Although the principle of fair subject selection is a widely recognized requirement of ethical clinical research, it often yields conflicting imperatives, thus raising major ethical dilemmas regarding participant selection. In this paper, we diagnose the source of this problem, arguing that the principle of fair subject selection is best understood as a bundle of four distinct sub-principles, each with normative force and each yielding distinct imperatives: (1) fair inclusion; (2) fair burden sharing; (3) fair opportunity; and (4) fair distribution of (...) third-party risks. We first map out these distinct sub-principles, and then identify the ways in which they yield conflicting imperatives for the design of inclusion and exclusion criteria, and the recruitment of participants. We then offer guidance for how decision makers should navigate these conflicting imperatives to ensure that participants are selected fairly. (shrink)

The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular institutional role. I examine (...) two types of institutional contexts: (1) public research agencies – agencies or departments of states that fund or conduct clinical research in the public interest; and (2) private-for-profit corporations. I argue that investigators who are employed or have their research sponsored by the former have a distinctive institutional obligation to conduct their research in a way that is consistent with the state's duty of distributive justice to provide its citizens with access to basic health care, and its duty to aid citizens of lower income countries. By contrast, I argue that investigators who are employed or have their research sponsored by private-for-profit corporations do not possess this obligation nor any other institutional obligation that is directly relevant to the ethics of RCTs. My account of the institutional obligations of investigators aims to contribute to the development of a reasonable, distributive justice-based account of standard of care. (shrink)

Governments are increasingly using randomized controlled trials (RCTs) to evaluate policy interventions. RCTs are often understood to provide the highest quality evidence regarding the causal efficacy of an intervention. While randomization plays an essential epistemic role in the context of policy RCTs however, it also plays an important distributive role. By randomly assigning participants to either the intervention or control arm of an RCT, people are subject to different policies and so, often, to different types and levels of benefits. In (...) this paper, I identify one necessary condition as well as a set of sufficient conditions for the permissible use of random assignment by government agencies. I argue first that random assignment is permissible only if it is consistent with governments’ duty to realize morally important outcomes. I argue second that random assignment is permissible in cases where investigators are in a state of genuine equipoise regarding all arms of the experiment and the policy to which people have a claim of justice. Finally, I defend a set of conditions under which random assignment is permissible in cases where one or more arms of a policy RCT are reasonably expected to be either superior or inferior to this policy. (shrink)

In this article, I ask whether a principle analogous to the principle of clinical equipoise should govern the design and conduct of RCTs evaluating the effectiveness of policy interventions. I answer this question affirmatively, and introduce and defend the principle of policy equipoise. According to this principle, all arms of a policy RCT must be, at minimum, in a state of equipoise with the best proven policy that is also morally and practically attainable and sustainable. For all arms of a (...) policy RCT, policy experts must either reasonably disagree about whether the trial arms are more effective than this policy, or know that they are. (shrink)

Australia, Canada, and New Zealand currently apply health requirements to prospective immigrants, denying residency to those with health conditions that are likely to impose an “excessive demand” on their publicly funded health and social service programs. In this paper, I investigate the charge that such policies are wrongfully discriminatory against persons with disabilities. I first provide a freedom-based account of the wrongness of discrimination according to which discrimination is wrong when and because it involves disadvantaging people in the exercise of (...) their freedom on the basis of morally arbitrary features of their identity. Discrimination is permissible, I suggest, when it is necessary to advance a valuable exercise of the discriminating agent’s freedom. I then apply this account to the case of social cost health requirements. Against critics of these requirements, I argue that it is sometimes permissible for states to discriminate against prospective immigrants with disabilities. States may do so, I suggest, when such discriminatory treatment is necessary to prevent an increase in rates of mortality and/or morbidity amongst citizens. Alongside critics of social cost health requirements however, I argue that existing policies are likely a form of wrongful discrimination insofar as they are too broad to satisfy this standard. (shrink)

The duty to rescue is a highly plausible and powerful ethical principle. It requires agents to assist others in extreme need in cases where doing so does not conflict with some weighty moral aim; requires little personal sacrifice; and is likely to significantly benefit the recipients.1 As a general obligation, it binds all persons simply qua persons, and it is owed to all persons simply qua persons. Clinical investigators working in low-income countries frequently encounter sick or destitute people to whom (...) they might possess a duty to rescue. Investigators may often ask themselves, what can I do, what should I do, to help? Such investigators often help people in the future by carrying out their... (shrink)

Many high-income countries have skill-selective immigration policies, favoring prospective immigrants who are highly skilled. I investigate whether it is permissible for high-income countries to adopt such policies. Adopting what Joseph Carens calls a " realistic approach " to the ethics of immigration, I argue first that it is in principle permissible for high-income countries to take skill as a consideration in favor of selecting one prospective immigrant rather than another. I argue second that high-income countries must ensure that their skill-selective (...) immigration policies do not contribute to the non-fulfillment of their duty to aid residents of low-and middle-income countries. (shrink)

A principal rationale for public policy is to address market failures. Pareto efficiency is therefore a highly common and relatively non-controversial evaluative criterion for many policy analyses and is discussed at length in policy analysis texts. This makes sense, for Pareto improvements involve making at least one person better off without making anyone worse off. Who could object to that? But does efficiency deserve the prominence it enjoys in public policy? Is one policy option better than another, at least in (...) one respect, simply because it is more Pareto efficient? Or, is efficiency valuable for some other reason? In this chapter, I discuss Pareto efficiency as an evaluative criterion and argue that it is a stand-in for a more foundational criterion: wellbeing. I begin with an overview of Pareto efficiency, discuss the various ways in which it is operationalized to evaluate policy options, and argue that it is valuable insofar as more efficient states of affairs promise more wellbeing than less efficient states of affairs. I then raise questions regarding whether the conception of wellbeing presupposed by Pareto efficiency – preference satisfaction – is a defensible conception of wellbeing. I go on to introduce three alternative conceptions of wellbeing which have been proposed and defended by both philosophers and policy scholars, namely, hedonism, objective goods views, and the capability approach, and suggest ways in which each can be operationalized as an evaluative criterion. I close by discussing four ‘theory-free’ approaches to thinking about the impact of policies on the quality of people’s lives. Such approaches reject the idea that there is one single theory of wellbeing that should be used to evaluate policy options, and instead develop ways to evaluate the impact of policies on people’s lives that are not grounded in a specific theory. (shrink)

In this article, we suggest that the evidence regarding the social determinants of health calls for a deep re‐thinking of our understanding of distributive justice. Focusing on John Rawls's theory of distributive justice in particular, we argue that a full reckoning with the social determinants of health requires a re‐working of Rawls's principles of justice. We argue first that the social bases of health – a Rawlsian conception of the social determinants of health – should be considered a social primary (...) good. We argue second that including the social bases of health as a social primary good would lead the parties to the original position to choose an additional principle of justice and assign it lexical priority over Rawls's second principle. According to this principle, inequalities in people's share of the social bases of health are to be arranged so as to improve the health status of those least advantaged on the social health gradient. -/- . (shrink)

The value of health states is often understood to depend on their impact on the goodness of people's lives. As such, prominent health states metrics are grounded in particular conceptions of wellbeing – e.g. hedonism or preference satisfaction. In this paper, I consider how liberals committed to the public justification requirement – the requirement that public officials choose laws and policies that are justifiable to their citizens – should evaluate health states. Since the public justification requirement prohibits public officials from (...) appealing to controversial conceptions of the good life, liberals committed to this principle face a significant puzzle. (shrink)

Soda taxes are controversial. While proponents point to their potential health benefits and the public projects that could be funded with their revenue, critics argue that they are paternalistic and regressive. In this paper, we explore the prospects for designing a just soda tax, one that appropriately balances the often-competing ethical considerations of promoting social welfare, respecting people’s autonomy, and ensuring distributive fairness. We argue that policymakers have several paths forward for designing a just soda tax, but that the considerations (...) relevant to ethical policy design are more complicated than is sometimes acknowledged. (shrink)

Policy analyses begin with a systematic overview of the policy problem they address. This includes a comprehensive discussion of the nature and context of the problem, and the institutional and behavioral factors responsible for its emergence. Problem statements must also explain why the status quo is bad or undesirable, why it is something that governments, rather than private actors, should address, and establish that the relevant government institutions have the legitimacy to intervene. In this chapter, I provide an overview of (...) the principal types of policy problems that it is morally appropriate for governments to address. Each type denotes a class of states of affairs that (1) are bad, undesirable, or unjust, (2) the government is particularly well-suited to address, and (3) arise from spheres of action over which the relevant government institutions have the right to intervene. I begin with a discussion of collective action problems, that is, states of affairs in which action by rational and self-interested private actors is collectively self-defeating. I then argue for two additional types of policy problems. First, since the goal of government action is the construction of a just legal order, not merely an efficient one, states of affairs which are unjust constitute an additional type of policy problem. Relatedly, second, whereas analyses of collective action problems typically presuppose the existence of effective government institutions which can address them, such institutions may be deficient and/or unjust. A third type of policy problem is therefore deficient government institutions. -/- . (shrink)

Journal of Political Philosophy, EarlyView.

Government agencies and nonprofit organizations have increasingly turned to randomized controlled trials (RCTs) to evaluate public policy interventions. Random assignment is widely understood to be fair when there is equipoise; however, some scholars and practitioners argue that random assignment is also permissible when an intervention is reasonably expected to be superior to other trial arms. For example, some argue that random assignment to such an intervention is fair when the intervention is scarce, for it is sometimes fair to use a (...) lottery to allocate scarce goods. We investigate the permissibility of randomization in public policy RCTs when there is no equipoise, identifying two sets of conditions under which it is fair to allocate access to a superior intervention via random assignment. We also reject oft-made claims that alternative study designs, including stepped-wedge designs and uneven randomization, offer fair ways to allocate beneficial interventions. (shrink)

Governments often aim to improve children’s wellbeing by targeting the decision-making of their parents. In this paper, I explore this phenomenon, providing an ethical evaluation of the ways in which governments target parental decision-making in the context of anti-poverty policies. I first introduce and motivate the concept of parent-targeted paternalism to categorize such policies. I then investigate whether parent-targeted paternalism is ever pro tanto wrong, arguing that it is when directed at parents who meet a threshold of parental competency. I (...) next explore the factors that affect the degree of pro tanto wrongness of paternalistic anti-poverty policies targeting parents, and provide an account of the conditions under which such policies are on balance permissible, and when they are not. Finally, I illustrate the plausibility and usefulness of my framework by considering a case. (shrink)

The field of public policy is dominated by the social sciences. Schools and departments of public policy and public administration are largely populated by economists, political scientists, and sociologists, and the vast majority of work in prestigious public policy journals employs empirical methods. This is unsurprising, in one respect, for collecting data, predicting and identifying the causal impacts of policies, and understanding political institutions and processes are massive, important tasks that require the tools of the social sciences. It is surprising, (...) in another respect however, since much policy scholarship and analysis aspires to offer recommendations to policymakers, and recommendations necessarily involve evaluative judgments, for example, that the status quo is deficient and that a certain course of action will make things better. To defend such judgments, policy scholars and analysts cannot appeal to the social sciences alone for these judgments concern the realm of values, not facts. Instead, careful ethical reflection and analysis is required. This need for ethical reflection in public policy is particularly evident in the practice of policy analysis, a principal analytic tool of the field. Policy analyses involve the identification of policy problems, the specification of criteria for evaluating possible solutions, and the recommendation that a policy option offers the best balance of trade offs. This identification of bads, the specification of goods policies should realize, and the weighing of these goods with the judgment that policymakers should or ought to pursue this course of action or that, are all deeply ethical activities. Ethical reflection and analysis is thus a constituent feature of policy analysis, and like the amassing of evidence and projection of outcomes, this reflection and analysis may be performed well or badly. The overall aim of this book is to provide students, scholars, and practitioners of public policy with guidance regarding the ethical dimensions of policy analysis. My aim in this chapter is to set the stage, providing an overview of these dimensions. After providing a brief overview of the practice of policy analysis, I identify the steps of an analysis where analysts must make ethical judgments in order to move forward, and fully articulate the ethical questions they must confront and take a position on. (shrink)

Governments are increasingly making use of field experiments to evaluate policy interventions in the spheres of education, public health and welfare. However, the research ethics literature is largely focused on the clinical context, leaving investigators, institutional review boards and government agencies with few resources to draw on to address the ethical questions they face regarding such experiments. In this article, we aim to help address this problem, investigating the conditions under which informed consent is required for ethical policy research conducted (...) or authorized by government. We argue that investigators need not secure participants' informed consent when conducting government policy experiments if: the government institution conducting or authorizing the experiment possesses a right to rule over the spheres of policy targeted by the research; and data collection does not involve the violation of participants' autonomy rights. (shrink)

The federal system for allocating donated livers in the United States is often criticized for allowing geographic disparities in access to livers. Critics argue that such disparities are unfair on the grounds that where one lives is morally arbitrary and so should not influence one's access to donated livers. They argue instead that livers should be allocated in accordance with the equal opportunity principle, according to which US residents who are equally sick should have the same opportunity to receive a (...) liver, regardless of where they live. In this paper, we examine a central premise of the argument for the equal opportunity principle, namely, that geographic location is a morally arbitrary basis for allocating livers. We raise some serious doubts regarding the truth of this premise, arguing that under certain conditions, factors closely associated with geographic location are relevant to the allocation of livers, and so that candidates' geographic location is sometimes a morally non-arbitrary basis for allocating livers. Geographic location is morally non-arbitrary, we suggest, since by taking it into account, the UNOS may better fulfill its central goals of facilitating the effective and efficient placement of organs for transplantation and increasing organ donation. (shrink)

Social scientists and research ethicists have begun, somewhat belatedly, to confront and address the ethical challenges raised by public policy experiments. In doing so however, they have not fully availed themselves of the large and sophisticated literature on the ethics of clinical research which has developed over the past 40 years. While clinical and public policy research are different, I argue that the clinical research ethics literature yields valuable insights for discussions of the ethics of policy experiments. Focusing on seven (...) ethical issues which have received a good deal of attention in public and scholarly discussions of the ethics of policy experiments, I make use of the history of reflection on the ethics of clinical research to provide guidance to researchers planning and conducting policy experiments. (shrink)

In this chapter, we provide an overview of the ethical considerations relevant to the use of nudges in organ donation policy. We do not defend a position on the permissibility of nudging in this context, but instead aim to clearly outline the strongest arguments on the different sides of this issue that have been presented in the English-language scholarly bioethics literature. We also highlight the questions that are in need of further investigation. In part 1, we briefly discuss nudging before (...) considering proposals to use nudges to increase the number of registered organ donors, including opt-out donor registration systems and the use of “nudge statements.” In part 2, we discuss the use of nudges to influence the decision-making of family members in circumstances where they have a veto over the donation of their loved one’s organs. (shrink)

This chapter provides a critical overview and interpretation of fair subject selection in clinical and social scientific research. It first provides an analytical framework for thinking about the problem of fair subject selection. It then argues that fair subject selection is best understood as a set of four subprinciples, each with normative force and each with distinct and often conflicting implications for the selection of participants: fair inclusion, fair burden sharing, fair opportunity, and fair distribution of third-party risks. It then (...) defends an approach to navigating the conflicting imperatives of these subprinciples, one which privileges the need to include epistemically distinct groups in research, before concluding by considering the most pressing research questions regarding fair subject selection. (shrink)

The principal goal of Alex John London's For the Common Good is to "articulate a new vision for the philosophical foundations of research ethics" which "moves issues of justice from the periphery of the field to the very center." At the core of this new vision is an understanding of research as a "collaborative social activity between free and equal persons," which aims to develop the knowledge public institutions require to establish and maintain a social order in which people may (...) set and pursue their plans of life. Clinical and social scientific research are not therefore morally optional activities, in London's view, but rather the way public institutions acquire the knowledge they... (shrink)