"The Bush administration and Congress are in concert on the goal of developing a fleet of unmanned aircraft that can reduce both defense costs and aircrew losses in combat by taking on at least the most dangerous combat missions. Unmanned combat aerial vehicles (UCAVs) will be neither inexpensive enough to be readily expendable nor-- at least in early development-- capable of performing every combat mission alongside or in lieu of manned sorties. Yet the tremendous potential of such systems is (...) widely recognized, and allies as well as potential adversaries are moving quickly to mount their own research and development programs. The United States is committed to fielding UCAV capabilities by 2010, principally for the missions of suppression of enemy air defense and deep strike, which are among the highest risk tasks for the Air Force and naval aviation."--Overview. (shrink)

Health systems research is widely identified as an indispensable means to achieve the goal of health equity between and within countries. Numerous health systems research consortia comprised of institutions from high-income countries and low and middle-income countries are currently undertaking programs of research in LMICs. These partnerships differ from collaborations that carry out single projects in the multiplicity of their goals, scope of their activities, and nature of their management. Recent conceptual work has explored what (...) features might be necessary for health systems research consortia and their research programs to promote health equity. Identified features include selecting research priorities that focus on improving access to high-quality health services and/or financial protection for disadvantaged populations in LMICs and conducting research capacity strengthening that promotes the independent conduct of health systems research in LMICs. Yet, there has been no attempt to investigate whether existing consortia have such characteristics. This paper describes the results of a survey undertaken with health systems research consortia leaders worldwide to assess how consistent current practice is with the proposed ethical guidance. The findings suggest that consortia may be fairly well organised to promote health equity, but have scope for improvement, particularly in terms of achieving inclusive priority-setting. (shrink)

To give substance to the rhetoric of ‘learning health systems’, a variety of novel trial designs are being explored to more seamlessly integrate research with medical practice, reduce study duration and reduce the number of participants allocated to ineffective interventions. Many of these designs rely on response adaptive randomisation. However, critics charge that RAR is unethical on the grounds that it violates the principle of equipoise. In this paper, I reconstruct critiques of RAR as holding that it is (...) inconsistent with five important ethical principles. I then argue that these criticisms rest on a faulty view of equipoise encouraged by the idea that a RAR study models the beliefs of a single rational agent about the relative merits of the interventions being studied. I outline a view in which RAR models an idealised health system in which diverse communities of fully informed experts shrink or grow as their constituent members update their expert opinions in light of reliable medical evidence. I show how a proper understanding of clinical equipoise can reconcile this conception of RAR with these five ethical principles. This analysis removes an in-principle objection to RAR and sheds important light on the relationship between clinical equipoise and transient diversity in the scientific community. (shrink)

Although moral distress is now a well-recognized phenomenon among all of the healthcare professions, few evidence-based strategies have been published to address it. In morally distressing situations, the “presenting problem” may be a particular patient situation, but most often signals a deeper unit- or system-centered issue. This article describes one institution’s ongoing effort to address moral distress in its providers. We discuss the development and evaluation of the Moral Distress Consultation Service, an interprofessional, unit/system-oriented approach to addressing and ameliorating moral (...) distress. (shrink)

In this paper, we analyse the most important documents establishing the criteria for the treatment and exclusion of COVID-19 patients, especially in regard to the giving of respiratory support, in Italy and Spain. These documents reflect a tension that stems from limited healthcare resources which are insufficient to save lives that, under normal conditions, could have been saved, or at least could have received the best possible treatment. First, we analyse the healthcare systems of these two countries before the (...) spread of the virus, both of which have seen decreases in the number of intensive care beds and have been marked by financial cuts during the last ten years. It is a fact that a greater number of people, especially those over 70 years of age, have been left without respiratory support treatment, and therefore, there have been a greater number of deaths. It is also a fact that there has been a higher infection rate among healthcare professionals due to the delay in the management of protective measures and the inability to provide adequate care for those in nursing homes, as recognised by WHO. In the context of this health emergency, healthcare professionals have suffered a real ‘moral distress’ because, knowing first-hand the causes of the limitation of resources, they have had to put triage protocols into practice. Finally, we set forth a series of concrete ethical proposals with which to face the successive waves of COVID-19 infection, as well as other future pandemics. (shrink)

Departing from theories of distributive justice and their relation with the distribution of health care within society, especially egalitarianism and libertarianism, this paper aims at demonstrating that the approach taken by the European Court of Justice regarding the application of the Internal Market principles (or the market freedoms) to the field of health care services has introduced new values which are more concerned with a libertarian view of health care. Moreover, the paper also addresses the question of (...) how these new values introduced by the Court may affect common principles of European health systems, such as equity and accessibility. (shrink)

There is increasing consensus that the right to health can provide ethical, policy and practical groundings for health systems development. The goals of the right to health are congruent with those of health systems development, which are about strengthening health promotion organizations and actions so as to improve public health. The poor shape and performance of health systems in Chad question the extent of realization of the right to health. (...) Due to its comprehensiveness and inclusiveness, the right to health has the potential of being an organizational and a normative backbone for public health policy and practice. It can then be understood and studied as an integral component of health systems development. (shrink)

Quality improvement is an important function of learning health systems, and public policy should promote QI activities. Use of systematic methodologies in QI has prompted substantial confusion regarding when QI is human subjects research under the Common Rule, and this confusion persists with the revised Rule. Difficulty distinguishing research from QI imposes costs on the quality improvement process. I offer guidance to IRBs to mitigate these costs and suggest a new regulatory exclusion for minimal risk quality improvement activities.

This paper discusses health policy and systems research in complex and rapidly changing contexts. It focuses on ethical issues at stake for researchers working with government policy makers to provide evidence to inform major health systems change at scale, particularly when the dynamic nature of the context and ongoing challenges to the health system can result in unpredictable outcomes. We focus on situations where ‘country ownership’ of HSR is relatively well established and where there is (...) significant involvement of local researchers and close ties and relationships with policy makers are often present. We frame our discussion around two country case studies with which we are familiar, namely China and South Africa and discuss the implications for conducting ‘embedded’ research. We suggest that reflexivity is an important concept for health system researchers who need to think carefully about positionality and their normative stance and to use such reflection to ensure that they can negotiate to retain autonomy, whilst also contributing evidence for health system change. A research process informed by the notion of reflexive practice and iterative learning will require a longitudinal review at key points in the research timeline. Such review should include the convening of a deliberative process and should involve a range of stakeholders, including those most likely to be affected by the intended and unintended consequences of change. (shrink)

The growing importance of health systems research has opened debate about appropriate ethical frameworks and guidelines for the ethical review and conduct of health systems research. In this article we consider a detailed proposal from Hyder et al. and consider it in relation to the conventional criteria for ethics review of clinical research outlined by Emanuel et al. and argue that the Emanuel criteria can be usefully applied to the review of health systems research (...) to supplement the Hyder et al. proposals. We argue further that health systems researchers and reviewers would benefit from many of the debates that have characterized the ethics of clinical research over the past three decades. (shrink)

Departing from theories of distributive justice and their relation with the distribution of health care within society, especially egalitarianism and libertarianism, this paper aims at demonstrating that the approach taken by the European Court of Justice regarding the application of the Internal Market principles (or the market freedoms) to the field of health care services has introduced new values which are more concerned with a libertarian view of health care. Moreover, the paper also addresses the question of (...) how these new values introduced by the Court may affect common principles of European health systems, such as equity and accessibility. (shrink)

Currently, health systems research is reviewed by the same ethical standards as clinical research, which has recently been argued in the literature to be an inappropriate standard of evaluation. The issues unique to HSR warrant a different review by research ethics committees, as it does not impose the same risks to study participants as other types of clinical or public health research. However, there are limited tools and supporting documents that clarify the ethical considerations. Therefore, there is (...) a need for additional reflection around ethical review of HSR and their consideration by RECs. The purpose of this paper is to review, understand, and synthesize the current state of literature and practice to inform these deliberations and the larger discourse on ethics review guidelines for HSR. This paper presents a review of the literature on ethics of HSR in the biomedical, public health, and implementation research to identify ethical considerations specific to HSR; and to identify examples of commonly available guidance and/or tools for the ethical review of HSR studies. Fifteen articles were identified on HSR ethics issues, and forty-two international academic institutions were contacted, no institution had special ethical guidelines for reviewing HSR) about their HSR ethics review guidelines. There appears to be a clear gap in the current health research ethics discourse around health systems research ethics. This review serves as a first step towards a larger dialogue on the topic. (shrink)

The ethical concept of responsiveness has largely been interpreted in the context of international clinical research. In light of the increasing conduct of externally funded health systems research in low- and middle-income countries, this article examines how responsiveness might be understood for such research and how it can be applied. It contends that four features set HSR in LMICs apart from international clinical research: a focus on systems; being context-driven; being policy-driven; and being closely linked to development (...) objectives. These features support reinterpreting responsiveness for HSR in LMICs as responsiveness to systems needs, where health system performance assessments can be relied upon to identify systems needs, and/or responsiveness to systems priorities, which entails aligning research with HSR priorities set through country-owned processes involving national and sub-national policymakers from host countries. Both concepts may be difficult to achieve in practice. Country ownership is not an established fact for many countries and alignment to their priorities may be meaningless without it. It is argued that more work is, therefore, needed to identify strategies for how the responsiveness requirement can be ethically fulfilled for HSR in LMICs under non-ideal conditions such as where host countries have not set HSR priorities via country-owned processes. Embeddedness is proposed as one approach that could be the focus of further development. (shrink)

Given that health systems research involves different aims, approaches, and methodologies as compared to more traditional clinical trials, the ethical issues present in HSR may be unique or particularly nuanced. This article outlines eight pertinent ethical issues that are particularly salient in HSR and argues that the ethical review process should be better tailored to ensure more efficient and appropriate oversight of HSR with adequate human protections, especially in low- and middle-income countries. The eight ethical areas we discuss (...) include the nature of intervention, types of research subjects, units of intervention and observation, informed consent, controls and comparisons, risk assessment, inclusion of vulnerable groups, and benefits of research. HSR involving human participants is necessary to ensure health systems strengthening and quality of care and to guide public policy intelligently. Health systems researchers must carefully define their intent and goals and openly clarify the values that may influence the premises and design of protocols. As new types of population-level research activities become more commonplace, it is critical that institutional review board and research ethics committee review processes evolve to evaluate these research protocols in ways that address the nuanced features of these studies. (shrink)

Hastings Center Report, Volume 52, Issue 3, Page 2-2, May–June 2022.

COVID-19 continues to spread across the globe at an exponential speed, infecting millions and overwhelming even the most prepared healthcare systems. Concerns are looming that the healthcare systems in low- and middle-income countries are mostly unprepared to combat the virus because of limited resources. The problems in LMICs are exacerbated by the fact that citizens in these countries generally exhibit low trust in the healthcare system because of its low quality, which could trigger a number of uncooperative behaviors. (...) In this paper, we focus on one such behavior and investigate the relationship between trust in the healthcare system and the probability of potential treatment-seeking behavior upon the appearance of the first symptoms of COVID-19. First, we provide motivating evidence from a unique national online survey administered in Armenia–a post-Soviet LMIC country. We then present results from a large-scale survey experiment in Armenia that provides causal evidence supporting the investigated relationship. Our main finding is that a more trustworthy healthcare system enhances the probability of potential treatment-seeking behavior when observing the initial symptoms. (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)

The Catholic moral tradition has a rich foundation that applies broadly to encompass all areas of human experience. Yet, there is comparatively little in Catholic thought on the ethics of the collection and use of data, especially in healthcare. We provide here a brief overview of terminology, concepts, and applications of data in the context of healthcare, summarize relevant theological principles and themes (including the Vatican’s Rome Call for AI Ethics), and offer key questions for ethicists and data managers to (...) consider as they analyze ethical implications pertinent to data governance and data management. (shrink)

In 2018-2019, at the Keck School of Medicine of the University of Southern California, we developed and piloted a narrative-based health systems science intervention for patients living with HIV and medical students in which medical students co-wrote patients’ life narratives for inclusion in the electronic health record. The pilot study aimed to assess the acceptability of the “life narrative protocol” from multiple stakeholder positions and characterize participants’ experiences of the clinical and pedagogical implications of the LNP. Students (...) were recruited from KSOM. Patients and staff were recruited from the Maternal, Child, and Adolescent/Adult Center for Infectious Disease and Virology at Los Angeles County+USC Medical Center. Ten patients, seventeen students, and ten MCA staff participated in the pilot study. Qualitative methods were used to gather data from students’, patients’, and staff’s perspectives. Three themes emerged from the thematic analysis: patients’ life narratives conveyed their unique life experiences and voices; the protocol could result in wide-ranging effects on HIV care; the LNP enabled students to contribute value to patients’ healthcare. Across groups, participants considered the LNP an acceptable intervention. The LNP, its limitations, and implications for HIV care, narrative medicine, and health information technology are presented. (shrink)

Given that health systems research involves different aims, approaches, and methodologies as compared to more traditional clinical trials, the ethical issues present in HSR may be unique or particularly nuanced. This article outlines eight pertinent ethical issues that are particularly salient in HSR and argues that the ethical review process should be better tailored to ensure more efficient and appropriate oversight of HSR with adequate human protections, especially in low- and middle-income countries. The eight ethical areas we discuss (...) include the nature of intervention, types of research subjects, units of intervention and observation, informed consent, controls and comparisons, risk assessment, inclusion of vulnerable groups, and benefits of research. HSR involving human participants is necessary to ensure health systems strengthening and quality of care and to guide public policy intelligently. Health systems researchers must carefully define their intent and goals and openly clarify the values that may influence the premises and design of protocols. As new types of population-level research activities become more commonplace, it is critical that institutional review board and research ethics committee review processes evolve to evaluate these research protocols in ways that address the nuanced features of these studies. (shrink)

Fair allocation of scarce healthcare resources has been much studied within philosophy and bioethics, but analysis has focused on a narrow range of cases. The Covid-19 pandemic provided significant new challenges, making powerfully visible the extent to which health systems can be fragile, and how scarcities within crucial elements of interlinked care pathways can lead to cascading failures. Health system resilience, while previously a key topic in global health, can now be seen to be a vital (...) concern in high-income countries too. Unfortunately, mainstream philosophical approaches to the ethics of rationing and prioritisation provide little guidance for these new problems of scarcity. Indeed, the cascading failures were arguably exacerbated by earlier attempts to make health systems leaner and more efficient. This paper argues that health systems should move from simple and atomistic approaches to measuring effectiveness to approaches that are holistic both in focusing on performance at the level of the health system as a whole, and also in incorporating a wider range of ethical concerns in thinking about what makes a health system good. (shrink)

ABSTRACT Although considerable attention has been given to ethical issues related to clinical research in developing countries, in particular related to HIV therapy, there has been limited focus on health systems research, despite its increasing importance in the light of current trends in development assistance. This paper examines ethical issues related to health systems research in ‘post’‐conflict situations, addressing both generic issues for developing countries and those issues specific to ‘post’‐conflict societies, citing examples from the author’s (...) Cambodian experience. It argues that the destruction of health infrastructure results in a loss of structures and processes that would otherwise protect prospective research subjects who are part of vulnerable populations. It identifies the growth of health systems research as part of a trend towards sectoral and programmatic development assistance, the emergence of ‘knowledge generation’ as a form of research linked to development, and the potential for conflict where multilateral and bilateral donors are both primary funders and users of health systems research. It also examines the position of the health system researcher in relation to the sponsors of this research, and the health system being analysed. (shrink)

Preparations for large-scale disasters have tended to focus on triage schema, stockpiling of materials, and other logistical concerns. Less attention has been given to the myriad of distressing and almost unthinkable ethically charged dilemmas that will emerge at the bedside during a catastrophe, and how they may be best managed. Yet, it is these bedside issues that may limit or thwart the effectiveness of disaster planning, and, therefore, they ought to be carefully considered.

Preparations for large-scale disasters have tended to focus on triage schema, stockpiling of materials, and other logistical concerns. Less attention has been given to the myriad of distressing and almost unthinkable ethically charged dilemmas that will emerge at the bedside during a catastrophe, and how they may be best managed. Yet, it is these bedside issues that may limit or thwart the effectiveness of disaster planning, and, therefore, they ought to be carefully considered.

Lee suggests a conceptualization of health data sharing not merely as an act of altruism, but as a gift. The difference is important, as the inscription of the latter in a social context inv...

In many European countries, the introduction of private hospitals into predominantly public health systems has raised serious questions of distributive justice about access to care and the extent of acceptable inequalities.

This article examines the barriers to quality health care for transgender, nonbinary, and gender-expansive people (TGE) who become pregnant and give birth, identifying three central themes that emerge from the literature. These insights suggest that significant reform will be necessary to ensure access to safe, appropriate, gender-affirming care for childbearing TGE people. After illustrating the need for systemic changes that untether rigid gender norms from the provision of perinatal care, the article proposes that the Midwives Model of Care offers (...) a set of values and clinical practices that are well-suited to meet the needs of many TGE patients during pregnancy and childbirth and which should be incorporated into the healthcare system more broadly. (shrink)

International research is an essential means of reducing health disparities between and within countries and should do so as a matter of global justice. Research funders from high-income countries have an obligation of justice to support health research in low and middle-income countries that furthers such objectives. This paper investigates how their current funding schemes are designed to incentivise health systems research in LMICs that promotes health equity. Semi-structured in-depth interviews were performed with 16 grants (...) officers working for 11 funders and organisations that support health systems research: the Alliance for Health Policy and Systems Research, Comic Relief, Doris Duke Foundation, European Commission, International Development Research Centre, Norwegian Agency for Development Cooperation, Research Council of Norway, Rockefeller Foundation, UK Department of International Development, UK Medical Research Council, and Wellcome Trust. Thematic analysis of the data demonstrates their funding schemes promote health systems research with five key features that advance health equity: being conducted with worst-off populations, focusing on research topics that advance equitable health systems, having LMIC ownership of the research agenda, strengthening LMIC research capacity, and having an impact on health disparities. The different types of incentives that encouraged proposed projects to have these features are identified and classified by their strength. It is suggested that research funders ought to create and maintain funding schemes with strong incentives for the features identified above in order to more effectively help reduce global health disparities. (shrink)

The Dutch health care system is developing a two, or multiple, tier system. How can moral principles be of help in assessing whether this is the right track? Instead of dismissing as unhelpful the principles that have been suggested so far and exchanging them for other, usually more complex, principles, it is suggested that the methods of moral inquiry be reconsidered. Keywords: diversification in health care, health care financing, public and private responsibility in health care CiteULike (...) Connotea Del.icio.us What's this? (shrink)

Most current management systems of healthcare institutions correspond to a model of market ethics with its demands of competitiveness. This approach has been called managerialism and is couched in terms of much‐needed efficiencies and effective management of budgetary constraints. The aim of this study was to analyse the decision‐making of nurses through the impact of health institution management models on clinical practice. Based on Foucault's ethical theory, a qualitative study was conducted through a discourse analysis of the nursing (...) records in a hospital unit. The results revealed that the health institution standardises health care practice, which has an impact on professional and patient autonomy as it pertains to decision‐making. The results of this research indicate that resistance strategies in the internal structures of health organisations can replace the normalisation and instrumentalisation of professional practice aimed at promoting patient self‐determination. (shrink)

Obesity is a particularly vexing public health challenge, since it not only underlies much disease and health spending but also largely stems from repeated personal behavioral choices. The newly enacted comprehensive health reform law contains a number of provisions to address obesity. For example, insurance companies are required to provide coverage for preventive-health services, which include obesity screening and nutritional counseling. In addition, employers will soon be able to offer premium discounts to workers who participate in (...) wellness programs that emphasize behavioral choices. These policies presume that government intervention to reduce obesity is necessary and justified. Some people, however, argue that individuals have a compelling interest to pursue their own health and happiness as they see fit, and therefore any government intervention in these areas is an unwarranted intrusion into privacy and one's freedom to eat, drink, and exercise as much or as little as one wants. This paper clarifies the overlapping individual, employer, and social interest in each person's health generally to avoid obesity and its myriad costs in particular. The paper also explores recent evidence on the impact of government interventions on obesity through case studies on food labeling and employer-based anti-obesity interventions. Our analysis suggests a positive role for government intervention to reduce and prevent obesity. At the same time, we discuss criteria that can be used to draw lines between government, employer, and individual responsibility for health, and to derive principles that should guide and limit government interventions on obesity as health reform's various elements (e.g., exchanges, insurance market reforms) are implemented in the coming years. (shrink)

The obesity epidemic is not only impairing the health of millions of Americans but also giving rise to billions of added dollars in health care spending. Climbing rates of obesity over the past decades are one of the predominant determinants behind the surging progression of health care expenses in the United States. Moreover, the less fit and less productive U.S. workforce has gradually eroded the nation’s industrial competitiveness. Since the early 1970s, adult obesity rates have doubled and (...) childhood obesity rates have more than tripled, while health expenditures have risen two percentage points faster than the Gross Domestic Product, burgeoning from 8.8 percent in 1980 to a projected 17.9 percent in 2011. Studies analyze that greater than a quarter of America’s health care expenses are attributed to obesity. The stunning growth in obesity has been imputed for 20 to 30 percent of the increase in health care costs since the late 1970s. If the proportion of obese population had stayed unchanged, then health care expenditures in America would be approximately 10 percent less on a per capita average than they are today. (shrink)