Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

Stem cell research. Drug company influence. Abortion. Contraception. Long-term and end-of-life care. Human participants research. Informed consent. The list of ethical issues in science, medicine, and public health is long and continually growing. These complex issues pose a daunting task for professionals in the expanding field of bioethics. But what of the practice of bioethics itself? What issues do ethicists and bioethicists confront in their efforts to facilitate sound moral reasoning and judgment in a variety of venues? Are those immersed (...) in the field capable of making the right decisions? How and why do they face moral challenge -- and even compromise -- as ethicists? What values should guide them? In The Ethics of Bioethics, Lisa A. Eckenwiler and Felicia G. Cohn tackle these questions head on, bringing together notable medical ethicists and people outside the discipline to discuss common criticisms, the field's inherent tensions, and efforts to assign values and assess success. Through twenty-five lively essays examining the field's history and trends, shortcomings and strengths, and the political and policy interplay within the bioethical realm, this comprehensive book begins a much-needed critical and constructive discussion of the moral landscape of bioethics. (shrink)

Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from (...) considering them in their decisions. Yet IRBs often do consider the social implications of research protocols and sometimes create significant delays in initiating or even prevent such research. The social implications of research are important topics for public scrutiny and professional discussion. This article examines the reasons that the federal regulations preclude IRBs from assessing the social risks of research, and examines alternative approaches that have been used with varying success by national advisory groups to provide such guidance. The article concludes with recommendations for characteristics of a national advisory group that could successfully fulfill this need, including sustainability, independence, diverse and relevant expertise, and public transparency. (shrink)

The grounds for global solidarity have been theorized and conceptualized in recent years, and many have argued that we need a global concept of solidarity. But the question remains: what can motivate efforts of the international community and nation-states? Our focus is the grounding of solidarity with respect to global inequities in health. We explore what considerations could motivate acts of global solidarity in the specific context of health migration, and sketch briefly what form this kind of solidarity could take. (...) First, we argue that the only plausible conceptualization of persons highlights their interdependence. We draw upon a conception of persons as ‘ecological subjects’ and from there illustrate what such a conception implies with the example of nurses migrating from low and middle-income countries to more affluent ones. Next, we address potential critics who might counter any such understanding of current international politics with a reference to real-politik and the insights of realist international political theory. We argue that national governments – while not always or even often motivated by moral reasons alone – may nevertheless be motivated to acts of global solidarity by prudential arguments. Solidarity then need not be, as many argue, a function of charitable inclination, or emergent from an acknowledgment of injustice suffered, but may in fact serve national and transnational interests. We conclude on a positive note: global solidarity may be conceptualized to helpfully address global health inequity, to the extent that personal and transnational interdependence are enough to motivate national governments into action. (shrink)

In recent years, the flow of undocumented labor from the global South to richer nations has increased considerably. Many undocumented women workers find employment as caregivers for the dependent elderly, whose numbers are burgeoning in affluent countries. Here we present a profile of undocumented non-citizen caregivers in the United States and delineate some of the key injustices they suffer. After identifying the causal factors responsible for the flow of undocumented labor from the global South to richer nations like the United (...) States, we discuss the criteria that a theory of transnational justice must meet if it is to address the problem of justice for this population. We argue that Iris Young's "social connection" model of responsibility is a promising approach for helping to correct the injustices suffered by undocumented, non-citizen caregivers. (shrink)

New mechanisms to ensure that counter ter ror ism ac t ivit ies do not contravene international law or ethical values and principles will require careful design. Apart from the ethical and legal grounds, there are good practical rea-sons to design more effective counterter-rorism measures. Preventable harms to population health contribute to mistrust and instability and undermine the stated objectives of the intelligence services.

I argue that a particular epistemological approach, “ecological thinking,” helps to demonstrate that long-term care work is organized transnationally—through health, economic, labor, and immigration policies established primarily by governments, transnational corporations, other for-profit entities, and international lending bodies—to create and sustain injustice against the dependent elderly and those who care for them, and to weaken the care capacities of countries and their health systems, especially those of source countries. An ecological approach also helps to reveal the grounding of global responsibilities (...) and an alternative conception of justice for long-term care and global health equity more generally. (shrink)

Disaster research has grown in scope and frequency. Research in the wake of disasters and during humanitarian crises – particularly in resource-poor settings – is likely to raise profound and unique ethical challenges for local communities, crisis responders, researchers, and research ethics committees. Given the ethical challenges, many have questioned how best to provide research ethics review and oversight. We contribute to the conversation concerning how best to ensure appropriate ethical oversight in disaster research and argue that ethical disaster research (...) requires of researchers and RECs a particular sort of ongoing, critical engagement which may not be warranted in less exceptional research. We present two cases that typify the concerns disaster researchers and RECs may confront, and elaborate upon what this ongoing engagement might look like – how it might be conceptualized and utilized – using the concept of real-time responsiveness. The central aim of RTR, understood here as both an ethical ideal and practice, is to lessen the potential for research conducted in the wake of disasters to create, perpetuate, or exacerbate vulnerabilities and contribute to injustices suffered by disaster-affected populations. Well cultivated and deployed, we believe that RTR may enhance the moral capacities of researchers and REC members, and RECs as institutions where moral agency is nurtured and sustained. (shrink)

ZusammenfassungSeit einigen Jahren erscheinen in deutschsprachigen Medien Beiträge, die einen neuen Trend in der Versorgung von langzeitpflegebedürftigen Menschen beschreiben: die Migration in ausländische Pflegeheime, insbesondere nach Thailand oder Ost-Europa. Diese Art der Migration wird kontrovers aufgenommen. Einige Medienbeiträge beschreiben diese Praxis u. a. als „Greisen-Export“, „gerontologischen Kolonialismus“ oder „inhumane Deportation“. Die Begriffe weisen darauf hin, dass diese Migration aus sogenannten High Income Countries in Low and Middle Income Countries aus ethischer Sicht problematisch sein könnte. Allerdings gibt es bislang keine wahrnehmbare (...) wissenschaftliche ethische Auseinandersetzung mit dem Phänomen. In diesem Beitrag diagnostizieren wir, dass es sich bei der Migration Langzeit-Pflegebedürftiger tatsächlich um ein ethisch relevantes Problem handelt, und wir ordnen die von uns identifizierten ethisch relevanten Bereiche unterschiedlichen Ebenen zu: einer individual-, einer gesellschafts-, und einer global-ethischen Ebene. Auf der individualethischen Ebene diskutieren wir Fragen der Autonomie, der Verwandtschaftsbeziehungen, der Rolle von Kultur und Traditionen und der „guten Pflege“. Auf der gesellschaftsethischen Ebene diskutieren wir strukturelle Herausforderungen der Langzeitpflege und Fragen der sozialen Gerechtigkeit. Auf der globalethischen Ebene verbinden wir unser Thema mit der ethischen Diskussion des Medizintourismus und des Brain Drains und mit Fragen globaler Gerechtigkeit. Um eine weiterführende normative Analyse vornehmen zu können, sind weitere empirische Daten zu dem Phänomen notwendig. (shrink)

Department of Philosophy and Center for Health Policy, Research and Ethics, George Mason University, 4400 University Avenue, MS 2D7, Fairfax, VA 22030, USA. Tel.: +1 703 993 1724; Fax: +1 5703 993 1555; Email: leckenwi{at}gmu.edu ' + u + '@' + d + ' '//--> . Abstract Here I consider the migration of health workers and propose a conception of transnational justice that can best address the concerns it raises, including the perpetuation of global health inequities. My focus will be (...) on nurses and direct care workers (DCWs), also called paraprofessionals—the vast majority of whom are women—coming from the global South to the United States. In the first part of the paper I will identify the factors behind this flow of what I will hereafter call ‘care workers’. From there, I will describe a conception of transnational justice that seems especially promising and explore selected policy options. Finally, I will conclude by offering specific prescriptions for action on the part of a wide range of agents, including institutions as well as individuals. CiteULike Connotea Del.icio.us What's this? (shrink)

: The model of moral reasoning used in Institutional Review Board review fails to uphold ethical ideals for research participants for it does not adequately acknowledge the particular context of research or of subjects, including their gender, their socioeconomic status, and the communities in which they lead their lives. The ethical review of research needs to take seriously the particularities of the research context as well as the situations of potential participants. A variety of conclusions are drawn for changes to (...) the system for ethical review. Most significant is a call for effective consultation with the various communities affected by research and greater reliance on subject representatives. Also proposed is national review for selected research. (shrink)

This commentary was submitted to the World Medical Association on behalf of the International Network on Feminist Approaches to Bioethics. Our submission included a description of feminist research ethics, suggestions for specific revisions to the Declaration, and elements found in other international research ethics codes that are important from a feminist perspective. Our goals were to encourage the WMA to craft a declaration that: conceptualizes issues of vulnerability in richer and more nuanced ways, resists the influence of profit motives, and (...) extends the scope of responsibility for ethical research more broadly. (shrink)

The Declaration of Helsinki is recognised worldwide as a cornerstone of research ethics. Working in the wake of the Nazi doctors’ trials at Nuremberg, drafters of the Declaration set out to codify the obligations of physician-researchers to research participants. Its significance cannot be overstated. Indeed, it is cited in most major guidelines on research involving humans and in the regulations of over a dozen countries.Although it has undergone five revisions,1 and most recently incorporated language aimed at addressing concerns over research (...) carried out in resource-poor countries,2–5 the Declaration could go much farther in addressing the profoundly altered landscape of research with humans. Research involving humans is now a global enterprise and often involves participants from resource-poor countries. Rather than being carried out at single institutions by veteran researchers, many studies are now conducted at many locations—including sites that are not academic medical centres—by new and relatively inexperienced investigators. A growing number of projects involve novel agents, based on innovative work in genomics and proteomics. Increasingly, research is sponsored by the for-profit sector. National governments and professional organisations around the globe provide laws, regulations and standards for the conduct of research involving humans. Considerable scholarship also critiques and guides this endeavour.In light of the current effort of the World Medical Association to revise the Declaration, we offer ideas on how to re-conceive the concept of “vulnerability” and its links with the principle of justice and, in turn, redirect the attention of researchers towards those who might be so designated.In the research context, “vulnerability” is associated with an inability partly or totally to protect one’s own interests. Typically, conceptions of vulnerability centre upon characteristics associated with particular groups that …. (shrink)

The conduct of research in settings affected by disasters such as hurricanes, floods and earthquakes is challenging, particularly when infrastructures and resources were already limited pre-disaster. However, since post-disaster research is essential to the improvement of the humanitarian response, it is important that adequate research ethics oversight be available. We aim to answer the following questions: 1) what do research ethics committee members who have reviewed research protocols to be conducted following disasters in low- and middle-income countries perceive as the (...) key ethical concerns associated with disaster research?, and 2) in what ways do REC members understand these concerns to be distinct from those arising in research conducted in non-crisis situations? This qualitative study was developed using interpretative description methodology; 15 interviews were conducted with REC members. Four key ethical issues were identified as presenting distinctive considerations for disaster research to be implemented in LMICs, and were described by participants as familiar research ethics issues that were amplified in these contexts. First, REC members viewed disaster research as having strong social value due to its potential for improving disaster response, but also as requiring a higher level of justification compared to other research settings. Second, they identified vulnerability as an overarching concern for disaster research ethics, and a feature that required careful and critical appraisal when assessing protocols. They noted that research participants’ vulnerabilities frequently change in the aftermath of a disaster and often in unpredictable ways. Third, they identified concerns related to promoting and maintaining safety, confidentiality and data security in insecure or austere environments. Lastly, though REC members endorsed the need and usefulness of community engagement, they noted that there are significant challenges in a disaster setting over and above those typically encountered in global health research to achieve meaningful community engagement. Disaster research presents distinctive ethical considerations that require attention to ensure that participants are protected. As RECs review disaster research protocols, they should address these concerns and consider how justification, vulnerability, security and confidentially, and community engagement are shaped by the realities of conducting research in a disaster. (shrink)

Journal of Social Philosophy, EarlyView.

Given that, globally, health professionals' involvement in crises—especially complex crises where human action plays a contributing role—has risen to new proportions, emergency preparedness is an increasingly integral capacity of health systems. As the United States has come to see itself as vulnerable to violence, its leaders have begun to reorganize the country's health system around protection from terrorism and other health emergencies, upholding this as an essential element or “indispensable pillar” in their strategy for securing the homeland. Biodefense and emergency (...) preparedness have thus come to capture the energies and expertise of nearly all health professionals and, increasingly, to define the specific ends that organize their work. a. (shrink)

Bioethics, Volume 36, Issue 5, Page 479-481, June 2022.

Journal of Social Philosophy, EarlyView.

The Law is a grim, unsmiling thing, Not Justice, though. Justice is witty and whimsical and kind and caring.Rohinton Misuy, A Fine Balance;When the South Carolina Supreme Court upheld the conviction and twelve-year sentence of Regina McKnight, it affirmed that state 's commitment to bring the full force of the law to the punishment of pregnant women who use drugs. Prosecutors linked the delivery of Ms.McKnight 's stillborn baby to her use of cocaine, and argued successfully for a finding of (...) homicide by child abuse. The McKnight judgment follows the South Carolina Supreme Court decision in the case of Cornelia Whitner. Whitner was sentenced to prison for illegal drug use during pregnancy on the grounds that the viable fetus is a child under the state s criminal child endangerment statute.On the basis of constitutional concerns such as due process and privacy, worries that criminal prosecutions may thwart public policy goals such as keeping families together and promoting the health of women and children, and findings that legislatures did not intend to include the fetus in the scope of drug laws or child abuse and neglect laws, criminal prosecution has been resisted in most jurisdictions. (shrink)

The Law is a grim, unsmiling thing, Not Justice, though. Justice is witty and whimsical and kind and caring.Rohinton Misuy, A Fine Balance;When the South Carolina Supreme Court upheld the conviction and twelve-year sentence of Regina McKnight, it affirmed that state 's commitment to bring the full force of the law to the punishment of pregnant women who use drugs. Prosecutors linked the delivery of Ms.McKnight 's stillborn baby to her use of cocaine, and argued successfully for a finding of (...) homicide by child abuse. The McKnight judgment follows the South Carolina Supreme Court decision in the case of Cornelia Whitner. Whitner was sentenced to prison for illegal drug use during pregnancy on the grounds that the viable fetus is a child under the state s criminal child endangerment statute.On the basis of constitutional concerns such as due process and privacy, worries that criminal prosecutions may thwart public policy goals such as keeping families together and promoting the health of women and children, and findings that legislatures did not intend to include the fetus in the scope of drug laws or child abuse and neglect laws, criminal prosecution has been resisted in most jurisdictions. (shrink)

Worldwide, the aging population is growing by leaps and bounds, affecting all regions and most countries (WHO 2006a; Weinberger 2007). These changing demographics generate a greater need for long-term care, whether provided in homes or institutional settings such as assisted living facilities and nursing homes. The majority of those in need will dwell in developing countries. Most will be women. The current state of the dependent elderly and of long-term care systems around the world is, by all accounts, precarious and (...) in urgent need of attention. While there are important differences in these systems and among populations living under different social, political, economic, and health-care structures .. (shrink)

COVID 19 has highlighted with lethal force the need to re-imagine and re-design the provisioning of human resources for health, starting from the reality of our radical interdependence and concern for global health and justice. Starting from the structured health injustice suffered by migrant workers during the pandemic and its impact on the health of others in both destination and source countries, I argue here for re-structuring the system for educating and distributing care workers around what I call a global (...) ecological ethic. Rather than rely on a system that privileges nationalism, that is unjust, and that sustains and even worsens injustice, including health injustice, and that has profound consequences for global health, a global ecological ethic would have us see health as interdependent and aim at “ethical place-making” across health ecosystems to enable people everywhere to have the capability to be healthy. (shrink)

In a White House ceremony on May 16, 1997, President Clinton issued an apology on behalf of the nation for the Tuskegee Syphilis Study, a forty-year research project in which African-American men were deceived and denied treatment in order to document the natural course of syphilis. Reflection on this occasion can give us pause to take pride in the progress made toward more ethical research with humans. The President's apology is perhaps the most public of a number of recent events (...) representing a renewed attention to ethics in research with human participants. Alongside it stand the efforts of treatment activists for people with acquired immune deficiency syndrome and the revelations of the human radiation experiments. In 1995, President Clinton called for the creation of the National Bioethics Advisory Commission, which was charged with a host of projects aimed at investigating the organization and function of the federal system for overseeing human subjects research in the United States, and giving guidance on specific forms of research. (shrink)

In a White House ceremony on May 16, 1997, President Clinton issued an apology on behalf of the nation for the Tuskegee Syphilis Study, a forty-year research project in which African-American men were deceived and denied treatment in order to document the natural course of syphilis. Reflection on this occasion can give us pause to take pride in the progress made toward more ethical research with humans. The President's apology is perhaps the most public of a number of recent events (...) representing a renewed attention to ethics in research with human participants. Alongside it stand the efforts of treatment activists for people with acquired immune deficiency syndrome and the revelations of the human radiation experiments. In 1995, President Clinton called for the creation of the National Bioethics Advisory Commission, which was charged with a host of projects aimed at investigating the organization and function of the federal system for overseeing human subjects research in the United States, and giving guidance on specific forms of research. (shrink)

Given that, globally, health professionals' involvement in crises—especially complex crises where human action plays a contributing role—has risen to new proportions, emergency preparedness is an increasingly integral capacity of health systems. As the United States has come to see itself as vulnerable to violence, its leaders have begun to reorganize the country's health system around protection from terrorism and other health emergencies, upholding this as an essential element or “indispensable pillar” in their strategy for securing the homeland. Biodefense and emergency (...) preparedness have thus come to capture the energies and expertise of nearly all health professionals and, increasingly, to define the specific ends that organize their work. a. (shrink)