw lessons that can benefit other LMICs. (shrink)

The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human biological resources (...) are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: - Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research. - With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials). - Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement. (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)