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.

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)

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.

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)

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)

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)

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)

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.

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)

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)

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)

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)

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)

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.

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

This book presents a collection of original essays by leading thinkers in political theory, philosophy, and bioethics on key issues concerning global justice and bioethics. It is the first collection to comprehensively address these pressing theoretical and practical questions about international distributive justice, humans rights, health care and medical research.

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.

We’re grateful for the thoughtful and incisive commentaries on our article, “Ethical Responsibilities for Companies that Process Personal Data” (McCoy et al. 2023). In the article, we propose the E...

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.

Certifications of immunity are sometimes called “immunity passports” but are better conceptualized as immunity-based licenses. Such policies raise important questions about fairness, stigma, and counterproductive incentives but could also further individual freedom and improve public health. Immunity licenses should not be evaluated against a baseline of normalcy, ie, uninfected free movement. Rather, they should be compared to the alternatives of enforcing strict public health restrictions for many months or permitting activities that could spread infection, both of which exacerbate inequalities and (...) impose serious burdens. This Viewpoint presents a framework for analyzing the ethics of immunity licenses. (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)

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)

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.