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)

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will (...) be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (shrink)

Despite recent advances in HIV prevention and treatment, high HIV incidence persists among people who inject drugs. Difficult legal and political environments and lack of services for PWID likely contribute to high HIV incidence. Some advocates question whether any HIV prevention research is ethically justified in settings where healthcare system fails to provide basic services to PWID and where implementation of research findings is fraught with political barriers. Ethical challenges in research with PWID include concern about whether research evidence will (...) be translated into practice; concerns that research might exacerbate background risks; and ethical challenges regarding the standard of HIV prevention in research. While these questions arise in other research settings, for research with PWID, these questions are especially controversial. This paper analyses four ethical questions in determining whether research could be ethically acceptable: Can researchers ensure that research does not add to the burden of social harms and poor health experienced by PWID? Should research be conducted in settings where it is uncertain whether research findings will be translated into practice? When best practices in prevention and care are not locally available, what standard of care and prevention is ethically appropriate? Does the conduct of research in settings with oppressive policies constitute complicity? We outline specific criteria to address these four ethical challenges. We also urge researchers to join the call to action for policy change to provide proven safe and effective HIV prevention and harm reduction interventions for PWID around the world. (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)

We reinvigorate vulnerability theory as a radically ethical device — ethical vulnerability analysis. We bring together fuller vulnerability analysis as theorized by Fineman and Grear in conversation with Levinas and Derrida’s radical vulnerability and the ethics of hospitality to construct a theoretical framework that is firmly anchored in the realities of the everyday that are vulnerability and migration. This novel framework offers a thinking space to subvert approaches to migrants and migration as it compels us to come face-to face with (...) the “other”, which in turn renders the political accountable by her. We deploy ethical vulnerability analysis to deconstruct the EU’s “migration crisis” and investigate whether the activation of temporary protection for displaced persons from Ukraine signifies a humanizing turn in the EU’s asylum and migration policies. In this regard, we submit that this hospitable moment constitutes an “exception to the rule” rather than a paradigm shift. (shrink)

The study of the neuroscience and genomics of mental illness are increasingly intertwined. This is mostly due to the translation of medical technologies into psychiatry and to technological convergence. This article focuses on psychosis. I argue that the convergence of neuroscience and genomics in the context of psychosis is morally problematic, and that ethics scholarship should go beyond the identification of a number of ethical, legal, and social issues. My argument is composed of two strands. First, I argue that we (...) should respond to technological convergence by developing an integrated, patient-centred approach focused on the assessment of individual vulnerabilities. Responding to technological convergence requires that we integrate insights from several areas of ethics, translate bioethical principles into the mental health context, and proactively try to anticipate future ethical concerns. Second, I argue that a nuanced understanding of the concept of vulnerability might help us to accomplish this task. I borrow Florencia Luna’s notion of ‘layers of vulnerability’ to show how potential harms or wrongs to individuals who experience psychosis can be conceptualised as stemming from different sources, or layers, of vulnerability. I argue that a layered notion of vulnerability might serve as a common ground to achieve the ethical integration needed to ensure that biomedical innovation can truly benefit, and not harm, individuals who suffer from psychosis. (shrink)

The U.S. Code of Federal Regulations governing federally funded research on human subjects assumes that harmful research is sometimes morally justifiable because the beneficiaries of that research share a particular vulnerability with its subjects. In this article, I argue against this assumption, which occurs in every subpart of the Code of Federal Regulations that deals with specific vulnerable populations . I argue that shared vulnerability is no exception to the general principle that harming one person in order to benefit another (...) is no more justifiable if the two people have traits in common. Further, shared vulnerability is not a reasonable proxy for any morally relevant desideratum of research, in particular the desire to benefit the worst off, the desire to avoid exploitation, and the desire to use vulnerable populations in research only when necessary. (shrink)

OBJECTIVE: Questions have been posed about the competence of persons with serious mental illness to consent to participate in clinical research. This study compared competence-related abilities of hospitalized persons with schizophrenia with those of a comparison sample of persons from the community who had never had a psychiatric hospitalization. METHODS: The study participants were administered the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), a structured instrument designed to aid in the assessment of competence to consent to clinical research. The (...) scores of 27 persons who met DSM-IV criteria for schizophrenia who were long-stay patients on a state hospital research ward were compared with those of 24 individuals from the community who were of similar age, gender, race, and socioeconomic status. RESULTS: Significant differences were found between the patients and the community sample on three measures of competence-related abilities: understanding, reasoning, and appreciation. Degree of psychopathology and cognitive functioning were significantly negatively correlated with understanding and appreciation among the patients with schizophrenia. Length of hospitalization was significantly negatively correlated with all measures of decision-making capacities. CONCLUSIONS: The generally poor performance of the long-stay patients with chronic schizophrenia highlights the difficulties this group is likely to encounter in providing consent to research. However, variation across the sample points to the need for individualized assessment and for validated techniques for facilitating decision making in the face of decisional impairments. (shrink)

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was formed over 20 years ago with a goal of harmonizing research regulations among the European Union, United States, and Japan. Harmonization was intended to speed approval of pharmaceuticals, avoid unnecessary repetition of studies, and ensure protection of research participants. This paper examines United States, European Union, and ICH pediatric research regulations in five domains: parental permission, assent/dissent, payment, risk/benefit and inclusion of disabled children/wards (...) of state. The purpose is to examine similarities and differences among the regulations to help investigators, policy makers and the public to understand what each regulatory framework can learn from the others. Additionally, the paper suggests philosophical differences in how these entities view pediatric research which may serve as barriers to harmonization in the future. (shrink)

The Food and Drug Administration and the European Medicines Agency have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use as a (...) mechanism for harmonizing clinical research regulations. The intent of harmonization was to improve patients’ “access to new drugs, to prevent unnecessary global development delays and to avoid animal and human study duplications” through policy reconciliation.FDA/EMA efforts at collaboration call for a reassessment of past harmonization efforts: to what extent are ICH member policies already synchronized and to what extent can they be harmonized in the future? This paper will focus on these questions through the lens of pediatric investigation. (shrink)

These CQ Sources were compiled by Bette Anton.

At healthcare facilities worldwide, women during childbirth undergo medical procedures they haven’t consented to and experience mistreatment and disrespect. This phenomenon is recognized as obstetric violence (OV), a distinct form of gender violence. The resulting trauma carries both immediate and long-term implications, making it vital to address for promoting women’s health. OV is partly shaped by a narrow, paternalistic conception of vulnerability. A flawed conception of the vulnerability of pregnant women and fetuses has opened the door to medical control and (...) coercion during childbirth. In this paper we examine what role notions of vulnerability play in perpetuating OV and consider recent attitudinal shifts in research ethics as a model for addressing it. (shrink)

Illicit drug users are frequently identified as a ‘vulnerable population’ requiring ‘special protection’ and ‘additional safeguards’ in research. However, without specific guidance on how to enact these special protections and safeguards, research ethics committee (REC) members sometimes fall back on untested assumptions about the ethics of illicit drug use research. In light of growing calls for ‘evidence-based research ethics’, this commentary examines three common assumptions amongst REC members about what constitutes ethical research with drug users, and whether such assumptions are (...) borne out by a growing body of empirical data. The assumptions that form the focus of this commentary are as follows: (i) drug users do not have the capacity to provide informed consent to research; (ii) it is ethically problematic to provide financial incentives to drug users to participate in research; and (iii) asking drug users about their experiences ‘re-traumatizes’ and ‘re-victimizes’ them. (shrink)

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

Pluralism and diversity are largely bound to a humancentric conception of difference, one which fails to consider the plurality of ontologies that constitute reality. The result has been the confinement of the subject of justice to social spaces, and hence the reinforcement of the dichotomous understanding of humanity and nature. This is in part because pluralist theories are largely concerned with one single manifestation of vulnerability: the vulnerability of minority groups. This essay begins by offering a distinctive definition of vulnerability, (...) one that is broad enough to incorporate both universal and dispositional accounts, while being narrow enough to rule out both vitalist and biocentric approaches. I use the notion to examine debates on political pluralism, and I argue that, as they currently stand, pluralist approaches are ill suited for understanding the struggles of Indigenous peoples against colonialism. I defend the view that the normative case for pluralism needs to be grounded in an ecologically aware ethics that can respond to the vulnerability of animate beings who sustain life. (shrink)

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

This article challenges the importance and necessity of confidentiality, which are often taken for granted, and questions whether the default promise of confidentiality to all participants, particularly in educational research, could in fact be an unnecessary concern. This article begins by reviewing the difference in the way confidentiality is handled in different fields and the applicability of some underlying assumptions. This is followed by an explanation of why confidentiality is investigated in the sense of anonymity in this article. Then the (...) article draws on an empirical study where original researchers and their original participants were interviewed about their views on anonymity. Lastly, the contradiction between the promises of confidentiality and the recognition of a participant’s contribution is highlighted. The article concludes with a call for more empirical observation and investigation into the importance of confidentiality. (shrink)

Biomedical research using data from participants’ mobile devices borrows heavily from the ethos of the “citizen science” movement, by delegating data collection and transmission to its volunteer subjects. This engagement gives volunteers the opportunity to feel like partners in the research and retain a reassuring sense of control over their participation. These virtues, in turn, give both grass-roots citizen science initiatives and institutionally sponsored mHealth studies appealing features to flag in recruiting participants from the public. But while grass-roots citizen science (...) projects are often community-based, mHealth research ultimately depends on the individuals who own and use mobile devices. This inflects the ethos of mHealth research towards a celebration of individual autonomy and empowerment, at the expense of its implications for the communities or groups to which its individual participants belong. But the prospects of group harms — and benefits — from mHealth research are as vivid as they are in other forms of data-intensive “precision health” research, and will be important to consider in the design of any studies using this approach. (shrink)

Despite the attempts to promote the inclusion of pregnant women into clinical research, this group is still widely excluded. An analysis of the “vulnerability of pregnant women” that questions deeply internalized stereotypes is necessary for finding the right balance in the protection of pregnant women as research participants. Criticism of the traditional account of vulnerability will lead to an alternative that focuses on situations rather than groups and on the obligations of responsible parties. The paper adds to the current general (...) discussion of vulnerability and at the same time addresses the specific problem of drug treatment during pregnancy. (shrink)

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)

This study aims to develop guidelines of key concepts and specific considerations to make the research more ethical when conducting neurological examinations and treatment interventions in mentally ill patients. We analyzed guideline development theory and literature, previous issues, and discussions with specialists of philosophy, medicine, sociology, and bioethics. The selection of research participants, drafting of intervention plans, and informed consent process were examined with reference to the dual burden; the minimal risk as a general rule of ethical allowance levels, assent (...) and dissent to assess the individual’s judgment capacity for consent, relational autonomy for personal consent with assistance by the proxy, and risk/benefit assessments. When conducting studies, this guideline requires that these three processes be set up appropriately on a case-by-case basis. (shrink)

Researchers and others involved in the research enterprise from 12 African countries met with those working in ethics and oversight in the United States as part of an effort to develop research ethics capacity. Drawing on a wealth of experience among participants, discussions at the meeting revealed five categories of issues that warrant careful attention by those engaged in similar efforts as well as international policymakers and those charged with oversight of research. Principal investigators should build ‘true research teams’ where (...) members of the team are meaningfully involved in decisions regarding the protocol and its implementation. There should be explicit discussion about the ‘standard of care’ at the outset of project planning that includes clarification of the terminology that is being used. While internationally collaborative research may involve populations that have inherent vulnerabilities, it is important to recognize the limitations of host country solutions and look for means to negotiate appropriate protections for those willing to participate. In conducting research involving biological materials it would be prudent to develop material transfer agreements at the outset of the study to clarify expectations and to minimize the likelihood of harm. Those engaged in internationally collaborative research need to be alert to the potential conflicts of interests of host country ethics committees during the approval process and to take measures to manage them if they indeed exist. (shrink)

The debate about ECT in Ireland in recent times has been vibrant and often polarised. The uniqueness of the Irish situation is that the psychiatric profession is protected by legislation whereby ECT treatment can be authorized by two consultant psychiatrists without the consent of the patient. This paper will consider if ECT is ever ethically justified, and if so, under what circumstances. The proposal is to investigate ECT from an ethical perspective with reference to the UNESCO Universal Declaration on Bioethics (...) and Human Rights. The enquiry will begin with an historical context to the origin and development of ECT as a treatment for severe mental illness. The application of various ethical principles will be considered in conjunction with the relevant literature before arriving at a conclusion. (shrink)

Scholars and policymakers continue to struggle over the meaning of the word “vulnerable” in the context of research ethics. One major reason for the stymied discussions regarding vulnerable populations is that there is no clear distinction between accounts of research vulnerabilities that exist for certain populations and discussions of research vulnerabilities that require special regulations in the context of research ethics policies. I suggest an analytic process by which to ascertain whether particular vulnerable populations should be contenders for additional regulatory (...) protections. I apply this process to two vulnerable populations: the cognitively vulnerable and the economically vulnerable. I conclude that a subset of the cognitively vulnerable require extra protections while the economically vulnerable should be protected by implementing existing regulations more appropriately and rigorously. Unless or until the informed consent process is more adequately implemented and the distributive justice requirement of the Belmont Report is emphasized and operationalized, the economically disadvantaged will remain particularly vulnerable to the harm of exploitation in research. (shrink)

This article addresses an important, overlooked regulatory challenge during global health emergencies. It provides novel insights into how, and why, best practice can support decision makers in interpreting and implementing key guidance on conducting research during GHEs. The ability to conduct research before, during and after such events is crucial. The recent West-African Ebola outbreaks and the Zika virus have highlighted considerable room for improvement in meeting the imperative to research and rapidly develop effective therapies. A means of effectively capturing (...) these experiences and folding them into future decision-making is lacking; the need for effective practical translational measures remains. The challenge for the research community lies in extracting meaningful action-guiding content from pre-existing guidelines—which draw upon practical examples of guidelines ‘in action’—that assist in determining how to act in a particular situation. Insights are provided into the role of best practice as a means to do so; such examples can provide invaluable support to decision makers in interpreting high-level guidance; overarching guidelines retain their necessary level of generality and flexibility, whilst corresponding best practice examples—which incorporate important lessons learned—illustrate how such guidelines can be interpreted at a practical level. (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)

Some jurisdictions that have decriminalized assisted dying exclude psychiatric patients on the grounds that their condition cannot be determined to be irremediable, that they are vulnerable and in need of protection, or that they cannot be determined to be competent. We review each of these claims and find that none have been sufficiently well-supported to justify the differential treatment psychiatric patients experience with respect to assisted dying. We find bans on psychiatric patients’ access to this service amount to arbitrary discrimination. (...) Proponents of banning the practice ignore or overlook alternatives to their proposal, like an assisted dying regime with additional safeguards. Some authors have further criticized assisted dying for psychiatric patients by highlighting allegedly problematic practices in those countries which allow it. We address recent evidence from the Netherlands, showing that these problems are either misrepresented or have straightforward solutions. Even if one finds such evidence troubling despite our analysis, other jurisdictions need not adopt every feature of the Dutch system. (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)

Some authors have argued that research subjects in developing nations should be considered vulnerable and that this designation can help to ensure that investigators take extra steps to protect the...

This paper advances a new criterion of a vulnerable population in research. According to this criterion, there are consent-based and fairness-based reasons for calling a group vulnerable. The criterion is then applied to the case of people with serious illnesses. It is argued that people with serious illnesses meet this criterion for reasons related to consent. Seriously ill people have a susceptibility to “enticing offers” that hold out the prospect of removing or alleviating illness, and this susceptibility reduces their ability (...) to safeguard their own interests. This explains the inclusion of people with serious illnesses in the Belmont Report’s list of populations needing special protections, and supports the claim that vulnerability is the rule, rather than the exception, in biomedical research. (shrink)

Solidarity within bioethics is increasingly being recognized as an important means of improving health for all. Its contribution seems particularly relevant when there are injustices or inequalities in health and different individuals or groups are disadvantaged. But the current context of ecological collapse, characterized mainly by a loss of biodiversity and ecosystem decline, affects global health in a different way to other factors. This scenario creates new challenges, risks and problems that require new insights from a bioethical perspective. I, therefore, (...) propose an argument in favor of ecological solidarity. The aim of this article is to re-define this concept, outlining which causes should incite action through ecological solidarity and who should be the main recipient of it. To this end, I discuss what the background for practicing ecological solidarity might be: an intrinsically altruistic motivation to attempt to be a better person or a forced response to a political obligation. Finally, by way of example, I argue for rewilding as an effective, practical strategy through which ecological solidarity can be applied in the belief that building ecological solidarity supports a number of key interdependencies and ensures ethical care for the health of the planet. (shrink)