Comprehensive in scope and research, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students alike.

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

Four ethical values — maximizing benefits, treating equally, promoting and rewarding instrumental value, and giving priority to the worst off — yield six specific recommendations for allocating medical resources in the Covid-19 pandemic: maximize benefits; prioritize health workers; do not allocate on a first-come, first-served basis; be responsive to evidence; recognize research participation; and apply the same principles to all Covid-19 and non–Covid-19 patients.

This book was inspired originally by the debates at the turn of the century about placebo controlled trials of antiretrovirals in HIV positive pregnant women in developing countries. Moving forward from this one limited example, the book includes several additional controversial cases of clinical research conducted in developing countries, and asks probing philosophical questions about the ethics of such trials. All clinical research by its very nature uses people to acquire generalizable knowledge to help future people. But what sorts of (...) "use" are morally permissible? What is it to exploit people? Suppose that a trial conducted in a developing country would not be ethically permissible in the developed world. Can we automatically conclude from this that the trial is unethical, that some sort of morally problematic double standard is in operation? Or might the differences in the two settings justify differences in trial design? This collection of philosophical essays examines these important questions about what exploitation is and when clinical research counts as exploitative. -/- "This is an outstanding contribution to the growing literature on the ethics of research with human subjects and a fine example of what bioethics can offer at its best. Anyone with a serious interest in these issues will need to read this book from start to finish." -Daniel Wikler, Harvard School of Public Health "This book contributes significantly to the literature on exploitation in clinical research conducted in the developing world."--Patricia Marshall, Case Western Reserve University . (shrink)

During the WHO-GloPID COVID-19 Global Research and Innovation Forum meeting held in Geneva on the 11th and 12th of February 2020 a number of different ethical concepts were used. This paper briefly states what a number of these concepts mean and how they might be applied to discussions about research during the COVID-19 pandemic and related outbreaks. This paper does not seek to be exhaustive and other ethical concepts are, of course, relevant and important.

In this article, we propose the Fair Priority Model for COVID-19 vaccine distribution, and emphasize three fundamental values we believe should be considered when distributing a COVID-19 vaccine among countries: Benefiting people and limiting harm, prioritizing the disadvantaged, and equal moral concern for all individuals. The Priority Model addresses these values by focusing on mitigating three types of harms caused by COVID-19: death and permanent organ damage, indirect health consequences, such as health care system strain and stress, as well as (...) economic destruction. It proposes proceeding in three phases: the first addresses premature death, the second long-term health issues and economic harms, and the third aims to contain viral transmission fully and restore pre-pandemic activity. -/- To those who may deem an ethical framework irrelevant because of the belief that many countries will pursue "vaccine nationalism," we argue such a framework still has broad relevance. Reasonable national partiality would permit countries to focus on vaccine distribution within their borders up until the rate of transmission is below 1, at which point there would not be sufficient vaccine-preventable harm to justify retaining a vaccine. When a government reaches the limit of national partiality, it should release vaccines for other countries. -/- We also argue against two other recent proposals. Distributing a vaccine proportional to a country's population mistakenly assumes that equality requires treating differently situated countries identically. Prioritizing countries according to the number of front-line health care workers, the proportion of the population over 65, and the number of people with comorbidities within each country may exacerbate disadvantage and end up giving the vaccine in large part to wealthy nations. (shrink)

The African intelligentsia played a pivotal role in the anti-colonial and anti-apartheid struggle in Africa. Not only did it provide intellectual resources to the political struggle leaders but also took active part in the political leadership. Since independence, this role has diminished tremendously, as some of the intelligentsia are ‘silenced’ and others become ‘captured’ by the newly independent states. As a result, a wedge is driven between the intelligentsia and the political leadership. However, given that there is a deficit in (...) efforts to reconstruct Africa, the pan-African intelligentsia are called upon to reinvigorate and reposition themselves to assist in developing organisations and institutions to serve African people worldwide. This call challenges them to take a creative, innovative role in the reconstructive task of Africa, thereby bidding farewell to intellectual isolationism. The article draws from Kwame Nkrumah’s ideas, thereby affirming the relevance of his political ideas in contemporary Africa. (shrink)

Commentators often claim that medical research subjects are coerced into participating in clinical studies. In recent years, such claims have appeared especially frequently in ethical discussions of research in developing countries. Medical research ethics is more important than ever as we move into the 21st century because worldwide the pharmaceutical industry has grown so much and shows no sign of slowing its growth. This means that more people are involved in medical research today than ever before, and in the future (...) even more will be involved. However, despite the pressing need for reflection on research ethics, it is important to carefully identify the concerns we have about research. Otherwise we run the risk that the moral language we use, and which we hear other people use, may do our moral thinking for us. We argue that many recent claims about the occurrence of coercion in medical research are misguided and misuse the word "coercion." We try to identify the real problems, and urge people to attend carefully to the implications of their descriptions of moral problems in research. (shrink)

This article describes the daunting challenge of precarious housing in Salvokop located in the southern part of inner City of Tshwane, Gauteng Province. Insecure tenure, unmaintained dwellings, overcrowding, mushrooming of backyard shacks and the rise of the informal settlement, all that led to deep levels of vulnerability and neighbourhood deterioration. Current conditions show that life in that neighbourhood is fraught as substandard housing degenerated into slum and squalor. This concern emerged among other salient pressing issues of poverty and vulnerability from (...) the World Café and Focus Groups with the inner city churches including those from Salvokop. The article set out to describe precarious housing, unpleasant living conditions owing to the fact that human beings stay in unsuitable dwellings while the environment deteriorates. Taking into account their circumstances, the article’s aim was to recapture the extent to which the residents suffer as a result of living in dwellings unfit for human habitation, rethinking an alternative model to respond. A theological agenda for future ecclesiological engagement was discerned forthwith recommendations. The article makes a contribution towards the theology of the city in that it stimulates church practices and housing of poor people in Tshwane. It does so by engaging in a unique way grassroots knowledge from the different inner city congregations. This process used the platform of surveys, World Café style gatherings and Focus Groups. In conversation with the primary source, this article also contributed with original data generated with the Salvokop residents whose stories helped to expend on horizons of housing, which is acknowledged. All the inner city church contributors of the realisation of the study objectives are also recognised. (shrink)

All parties involved in researching, developing, manufacturing, and distributing COVID-19 vaccines need guidance on their ethical obligations. We focus on pharmaceutical companies' obligations because their capacities to research, develop, manufacture, and distribute vaccines make them uniquely placed for stemming the pandemic. We argue that an ethical approach to COVID-19 vaccine production and distribution should satisfy four uncontroversial principles: optimising vaccine production, including development, testing, and manufacturing; fair distribution; sustainability; and accountability. All parties' obligations should be coordinated and mutually consistent. For (...) instance, companies should not be obligated to provide host countries with additional booster shots at the expense of fulfilling bilateral contracts with countries in which there are surges. Finally, any satisfactory approach should include mechanisms for assurance that all parties are honouring their obligations. This assurance enables countries, pharmaceutical companies, global organisations, and others to verify compliance with the chosen approach and protect ethically compliant stakeholders from being unfairly exploited by unethical behaviour of others. (shrink)

1. The opinions expressed are the author's own. They do not reflect any position or policy of the National Institutes of Health, Public Health Service, Department of Health and Human Services, or any of the authors affiliated organizations.

INTRODUCTION The Questions of Medical Ethics Call him Andrew. His face is gaunt and unshaven but peaceful. His eyelids are gently closed. ...

For decades, worries about undue inducement have Pervaded clinical research, and are especially common when research is accompanied by payment or conducted in developing countries. Few ethical judgments carry as much moral opprobrium or are thought to undermine the ethical soundness of a clinical trial as thoroughly as undue inducement. Indeed, the admonition to prevent undue inducement is one of the few explicit instructions in the Common Rules requirements for informed consent.Despite their long history and pervasiveness, charges of undue inducement (...) in clinical research are almost always mistaken. Indeed, I will advance an even more radical claim: Aresearch trial that otherwise fulfills the fundamental ethical requirements for human subjects research inherently cannot create the possibility of undue inducement because substantial risk of serious harm isprecluded. Charges of undue inducement tend to express displaced and mislabeled ethical concerns about other aspects of human subjects research. Consequently, claims of undue inducement should rarely be made, and when they are advanced should be treated with skepticism, placing a heavy burden of proofon those advancing such charges. (shrink)

COVID-19 vaccines are likely to be scarce for years to come. Many countries, from India to the U.K., have demonstrated vaccine nationalism. What are the ethical limits to this vaccine nationalism? Neither extreme nationalism nor extreme cosmopolitanism is ethically justifiable. Instead, we propose the fair priority for residents framework, in which governments can retain COVID-19 vaccine doses for their residents only to the extent that they are needed to maintain a noncrisis level of mortality while they are implementing reasonable public (...) health interventions. Practically, a noncrisis level of mortality is that experienced during a bad influenza season, which society considers an acceptable background risk. Governments take action to limit mortality from influenza, but there is no emergency that includes severe lockdowns. This “flu-risk standard” is a nonarbitrary and generally accepted heuristic. Mortality above the flu-risk standard justifies greater governmental interventions, including retaining vaccines for a country's own citizens over global need. The precise level of vaccination needed to meet the flu-risk standard will depend upon empirical factors related to the pandemic. This links the ethical principles to the scientific data emerging from the emergency. Thus, the FPR framework recognizes that governments should prioritize procuring vaccines for their country when doing so is necessary to reduce mortality to noncrisis flu-like levels. But after that, a government is obligated to do its part to share vaccines to reduce risks of mortality for people in other countries. We consider and reject objections to the FPR framework based on a country: having developed a vaccine, raising taxes to pay for vaccine research and purchase, wanting to eliminate economic and social burdens, and being ineffective in combating COVID-19 through public health interventions. (shrink)

For decades, worries about undue inducement have Pervaded clinical research, and are especially common when research is accompanied by payment or conducted in developing countries. Few ethical judgments carry as much moral opprobrium or are thought to undermine the ethical soundness of a clinical trial as thoroughly as undue inducement. Indeed, the admonition to prevent undue inducement is one of the few explicit instructions in the Common Rules requirements for informed consent.Despite their long history and pervasiveness, charges of undue inducement (...) in clinical research are almost always mistaken. Indeed, I will advance an even more radical claim: Aresearch trial that otherwise fulfills the fundamental ethical requirements for human subjects research inherently cannot create the possibility of undue inducement because substantial risk of serious harm isprecluded. Charges of undue inducement tend to express displaced and mislabeled ethical concerns about other aspects of human subjects research. Consequently, claims of undue inducement should rarely be made, and when they are advanced should be treated with skepticism, placing a heavy burden of proofon those advancing such charges. (shrink)

The current prevailing view is that participation in biomedical research is above and beyond the call of duty. While some commentators have offered reasons against this, we propose a novel public goods argument for an obligation to participate in biomedical research. Biomedical knowledge is a public good, available to any individual even if that individual does not contribute to it. Participation in research is a critical way to support an important public good. Consequently, all have a duty to participate. The (...) current social norm is that individuals participate only if they have a good reason to do so. The public goods argument implies that individuals should participate unless they have a good reason not to. Such a shift would be of great aid to the progress of biomedical research, eventually making society significantly healthier and longer lived. (shrink)

ABSTRACT This paper adds to efforts to retrieve the long-neglected philosophical contributions of Karoline von Günderrode, and is one of the first to seriously address the political commitments in Günderrode’s work, especially regarding revolution. This idea gains an unusual status in the context of Günderrode’s metaphysics, and is key to understanding the connections between Günderrode’s more obviously philosophical writings and her literary work. I argue that Günderrode’s concept of revolution resembles, in some respects, the ideas of other thinkers of her (...) time, but has ramifications for conceiving of human individuals and their relationships to society and nature that are unique to Günderrode. First, I use a comparison with the work of contemporaries on revolution to justify interpreting Günderrode’s metaphysics in relation to her thought on politics. Günderrode often masks her political thought in the form of plays, and the paper next considers the theme of revolution in her plays Muhammad, the Prophet of Mecca, and Udohla. Lastly, the paper contrasts Günderrode’s position on revolution to claims by Herder and Fichte, arguing that Günderrode’s conception of a cycle of enhancement and decay of natural forces, political power and social cohesion differs from androcentric models that emphasize the development of consciousness. (shrink)

All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing the (...) trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested. (shrink)

The 2010 Patient Protection and Affordable Care Act was designed to increase health insurance coverage in the United States. Its most controversial feature is the requirement that US residents purchase health insurance. Opponents of the mandate argue that requiring people to contribute to the collective good is inconsistent with respect for individual liberty. Rather than appeal to the collective good, this Viewpoint argues for a duty to buy health insurance based on the moral duty individuals have to reduce certain burdens (...) they pose on others. When some people have a duty to rescue, others may have a duty to take rescue precautions, in this case, to purchase health insurance to cover acute and emergency care needs. Requiring that individuals meet this obligation is consistent with respect of individual liberty. (shrink)

Poetic Fragments is the second collection of writings by the neglected German poet, dramatist and philosopher Karoline von Günderrode (1780–1806), which she published in 1805. This bilingual English-German edition is the first volume of Günderrode’s work to appear with an English translation. An introduction and three essays argue for the philosophical significance and originality of the pieces included in Poetic Fragments and relate Günderrode’s thought to its Romantic and German Idealist context. This critical material argues that in Poetic Fragments Günderrode (...) presents a radical and unique consideration of the nature of the universe, death, religion, agency, power, and gender roles, which deserves to be included in the academic study of German Romanticism and post-Kantian Idealism. (shrink)

This chapter explores the importance of writing by early nineteenth-century women for post-structuralist accounts of philosophy of art in German Idealism and Romanticism. Work by Romantic writers Karoline von Günderrode and Bettina Brentano-von Arnim is related to post-structuralist analyses of the sublime, the fragment, the work of art, and the artist/genius.

The understanding of appropriate ethical protections for participants of biomedical research has not been static. It has evolved over time, with the evolution of biomedical research as well as social values. Since World War II, there have been four major paradigms of research and research oversight operative in the United States. These paradigms incorporate different values and provide different approaches to research oversight and the protection of research participants.

Glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide, and dual GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, such as tirzepatide, have been found to be effective for treating obesity and diabetes, significantly reducing weight and the risk or predicted risk of adverse cardiovascular events. There is a global shortage of these medications that could last several years and raises questions about how limited supplies should be allocated. We propose a fair-allocation framework that enables evaluation of the ethics of current (...) practices and could guide governments, professional societies, and physicians in allocation decisions. (shrink)

We argue that the ethical case for instituting vaccine benefit programs is justified by 2 widely recognized values: (1) reducing overall harm from COVID-19 and (2) protecting disadvantaged individuals. We then explain why they do not coerce, exploit, wrongfully distort decision-making, corrupt vaccination's moral significance, wrong those who have already been vaccinated, or destroy willingness to become vaccinated. However, their cost impacts and their effects on public perception of vaccines should be evaluated.

Debates about what constitutes benefits in human research continue to be less informed due to a lack of empirical evidence from the developing world. This study aimed to explore what constitutes benefits in HIV vaccine trials in Tanzania and examine inherent ethical implications. A qualitative case study design was deployed and a total of 29 purposively selected study participants comprising of experienced researchers, institutional review board members and community advisory board members were included. Collected data were analyzed by thematic analysis (...) aided by computer software: MAXQDA version 20.4.0. The study findings indicate that there is a growing appreciation of benefits beyond actual vaccines to include 1) capacity building at individual, community, institutional and regulatory levels; and 2) non‐capacity building related benefits such as strengthened collaborations, ancillary care and employment opportunities. So, as the struggle for viable HIV vaccines continues, other benefits that have accrued from such trials are not to be blindsided especially for developing countries like Tanzania. (shrink)

We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.

The debate about justice and health care has occurred largely at a remove from the institutions it concerns; it has been about our most general moral principles, and about what things we value. This debate has foundered. But if the debate is turned in another direction, toward some moral principles that are widely accepted within those institutions, and toward principles that have to do with control over allocation decisions rather than with actually how to make those decisions, agreement may be (...) nearer at hand. (shrink)

Karoline von Günderrode (1780–1806) has long enjoyed a reputation as a Romantic poet, but her philosophical contributions have largely been neglected. This paper is one of the first to address Günderrode’s political thought, especially her view of the interrelationship between human society and the broader environment. The paper argues that Günderrode develops resources for reconceiving the relationship of human beings to the nonhuman and to each other that work against an instrumentalizing view of nature and programmatic political ideals. Günderrode’s normative (...) restraint, concept of harmony, and view of human beings as part of and the same in kind as the rest of nature contribute to a vision of sociality, grounded in her metaphysics, that envisions small communities fostering connections between human beings and the nonhuman. On Günderrode’s model, these connections can grow and strengthen and eventually, perhaps, enable the emergence of the single, perfect organism that she calls the “realized idea of the earth.”. (shrink)

The abrupt shift in learning mode demands students to adjust from the comfort of their homes, as well as the challenges of face-to-face learning. As a result, as the pandemic fades, institutions in the Philippines have begun to reopen their doors to students. Hence, this study employed a correlational design to investigate the relationship between procrastination and academic burnout among 150 first-year college students in a state university. Based on the statistical analysis, the r coefficient of 0.67 indicates a moderate (...) positive correlation between the variables. The p-value of 0.00, which is less than 0.05, leads to the decision to reject the null hypothesis. Hence, a significant relationship exists between procrastination and academic burnout among first-year college students. Implications and recommendations were discussed in the study. (shrink)

Global health is at a crossroads. The 2030 Agenda for Sustainable Development has come with ambitious targets for health and health services worldwide. To reach these targets, many more billions of dollars need to be spent on health. However, development assistance for health has plateaued and domestic funding on health in most countries is growing at rates too low to close the financing gap. National and international decision-makers face tough choices about how scarce health care resources should be spent. Should (...) additional funds be spent on primary prevention of stroke, treating childhood cancer, or expanding treatment for HIV/AIDS? Should health coverage decisions take into account the effects of illness on productivity, household finances, and children's educational attainment, or just focus on health outcomes? Does age matter for priority setting or should it be ignored? Are health gains far in the future less important than gains in the present? Should higher priority be given to people who are sicker or poorer? Global Health Priority-Setting provides a framework for how to think about evidence-based priority-setting in health. Over 18 chapters, ethicists, philosophers, economists, policy-makers, and clinicians from around the world assess the state of current practice in national and global priority setting, describe new tools and methodologies to address establishing global health priorities, and tackle the most important ethical questions that decision-makers must consider in allocating health resources. (shrink)

The COVID-19 pandemic has helped to clarify the fair and equitable allocation of scarce medical resources, both within and among countries. The ethical allocation of such resources entails a three-step process: (1) elucidating the fundamental ethical values for allocation, (2) using these values to delineate priority tiers for scarce resources, and (3) implementing the prioritisation to faithfully realise the fundamental values. Myriad reports and assessments have elucidated five core substantive values for ethical allocation: maximising benefits and minimising harms, mitigating unfair (...) disadvantage, equal moral concern, reciprocity, and instrumental value. These values are universal. None of the values are sufficient alone, and their relative weight and application will vary by context. In addition, there are procedural principles such as transparency, engagement, and evidence-responsiveness. Prioritising instrumental value and minimising harms during the COVID-19 pandemic led to widespread agreement on priority tiers to include health-care workers, first responders, people living in congregate housing, and people with an increased risk of death, such as older adults and individuals with medical conditions. However, the pandemic also revealed problems with the implementation of these values and priority tiers, such as allocation on the basis of population rather than COVID-19 burden, and passive allocation that exacerbated disparities by requiring recipients to spend time booking and travelling to appointments. This ethical framework should be the starting point for the allocation of scarce medical resources in future pandemics and other public health conditions. For instance, allocation of the new malaria vaccine among sub-Saharan African countries should be based not on reciprocity to countries that participated in research, but on maximally reducing serious illness and deaths, especially among infants and children. (shrink)

This paper considers how women and gender are conceptualised within early German Romanticism and argues that work by early German Romantic women should be addressed in scholarship on this movement. The chapter addresses feminist critiques of early German Romanticism as exemplified by the work of Friedrich Schlegel and Novalis, concluding that an essentialist view of traditional gender characteristics informs central aspects of these writers’ work, including their view of the relationship between human beings and nature and their theories of language (...) and poetry. The paper argues that a thoroughgoing critique of gender categories and development of the implications of this critique are found in the early German Romantic writings, not of Schlegel and Novalis, but of Dorothea Veit-Schlegel and Karoline von Günderrode. (shrink)

Karoline von Günderrode’s reputation as a mystical writer makes her a likely candidate as a proponent of a negative philosophy. However, the historical emphasis on Günderrode’s mystical and lyrical writings reflects gender stereotypes about women’s writing and ignores Günderrode’s strengths as an epic and historical writer. It is therefore important to approach claims about Günderrode’s supposed mysticism carefully. This paper is a preliminary attempt to investigate Günderrode’s claims about knowledge, including knowledge of the absolute, asking: What does Günderrode think knowledge (...) is? What does she think the purpose of knowledge is—i.e., what does she think knowledge gets us, or does for us? And how do her claims differ from those philosophers, such as Novalis, whose thinking on knowledge (including of the absolute) seems to resemble hers? I argue that Günderrode maintains that human beings can experience, or “know,” a reality behind the discrete objects and events that comprise the world of appearances, and that she integrates this idea into a coherent worldview in a unique way. Specifically, I argue that Günderrode reconceptualizes the nature of death and selfhood in specific ways that allow her to make sense of the possibility of experiencing the true nature of the world behind the divisions that are characteristic of human knowledge and existence. (shrink)

In 1804, when asked by the aspiring writer Clemens Brentano why she had chosen to publish her work, Karoline von Günderrode wrote that she longed “mein Leben in einer bleibenden Form auszusprechen, in einer Gestalt, die würdig sei, zu den Vortreflichsten hinzutreten, sie zu grüssen und Gemeinschaft mit ihnen zu haben.” In light of this kind of statement, it is perhaps not surprising if, despite some exceptions, much of the still relatively scant literature on Günderrode reads her works largely in (...) terms of how they articulate and manifest Günderrode’s desires, frustrations, and character, for the most part ignoring their imaginary, creative, and intellectual aspects. This interpretation of the author’s works as biography is, in Günderrode’s case, often accompanied by an interpretation of her biography, particularly her suicide, as literary work. This paper is not the first to question the conflation of Günderrode’s life, death, and writing, but it is one of only a handful that aim to address the autopoietic element of Günderrode’s work in a way that does not reduce her writings to biographical and psychological expressions, or Günderrode herself to an image – or a legend – encapsulated by her writings and her relationship to them. This paper argues that Günderrode’s own position on what the self is has been largely neglected as a result of this conflation, and that taking this position into account changes how we understand Günderrode’s articulations of self in her writings. Thus this paper has two goals: to address difficulties in articulating and even constituting oneself sincerely when one’s efforts are unrecognized, belittled, censored, and forced to conform to the conventions of a society in which one is marginalized; and to unearth a neglected and potentially rich account of the modern self. (shrink)

We consider an ethical dilemma in global health: is it ethically acceptable to provide some patients cheaper treatments that are less effective or more toxic than the treatments other patients receive? We argue that it is ethical to consider local resource constraints when deciding what interventions to provide. The provision of cheaper, less effective health care is frequently the most effective way of promoting health and realizing the ethical values of utility, equality, and priority to the worst off.