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)

Most research ethics literature on vulnerability focuses on the vulnerability of individuals and populations defined by the potential vulnerability of their members. However, research involving human participants does not always take the individual as the unit of analysis: political experiments may apply an intervention to a community as a whole. This paper argues that community-level vulnerability is not reducible to the sum of the vulnerabilities of community members, and that there is thus a need to consider vulnerability at the community (...) level of analysis when analyzing the ethical implications of political field experiments. I first review ethical literature on community intervention research and the emerging scholarship on the ethics of political field experiments. I then highlight key accounts of the concept of vulnerability at an individual level. Drawing on Whitfield’s concept of “collective wrongs,” I argue that communities can be negatively affected in ways that are distinct from harms to individual community members, and that variation in susceptibility to such wrongs at the community level is largely consistent with existing conceptualizations of vulnerability. I suggest questions that researchers should consider when designing political field experiments to ensure that community-level vulnerabilities are taken into account. (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)

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.

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)

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)

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)

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)

This article examines and critiques the use of the term “vulnerability” in U.S. and international regulations and guidelines on research ethics. After concluding that the term is currently used in multiple, often inconsistent, senses, it calls on regulators to differentiate between three distinct types of vulnerability: “consent-based vulnerability,”“risk-based vulnerability,” and “justice-based vulnerability.”.

HIV remission clinical researchers are increasingly seeking study participants who are diagnosed and treated during acute HIV infection—the brief period between infection and the point when the body creates detectable HIV antibodies. This earliest stage of infection is often marked by flu-like illness and may be an especially tumultuous period of confusion, guilt, anger, and uncertainty. Such experiences may present added ethical challenges for HIV research recruitment, participation, and retention. The purpose of this paper is to identify potential ethical challenges (...) associated with involving acutely diagnosed people living with HIV in remission research and considerations for how to mitigate them. We identify three domains of potential ethical concern for clinicians, researchers, and ethics committee members to consider: 1) Recruitment and informed consent; (2) Transmission risks and partner protection; and (3) Ancillary and continuing care. We discuss each of these domains with the aim of inspiring further work to advance the ethical conduct of HIV remission research. For example, experiences of confusion and uncertainty regarding illness and diagnosis during acute HIV infection may complicate informed consent procedures in studies that seek to recruit directly after diagnosis. To address this, it may be appropriate to use staged re-consent procedures or comprehension assessment. Responsible conduct of research requires a broad understanding of acute HIV infection that encompasses its biomedical, psychological, social, and behavioral dimensions. We argue that the lived experience of acute HIV infection may introduce ethical concerns that researchers and reviewers should address during study design and ethical approval. (shrink)

Journal of Social Philosophy, EarlyView.

Institute for Biomedical Ethics, Geneva University Medical School * Corresponding author: Médecins Sans Frontières (OCG), rue de Lausanne 78, CH-1211 Geneva 21, Switzerland. Tel.: +41 (0)22 849 89 29; Fax: +41 (0)22 849 84 88; Email: philippe_calain{at}hotmail.com ' + u + '@' + d + ' '//--> Abstract Outbreaks of filovirus (Ebola and Marburg) hemorrhagic fevers in Africa are typically the theater of rescue activities involving international experts and agencies tasked with reinforcing national authorities in clinical management, biological diagnosis, sanitation, (...) public health surveillance and coordination. These outbreaks can be seen as a paradigm for ethical issues posed by epidemic emergencies, through the convergence of such themes as: isolation and quarantine, privacy and confidentiality and the interpretation of ethical norms across different ethnocultural settings. With an emphasis on the boundaries between public health investigations and research, this article reviews specific challenges, past practices and current normative documents relevant to the application of ethical standards in the course of outbreaks of filovirus hemorrhagic fevers. Aside from commonly identified issues of informed consent and institutional review processes, we argue for more clarity over the specification of which communities are expected to share benefits, and we advocate for the use of collective definitions of duty to care and standard of care. We propose new elaborations around existing normative instruments, and we suggest some pathways toward more comprehensive approaches to the ethics of research in outbreak situations. CiteULike Connotea Del.icio.us What's this? (shrink)

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

The concept of vulnerability has become widely acknowledged as a fundamental concept for medical ethics and research ethics, yet rarely considered with respect to ethical assessments of human germline genome editing. A first aim of this paper is to make vulnerability ethics considerations fruitful for issues related to these technical innovations. The possibility of altering the genome promises to overcome forms of vulnerability inherently connected to our existence as physical beings and would hence allow to increase the resilience of human (...) nature or even to move evolution forward by equipping people with new character traits and enhanced capabilities. I suggest a more fine-grained distinction of various applications purposes than the dichotomy of therapeutic and enhancement. I support the rejection of most application purposes as ‘therapeutic’ and claim that framing them as ‘therapeutic’ in the context of the current discursive constellation runs the risk of accentuating existing vulnerabilities. With respect to intergenerational responsibilities, I reject the view that editing the germline necessarily leads to corrupt intergenerational relations based on which it must be categorically excluded. I conclude that it is nevertheless important to take a very close look at the challenges that arise, especially from a vulnerability perspective, before irreversible facts are created overhastily. (shrink)

Background The expressions of a “wish to hasten death” or “wish to die” raise ethical concerns and challenges. These expressions are related to ethical principles intertwined within the field of medical ethics, particularly in end-of-life care. Although some reviews were conducted about this topic, none of them provides an in-depth analysis of the meanings behind the “wish to hasten death/die” based specifically on the ethical principles of autonomy, dignity, and vulnerability. The aim of this review is to understand if and (...) how the meanings behind the “wish to hasten death/die” relate to and are interpreted in light of ethical principles in palliative care. Methods We conducted a meta-ethnographic review according to the PRISMA guidelines and aligned with Noblit and Hare’s framework. Searches were performed in three databases, Web of Science, PubMed, CINAHL, with no time restrictions. Original qualitative studies exploring the meanings given by patients, family caregivers and healthcare professionals in any context of palliative and end-of-life care were included. A narrative synthesis was undertaken. PROSPERO registration CRD42023360330. Results Out of 893 retrieved articles, 26 were included in the analysis, accounting for the meanings of a total of 2,398 participants. Several factors and meanings associated with the “wish to hasten death” and/or “wish to die” were identified and are mainly of a psychosocial and spiritual nature. The ethical principles of autonomy and dignity were the ones mostly associated with the “wish to hasten death”. Ethical principles were essentially inferred from the content of included articles, although not explicitly stated as bioethical principles. Conclusions This meta-ethnographic review shows a reduced number of qualitative studies on the “wish to hasten death” and/or “wish to die” explicitly stating ethical principles. This suggests a lack of bioethical reflection and reasoning in the empirical end-of-life literature and a lack of embedded ethics in clinical practice. There is a need for healthcare professionals to address these topics compassionately and ethically, taking into account the unique perspectives of patients and family members. More qualitative studies on the meanings behind a wish to hasten death, their ethical contours, ethical reasoning, and implications for clinical practice are needed. (shrink)

These CQ Sources were compiled by Bette Anton.

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)

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,...

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)

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)

Bioethics has made a compelling case for the role of experience and empirical research in ethics. This may explain why the movement for empirical ethics has such a firm grounding in bioethics. However, the theoretical framework according to which empirical research contributes to ethics—and the specific role it can or should play—remains manifold and unclear. In this paper, we build from pragmatic theory stressing the importance of experience and outcomes in establishing the meaning of ethics concepts. We then propose three (...) methodological steps according to which the meaning of ethics concepts can be refined based on experience and empirical research: function identification, function enrichment, and function testing. These steps are explained and situated within the broader commitment of pragmatic ethics to a perspective of moral growth and human flourishing. We hope that this proposal will give specific direction to the bridging of theoretical and empirical research in ethics and thus support stronger actualization of ethics concepts. (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)

This paper examines the institutional mechanisms supporting the ethical oversight of human participant research conducted by the United Nations (UN). The UN has served an instrumental role in shaping international standards on research ethics, which invariably require ethical oversight of all research studies with human participants. The authors’ experiences of conducting research collaboratively with UN agencies, in contrast, have led to concern that the UN frequently sponsors, or participates in, studies with human participants that have not received appropriate ethical oversight. (...) It is argued that the institutional mechanisms in place to prevent research with human participants from being undertaken by the UN without ethical oversight do not, at present, extend substantively beyond the provision of guidelines and online training offered by a minority of UN bodies. The WHO and UNICEF are identified as notable exceptions, having implemented various measures to prevent health research with human participants from being undertaken without ethical oversight. Yet, it is highlighted that the WHO and UNICEF are not the only UN bodies that undertake health research with human participants and there are countless actors under the umbrella of the UN system that are regularly involved in non-health research with human participants. Arguments for the pursuit of the highest standard of ethical oversight by UN bodies are presented. Moving forward, the paper asks the question: is it time for the UN to set the standards for the oversight of ethical oversight? (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)

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

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)

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

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)