There are competing ethical concerns when it comes to designing any clinical research study. Clinical trials of possible treatments for Ebola virus are no exception. If anything, the competing ethical concerns are exacerbated in trying to find answers to a deadly, rapidly spreading, infectious disease. The primary goal of current research is to identify experimental therapies that can cure Ebola or cure it with reasonable probability in infected individuals. Pursuit of that goal must be methodologically sound, practical and consistent with (...) prevailing norms governing human subjects research. Some maintain that only randomized controlled trials with a placebo or standard-of-care arm can meet these conditions. We maintain that there are alternative trial designs that can do so as well and that sometimes these are preferable to RCTs. (shrink)

Institute for Biomedical Ethics, Geneva University Medical School * Corresponding author: Médecins Sans Frontières (OCG), rue de Lausanne 78, CH-1211 Geneva 21, Switzerland. Tel.: +41 (0)22 849 89 29; Fax: +41 (0)22 849 84 88; Email: philippe_calain{at}hotmail.com ' + u + '@' + d + ' '//--> Abstract Outbreaks of filovirus (Ebola and Marburg) hemorrhagic fevers in Africa are typically the theater of rescue activities involving international experts and agencies tasked with reinforcing national authorities in clinical management, biological diagnosis, sanitation, (...) public health surveillance and coordination. These outbreaks can be seen as a paradigm for ethical issues posed by epidemic emergencies, through the convergence of such themes as: isolation and quarantine, privacy and confidentiality and the interpretation of ethical norms across different ethnocultural settings. With an emphasis on the boundaries between public health investigations and research, this article reviews specific challenges, past practices and current normative documents relevant to the application of ethical standards in the course of outbreaks of filovirus hemorrhagic fevers. Aside from commonly identified issues of informed consent and institutional review processes, we argue for more clarity over the specification of which communities are expected to share benefits, and we advocate for the use of collective definitions of duty to care and standard of care. We propose new elaborations around existing normative instruments, and we suggest some pathways toward more comprehensive approaches to the ethics of research in outbreak situations. CiteULike Connotea Del.icio.us What's this? (shrink)

The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary – whether on grounds of primary purpose, temporality, underlying (...) legal authority, departure from usual practice, or direct benefits to participants – have been unsatisfactory. (shrink)

The four principles approach to medical ethics plus specification is used in this paper. Specification is defined as a process of reducing the indeterminateness of general norms to give them increased action guiding capacity, while retaining the moral commitments in the original norm. Since questions of method are central to the symposium, the paper begins with four observations about method in moral reasoning and case analysis. Three of the four scenarios are dealt with. It is concluded in the “standard” Jehovah’s (...) Witness case that having autonomously chosen the authority of his religious institution, a Jehovah’s Witness has a reasonable basis on which to refuse a recommended blood transfusion. The author’s view of the child of a Jehovah’s Witness scenario is that it is morally required—not merely permitted—to overrule this parental refusal of treatment. It is argued in the selling kidneys for transplantation scenario that a fair system of regulating and monitoring would be better than the present system which the author believes to be a shameful failure. (shrink)

The exercise of identifying lessons in the aftermath of a major public health emergency is of immense importance for the improvement of global public health emergency preparedness and response. Despite the persistence of the Ebola Virus Disease outbreak in West Africa, it seems that the Ebola ‘lessons learned’ exercise is now in full swing. On our assessment, a significant shortcoming plagues recent articulations of lessons learned, particularly among those emerging from organizational reflections. In this article we argue that, despite not (...) being recognized as such, the vast majority of lessons proffered in this literature should be understood as ethical lessons stemming from moral failures, and that any improvements in future global public health emergency preparedness and response are in large part dependent on acknowledging this fact and adjusting priorities, policies and practices accordingly such that they align with values that better ensure these moral failures are not repeated and that new moral failures do not arise. We cannot continue to fiddle at the margins without critically reflecting on our repeated moral failings and committing ourselves to a set of values that engenders an approach to global public health emergencies that embodies a sense of solidarity and global justice. (shrink)

The Médecins Sans Frontières ethics review board has been solicited in an unprecedented way to provide advice and review research protocols in an ‘emergency’ mode during the recent Ebola epidemic. Twenty-seven Ebola-related study protocols were reviewed between March 2014 and August 2015, ranging from epidemiological research, to behavioural research, infectivity studies and clinical trials with investigational products at early development stages. This article examines the MSF ERB’s experience addressing issues related to both the process of review and substantive ethical issues (...) in this context. These topics include lack of policies regarding blood sample collection and use, and engaging communities regarding their storage and future use; exclusion of pregnant women from clinical and vaccine trials; and the difficulty of implementing timely and high-quality qualitative/anthropological research to consider potential upfront harms. Having noticed different standards across ethics committees, we propose that when multiple ethics reviews of clinical and vaccine trials are carried out during a public health emergency they should be accompanied by transparent communication between the ECs involved. The MSF ERB experience should trigger a broader discussion on the ‘optimal’ ethics review in an emergency outbreak and what enduring structural changes are needed to improve the ethics review process. (shrink)

Médecins Sans Frontières is one of the world’s leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper.

The notion that it is useful to specify norms progressively in order to resolve doubts about what to do, which I developed initially in a 1990 article, has been only partly assimilated by the bioethics literature. The thought is not just that it is helpful to work with relatively specific norms. It is more than that: specification can replace deductive subsumption and balancing. Here I argue against two versions of reliance on balancing that are prominent in recent bioethical discussions. Without (...) meaning to address the substance or the overall merits of either view I criticize, I attack Gert, Culver and Clouser's implicit reliance on some overall dimension of balancing as a basis of resolving conflicts among norms and Beauchamp and Childress's residual acceptance of 'justified balancing'. The former authors' description of resolving conflicts depends upon a type of value commensurability that (as they otherwise seem to admit) does not obtain, while the latter authors' role for justified balancing would be better served by continued specification. (shrink)

Since it appeared in 1971, John Rawls's A Theory of Justice has become a classic. The author has now revised the original edition to clear up a number of difficulties he and others have found in the original book. Rawls aims to express an essential part of the common core of the democratic tradition--justice as fairness--and to provide an alternative to utilitarianism, which had dominated the Anglo-Saxon tradition of political thought since the nineteenth century. Rawls substitutes the ideal of the (...) social contract as a more satisfactory account of the basic rights and liberties of citizens as free and equal persons. "Each person," writes Rawls, "possesses an inviolability founded on justice that even the welfare of society as a whole cannot override." Advancing the ideas of Rousseau, Kant, Emerson, and Lincoln, Rawls's theory is as powerful today as it was when first published. (shrink)

Medical ethical analysis remains dominated by the principlist account first proposed by Beauchamp and Childress. This paper argues that the principlist model is unreflective of how ethical decisions are taken in clinical practice. Two kinds of medical ethical decisions are distinguished: biosocial ethics and clinical ethics. It is argued that principlism is an inappropriate model for clinical ethics as it is neither sufficiently action-guiding nor does it emphasise the professional integrity of the clinician. An alternative model is proposed for decision (...) making in the realm of clinical ethics. (shrink)

Moral theory has generally focused on resolving ethical dilemmas by identifying ethically sound options. Whether the focus is on consequences, duties, principles or virtues, ethical cases are often approached in ways that assume morally sound solutions can be found and followed. Such ‘ideal morality’ assumes that moral goodness is always possible, leaving people confident they have done the right thing. Such an approach becomes inadequate in disaster settings where any good solution is often difficult to see. This paper examines recent (...) work on nonideal moral theory as a useful model for disaster bioethics. This approach views moral dilemmas as situations where no choice is ideal and every option involves some element of unavoidable wrongdoing. Rather than straining for ideal answers, this approach acknowledges that sometimes the lesser of two evils is the best that can be done. Such situations inevitably lead to feelings of regret or guilt, commonly encountered in discussions of disaster bioethics. This paper explores the practical implications of nonideal approaches for disaster responders working in tragic situations. (shrink)

In medical ethics, business ethics, and some branches of political philosophy (multi-culturalism, issues of just allocation, and equitable distribution) the literature increasingly combines insights from ethics and the social sciences. Some authors in medical ethics even speak of a new phase in the history of ethics, hailing "empirical ethics" as a logical next step in the development of practical ethics after the turn to "applied ethics." The name empirical ethics is ill-chosen because of its associations with "descriptive ethics." Unlike descriptive (...) ethics, however, empirical ethics aims to be both descriptive and normative. The first question on which I focus is what kind of empirical research is used by empirical ethics and for which purposes. I argue that the ultimate aim of all empirical ethics is to improve the context-sensitivity of ethics. The second question is whether empirical ethics is essentially connected with specific positions in meta-ethics. I show that in some kinds of meta-ethical theories, which I categorize as broad contextualist theories, there is an intrinsic need for connecting normative ethics with empirical social research. But context-sensitivity is a goal that can be aimed for from any meta-ethical position. (shrink)

Conducting research during or in the aftermath of disasters poses many specific practical and ethical challenges. This is particularly the case with research involving human subjects. The extraordinary circumstances of research conducted in disaster settings require appropriate regulations to ensure the protection of human participants. The goal of this study is to systematically and qualitatively review the existing ethical guidelines for disaster research by using the constant comparative method. We performed a systematic qualitative review of disaster research ethics guidelines to (...) collect and compare existing regulations. Guidelines were identified by a three-tiered search strategy: 1) searching databases, 2) an Internet search, and 3) a search of the references in the included documents from the first two searches. We used the constant comparative method for analysis of included guidelines. Fourteen full text guidelines were included for analysis. The included guidelines covered the period 2000-2014. Qualitative analysis of the included guidelines revealed two core themes: vulnerability and research ethics committee review. Within each of the two core themes, various categories and subcategories were identified. Some concepts and terms identified in analyzed guidelines are used in an inconsistent manner and applied in different contexts. Conceptual clarity is needed in this area as well as empirical evidence to support the statements and requirements included in analyzed guidelines. (shrink)

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

Priority setting (also known as resource allocation or rationing) occurs at every level of every health system and is one of the most significant health care policy questions of the 21st century. Because it is so prevalent and context specific, improving priority setting in a health system entails improving it in the institutions that constitute the system. But, how should this be done? Normative approaches are necessary because they help identify key values that clarify policy choices, but insufficient because different (...) approaches lead to different conclusions and there is no consensus about which ones are correct, and they are too abstract to be directly used in actual decision making. Empirical approaches are necessary because they help to identify what is being done and what can be done, but are insufficient because they cannot identify what should be done. Moreover, to be really helpful, an improvement strategy must utilize rigorous research methods that are able to analyze and capture experience so that past problems are corrected and lessons can be shared with others. Therefore, a constructive, practical and accessible improvement strategy must be research-based and combine both normative and empirical methods. In this paper we propose a research-based improvement strategy that involves combining three linked methods: case study research to describe priority setting; interdisciplinary research to evaluate the description using an ethical framework; and action research to improve priority setting. This describe-evaluate-improve strategy is a generalizable method that can be used in different health care institutions to improve priority setting in that context. (shrink)

A new study published in Journal of Medical Ethics by van der Zande et al 1 further highlights why classifying pregnant women as a ‘vulnerable population’ in the context of research is deeply problematic. Because the designation of ‘vulnerable’ is otherwise applied to populations whose decision-making capacity about research participation is somehow compromised—such as children and adults of limited cognitive ability—many of us have been arguing for some time that using this designation for pregnant women is inappropriate and disrespectful.2–4 There (...) is nothing about the state of pregnancy that renders pregnant women incapable of offering valid research consents or refusals. Moreover, rather than protecting the health interests of pregnant women and their offspring, this designation has had the opposite effect. It has contributed to the widespread exclusion of pregnant women from research activities, which is itself pernicious to the health of pregnant women.5 We know that pregnant women encounter a range of health needs across their pregnancies. In the USA, for example, approximately 9 out of every 10 women use some kind of medication during pregnancy to manage health conditions.6 Yet because pregnant women have largely been …. (shrink)

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such (...) framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion. (shrink)

Though the revised edition of A Theory of Justice, published in 1999, is the definitive statement of Rawls's view, so much of the extensive literature on Rawls's theory refers to the first edition. This reissue makes the first edition once again available for scholars and serious students of Rawls's work.

In this paper a plea is made for an unprincipled approach to biomedical ethics, unprincipled of course just in the sense that the four principles are neither the start nor the end of the process of ethical reflection. While the four principles constitute a useful “checklist” approach to bioethics for those new to the field, and possibly for ethics committees without substantial ethical expertise approaching new problems, it is an approach which if followed by the bioethics community as a whole (...) would, the author believes, lead to sterility and uniformity of approach of a quite mindbogglingly boring kind. Moreover, much of bioethics is not concerned with identifying the principles or values appropriate to a particular issue, but rather involves analysing the arguments that are so often already in play and which present themselves as offering solutions in one direction or another. Here, as I try to show in discussion of these four scenarios, the principles allow massive scope in interpretation and are, frankly, not wonderful as a means of detecting errors and inconsistencies in argument. (shrink)

A number of ethical frameworks have been proposed to support decision-making in public health and the evaluation of public health policy and practice. This is encouraging, since ethical considerations are of paramount importance in health policy. However, these frameworks have various deficiencies, in part because they incorporate substantial ethical positions. In this article, we discuss and criticise a framework developed by James Childress and Ruth Bernheim, which we consider to be the state of the art in the field. Their framework (...) distinguishes aims, such as the promotion of public health, from constraints on the pursuit of those aims, such as the requirement to avoid limitations to liberty, or the requirement to be impartial. We show how this structure creates both theoretical and practical problems. We then go on to present and defend a more practical framework, one that is neutral in avoiding precommitment to particular values and how they ought to be weighted. We believe ethics is at the very heart of such weightings and our framework is developed to reflect this belief. It is therefore both pluralist and value-based. We compare our new framework to Childress and Bernheim’s and outline its advantages. It is justified by its impetus to consider a wide range of alternatives and its tendency to direct decisions towards the best alternatives, as well as by the information provided by the ranking of alternatives and transparent explication of the judgements that motivate this ranking. The new framework presented should be useful to decision-makers in public health, as well as being a means to stimulate further reflection on the role of ethics in public health. (shrink)

In his article 'Specifying, balancing and interpreting bioethical principles' (Richardson, 2000), Henry Richardson claims that the two dominant theories in bioethics - principlism, put forward by Beauchamp and Childress in Principles of Bioethics , and common morality, put forward by Gert, Culver and Clouser in Bioethics: A Return to Fundamentals - are deficient because they employ balancing rather than specification to resolve disputes between principles or rules. We show that, contrary to Richardson's claim, the major problem with principlism, either the (...) original version, or the specified principlism of Richardson, is that it conceives of morality as being composed of free-standing principles, rather than as common morality conceives it, as being a complete public system, composed of rules, ideals, morally relevant features, and a procedure for determining when a rule can be justifiably violated. (shrink)

Despite the growing importance of ‘social value’ as a central feature of research ethics, the term remains both conceptually vague and to a certain extent operationally rigid. And yet, perhaps because the rhetorical appeal of social value appears immediate and self-evident, the concept has not been put to rigorous investigation in terms of its definition, strength, function, and scope. In this article, we discuss how the anthropological concept of liminality can illuminate social value and differentiate and reconfigure its variegated approaches. (...) Employing liminality as a heuristic encourages a reassessment of how we understand the mobilization of ‘social value’ in bioethics. We argue that social value as seen through the lens of liminality can provide greater clarity of its function and scope for health research. Building on calls to understand social value as a dynamic, rather than a static, concept, we emphasize the need to appraise social value iteratively throughout the entire research as something that transforms over multiple times and across multiple spaces occupied by a range of actors. (shrink)

Background Notwithstanding the need to produce evidence-based knowledge on medications for pregnant women, they remain underrepresented in clinical research. Sometimes they are excluded because of their supposed vulnerability, but there are no universally accepted criteria for considering pregnant women as vulnerable. Our aim was to explore whether and if so to what extent pregnant women are vulnerable as research subjects. Method We performed a conceptual and empirical analysis of vulnerability applied to pregnant women. Analysis A conceptual analysis supports Hurst's definition (...) of vulnerability. Consequently, we argue that pregnant women are vulnerable if they encounter an identifiably increased likelihood of incurring additional or greater wrong. According to the literature, this increased likelihood could exist of four alleged features for pregnant women's vulnerability: informed consent, susceptibility to coercion, higher exposure to risk due to lack of knowledge, vulnerability of the fetus. Discussion Testing the features against Hurst's definition demonstrates that they all concern the same issue: pregnant women are only vulnerable because a higher exposure to risk due to lack of scientific knowledge comprises an increased wrong. Research Ethics Committees have a responsibility to protect the vulnerable, but a higher exposure to risk due to lack of scientific knowledge is a much broader issue and also needs to be addressed by other stakeholders. Conclusions The only reason why pregnant women are potentially vulnerable is to the extent that they are increasingly exposed to higher risks due to a lack of scientific knowledge. Accordingly, the discussion can advance to the development of practical strategies to promote fair inclusion of pregnant women in clinical research. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

Disaster research has grown in scope and frequency. Research in the wake of disasters and during humanitarian crises – particularly in resource-poor settings – is likely to raise profound and unique ethical challenges for local communities, crisis responders, researchers, and research ethics committees. Given the ethical challenges, many have questioned how best to provide research ethics review and oversight. We contribute to the conversation concerning how best to ensure appropriate ethical oversight in disaster research and argue that ethical disaster research (...) requires of researchers and RECs a particular sort of ongoing, critical engagement which may not be warranted in less exceptional research. We present two cases that typify the concerns disaster researchers and RECs may confront, and elaborate upon what this ongoing engagement might look like – how it might be conceptualized and utilized – using the concept of real-time responsiveness. The central aim of RTR, understood here as both an ethical ideal and practice, is to lessen the potential for research conducted in the wake of disasters to create, perpetuate, or exacerbate vulnerabilities and contribute to injustices suffered by disaster-affected populations. Well cultivated and deployed, we believe that RTR may enhance the moral capacities of researchers and REC members, and RECs as institutions where moral agency is nurtured and sustained. (shrink)

This essay focuses on how casuistry can become a useful technique of practical reasoning for the clinical ethicist or ethics consultant. Casuistry is defined, its relationship to rhetorical reasoning and its interpretation of cases, by employing three terms that, while they are not employed by the classical rhetoricians and casuists, conform, in a general way, to the features of their work. Those terms are (1) morphology, (2) taxonomy, (3) kinetics. The morphology of a case reveals the invariant structure of the (...) particular case whatever its contingent features, and also the invariant forms of argument relevant to any case of the same sort: these invariant features can be called topics. Taxonomy situates the instant case in a series of similar cases, allowing the similarities and differences between an instant case and a paradigm case to dictate the moral judgment about the instant case. This judgment is based, not merely on application of an ethical theory or principle, but upon the way in which circumstances and maxims appear in the morphology of the case itself and in comparison with other cases. Kinetics is an understanding of the way in which one case imparts a kind of moral movement to other cases, that is, different and sometimes unprecedented circumstances may move certain marginal or exceptional cases to the level of paradigm cases. In conclusion, casuistry is the exercise of prudential or practical reasoning in recognition of the relationship between maxims, circumstances and topics, as well as the relationship of paradigms to analogous cases. (shrink)