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)

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)

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)

Zusammenfassung Lebensweltliche Bedingungen können sich als Barrieren in Hinblick auf die Durchführung einer von den Patient*innen gewählten – beispielsweise onkologischen – Therapie erweisen und den Therapieerfolg gefährden. Solche lebensweltlichen Herausforderungen lassen sich als Schichten sozialer Vulnerabilität begreifen. In dieser Arbeit wird untersucht, ob es geboten ist, herausfordernde soziale Lebensbedingungen von Patient*innen systematisch bei Therapieentscheidungen zu berücksichtigen. Hierfür wird der Befähigungsansatz nach Martha Nussbaum herangezogen, der die Achtung der Patient*innenautonomie mit der Möglichkeit der Unterstützung durch Dritte zusammenbringt. Anschließend werden anhand des (...) Schichten-Konzeptes von Florencia Luna Vorschläge dafür formuliert, wie soziale Vulnerabilitäten in der Praxis erfasst werden könnten. Obwohl die Überlegungen zum vorliegenden Text aus Beobachtungen der onkologischen Behandlungssituation heraus entstanden sind, lassen sie sich auch auf andere Therapiefelder, die lange Behandlungsdauern mit regelmäßigen Anwesenheiten verlangen, übertragen. Die vorliegende Untersuchung kommt zu dem Ergebnis, dass die ethische Pflicht besteht, lebensweltliche Faktoren in gemeinsame Therapieentscheidungen miteinzubeziehen und den Patient*innen ggf. Unterstützung anzubieten, um den Zugang zu der von ihnen gewählten Therapie zu ermöglichen. (shrink)

The notion of vulnerable groups has gained relevance in international legal instruments while being criticised in philosophical literature for its disabling potential and disempowering consequences. The article argues that the category of group vulnerability should not be abandoned, being an opportunity for resistance, visibility, and a place for dissent: vulnerable groups can both function as a sounding board for claims and make demands for recognition, resetting the political agenda and the topics of public debate, and allow the level of collective (...) needs to emerge from the level of individual interests, thereby guaranteeing a fairer distribution of resources. For this purpose, the article provides two definitions of group vulnerability that avoid both the risks of essentialism and of labelling outcomes. The article also analyses the political value of vulnerable groups, highlighting that it is conceivable as an enabling condition, a source of political agency and mobilisation. (shrink)

The authors offer their sincere thanks to all of the commentators for taking the time to comment on our work ; one of the advantages of the AJOB format is immediate feedback,...

This paper attempts to philosophically articulate empirical evidence on the positive effects of illness within the wider context of a discussion of the positive aspects of vulnerability. The conventional understanding holds that to be vulnerable is to be open to harms and wrongs; it is to be fragile, defenseless, and of compromised autonomy. In this paper, we challenge the assumption that vulnerability consists of nothing but powerlessness and dependence on others. This paper attempts to: (1) outline the theoretical conceptualisation of (...) the positive aspects of coping with illness, while simultaneously showing how these findings provide empirical support for some classical philosophical ideas; (2) influence a change in the manners in which the ill are usually perceived (as weak, dependent, robbed of a good life) and (3) point to the importance of modernising the prevalent biomedical conception of illness with the subjective dimension of health. Biomedical understanding of illness focuses on the vulnerable experience of the sufferer, suggesting the importance of philosophical additions. (shrink)

The goal of this paper is to propose a relational turn in healthcare professionalism, to improve the responsiveness of both healthcare professionals and organizations towards care of patients, but also professionals. To this end, it is important to stress the way in which difficult situations and vulnerability faced by professionals can have an impact on their performance of work. This article pursue two objectives. First, I focus on understanding and making visible shared vulnerability that arises in clinical settings from a (...) triple perspective: patient and family, health professionals, and institutions. Second, to address this challenge for professionalism, in this paper I articulate the term "relational centered-patient professionalism", which has two main axes. The relational approach means taking into account how the relationships among professionals, patients and institutions determine the constitution and evolution of those professional values. The focus on patient centered care is indispensable, because it is the ultimate goal pursued by the development of these professional values, and must always be at the center. (shrink)

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)

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)

Over the last three quarters of a century, international guidelines and regulations have undergone significant changes in how children are problematised as participants in biomedical research. While early guidelines enacted children as vulnerable subjects with diminished autonomy and in need of special protection, beginning in the early 2000s, international regulatory frameworks defined the paediatric population as vulnerable due to unaddressed public health needs. More recently, ethical recommendations have promoted the active engagement of minors as research partners. In this paper, I (...) adopt a post-structuralist approach to policy analysis to examine deep-seated assumptions and presuppositions underlying the changes in the problematisation of children as biomedical research participants over time. While biomedical research ethics focuses on the autonomy and vulnerability of minors, ethical guidelines are situated in specific sociocultural contexts, shaped, among other things, by contingent public health needs and changing conceptions of the value of research and science for society. In the process, I demonstrate the challenge of moving away from an approach that in taking adults as the model overshadows the complexity of children’s lived experiences as well as their personal, cultural, and social lives. The lack of acknowledgement of this complexity makes children vulnerable to epistemic injustice, which is particularly crucial to address in public involvement initiatives. (shrink)

There is a consensus that the effects of medical brain drain, especially in the Sub-Saharan African countries, ought to be perceived as more than a simple misfortune. Temporary restrictions on the emigration of health workers from the region is one of the already existing policy measures to tackle the issue—while such a restrictive measure brings about the need for quite a justificatory work. A recent normative contribution to the debate by Gillian Brock provides a fruitful starting point. In the first (...) step of her defence of emigration restrictions, Brock provides three reasons why skilled workers themselves would hold responsibilities to assist with respect to vital needs of their compatriots. These are fair reciprocity, duty to support vital institutions, and attending to the unintended harmful consequences of one’s actions. While the first two are explained and also largely discussed in the literature, the third requires an explication on how and on which basis skilled workers would have a responsibility as such. In this article, I offer a vulnerability approach with its dependency aspect that may account for why the health workers in underserved contexts would have a responsibility to attend to the unintended side effects of their actions that may lead to a vital risk of harm for the population. I discuss HIV/AIDS care in Zimbabwe as a case in point in order to show that local health workers may have responsibilities to assist the population who are vulnerable to their mobility. (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)

In connection with research on humans, the term “vulnerability” is only appropriate to identify the special need for protection of certain sections of the population and individuals, if this term refers to the additional risk of certain groups of subjects. Authors who focus on the additional risk suffering of a subject group when defining vulnerability succeed in considering the specific worthiness of protection in a context-sensitive way. The attempt to define the risk–benefit assessment for vulnerable subject groups on a binding (...) basis faces considerable difficulties. This assessment depends both on the research situation and on the test subject. The normative aspect of this decision could be solved by referring to Rawl’s decision model of an original position. In cases where there is no benefit for the subject, arguments in the discussion of the risks and benefits that are based on a “group or overall benefit” and an “objective interest,” cannot be fully sustained. (shrink)

BackgroundThe nature of the relationship between a clinical investigator and a research subject has generated considerable debate because the investigator occupies two distinct roles: clinician and scientist. As a clinician, the investigator has duties to provide the patient with optimal care and undivided loyalty. As a scientist, the investigator has duties to follow the rules, procedures and methods described in the protocol.Results and conclusionIn this article, I present a contextual approach to the investigator-subject relationship. The extent of the investigator's duty (...) to provide the patient/subject with clinical care can vary from one situation to the next, as a function of several factors, including: the research design, benefits and risks of the research; the subject's reasonable expectations, motivations, and vulnerabilities; the investigator's ability to benefit the subject; and the investigator's prior relationship with the subject. These and other factors need to be considered when determining the clinical investigator's obligations to provide clinical care to human research subjects. In some research contexts, the investigator has extensive clinical obligations to the patient/subject; in others, the investigator has minimal ones. (shrink)

These CQ Sources were compiled by Bette Anton.

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)

Non-therapeutic research with imminently dying patients in intensive care presents complex ethical issues. The vulnerabilities of the imminently dying, together with societal disquiet around death and dying, contribute to an intuition that such research is beyond the legitimate scope of scientific inquiry. Yet excluding imminently dying patients from research hinders the advancement of medical science to the detriment of future patients. Building on existing ethical guidelines for research, we propose a framework for the ethical design and conduct of research involving (...) the imminently dying. To enable rapid translation to practice, we frame the approach in the form of eight ethical questions that researchers and research ethics committees ought to answer prior to conducting any research with this patient population. (1) Does the study hypothesis require the inclusion of imminently dying patients? (2) Are non-therapeutic risks and burdens minimised consistent with sound scientific design? (3) Are the risks of these procedures no more than minimal risk? (4) Are these non-therapeutic risks justified insofar as they are reasonable in relation to the anticipated benefits of the study? (5) Will valid informed consent be obtained from an authorised surrogate decision maker? (6) How will incidental findings be handled? (7) What additional steps are in place to protect families and significant others of research participants? (8) What additional steps are in place to protect clinical staff and researchers? Several ethical challenges hinder research with imminently dying patients. Nonetheless, provided adequate protections are in place, non-therapeutic research with imminently dying patients is ethically justifiable. Applying our framework to an ongoing study, we demonstrate how our question-driven approach is well suited to guiding investigators and research ethics committees. (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)

“Vulnerability” is a key concept for research ethics and public health ethics. This term can be discussed from either a conceptual or a practical perspective. I previously proposed the metaphor of layers to understand how this concept functions from the conceptual perspective in human research. In this paper I will clarify how my analysis includes other definitions of vulnerability. Then, I will take the practical‐ethical perspective, rejecting the usefulness of taxonomies to analyze vulnerabilities. My proposal specifies two steps and provides (...) a procedural guide to help rank layers. I introduce the notion of cascade vulnerability and outline the dispositional nature of layers of vulnerability to underscore the importance of identifying their stimulus condition. In addition, I identify three kinds of obligations and some strategies to implement them. This strategy outlines the normative force of harmful layers of vulnerability. It offers concrete guidance. It contributes substantial content to the practical sphere but it does not simplify or idealize research subjects, research context or public health challenges. (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)

Since 1964, through 7 revisions, the World Medical Association’s Declaration of Helsinki has stood as an important statement regarding the ethical principles guiding medical research with human participants. It is consulted by ethics review committees, funders, researchers, and research participants. It has been incorporated into national legislation and is routinely invoked to ascertain the ethical appropriateness of clinical trials. There is much to praise about the revision process and the latest revision, which coincides with the declaration’s 50th anniversary. Nevertheless, the (...) proposed declaration contains persistent flaws... (shrink)

People in extraordinary situations are vulnerable. As research participants, they are additionally threatened by abuse or exploitation and the possibility of harm through research. To protect people against these threats, informed consent as an instrument of self-determination has been introduced. Self-determination requires autonomous persons, who voluntarily make decisions based on their values and morals. However, in nursing research, this requirement cannot always be met. Advanced age, chronic illness, co-morbidity and frailty are reasons for dependencies. These in turn lead to limited (...) abilities or opportunities for decision-making and self-determination. Exclusion of vulnerable people from research projects would disadvantage them by not covering their needs, which would violate the ethical principles of justice and beneficence. Commonly, vulnerability is attributed to social groups. The consequence for individuals, attributed as belonging to such a vulnerable group, is that the principles of respect for autonomy, justice and beneficence are subordinated to the principle of non-maleficence, understood as avoiding the risk to cause more harm than good. In addition, group-specific attribution could lead to stigmatizing because labelling a person as deviation from a norm violates integrity. For clinical nursing research, the question arises how the protection of vulnerable people could be granted without compromising ethical principles. The concept of relational ethics provides a possible approach. It defines vulnerability as the relation between a person’s health status and the extent to which this person is dependent on the researcher and the research context. Vulnerability is not attributed solely to a person but to a situation, meaning the person is viewed in context. By combining vulnerability as a context-related and situational concept with existing approaches of informed consent, the different ethical principles can be balanced and preserved at every step of the research process. (shrink)

Sometimes physicians lie to third-party payers in order to grant their patients treatment they would otherwise not receive. This strategy, commonly known as gaming the system, is generally condemned for three reasons. First, it may hurt the patient for the sake of whom gaming was intended. Second, it may hurt other patients. Third, it offends contractual and distributive justice. Hence, gaming is considered to be immoral behavior. This article is an attempt to show that, on the contrary, gaming may sometimes (...) be a physician's duty. Under specific circumstances, gaming may be necessary from the viewpoint of the internal morality of medicine. Moreover, the objections against gaming are examples of what we call the idealistic fallacy, that is, the fallacy of passing judgments in a nonideal world according to ideal standards. Hence, the objections are inconclusive. Gaming is sometimes justified, and may even be required in the name of beneficence. (shrink)

The American Journal of Bioethics, Volume 12, Issue 1, Page 11-13, January 2012.

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)

Background Mental healthcare users and patients were described as a particularly vulnerable group in the debate on the burdens of the COVID-19 pandemic. Just what this means and what normative conclusions can be derived from it depend to a large extent on the underlying concept of vulnerability. While a traditional understanding locates vulnerability in the characteristics of social groups, a situational and dynamic approach considers how social structures produce vulnerable social positions. The situation of users and patients in different psychosocial (...) settings during the COVID-19 pandemic has not yet been comprehensively considered and ethically analyzed under the aspect of situational vulnerability. Methods We present the results of a retrospective qualitative analysis of a survey of ethical challenges in different mental healthcare facilities of a large regional mental healthcare provider in Germany. We evaluate them ethically using a dynamic and situational understanding of vulnerability. Results Difficulties in implementing infection prevention measures, restrictions of mental health services in favor of infection prevention, social isolation, negative health effects on mental healthcare users and patients, and challenges in implementing regulations on state and provider levels within the local specificities emerged across different mental healthcare settings as ethically salient topics. Conclusions Applying a situational and dynamic understanding of vulnerability allows the identification of specific factors and conditions that have contributed to an increased context-dependent vulnerability for mental healthcare users and patients. These factors and conditions should be considered on the level of state and local regulations to reduce and address vulnerability. (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)

Research Ethics, Volume 18, Issue 2, Page 132-150, April 2022. Limited research has been done among pregnant people participating in investigational drug trials. To enhance the ethical understanding of pregnant people’s perspectives on research participation, we sought to describe motives and risk perceptions of participants in a phase 1 trial of ledipasvir/sofosbuvir treatment for chronic Hepatitis C virus during pregnancy. Pregnant people with chronic HCV infection enrolled in an open-label, phase 1 study of LDV/SOF participated in semi-structured, in-depth interviews to (...) explore their reasons for participation and experiences within the study. Pregnant people took 12 weeks of LDV/SOF and were interviewed at enrollment and at the end of study. We recorded the interviews, transcribed them verbatim, coded them using NVivo software, and performed inductive thematic analysis. Nine women completed the study yielding 18 interview transcripts. We identified two themes regarding motives and one regarding risk perception. Motives— Women conceptualized study participation as part of the caregiving role they associate with motherhood; participating was viewed as an act of caregiving for their infants, their families, themselves, and other pregnant women with chronic HCV. Women also noted that they faced multiple barriers to treatment prior to pregnancy that created a desire to receive therapy through trial participation. Risk perception— Women acknowledged personal and fetal risk associated with participation. Acceptance of risk was influenced by women’s concepts of motherhood, preexisting knowledge of HCV and medical research, family members, intimate partners, or by the study design. Women enrolled in a phase 1 trial for chronic HCV therapy during pregnancy acknowledged risks of participation and were motivated by hopes for fetal and personal benefit and by lack of prenatal access to treatment. Ethical inclusion of pregnant people in research should acknowledge structural factors that contribute to vulnerability and data deficiencies for treatment in pregnancy. (shrink)

Journal of Social Philosophy, EarlyView.

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)

Biomedical research is increasingly carried out in low- and middle-income countries. International consensus has largely been achieved around the importance of valid consent and protecting research participants from harm. But what are the responsibilities of researchers and funders to share the benefits of their research with research participants and their communities? After setting out the legal, ethical and conceptual frameworks for benefit sharing, this collection analyses seven historical cases to identify the ethical and policy challenges that arise in relation to (...) benefit sharing. A series of recommendations address possible ways forward to achieve justice for research participants in low- and middle-income countries. (shrink)

The recent change in Canadian law to allow access to medical assistance in dying restricts eligibility, among its other criteria, to those for whom “natural death has become reasonably foreseeable.” A recent review of certain aspects of the law examined the evidence pertaining to extending access to assisted dying in three particular request situations currently denied: requests by mature minors, advance requests, and requests where mental illness is the sole underlying medical condition [1]. The requirement for this review was included (...) in the legislation that introduced medical assistance in dying in Canada. Both the original change in the law and the review itself neglected to consider those with intolerable suffering for whom natural death is not reasonably foreseeable. This paper explores the possibility that access to assisted dying should be extended by removing this limiting criterion. It also considers the ethical challenges this might present for those who work in rehabilitation. (shrink)

Bioethics has changed considerably over the last few years. Increased global interaction, through the off-shoring of clinical trials, cross-border surrogacy, organ trafficking, and medical tourism, among others practices, has brought additional considerations to a discipline that has been, until recently, relatively contained within national borders. We aim to contribute to the discourse on exploitation and vulnerability in a way that reflects such global changes. We will explore the link between vulnerability and exploitation, and argue that exploitation can be understood as (...) taking advantage of vulnerabilities, provided we recognize that vulnerabilities are often embedded within existing structural injustices. (shrink)

Vulnerability is a broad concept widely addressed in recent scholarly literature. Lesbian, gay, bisexual, and transgender people are among the vulnerable populations with significant disadvantages related to health and the social determinants of health. Medical ethics discourse tackles vulnerability from philosophical and political perspectives. LGBT people experience several disadvantages from both perspectives. This article aims to justify the right to health for LGBT people and their particular claims regarding healthcare because they belong to a vulnerable group. Rawls’ theory of justice (...) and Norman Daniels’ normal functioning approach will be discussed in this context. Despite the fact that the right to health can be justified by Daniels’ normal functioning approach, there is still a theoretical gap in justifying the right to health for particular vulnerable populations such as LGBT peopleand discussing society’s duty to compensate for these disadvantages. In search of solid theoretical grounds for the justification of the right to health for LGBT people, the present author takes the opportunity to utilize Daniels’ flexible definition of normal functioning to show that normal functioning not only varies by age but also by different states of human existence, including sexual orientation and gender identity, and to propose replacing the life span approach with normal states of human existence. (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)

ZusammenfassungIm Spielfilm Never Let Me Go werden Klone als vulnerable und heteronome Individuen dargestellt, die zur anonymen Organspende gezwungen werden. In diesem Beitrag wird die Darstellung dieser Figuren in ihrer individuellen Entwicklung und gesellschaftlichen Sozialisation unter der Frage untersucht, welche Bezüge sich zu bioethischen Aspekten ergeben. Die Klone befinden sich in einer Situation der „privilegierten Deprivation“: Aus Sicht der Zuschauer sind sie sozial benachteiligt und können sich nicht zu komplett autonomen Wesen entwickeln, aber aus ihrer eigenen Perspektive sind sie im (...) dystopischen System immer noch „privilegiert“. Wir argumentieren, dass dieser Film auf symbolische Weise diejenigen Individuen fokussiert, die vom medizinischen Fortschritt nicht profitieren oder die nicht genügend Handlungsspielraum haben, um sich gegen geltende Praxen zu positionieren. Filme wie Never Let Me Go können deshalb ein Beitrag sein, um die Perspektive marginalisierter Personen im medizinischen System einzunehmen. (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)

Traditional accounts of vulnerability tend to label entire populations as vulnerable. This approach is of limited utility. Instead, this article utilizes a layered approach to vulnerability, identifying multiple vulnerabilities that older people experience. It focuses on distinguishing the different layers of vulnerability that may be experienced by the elderly in middle-income countries of Latin America. In doing so, I show how the layered approach to vulnerability functions, and demonstrate why it is more interesting and useful than the traditional approach. The (...) article achieves three things. First, it unwraps the different potential layers of vulnerability that develop in old age and the multidimensionality aspects of aging. Second, it reestablishes the usefulness of the concept of vulnerability and explains its functioning. Finally, it shows how different policies can be designed in order to address each vulnerability layer. The layered account promotes a multifaceted approach to public policy analyses and design. In this sense, the layered concept of vulnerability is an appealing concept to consider in public health ethics. (shrink)

Informed consent is thought to exist as a well-defined entity. Altered concepts of patient autonomy, differential cultural understanding of the entity, and the failure of clients to distinguish between research and clinical ethics, and various hierarchical cultural views of informed consent all suggest that alterations may be needed in the traditional concept. By using the methodology outlined by Gasking in which he defines the idea of “cluster concepts,” one may be able to enlarge the definition and augment the understanding of (...) the informed consent and include the time and culture-specific variants which exist. (shrink)

Concerns arising from global sociopolitical differences, and increasing economic and health disparities, have brought new considerations to the field of bioethics, both in terms of applications and to foundational concepts such as exploitation and vulnerability.In this paper, we aim to contribute to the discourse on exploitation and vulnerability in a way that reflects such global changes. We will explore the link between vulnerability and exploitation, and argue that exploitation can be understood as taking advantage of vulnerabilities, provided we recognize that (...) vulnerabilities are often embedded within existing structural injustices.We begin by presenting an example of organ trading, which helps to illustrate .. (shrink)

This paper explores the vulnerability of Latin American human subjects, and how their vulnerability is ignored due to the complexities and inconsistencies of oversight committees and institutional policies. Secondly, the concept of apology is examined and its meaning to victims of past research abuses.

The American Journal of Bioethics, Volume 12, Issue 5, Page 38-39, May 2012.