This paper examines the case of a recent H5N1virus (avian influenza) outbreak in West Bengal, an eastern state of India, and argues that poorly executed pandemic management may be viewed as a moral lapse. It further argues that pandemic management initiatives are intimately related to the concept of health as a social 'good' and to the moral responsibility of protection from foreseeable social harm from an infectious disease. The initiatives, therefore, have to be guided by special moral obligations towards biorisk (...) reduction, obligations which remain unfulfilled when a public body entrusted with the responsibility fails to manage satisfactorily the prevention and control of the infection. The overall conclusion is that pandemic management has a moral dimension. The gravity of the threat that fatal infectious diseases pose for public health creates special moral obligations for public bodies in pandemic situations. However, the paper views the West Bengal case as a learning opportunity, and considers the lapses cited as challenges that better, more effectively conducted pandemic management can prepare for. It is hoped that this paper will provoke constructive bioethical deliberations, particularly pertinent to the developing world, on how to ensure that the obligations towards health are fulfilled ethically and more effectively. (shrink)

In the context of clinical and non-clinical biomedical practices, negligence is usually understood as a lapse of a specific professional duty by a healthcare worker or by a medical facility. This paper tries to delineate systemic negligence as another kind of negligence in the context of health systems, particularly in developing countries, that needs to be recognized and addressed. Systemic negligence is not just a mere collection of stray incidences of medical errors and system failures in a health system, (...) but is proposed in this paper as a more pervasive kind of neglect. Several non-medical factors, such as lack of social and political will, also contribute to it and hence is more difficult to address in a health system. This paper argues that recognizing systemic negligence and including it research agenda have special moral importance for researchers in developing world bioethics, public health ethics and for health activists in the developing world. For, it can be a potent health system barrier, and can seriously impair efforts to ensure patient safety, particularly in the weaker health systems. As it erodes accountability in a health system, addressing it is also important for the twin goals of ensuring patient safety and improving health system performance. Above all, it needs to be addressed because the tolerance of its persistence in a health system seems to undervalue health as a social good. (shrink)

How do bioethics gatekeepers located in wealthy nations treat bioethics workers from developing countries? Can the policies of leading international bioethics journals—based on a concern for profit that effectively restricts access for most researchers from developing countries—be ethically justified? We examined these policies focusing on the way they influence the ability of researchers in resource-poor countries to participate in the development of the field of bioethics. Eight of the fourteen leading bioethics journals are (...) published by three transnational publishing houses, all of which are based in wealthy nations. None of these eight journals participates in the Health InterNetwork Access to Research Initiative of the World Health Organization, a program that provides free or very low-cost online access to the major journals by researchers in developing countries. Lack of access to these essential resources makes it extremely difficult, if not impossible, for bioethicists in developing countries to learn from, and engage in, the global bioethics dialogue. Thus, exclusionary practices of leading bioethics journals sustain the hegemony of Western bioethics, raising serious questions about professed aspirations to create a truly “global” bioethics. This phenomenon indicates lack of empathy and moral imagination of bioethicists in developed countries, raises serious questions about the ethics of bioethics, and highlights the urgent need for creative solutions to remedy this social injustice. (shrink)

We identify the ways the policies of leading international bioethics journals limit the participation of researchers working in the resource-constrained settings of low- and middle-income countries in the development of the field of bioethics. Lack of access to essential scholarly resources makes it extremely difficult, if not impossible, for many LMIC bioethicists to learn from, meaningfully engage in, and further contribute to the global bioethics discourse. Underrepresentation of LMIC perspectives in leading journals sustains the hegemony of Western (...) bioethics, limits the presentation of diverse moral visions of life, health, and medicine, and undermines aspirations to create a truly “global” bioethics. Limited attention to this problem indicates a lack of empathy and moral imagination on the part of bioethicists in high-income countries, raises questions about the ethics of bioethics, and highlights the urgent need to find ways to remedy this social injustice. (shrink)

This book is a case of “too little, too late”: too little in that it represents voices not from the developing world as a whole but from a particular Catholic viewpoint in the Philippines, too late in that others have already gone “beyond a Western bioethics”—which, in any case, is not the unified and rigid set of principles that the authors make it out to be. The publication is a long delayed spinoff of a series of (...) class='Hi'>bioethics seminars held in Manila and Houston under the leadership of H Tristram Engelhardt Jr, who has contributed an introduction to the volume on Western bioethics reconsidered. (As Engelhardt writes: “Like good wine, this work has come slowly into its own” (page xii). Engelhardt’s bias is evident in the phrase he uses early on in this introduction, “the customary American/western European indoctrination in …. (shrink)

This paper examines the moral force of exploitation in developing world research agreements. Taking for granted that some clinical research which is conducted in the developing world but funded by developed world sponsors is exploitative, it asks whether a third party would be morally justified in enforcing limits on research agreements in order to ensure more fair and less exploitative outcomes. This question is particularly relevant when such exploitative transactions are entered into voluntarily by all (...) relevant parties, and both research sponsors and host communities benefit from the resulting agreements. I show that defenders of the claim that exploitation ought to be permitted rely on a mischaracterization of certain forms of interference as unjustly paternalistic and two dubious empirical assumptions about the results of regulation. The view I put forward is that by evaluating a system of constraints on international research agreements, rather than individual transaction-level interference, we can better assess the alternatives to permitting exploitative research agreements. (shrink)

Developing World Bioethics, Volume 22, Issue 2, Page 112-122, June 2022.

This collection brings together fourteen contributions by authors from around the globe. Each of the contributions engages with questions about how local and global bioethical issues are made to be comparable, in the hope of redressing basic needs and demands for justice. These works demonstrate the significant conceptual contributions that can be made through feminists' attention to debates in a range of interrelated fields, especially as they formulate appropriate responses to developments in medical technology, global economics, population shifts, and poverty.

This collection brings together fourteen contributions by authors from around the globe. Each of the contributions engages with questions about how local and global bioethical issues are made to be comparable, in the hope of redressing basic needs and demands for justice. These works demonstrate the significant conceptual contributions that can be made through feminists' attention to debates in a range of interrelated fields, especially as they formulate appropriate responses to developments in medical technology, global economics, population shifts, and poverty.

This paper discusses the economic, legal, moral, and political difficulties in developing drugs for the developing world. It argues that large, global pharmaceutical companies have social responsibilities to the developing world, and that they may exercise these responsibilities by investing in research and development related to diseases that affect developing nations, offering discounts on drug prices, and initiating drug giveaways. However, these social responsibilities are not absolute requirements and may be balanced against other obligations (...) and commitments in light of economic, social, legal, political, and other conditions. How a company decides to exercise its social responsibilities to the developing world depends on the prospects for a reasonable profit and the prospects for a productive business environment. Developing nations can either help or hinder the pharmaceutical industry’s efforts to exercise social responsibility through various policies and practices. To insure that companies can make a reasonable profit, developing nations should honor pharmaceutical product patents and adhere to international intellectual property treaties, such as the Trade‐Related Aspects of Intellectual Property Rights agreement. To insure the companies have a good business environment, developing nations should try to promote the rule of law, ethical business practices, stable currencies, reliable banking systems, free and open markets, democracy, and other conditions conducive to business. Overall, this paper advocates for reciprocity and cooperation between pharmaceutical companies and developing nations to address the problem of developing drugs for the developing world. In pursuing this cooperative approach, developing nations may use a variety of other techniques to encourage pharmaceutical companies to act responsibly, such as subsidizing pharmaceutical research, helping to design and implement research protocols, providing a guaranteed market, and bulk buying. (shrink)

Infertile women in the developing world face an additional layer of vulnerability compared to their counterparts in the developed world due to social, cultural, political, and socioeconomic factors that truly render their infertility a disability. After exploring how infertility in the developing world fits the World Health Organization’s biopsychosocial model of disability, we will argue that feminists and disability rights proponents should jointly articulate and advocate for change.

As in other countries, medical ethics in Mexico has rescued the world of philosophical ethics from oblivion. The needs of clinical medicine gave birth to Mexican bioethics. After the growth of scientific and technologic subjects in medical schools, the humanities, such as medical history, deontology, and medical philosophy, were replaced by such core subjects as radiology, pharmacology, and microbiology. Since the 1950s, graduates from Mexican medical schools have not been exposed to any courses in the medical humanities.

Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) research (...) (P = 0.001), more sponsor‐country authors (P = 0.003), sponsor‐country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host‐country involved (P = 0.002), journals having sponsor‐country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor‐country editors and research being biomedical.Conclusions: One‐third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards. (shrink)

This chapter contains sections titled: Introduction Medical Migration and Moral Responsibility Lending Money to Developing Countries Culture and Religion Health Research and Resources Conclusions References.

Scientists engaged in global health research are increasingly faced with barriers to access and use of human tissues from the developing world communities where much of their research is targeted. In part, the problem can be traced to distrust of researchers from affluent countries, given the history of 'scientific-imperialism' and 'biocolonialism' reflected in past well publicized cases of exploitation of research participants from low to middle income countries. To a considerable extent, the failure to adequately engage host communities, (...) the opacity of informed consent, and the lack of fair benefit-sharing have played a significant role in eroding trust. These ethical considerations are central to biomedical research in low to middle income countries and failure to attend to them can inadvertently contribute to exploitation and erode trust. A 'tissue trust' may be a plausible means for enabling access to human tissues for research in a manner that is responsive to the ethical challenges considered. Preventing exploitation and restoring trust while simultaneously promoting global health research calls for innovative approaches to human tissues research. A tissue trust can reduce the risk of exploitation and promote host capacity as a key benefit. (shrink)

The so-called Brundtland-Report defines Sustainable Development as a conception of intra- and intergenerational justice, which is to be realized by a globally just distribution of possibilities for satisfying human basic needs as well as assuring such possibilities for future generations. Hence, any political and/orsocietal decision is addressed by the ethical demands of Sustainable Development insofar it affects possibilities for satisfying human basic needs. In particular, this concerns – contrary to the widespread opinion that Sustainable Development only has to deal with (...) problems of environmental ethics – the legitimization of biomedical applications. After all, especially such decisions often face the problem of measuring and trading‐off potential advantages and disadvantages regarding possibilities for satisfying human basic needs. Based on the example of decisions about establishing biobanks, my talk firstly will show that Sustainable Development actually demands much more from political and societal decisions than just being concerned about environmental ethics. Secondly, it will clarify these demands in detail. Thirdly, it will address the issues of how these demands can be implemented adequately. My talk therefore will show which conditions political and/or societal decision processes have to meet in order to comply with Sustainable Development. (shrink)

Increasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear.METHODS: I conducted in-depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%).RESULTS: US IRBs (...) face ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs' quality, resources and training; and health systems in some countries may have long-standing practices of corruption. These US IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures' differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, and ‘negotiate’ for maximum benefits for participants and fearing ‘worst-case scenarios’.CONCLUSIONS: US and foreign IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice. (shrink)

ABSTRACT This paper reports on a multidisciplinary meeting held to discuss ethical issues in medical research in the developing world. Many studies, including clinical trials, are conducted in developing countries with a high burden of disease. Conditions under which this research is conducted vary because of differences in culture, public health, political, legal and social contexts specific to these countries. Research practices, including standards of care for participants, may vary as a result. It is therefore not surprising (...) that ethical issues emerge. This meeting sought to identify and discuss these issues from the perspectives of the many actors in such research, including community representatives, with a view to finding ethical and pragmatic solutions to these issues. Dialogue between these actors was also promoted, with a view to identifying the need to develop such dialogue in future. Drawing from the experiences of the speakers, the colloquium attempted to outline some answers to several key questions characterising the field today. Experiences related to epidemiologic research, vaccine trials, drug trials, diagnostic tests and to some fundamental ethical issues in health research. Speakers were from different countries, disciplines and professions. The meeting provided a forum for consultation and debate between different ethics actors. Both encouraging findings and challenges emerged. (shrink)

Since the adoption of the WTO-TRIPS Agreement in 1994, there has been significant controversy over the impact of pharmaceutical patent protection on the access to medicines in the developing world. In addition to the market exclusivity provided by patents, the pharmaceutical industry has also sought to further extend their monopolies by advocating the need for additional ‘regulatory’ protection for new medicines, known as data exclusivity. Data exclusivity limits the use of clinical trial data that need to be submitted (...) to the regulatory authorities before a new drug can enter the market. For a specified period, generic competitors cannot apply for regulatory approval for equivalent drugs relying on the originator's data. As a consequence, data exclusivity lengthens the monopoly for the original drug, impairing the availability of generic drugs. This article illustrates how the pharmaceutical industry has convinced the US and the EU to impose data exclusivity on their trade partners, many of them developing countries. The key arguments formulated by the pharmaceutical industry in favor of adopting data exclusivity and their underlying ethical assumptions are described in this article, analyzed, and found to be unconvincing. Contrary to industry's arguments, it is unlikely that data exclusivity will promote innovation, especially in developing countries. Moreover, the industry's appeal to a property rights claim over clinical test data and the idea that data exclusivity can prevent the generic competitors from ‘free-riding’ encounters some important problems: Neither legitimize excluding all others. (shrink)

ABSTRACTRelatively little has been written about the ethics of conducting early phase clinical trials involving subjects from the developing world. Below, I analyze ethical issues surrounding one of gene transfer’s most widely praised studies conducted to date: in this study, Italian investigators recruited two subjects from the developing world who were ineligible for standard of care because of economic considerations. Though the study seems to have rendered a cure in these two subjects, it does not appear (...) to have complied with various international guidelines that require that clinical trials conducted in the developing world be responsive to their populations’ health needs. Nevertheless, policies devised to address large scale, late stage trials, such as the AZT short‐course placebo trials, map somewhat awkwardly to early phase studies. I argue that interest in conducting translational research in the developing world, particularly in the context of hemophilia trials, should motivate more rigorous ethical thinking around clinical trials involving economically disadvantaged populations. (shrink)

Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) research (...) (P = 0.001), more sponsor-country authors (P = 0.003), sponsor-country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host-country involved (P = 0.002), journals having sponsor-country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor-country editors and research being biomedical.Conclusions: One-third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards. (shrink)

In our time there is growing interest in developing a systematic approach to oncologic patients and end-of-life care. An important goal within this domain is to identify the values and ethical norms that guide physicians’ decisions and their recourse to technological aids to preserve life. Though crucial, this objective is not easy to achieve.

Concern about the rapid ageing of all societies reaches alarming proportions as healthcare inequities are steeply rising, prompting the elderly to live longer but subject to insufficient social protection and healthcare in the wake of dwindling public resources. The aged population of developing nations are facing additional hardships due to the growing gap between needs and the financial reductions of public institutions, retirement funds, and the trend towards privatization of essential services turned into commodities. Current approaches to allocation of (...) insufficient resources without ageist discrimination are briefly discussed: individual self‐care aimed at successful, active and healthy ageing based on resourcefulness of the privileged elderly; utilitarian approaches founded on QALY and fair innings, and human rights focused on the plights of the elderly. These approaches cannot apply to resources poor nations, who need to engage in context‐bound bioethics dealing with the realities of their exposed ageing population. A developing world bioethics is needed to face the plights of the elderly in countries with low and middle‐income and insufficient social capital. Suggested are: 1) a phenomenological approach based on the interaction of bioethics and ethnology, furthering grass‐roots input from the elderly; 2) Create small communities –campus‐like boroughs– to simplify accessibility to social services and healthcare facilities, as an alternative to the high‐cost WHO proposal of age‐friendly large cities. (shrink)

ABSTRACTThe principle of informed refusal poses a specific problem when it is invoked by a pregnant woman who, in spite of having accepted her pregnancy, refuses the diagnostic and/or therapeutic measures that would ensure the well‐being of her endangered fetus. Guidelines issued by professional bodies in the developed world are conflicting: either they allow autonomy and informed consent to be overruled to the benefit of the fetus, or they recommend the full respect of these principles. A number of medical (...) ethicists advocate the overruling of alleged irrational or unreasonable refusal for the benefit of the fetus. The present essay supports the view of fetal rights to health and to life based on the principle that an ‘accepted’ fetus is a ‘third person’. In developing countries, however, the implementation of the latter principle is likely to be in conflict with a ‘communitarian’ perception of the individual – in this case, the pregnant woman. Within the scope of the limitations to the right to autonomy of J.S. Mill's ‘harm principle’, the South African Patients’ Charter makes provision for informed refusal. The fact that, in practice, it is not implemented illustrates the well‐known difficulty of applying Western bioethical principles in real life in the developing world. (shrink)

ABSTRACT:This essay argues for the importance of formalizing public engagement efforts around bioethics as something we might call "bioethics communication," and it outlines the Johns Hopkins Berman Institute of Bioethics' plans for engaging in this effort. Because science is complex and difficult to explain to nonexperts, the field of science communication has arisen to meet this need. The field involves both a practice and a subject of empirical research. Like science, bioethics is also complex and difficult (...) to explain, which is why the world needs bioethics communication. The authors are engaged in a brand-new effort to establish the sort of public bioethics efforts that would constitute bioethics communication, through a program which they call the Dracopoulos-Bloomberg iDeas Lab. The authors invite colleagues to experiment and learn with them as they invest in the development of bioethics communicators and their products. (shrink)

The so-called Brundtland-Report defines Sustainable Development as a conception of intra- and intergenerational justice, which is to be realized by a globally just distribution of possibilities for satisfying human basic needs as well as assuring such possibilities for future generations. Hence, any political and/or societal decision is addressed by the ethical demands of Sustainable Development insofar it affects possibilities for satisfying human basic needs. In particular, this concerns – contrary to the widespread opinion that Sustainable Development only has to deal (...) with problems of environmental ethics – the legitimization of biomedical applications. After all, especially such decisions often face the problem of measuring and trading-off potential advantages and disadvantages regarding possibilities for satisfying human basic needs. Based on the example of decisions about establishing biobanks, my talk firstly will show that Sustainable Development actually demands much more from political and societal decisions than just being concerned about environmental ethics. Secondly, it will clarify these demands in detail. Thirdly, it will address the issues of how these demands can be implemented adequately. My talk therefore will show which conditions political and/or societal decision processes have to meet in order to comply with Sustainable Development. (shrink)

CITATION: Horn, L. M. 2015. Promoting responsible research conduct in a developing world academic context. South African Journal of Bioethics and Law, 6:21-24, doi:10.7196/SAJBL.256.

In this paper we extend Heidi Hurd’s “correspondence thesis” to the termination of pregnancy debate and argue that the same reasons that determine the permissibility of abortion also determine the justifiability of acts involving conscientious objection against its performance. Essentially, when abortion is morally justified, acts that prevent or obstruct it are morally unjustified. Therefore, despite conscientious objection being legally permitted in some global south countries, we argue that such permission to conscientiously object would be morally wrong in cases of (...) morally justifiable termination of pregnancy. After presenting and defending our “correspondence argument” we suggest that conscientious objection should be denied as a matter of public health policy in developing counties, even in cases where adequate referral services are possible. Towards the end, we extend our argument to midwives, nurses, and prospective students in the field. Given their essential position in resource‐poor contexts; they too have no claim to conscientious objection. (shrink)

The triumvirate of HIV/AIDS, tuberculosis, and malaria have dominated our public health focus in the developing world. Having claimed millions of lives, these infectious diseases have prompted a large-scale response. Concomitant with these efforts has been a burgeoning bioethics literature examining global health and distributive justice. A scholarly waste-land only a decade ago, there is now a growing and rich literature that aims to unpack our moral obligations when it comes to diseases that affect the majority of (...) the world (many living in absolute poverty). Now, added to the persistent challenges posed by infectious diseases is the growing burden of diseases such as cancer, which disproportionately affect .. (shrink)

ABSTRACT In recent years there has been intense debate regarding the level of medical care provided to ‘standard care’ control groups in clinical trials in developing countries, particularly when the research sponsors come from wealthier countries. The debate revolves around the issue of how to define a standard of medical care in a country in which many people are not receiving the best methods of medical care available in other settings. In this paper, we argue that additional dimensions of (...) the standard of care have been hitherto neglected, namely, the structure and efficiency of the national health system. The health system affects locally available medical care in two important ways: first, the system may be structured to provide different levels of care at different sites with referral mechanisms to direct patients to the appropriate level of care. Second, inefficiencies in this system may influence what care is available in a particular locale. As a result of these two factors locally available care cannot be equated with a national ‘standard’. A reasonable approach is to define the national standard of care as the level of care that ought to be delivered under conditions of appropriate and efficient referral in a national system. This standard is the minimum level of care that ought to be provided to a control group. There may be additional moral arguments for higher levels of care in some circumstances. This health system analysis may be helpful to researchers and ethics committees in designing and reviewing research involving standard care control groups in developing country research. (shrink)