Any view of equipoise faces perhaps the most radical and far-reaching objections from moral foundations. These objections hold that the equipoise requirement conflates the ethics of medical research and the ethics of clinical medicine. Once this conflation is recognized, this position holds, research can be given a new foundation on the imperative to avoid exploiting research participants. This article argues that what is novel in this critique is not as successful as its proponents claim and that the ultimate success of (...) this approach actually hinges on a version of the objection from utility. Nevertheless, this criticism highlights the limited scope of applicability of the equipoise requirement. The article concludes, therefore, by describing the outlines of what the article calls an ‘integrative approach’ to clinical trials. This approach represents one way in which the normative requirements of equipoise and the non-exploitation approach might be unified under a single, broad framework. (shrink)

Scientific research and ethics -- Ethical theory and decision making -- Data acquisition and management -- Mentoring and professional relationship -- Collaboration in research -- Authorship -- Publication and peer review -- Misconduct in research -- Intellectual property -- Conflicts of interest and scientific objectivity -- The use of animals in research -- The use of human subjects in research -- The use of vulnerable subjects in research -- Genetics, cloning, and stem cell research -- International research.

v. 1. Editorial introduction -- v. 2. The English and Latin texts (i) -- v. 3. The English and Latin texts (ii).

This important new work surveys the source and ramifications of the famed Nuremburg Code -- recognized around the world as one of the cornerstones of modern bioethics.

This new edition of Charles Fried's 'Medical Experimentation' includes a general introduction by Franklin Miller and the late Alan Wertheimer, a reprint of the 1974 text, an in-depth analysis by Harvard Law School scholars I. Glenn Cohen and D. James Greiner, and a new essay by Fried reflecting on the original text and how it applies to the contemporary landscape of medicine and medical experimentation.

Natural Law and Natural Rights is widely recognised as a seminal contribution to the philosophy of law, and an essential reference point for all students of the subject. This new edition includes a substantial postscript by the author responding to thirty years of comment, criticism, and further work in the field.

Winner of the 1975 National Book Award, this brilliant and widely acclaimed book is a powerful philosophical challenge to the most widely held political and social positions of our age--liberal, socialist, and conservative.

Challenging, with several powerful arguments, some of our deepest beliefs about rationality, morality, and personal identity, Parfit claims that we have a false view about our own nature. It is often rational to act against our own best interersts, he argues, and most of us have moral views that are self-defeating. We often act wrongly, although we know there will be no one with serious grounds for complaint, and when we consider future generations it is very hard to avoid conclusions (...) that most of us will find very disturbing. (shrink)

How should medical services be distributed within society? Who should pay for them? Is it right that large amounts should be spent on sophisticated technology and expensive operations, or would the resources be better employed in, for instance, less costly preventive measures? These and others are the questions addreses in this book. Norman Daniels examines some of the dilemmas thrown up by conflicting demands for medical attention, and goes on to advance a theory of justice in the distribution of health (...) care. The central argument is that health care, both preventive and acute, has a crucial effect on equality of opportunity, and that a principle guaranteeing equality of opportunity must underly the distribution of health-care services. Access to care, preventive measures, treatment of the elderly, and the obligations of doctors and medical administrations are fully discussed, and the theory is shown to underwrite various practical policies in the area. (shrink)

International research, sponsored by for-profit companies, is regularly criticised as unethical on the grounds that it exploits research subjects in developing countries. Many commentators agree that exploitation occurs when the benefits of cooperative activity are unfairly distributed between the parties. To determine whether international research is exploitative we therefore need an account of fair distribution. Procedural accounts of fair bargaining have been popular solutions to this problem, but I argue that they are insufficient to protect against exploitation. I argue instead (...) that a maximin principle of fair distribution provides a more compelling normative account of fairness in relationships characterised by extreme vulnerability and inequality of bargaining potential between the parties. A global tax on international research would provide a mechanism for implementing the maximin account of fair benefits. This model has the capacity to ensure fair benefits and thereby prevent exploitation in international research. (shrink)

In this revised edition of his 1979 classic Political Theory and International Relations, Charles Beitz rejects two highly influential conceptions of international theory as empirically inaccurate and theoretically misleading. In one, international relations is a Hobbesian state of nature in which moral judgments are entirely inappropriate, and in the other, states are analogous to persons in domestic society in having rights of autonomy that insulate them from external moral assessment and political interference. Beitz postulates that a theory of international politics (...) should include a revised principle of state autonomy based on the justice of a state’s domestic institutions, and a principle of international distributive justice to establish a fair division of resources and wealth among persons situated in diverse national societies. (shrink)

This chapter outlines the main ideas of my book National responsibility and global justice. It begins with two widely held but conflicting intuitions about what global justice might mean on the one hand, and what it means to be a member of a national community on the other. The first intuition tells us that global inequalities of the magnitude that currently exist are radically unjust, while the second intuition tells us that inequalities are both unavoidable and fair once national responsibility (...) is allowed to operate. This conflict might be resolved either by adopting a cosmopolitan theory of justice (which leaves no room for national responsibility) or by adopting a ?political? theory of justice (which denies that questions of distributive justice can arise beyond the walls of the sovereign state). Since neither resolution is satisfactory, the chapter defends the idea of national responsibility and proposes a new theory of global justice, whose main elements are the protection of basic human rights worldwide, and fair terms of interaction between independent political communities. (shrink)

The surprising case for liberal nationalism Around the world today, nationalism is back—and it’s often deeply troubling. Populist politicians exploit nationalism for authoritarian, chauvinistic, racist, and xenophobic purposes, reinforcing the view that it is fundamentally reactionary and antidemocratic. But Yael Tamir makes a passionate argument for a very different kind of nationalism—one that revives its participatory, creative, and egalitarian virtues, answers many of the problems caused by neoliberalism and hyperglobalism, and is essential to democracy at its best. In Why Nationalism, (...) she explains why it is more important than ever for the Left to recognize these positive qualities of nationalism, to reclaim it from right-wing extremists, and to redirect its power to progressive ends. Provocative and hopeful, Why Nationalism is a timely and essential rethinking of a defining feature of our politics. (shrink)

Outlining the major competing theories in the history of political and moral philosophy--from Locke and Hume through Hart, Rawls, and Nozick--John Simmons attempts to understand and solve the ancient problem of political obligation. Under what conditions and for what reasons, he asks, are we morally bound to obey the law and support the political institutions of our countries?

Beyond Consent examines the concept of justice, and its application to human subject research, through the different lenses of various research populations: children, the vulnerable sick, captive and convenient populations, women, people of colour, and subjects in international settings. Separate chapters address the evolution of research policies, implications of the concept of justice for the future of human subject research, and the ramifications of this concept throughout the research enterprise.

This paper argues that a sweatshop worker's choice to accept the conditions of his or her employment is morally significant, both as an exercise of autonomy and as an expression of preference. This fact establishes a moral claim against interference in the conditions of sweatshop labor by third parties such as governments or consumer boycott groups. It should also lead us to doubt those who call for MNEs to voluntarily improve working conditions, at least when their arguments are based on (...) the claim that workers have a moral right to such improvement. These conclusions are defended against three objections: 1) that sweatshop workers' consent to the conditions of their labor is not fully voluntary, 2) that sweatshops' offer of additional labor options is part of an overall package that actually harms workers, 3) that even if sweatshop labor benefits workers, it is nevertheless wrongfully exploitative. (shrink)

There is growing interest in understanding and eliciting division of labor within groups of scientists. This paper illustrates the need for this division of labor through a historical example, and a formal model is presented to better analyze situations of this type. Analysis of this model reveals that a division of labor can be maintained in two different ways: by limiting information or by endowing the scientists with extreme beliefs. If both features are present however, cognitive diversity is maintained indefinitely, (...) and as a result agents fail to converge to the truth. Beyond the mechanisms for creating diversity suggested here, this shows that the real epistemic goal is not diversity but transient diversity. (shrink)

It has long been taken for granted that clinical research involving human subjects is ethical only if it holds out the prospect of producing socially valuable knowledge. Recently, this social value requirement has come under scrutiny, with prominent ethicists arguing that the social value requirement cannot be substantiated as an ethical limit on clinical research, and others attempting to offer new support. In this paper, I argue that both criticisms and existing defenses of the social value requirement are predicated on (...) what I call the “transactional model of stakeholder obligations”. I go on to problematize this framework, and to introduce an alternative framework for conceptualizing ethical obligations within clinical research. In defending this framework, which I call the “basic structure model of stakeholder obligations”, I also demonstrate how it provides a stronger grounding for the social value requirement that is not vulnerable to critiques grounded in the transactional model. (shrink)

Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this (...) gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. (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)

Dual-track assessment directs research ethics committees to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.Research guidelines around the world recognise that clinical research is ethical only when the risks to participants are (...) reasonable.1 Appropriate implementation of this requirement is vital to protecting research participants and allowing research to proceed when it poses acceptable risks. Unfortunately, as the US National Bioethics Advisory Commission notes: “current regulations do not further elaborate how risks and potential benefits are to be assessed, and little additional guidance is available to IRBs.”1The NBAC, as well as numerous commentators, recommend that research ethics committees , ethics review committees and institutional review boards should adopt what may be called dual-track risk assessment.2–5 Yet, dual-track assessment unnecessarily divides research interventions into two different categories before assessing their risks and relies on the unclear distinction between therapeutic and non-therapeutic interventions. As a result, dual-track assessment provides RECs with confusing guidance and has the potential to block valuable research that poses acceptable risks. This paper describes one alternative, the net risks test, and argues that this approach offers a better method for assessing research risks, one that puts RECs in a position to protect participants without blocking appropriate research studies.BACKGROUNDClinical research exposes participants to interventions and procedures to gather systematic data that may be used to improve overall health and well-being. To ensure that research is ethical, RECs must ensure that the risks and burdens to participants are not excessive and that …. (shrink)

The institutional review board is the social-oversight mechanism charged with protecting research subjects. Performing this task competently requires that the IRB scrutinize informed-consent procedures, the balance of risks and potential benefits, and subject-selection procedures in research protocols. Unfortunately, it may be said that IRBs are spending too much time editing informed-consent forms and too little time analyzing the risks and potential benefits posed by research. This time mismanagement is clearly reflected in the research ethics literature. A review of articles published (...) between 1979 and 1990 in IRB: A Review of Human Subjects Research, for example, reveals a large number of articles on informed consent and confidentiality and considerably fewer on the assessment of risks and potential harms, study design, and subject-selection procedures. (shrink)

Is there no balm in Gilead; is there no physician there? Why then is not the health of the daughter of my people recovered?In July of 2004, Cambodian sex workers staged a protest of an HIV prevention trial set to enroll 900 sex workers in Phnom Penh, charging the study planners with exploitation. The Cambodian study was one of a series of international clinical trials sponsored by the U.S. National Institutes of Health, U.S. Centers for Disease Control and Prevention, and (...) the Bill and Melinda Gates Foundation testing the safety and efficacy of tenofovir, an antiretroviral drug produced by Gilead Sciences, Inc., to prevent HIV transmission. To date, two of these international studies have been closed and one is suspended, prompting calls for re-examination of the ethics of HIV prevention trials. (shrink)

The continuous pursuit and support of medical research on both a societal and individual level is frequently presupposed as laudable, or even obligatory. However, some critics have challenged the assumption that medical research ought to be conducted. These critics reject claims that there is a moral obligation to pursue research, and that medical research may always be justifiable given adequate safeguards and regulations. We align ourselves with critics of the research imperative to the extent that we believe that medical research (...) may only be an imperfect obligation, grounded in the principle of beneficence. Our central purpose in this article, however, is not to advance an original argument concerning the .. (shrink)

In this article, the main complexities of understanding and curbing the HIV/AIDS pandemic in (South) Africa, are discussed. These are: 1. Poverty as niche or social context of the pandemic, 2. Denial, lack of leadership and the politicization of the public discourse on AIDS, 3. Problems related to accomplishing behavior changes under conditions of deprivation and illiteracy, 4. Women's vulnerability, and 5. The disenchantment of intimacy brought about by the pandemic. In each case, some solutions are suggested, although the notion (...) of complexity does not allow for definitive solutions. Concluding remarks deal with the possible philosophical and moral sense that we might make of the pandemic. (shrink)

Recent economic and political advances in developing countries on the African continent and South East Asia are threatened by the rising death and morbidity rates of HIV/AIDS. In the first part of this paper we explain the reasons for the absence of affordable access to essential AIDS medication. In the second part we take a closer look at some of the pivotal frameworks relevant for this situation and undertake an ethical analysis of these frameworks. In the third part we discuss (...) a few of the proposed solutions to the problem and conclude with an argument in support of our preferred course of action. In this article we argue for compulsory licensing of essential AIDS medications in the current conditions of public health emergency. We argue on broadly consequentialist grounds that compulsory licensing is preferable both morally and pragmatically to the alternatives, notably the currently offered price cuts and drug donation schemes. (shrink)

One widely accepted way of justifying universal access to health care is to argue that access to health care is necessary to ensure health, which is necessary to provide equality of opportunity. But the evidence on the social determinants of health undermines this argument.

This paper discusses obligations of international distributive justice-specifically, obligations rich countries have to transfer resources to poor countries. It argues that the major seven OECD countries each have an obligation to transfer at least one percent of their GDP to developing countries. -/- The strategy of the paper is to defend this position without having to resolve the many debates that attend questions of international distributive justice. In this respect, it belongs to the neglected category of nonideal theory. The key (...) to the strategy is to show that a significant amount of good would be accomplished by a one percent transfer, despite the fact that one percent is quite a small amount. -/- To make this showing, the paper takes health as a fundamental measure of individual well-being and examines the improvement in life expectancy that would likely result from devoting the one percent transfer to the major determinants of health. It adduces data indicating that substantial progress towards raising life expectancy in developing countries to the global average of 64.5 years can be expected from expenditures of $125 per capita, divided between health care, education, and basic nutrition and income support. A one percent transfer from the major seven is enough to cover expenditures on that scale for the poorest fifth of the world's population. (shrink)

The work of Tversky, Kahneman and others suggests that people often make use of cognitive heuristics such as availability, salience and representativeness in their reasoning and decision making. Through use of a historical example--the recent plate tectonics revolution in geology--I argue that such heuristics play a crucial role in scientific decision making also. I suggest how these heuristics are to be considered, along with noncognitive factors (such as motivation and social structures) when drawing historical and epistemological conclusions. The normative perspective (...) is community-wide, contextual, and instrumental. (shrink)

Background : researchers and sponsors increasingly confront the issue of whether participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. Purpose: to systematically review reasons why drug trial participants should, or need not be ensured PTA to the trial drug (...) and the uses of such reasons. Data sources: databases in science/medicine, law and ethics, thesis databases, bibliographies, research ethics books and included publications’ notes/bibliographies. Publication selection: a publication was included if it included a reason as above. See article for detailed inclusion conditions. Data extraction and analysis: two reviewers extracted and analyzed data on publications and reasons. Results: of 2060 publications identified, 75 were included. These mentioned reasons based on morality, legality, interests/incentives, or practicality, comprising 36 broad (235 narrow) types of reason. None of the included publications, which included informal reviews and reports by official bodies, mentioned more than 22 broad (59 narrow) types. For many reasons, publications differed about the reason’s interpretation, implications and/or persuasiveness. Publications differed also regarding costs, feasibility and legality of PTA. Limitations: reason types could be applied differently. The quality of reasons was not measured. Conclusion: this review captured a greater variety of reasons and of their uses than any included publication. Decisions based on informal reviews or sub-sets of literature are likely to be biased. Research is needed on PTA ethics, costs, feasibility and legality and on assessing the quality of reason-based literature. (shrink)

We discuss several features of coherent choice functions—where the admissible options in a decision problem are exactly those that maximize expected utility for some probability/utility pair in fixed set S of probability/utility pairs. In this paper we consider, primarily, normal form decision problems under uncertainty—where only the probability component of S is indeterminate and utility for two privileged outcomes is determinate. Coherent choice distinguishes between each pair of sets of probabilities regardless the “shape” or “connectedness” of the sets of probabilities. (...) We axiomatize the theory of choice functions and show these axioms are necessary for coherence. The axioms are sufficient for coherence using a set of probability/almost-state-independent utility pairs. We give sufficient conditions when a choice function satisfying our axioms is represented by a set of probability/state-independent utility pairs with a common utility. (shrink)

Each year thousands of individuals enrol in clinical trials as healthy volunteers to earn money. Some of them pursue research participation as a full-time or at least a part-time job. They call themselves professional or semiprofessional guinea pigs. The practice of paying healthy volunteers raises numerous ethical concerns. Different payment models have been discussed in literature. Dickert and Grady argue for a wage-payment model. This model gives research subjects a standardised hourly wage, and it is based on an assumption that (...) research participation is morally indistinguishable from other forms of unskilled labour. In this paper, I will challenge this assumption. I will argue that human guinea pigging has particular characteristics which taken together make it significantly different from other forms of labour. Participation in research is skill-independent. Healthy volunteers are valuable not because they are skilful persons, but because they are human bodies. The role of research volunteers is mainly passive. They are not asked to produce goods or deliver services. They are paid for enduring unpleasant, painful and risky interventions performed by investigators. Research volunteering involves inherent risks and uncertainties, and subjects have little or no control over their minimisation and materialisation. I conclude that participation in clinical research is a specific kind of activity. It is more like renting out one’s body to strangers, than working. Thus, research participation should not be treated on par with other forms of employment. (shrink)

While there is a growing body of work on moral issues and global governance in the fields of global justice and international relations, little work has connected principles of global health justice with those of global health governance for a theory of global health. Such a theory would enable analysis and evaluation of the current global health system and would ethically and empirically ground proposals for reforming it to more closely align with moral values. Global health governance has been framed (...) as an issue of national security, human security, human rights, and global public goods. The global health governance literature is essentially untethered to a theorized framework to illuminate or evaluate governance. This article ties global health justice and ethics to principles for governing the global health realm, developing a theoretical framework for global and domestic institutions and actors. (shrink)

This book originated as lectures for a course on political philosophy that Rawls taught regularly at Harvard in the 1980s.

An axiom of medical research ethics is that a protocol is moral only if it has a “favorable risk-benefit ratio”. This axiom is usually interpreted in the following way: a medical research protocol is moral only if it has a positive expected value -- that is, if it is likely to do more good (to both subjects and society) than harm. I argue that, thus interpreted, the axiom has two problems. First, it is unusable, because it requires us to know (...) more about the potential outcomes of research than we ever could. Second, it is false, because it conflicts with the so-called “soft paternalist” principles of liberal democracy. In place of this flawed rule I propose a new way of making risk-benefit assessments, one that does comport with the principles of liberalism. I argue that a protocol is moral only if it would be entered into by competent subjects who are informed about the protocol. The new rule this eschews all pseudo-utilitarian calculation about the protocol’s likely harms and benefits. (shrink)

Scholarship focusing on how international research can contribute to justice in global health has primarily explored requirements for the conduct of clinical trials. Yet health systems research in low- and middle-income countries has increasingly been identified as vital to the reduction of health disparities between and within countries. This paper expands an existing ethical framework based on the health capability paradigm – research for health justice – to externally-funded health systems research in LMICs. It argues that a specific form of (...) health systems research in LMICs is required if the enterprise is to advance global health equity. “Research for health justice” requirements for priority setting, research capacity strengthening, and post-study benefits in health systems research are derived in light of the field's distinctive characteristics. Specific obligations are established for external research actors, including governments, funders, sponsors, and investigators. How these framework requirements differ from those for international clinical research is discussed. (shrink)