Douglas MacKay

National and international agencies and organizations are currently considering which ethical principles should inform the governance and use of heritable and non-heritable human genome editing. In this paper, we consider the prevalence principle, according to which heritable and non-heritable genome editing in humans is permissible if and only if it involves the conversion of variants to ones expected to produce traits that are prevalent in the relevant population. This principle thus permits genome editing targeting variants responsible for disease and disability but prohibits genetic enhancement. We consider whether the prevalence principle is supported by considerations of egalitarian justice, as its proponents claim. We argue that it is not and that prominent theories of egalitarian justice instead offer different approaches to genome editing governance. We identify four egalitarian principles policymakers should consider when crafting anticipatory guidance for heritable and non-heritable genome editing.

ABSTRACT The problem of standard‐of‐care in clinical research concerns the level of care that investigators ought to provide to research subjects in the control arm of their clinical trials. Commentators differ sharply on whether subjects in trials conducted in lower income countries should be provided with the same level of care as subjects in trials conducted in higher income countries. I consider an argument that commentators have employed on both sides of this debate: professional role arguments. These arguments claim to justify a conclusion to the standard‐of‐care problem solely by appeal to the professional obligations that investigators possess. I argue that prominent versions of professional role arguments cannot justify a solution to the problem of standard‐of‐care that is both determinate and reasonable simply by appeal to the professional obligations of investigators. Instead, to do so, one must also (1) determine the level of care or types of treatment that individuals are entitled to as a matter of distributive justice, and (2) identify which agents possess the duties that correspond to these entitlements. The level of care that investigators owe to subjects in the control arm of their clinical trials is thus in part dependent on the level of care that these subjects are entitled to as a matter of distributive justice, and whether it is the investigators who possess the corresponding distributive obligation to provide them with the care that they are entitled to.

Seth A. Berkowitz’s Equal Care: Health Equity, Social Democracy, and the Egalitarian State is a book about public policy, written by a primary care physician at once amazed by the medical technologies available to some patients in the contemporary United States but also deeply frustrated by people’s lack of access to the basic social conditions they need to be healthy—nutritious food, safe housing, and an adequate income, among others. Equal Care offers a normatively defensible and empirically informed blueprint for addressing these drastic health inequities. In Berkowitz’s (2024, 3) vision, health equity is achieved when governments fulfill their “duty of equal care” to all over whom they rule, establishing... Read More.

Ethical and legal expertise can usefully inform policy decisions about the public display of wastewater monitoring data. These decisions can sometimes involve conflicts between ethical values: for instance, public display of wastewater surveillance data may promote good governance and enable the public to better protect their health, but also raises privacy concerns and the possibility of stigmatization. In this Essay, we propose an ethics framework for considering whether and how to display information about pathogens detected in wastewater to the public. We then apply that framework to specific examples.

While somatic cell editing to treat disease is widely accepted, the use of human genome editing for “enhancement” remains contested. Scientists and policy-makers routinely cite the prospect of enhancement as a salient ethical challenge for human genome editing research. If preventive genome editing projects are perceived as pursuing human enhancement, they could face heightened barriers to scientific, public, and regulatory approval. This article outlines what we call “preventive strengthening research” (or “PSR”) to explore, through this example, how working to strengthen individuals’ resistance to disease beyond what biomedicine considers to be the human functional range may be interpreted as pursuing human enhancement. Those involved in developing guidance for PSR will need to navigate the interface between preventive goals and enhancement implications. This article identifies and critiques three of these ideas in the interest of anticipating the wider emergence of PSR and the need for a normative approach for its pursuit. All three “candidate criteria” merit attention, but each also faces challenges that will need to be addressed as further research policy is developed.

According to the norm of policy equipoise, it is permissible to randomly assign participants to two or more interventions in a public policy randomized controlled trial (RCT) when there is meaningful uncertainty among the relevant expert community regarding which intervention is superior. While this norm is gaining traction in the research ethics literature, the idea of interventional superiority remains unclear. Is one intervention superior to another if it is reasonably expected to realize one outcome of interest more effectively, even though there is uncertainty regarding other outcomes of interest? Or must an intervention be reasonably expected to realize all outcomes of interest more effectively? I address this question in this paper. My aim is to develop and defend an account of interventional superiority for policy RCTs that are authorized, funded, or conducted by government institutions. I defend the greatest value view, according to which one intervention is superior to another if and only if it is reasonably expected to more effectively realize a set of outcomes with greater value.

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.

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.

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.

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.

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.

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.

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.

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...

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.

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.

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Hospital systems commonly face the challenge of determining just ways to allocate scarce drugs during national shortages. There is no standardised approach of how this should be instituted, but principles of distributive justice are commonly used so that patients who are most likely to benefit from the drug receive it. As a result, clinical indications, in which the evidence for the drug is assumed to be established, are often prioritised over research use. In this manuscript, we present a case of a phase II investigational trial of intravenous thiamine for delirium prevention in patients undergoing haematopoietic stem cell transplantation to emphasise several shortcomings in the overarching prioritisation of clinical over research uses of scarce drugs. Specifically, we present the following considerations: (1) clinical use may not have stronger evidence than research use; (2) a strong scientific rationale for research use may outweigh the claim for clinical indications in which there is weak evidence; (3) treatment within the context of a clinical trial may be the standard of care; and (4) research use may not only benefit patients receiving the treatment but also offers the prospect of improving future clinical care. In summary, we argue against allocation schemes that prohibit all research uses of scarce drugs and instead recommend that allocation schemes include a balanced approach that weighs risks and benefits of access to scarce drugs irrespective of the research versus clinical use designation.

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.

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.

Controlled human infection (CHI) studies involve the deliberate exposure of healthy research participants to infectious agents to study early disease processes and evaluate interventions under controlled conditions with high efficiency. Although CHI studies expose participants to the risk of infection, they are designed to offer investigators unique advantages for studying the pathogenesis of infectious diseases and testing potential vaccines or treatments in humans. One of the central challenges facing investigators involves the fair selection of research subjects to participate in CHI studies. While there is widespread agreement that investigators have a duty to select research participants fairly, this principle also yields conflicting ethical imperatives, for example requiring investigators to both exclude potential participants with co‐morbidities since they face increased risks, but also to include them in order to ensure generalizability. In this paper we defend an account of fair subject selection that is tailored to the context of CHI studies. We identify the considerations of fairness that bear directly on selecting participants for CHI studies and provide investigators and members of IRBs and RECs with a principled way to navigate the conflicting imperatives to which these considerations give rise.

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.

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

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...

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.