Matthew McCoy

From aggressive billing practices to neglectful or discriminatory care, news stories about the misconduct of healthcare organizations abound. Yet there has been limited ethical scrutiny of hospitals and other healthcare organizations in the bioethics literature. In this paper, we explore what philosophy and organizational theory can offer in terms of concepts for articulating the obligations of healthcare organizations, specifically hospitals. We highlight how the concepts of institutional agency and responsibility, administrative harms and burdens, and communicative blame provide theoretical resources that can help bioethics get closer to a more robust organizational ethics. We advance two claims: first, these concepts help us make sense of how hospitals or healthcare organizations—not just individuals and the broader systems they operate within—can be morally responsible or blameworthy. Second, critical reflection on these concepts as they apply to several historical examples suggest some prima facie obligations of organizations that provide patient care.

Recent years have seen growing enthusiasm for public engagement in priority-setting. But despite this widespread support, there remains uncertainty both about the precise benefits of public engagement in priority-setting and about how public engagement activities should be structured in order to realize those benefits. The authors aim to move beyond generalizations about the value of public engagement by presenting several distinct rationales for engaging the public in priority-setting. The authors illustrate how these rationales can be achieved in practice using the case study of directly observed therapy for tuberculosis. They then highlight a number of practical challenges involved in implementing engagement activities and offer advice for addressing them. The chapter pays particular attention to challenges that arise in low- and middle-income countries, where efforts to engage the public face unique structural barriers.

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.

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.

Background A number of patient organizations have recently embraced venture philanthropy, a model of patient advocacy that purports to use practices from venture capitalism in pursuit of philanthropic goals. However, a clear understanding of what venture philanthropy entails and what these organizations do remains elusive, hindering efforts to assess ethical implications of the model’s growth.Methods We conducted a qualitative content analysis of self-reported profiles of 130 organizations in an affinity network promoting principles of venture philanthropy. We analyzed organizations’ research goals, funding strategies, activities, and patient engagement efforts.Results Despite finding substantial variation in age, revenue, and disease focus, we identified shared assumptions and approaches that represent defining characteristics of venture philanthropy. First, organizations consistently present facilitating the development of new therapies as the most urgent need for patients. Second, organizations participate in financing and managing research across the development pipeline, rather than focusing on basic research as many patient organizations historically have done. Third, organizations seek to position themselves within established research and drug development networks, fostering collaborative relationships with key stakeholders, including pharmaceutical companies. We also find that some of the most transformative practices associated with venture philanthropy, such as direct investment in for-profit companies, remain relatively uncommon.Conclusions Venture philanthropy represents an evolution in the ambitions and activities of patient organizations, with organizations becoming more fully enmeshed in the drug development process. Our findings raise ethical questions about how patient organizations conceptualize and advance patient interests and about tradeoffs inherent to the venture philanthropy model.

Patient organisations aim to advance the interests of patient populations living with various diseases, disabilities and health conditions. However, because the members of a given patient population often have varied or even conflicting interests, the way in which a patient organisation pursues its mission can be contentious, as it typically involves prioritising the interests of some patients over others. There is some evidence to suggest that in recent years, patient organisations have increasingly directed resources toward supporting research, a trend that may be spurred by the rise of venture philanthropy—an emerging model in which patient organisations make high-risk, high-reward research investments with the goal of advancing treatments and cures. While venture philanthropy has garnered significant support, it has also faced criticism from patients currently living with serious illnesses, who argue that research investments benefit future patients at the expense of services for current patients. Against the backdrop of these developments, this paper investigates the ethics of patient organisations pursuing cures over care. I begin by identifying a key assumption shared by proponents and critics of venture philanthropy, which suggests that patient organisations can permissibly choose whether they aim to benefit current or future patients. Yet I go on to argue that even if patient organisations may permissibly prioritise future patients, their promissory, stewardship and representative obligations may, under some circumstances, limit their discretion to invest in research. Under other circumstances, however, these same obligations may give patient organisations reasons to prioritise research.

It is increasingly common for bioethicists to consult with the public to solicit their judgments and attitudes about ethical questions and issues, especially ones that arise with new and emerging technologies. However, it is not always clear what the purpose of this engagement is or ought to be: do bioethicists seek the input of the public to help them arrive at a morally correct justified policy position, or do they seek this input to help them shape and frame their already-established moral position, or something else entirely? In this essay, we discuss four distinct possible functions of collecting moral judgments from the public: issue spotting, messaging for adherence and social stability, substantive moral guidance, and procedural fairness. For each function, we offer core examples from the literature before discussing the strengths and weaknesses attendant to each. We conclude with several preliminary questions bioethicists can ask themselves to clarify their own purpose for soliciting moral judgments from the public.

Preventing and addressing research misconduct demands more than imploring scientists to do better. It is also essential to address the structural issues that allow misconduct to flourish. With these structural factors in mind, this Special Issue explores the institutional obligations of journals and publishers, research institutions, funders, and the government to promote scientific integrity and advance trust in science. Articles from researchers affected by fraud, science “sleuths,” systematic reviewers, journal editors, academic officials, regulators, and leading experts on research integrity offer a range of ideas for responding to the research misconduct crisis, including increased transparency, stronger journal processes for review and retraction, improved scientific lab culture, and efforts to hold investigators prospectively accountable for scientific integrity, among several others.

Population-level biomedical research offers new opportunities to improve population health, but also raises new challenges to traditional systems of research governance and ethical oversight. Partly in response to these challenges, various models of public involvement in research are being introduced. Yet, the ways in which public involvement should meet governance challenges are not well understood. We conducted a qualitative study with 36 experts and stakeholders using the World Café method to identify key governance challenges and explore how public involvement can meet these challenges. This brief report discusses four cross-cutting themes from the study: the need to move beyond individual consent; issues in benefit and data sharing; the challenge of delineating and understanding publics; and the goal of clarifying justifications for public involvement. The report aims to provide a starting point for making sense of the relationship between public involvement and the governance of population-level biomedical research, showing connections, potential solutions and issues arising at their intersection. We suggest that, in population-level biomedical research, there is a pressing need for a shift away from conventional governance frameworks focused on the individual and towards a focus on collectives, as well as to foreground ethical issues around social justice and develop ways to address cultural diversity, value pluralism and competing stakeholder interests. There are many unresolved questions around how this shift could be realised, but these unresolved questions should form the basis for developing justificatory accounts and frameworks for suitable collective models of public involvement in population-level biomedical research governance.

It has become increasingly difficult for individuals to exercise meaningful control over the personal data they disclose to companies or to understand and track the ways in which that data is exchanged and used. These developments have led to an emerging consensus that existing privacy and data protection laws offer individuals insufficient protections against harms stemming from current data practices. However, an effective and ethically justified way forward remains elusive. To inform policy in this area, we propose the Ethical Data Practices framework. The framework outlines six principles relevant to the collection and use of personal data—minimizing harm, fairly distributing benefits and burdens, respecting autonomy, transparency, accountability, and inclusion—and translates these principles into action-guiding practical imperatives for companies that process personal data. In addition to informing policy, the practical imperatives can be voluntarily adopted by companies to promote ethical data practices.

Patient and public involvement (PPI) has gained widespread support in health research and health policy circles, but there is little consensus on the precise meaning or justifications of PPI. We argue that an important step towards clarifying the meaning and justification for PPI is to split apart the familiar acronym and draw a distinction between patient and public involvement. Specifically, we argue that patient involvement should refer to the practice of involving individuals in health research or policy on the basis of their experience with a particular condition, while public involvement should refer to the practice of involving individuals in health policy or research based on their status as members of a relevant population. Analyzing cases from the UK, Australia, and the USA, we show how our proposed distinction can deliver much needed clarity to conversations on PPI, while guiding the development and evaluation of future PPI‐based policies.

Biomedical research funding bodies across Europe and North America increasingly encourage—and, in some cases, require—investigators to involve members of the public in funded research. Yet there remains a striking lack of clarity about what ‘good’ or ‘successful’ public involvement looks like. In an effort to provide guidance to investigators and research organisations, representatives of several key research funding bodies in the UK recently came together to develop the National Standards for Public Involvement in Research. The Standards have critical implications for the future of biomedical research in the UK and in other countries as researchers and funders abroad look to the Standards as a model for their own policy development. We assess the Standards and find that despite offering useful suggestions for dealing with practical challenges associated with public involvement, the Standards fail to address fundamental questions about when, why and with whom public involvement should be undertaken in the first place. We show that presented without this justificatory context, many of the recommendations in the Standards are, at best, fragments that require substantial elaboration by those looking to apply the Standards in their own work and, at worst, subject to potentially harmful misapplication by well-meaning investigators. As funding bodies increasingly push for public involvement in research, the key lesson of our analysis is that future recommendations about how public involvement should be conducted cannot be coherently formulated without a clear sense of the underlying goals and rationales for public involvement.

To ensure that the information resulting from research is relevant to patients, the Patient‐Centered Outcomes Research Institute eschews the “traditional health research” paradigm, in which investigators drive all aspects of research, in favor of one in which patients assume the role of research partner. If we accept the premise that patient engagement can offer fresh perspectives that shape research in valuable ways, then at least two important sets of questions present themselves. First, how are patients being engaged—and how should they be engaged? Second, which patients are being engaged—and which patients should be? This set has received relatively less attention, and the neglect is surprising, given that the “who” question is conceptually prior to the question of “how.”This article focuses attention on the “who” of patient engagement in research. First, we provide background on the rationale for patient engagement, underscoring the importance of ensuring the representativeness of engaged patients. Second, we present what little is known about patients engaged in PCORI‐funded research. Third, we identify and discuss the ethical implications of ways in which current practices of patient identification and recruitment may lead to a lack of representativeness. These practices include reliance on the well‐connected and well‐informed, reliance on patients who are not well trained or well‐informed, and reliance on patient advocacy organizations. Finally, we consider several strategies for addressing these pitfalls in order to maximize the positive goals of patient engagement. Patient engagement is intended to address the inability of researchers, funders, and others to fully represent patient views and priorities, but without sufficient attention, the patients selected for this role may still leave important gaps.

Glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide, and dual GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, such as tirzepatide, have been found to be effective for treating obesity and diabetes, significantly reducing weight and the risk or predicted risk of adverse cardiovascular events. There is a global shortage of these medications that could last several years and raises questions about how limited supplies should be allocated. We propose a fair-allocation framework that enables evaluation of the ethics of current practices and could guide governments, professional societies, and physicians in allocation decisions.

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.