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.

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

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)

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)

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)

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.

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.

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)

An encyclopedia entry on Romantic writer and philosopher's fascinating reconceptualisation of the concept of death.

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)

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)

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)

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)

Our Viewpoint argues that expanding access to less effective or more toxic treatments is supported not only by utilitarian ethical reasoning but also by two other ethical frameworks: those that emphasise equality and those that emphasise giving priority to the patients who are worst off. The inadequate resources available for global health reflect not only natural constraints but also unwise social and political choices. However, pitting efforts to reduce inequality and better fund global health against efforts to put available resources (...) to their best use mistakes complementary objectives for conflicting ones. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Blossoming of Bioethics at NIHEzekiel J. Emanuel (bio)The establishment of the Department of Clinical Bioethics at the Warren G. Magnuson Clinical Center of the National Institutes of Health (NIH) has coincided with a burgeoning of interest and activity related to bioethical issues at NIH. The department has precipitated a reexamination and revitalization of existing bioethics activities in the Clinical Center and has launched new programs especially in the (...) areas of education and research. In addition, the department contributes to the work of others throughout NIH who address bioethical issues.The Organizational Location of the Department of Clinical BioethicsBefore describing the history and current activities of the Department of Clinical Bioethics, I will say something about it administrative location. Comprehension of the department’s organizational location is essential to understanding its history, role, and function. Prior to interviewing for the position of chair of the department, I did not—and, if truth be told, still do not fully—understand the details of the organizational structure of NIH. I therefore assume that many other bioethicists outside of the Institutes, especially those who do not regularly receive NIH funding, may not fully grasp its organizational intricacies.The Department of Clinical Bioethics is a department within the Warren G. Magnuson Clinical Center, which is NIH’s “hospital.” Hospital is in quotes because all of the patients at the Clinical Center must be enrolled in a research protocol and, therefore, are research subjects. The Clinical Center is where NIH’s clinical researchers admit their research subjects or see them in the out-patient setting. The Department of Clinical Bioethics reports directly to the Director of the Clinical Center, John I. Gallin, M.D., and receives its finances, space, and other resources from the Clinical Center.In this way, the department is part of NIH’s intramural (“inside”) program. People employed by NIH conduct intramural research, training, and other initiatives. The extramural program, which receives approximately 87 percent of NIH’s budget, funds research at institutions outside NIH. The extramural program awards grants and contracts for research, training, and conferences conducted [End Page 455] by investigators who are not affiliated with NIH. The National Human Genome Research Institute’s ELSI (Ethical, Legal, and Social Implications) program, for example, is part of NIH’s extramural program. As part of the NIH intramural program, the Department of Clinical Bioethics is not empowered to fund independent initiatives of people outside of NIH through grants and contracts. However, the department can collaborate with bioethicists and others on research, educational, and other programs outside of NIH and has some funds to support these collaborations.In addition, it is important for bioethicists to understand that NIH is a collection of 24 institutes and centers. Although there is coordination and collaboration between the institutes and centers, each is funded separately, and each has its own scope, programs, administrative structures, research agendas, training priorities, boards of advisors, and so forth. In this sense, NIH is more like a university that has many distinct schools, each with its own dean, faculty, budget, and fund raising office, than one that is tightly integrated and centrally-administered. Within NIH’s diffuse administrative structure, the Department of Clinical Bioethics is located within one of the centers (the Clinical Center) and has defined authority and responsibility only for bioethics within that center; in addition, because the Clinical Center’s mission is to support clinical research at other institutes, the department’ mission includes supporting the work of those institutes as well. Intellectual exchanges and relationships with other institutes and centers are neither pre-ordained nor administratively established; such relationships must be developed case-by-case, topic-by-topic, and initiative-by-initiative.The History and the Development of the Department of Clinical BioethicsThe Department of Clinical Bioethics was launched in late 1996. Although the department’s creation marked a major commitment to bioethics by the Clinical Center, and especially by its director, Dr. Gallin, it was formed on a pre-existing foundation of bioethics activities at NIH. 1In 1977, John Fletcher, Ph.D., was appointed by then Director Mortimer Lipsett as the bioethicist at the Clinical Center; his official title was Assistant for Bioethics... (shrink)

In a pluralistic society, the “best interests” standard is an inadequate criterion for determining what level of medical care to provide incompetent patients. Instead, the standard of care should be derived from the deliberations of particular communities. A “community‐federated” plan would enhance individual choice and diminish family and physician uncertainty.

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)

In this chapter, Rosa Luxemburg examines the basic structure of wage labor. For Luxemburg, wage labor is a condition for the systemic, economical exploitation of one free human being by another. Luxemburg analyzes the capitalists’ thinking about wages, their interest in extending the workday and in lowering the pay, and the conflict of interest between the worker and the owner of capital. She also discusses the role of trade unions in keeping not only the real wages but also the social (...) wages above the level of mere sustenance for the individual worker. (shrink)

A prematurely menopausal woman who underwent chemotherapy for breast cancer wants to have a child with her husband with help from an infertility clinic. Two doctors discuss the risks involved for the couple.

Budgets of governments and private insurances are limited. Not all drugs and services that appear beneficial to patients or physicians can be covered. Is there a core set of benefits that everyone should be entitled to? If so, how should this set be determined? Are fair decisions just impossible, if we know from the outset than not all needs can be met? While early work in bioethics has focused on clinical issues and a narrow set of principles, in recent years (...) there has been a marked shift towards addressing broader population-level issues, requiring consideration of more demanding theories in philosophy, political science, and economics. At the heart of bioethics' new orientation is the goal of clarity on a complex set of questions in rationing and resource allocation. Rationing and Resource Allocation in Healthcare: Essential Readings provides key excerpts from seminal and pertinent texts and case studies about these topics, contextualized by original introductions. The volume is divided into three broad sections: Conceptual Distinctions and Ethical Theory; Rationing; and Resource Allocation. Containing the most important and classic articles surrounding the theoretical and practical issues related to rationing and how to allocate scare medical resources, this collection aims to assist and inform those who wish to be a part of bioethics' 21st century shift including practitioners and policy-makers, and students and scholars in the health sciences, philosophy, law, and medical ethics. (shrink)

This article traces the French construction and demonization of American feminism by a segment of the women's movement and by public left-wing intellectuals. The joining of anti-American and anti-feminist traditions produces a new entity, dubbed French anti-amér-féminisme. The development is traced in the writings of one women's group, Psychanalyse et Politique, and in the debates around a so-called political correctness. Defending the image of a France distinguished by harmonious gender rapport and relations of seduction, this entity is used as a (...) mechanism to encourage French women to reject feminism or to define a different, homegrown heterosocial version. Using the examples of debates in women's studies, parity democracy and sexual harassment, the author demonstrates how anti-amér-féminisme has had material repercussions on French women's lives, such as limiting the scope of sexual harassment law. (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)

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.

In response to commentators, we argue that whether waiving patent rights will meaningfully improve access to COVID-19 vaccines for low income and middle-income countries (LMICs), particularly in the short term, is an empirical matter. We also reject preferentially allocating vaccines to countries that hosted trials because doing so unethically favours those with research infrastructure, rather than those facing the worst burdens from COVID-19.

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)

An article publicising the philosophical contributions of German women writers in the late 18th and 19th centuries.

Now might be the time, if the proposal is crafted right.

Novalis "Novalis" was the pseudonym of Georg Philipp Friedrich Freiherr von Hardenberg, an early German Romantic philosopher, poet, and novelist. Born into a Pietistic family of minor, slightly cash-strapped, Saxon nobility in 1772, he died of tuberculosis in 1801 at the age of 28. Novalis is sometimes seen as … Continue reading Novalis →.

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)

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.