This paper examines the role of equipoise in evaluating international research. It distinguishes two possible formulations of the equipoise requirement that license very different evaluations of international research proposals. The interpretation that adopts a narrow criterion of similarity between clinical contexts has played an important role in one recent controversy, but it suffers from a number of problems. An alternative interpretation that adopts a broader criterion of similarity does a better job of avoiding both exploitation of the brute fact of (...) social deprivation and the exploitation of needy populations for the benefit of more well-off populations. It also holds out the promise of reconciling the need to find interventions that can be employed in developing world contexts with the cluster of moral values that must constrain the way such research is carried out. (shrink)

To judge from the rash of recent law review articles, it is a miracle that research with human subjects in the U.S. continues to draw breath under the asphyxiating heel of the rent-seeking, creativity-stifling, jack-booted bureaucrethics that is the current system of research ethics oversight and review. Institutional Review Boards, sometimes called Research Ethics Committees, have been accused of perpetrating “probably the most widespread violation of the First Amendment in our nation's history,” resulting in a “disaster, not only for academics, (...) but for the whole nation.” One member of the President's Council on Bioethics went so far as to assert, “There has been no greater damage to academic freedom in the United States in my lifetime. And my lifetime encompasses McCarthy and it encompasses political correctness, both.” Locked in the bureaucratic “iron cage” of IRB oversight, critics charge that researchers have been transformed into a vulnerable, exposed population, subject to domination, that has been likened in one case to a kind of “Tuskegee in reverse.”. (shrink)

: An Aristotelian conception of practical ethics can be derived from the account of practical reasoning that Aristotle articulates in his Rhetoric and this has important implications for the way we understand the nature and limits of practical ethics. An important feature of this conception of practical ethics is its responsiveness to the complex ways in which agents form and maintain moral commitments, and this has important implications for the debate concerning methods of ethics in applied ethics. In particular, this (...) feature enables us to understand casuistry, narrative, and principlism as mutually supportive modes of moral inquiry, rather than divergent and mutually exclusive methods of ethics. As a result, an Aristotelian conception of practical ethics clears the conceptual common ground upon which practical ethicists can forge a stable and realistic self-understanding. (shrink)

This paper examines the concept of a 'standard of care' as it has been used in recent arguments over the ethics of international human-subjects research. It argues that this concept is ambiguous along two different axes, with the result that there are at least four possible standard of care arguments that have not always been clearly distinguished. As a result, it has been difficult to assess the implications of opposing standard of care arguments, to recognize important differences in their supporting (...) rationales, and even to locate the crux of the disagreement in some instances. The goal of the present discussion, therefore, is to disambiguate the concept of a 'standard of care' and to highlight the areas of genuine disagreement among different standards. In the end it is argued that one standard of care argument in particular is more complex than either its proponents or its critics may have recognized and that understanding this possibility opens up a potentially promising avenue of inquiry that remains to be carefully explored. (shrink)

in Angelique M. Rietsma and Jonathan D. Moreno eds., Ethical Guidelines for Innovative Surgery. (Hagerstown, MD: University Publishing Group) 19-52. [PDF].

Innovation is disruptive and a deeply social phenomenon. As a result, discussions of innovation in the Anglo-American philosophical tradition are often tightly bound up with concerns about individual freedom and pluralism, including pluralism about ethical values. In response, stakeholders looking to evaluate and assess ethical aspects of the innovation ecosystem are often driven to pragmatic approaches that utilize a set of ethical values that can be regarded as “free-standing,” or “thin” in the sense that they are not tied to any (...) particular, substantive conception of the good. This set often includes values such as beneficence, nonmaleficence, respect for autonomy, fairness, and justice. Discussions focused on justice, however, are the least extensive and least well-developed. As a result, most approaches are well-suited to surfacing first-order or direct effects of the discrete activities of a relatively narrow set of stakeholders. Paradoxically, however, such analyses are often not well-suited to identifying and evaluating (a) quintessentially social or higher-order effects (such as network-level or institutional level effects), (b) the role of a larger number of stakeholders who shape the innovation ecosystem in more indirect ways, and (c) some of the positive ethical claims of individuals that are relevant to evaluating innovation. After articulating these shortcomings, I argue that they might be overcome by adopting a justice-led framework for evaluating innovation. (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 decision‐making algorithms are not new to medicine, the availability of vast stores of medical data, gains in computing power, and breakthroughs in machine learning are accelerating the pace of their development, expanding the range of questions they can address, and increasing their predictive power. In many cases, however, the most powerful machine learning techniques purchase diagnostic or predictive accuracy at the expense of our ability to access “the knowledge within the machine.” Without an explanation in terms of reasons or (...) a rationale for particular decisions in individual cases, some commentators regard ceding medical decision‐making to black box systems as contravening the profound moral responsibilities of clinicians. I argue, however, that opaque decisions are more common in medicine than critics realize. Moreover, as Aristotle noted over two millennia ago, when our knowledge of causal systems is incomplete and precarious—as it often is in medicine—the ability to explain how results are produced can be less important than the ability to produce such results and empirically verify their accuracy. (shrink)

Volume 24, Issue 12, December 2024, Page 23-25.

Volume 24, Issue 12, December 2024, Page 29-32.

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

An Aristotelian conception of practical ethics can be derived from the account of practical reasoning that Aristotle articulates in his Rhetoric and this has important implications for the way we understand the nature and limits of practical ethics. An important feature of this conception of practical ethics is its responsiveness to the complex ways in which agents form and maintain moral commitments, and this has important implications for the debate concerning methods of ethics in applied ethics. In particular, this feature (...) enables us to understand casuistry, narrative, and principlism as mutually supportive modes of moral inquiry, rather than divergent and mutually exclusive methods of ethics. As a result, an Aristotelian conception of practical ethics clears the conceptual common ground upon which practical ethicists can forge a stable and realistic self-understanding. (shrink)

Volume 45, Issue 3, August 2024, Page 376-378.

One of the fundamental challenges in any field of practical ethics is to articulate a framework for deliberation and decision making that is capable of providing warranted guidance about contentious ethical questions.1 Such a framework has to function effectively in the face of empirical uncertainty and what Rawls refers to as the fact of reasonable pluralism—the fact that individuals often differ in their ideals, ambitions, preferences and conceptions of the good life. One of the perennial questions in normative and metaethics (...) concerns the source of the warrant for such judgments, and a major preoccupation of practical ethics has been to find a way to generate such warrant without having to first settle all contentious philosophical questions about the nature and source of normativity. To the extent that scholars use the term ‘common morality’ to refer to a set of moral norms or concerns that are sufficiently common and widespread that they can be used as starting points for moral deliberation and inquiry, I am sympathetic to the term.2 To the extent that appeals to common morality are supposed to do more significant epistemic or justificatory work, they have always struck me as dangerously ad hoc and insufficiently responsive to the legitimate need to explain the ground for common normative claims. Although I am relatively sceptical of appeals to common morality, I am concerned that the version of this view that is critiqued in ‘Why not common morality’ is simply a straw person. Throughout the paper, Rhodes treats common morality as synonymous with everyday ethics and the ethics of everyday life. She says, ‘If common morality and medical ethics were the same, then the ethically justified behaviour for medical professionals and everyone else would be the same’ (Rhodes, p7).3 In effect, the view that Rhodes attacks is …. (shrink)

Volume 24, Issue 12, December 2024, Page 89-91.

Background: International codes of ethics play an important role in guiding professional practice in developing countries. In the occupational health setting, codes developed by international agencies have substantial import on protecting working populations from harm. This is particularly so under globalisation which has transformed processes of production in fundamental ways across the globe. As part of the process of revising the Ethical Code of the International Commission on Occupational Health, an Africa Working Group addressed key challenges for the relevance and (...) cogency of an ethical code in occupational health for an African context through an iterative consultative process. Discussion: Firstly, even in the absence of strong legal systems of enforcement, and notwithstanding the value of legal institutionalisation of ethical codes, guidelines alone may offer advantageous routes to enhancing ethical practice in occupational health. Secondly, globalisation has particularly impacted on health and safety at workplaces in Africa, challenging occupational health professionals to be sensitive to, and actively redress imbalance of power. Thirdly, the different ways in which vulnerability is exemplified in the workplace in Africa often places the occupational health professional in invidious positions of Dual Loyalty. Fourth, the particular cultural emphasis in traditional African societies on collective responsibilities within the community impacts directly on how consent should be sought in occupational health practice, and how stigma should be dealt with, balancing individual autonomy with ideas of personhood that are more collective as in the African philosophy of ubuntu. To address stigma, practitioners need to be additionally sensitive to how power imbalances at the workplace intersect with traditional cultural norms related to solidarity. Lastly, particularly in the African context, the inseparability of workplace and community means that efforts to address workplace hazards demand that actions for occupational health extend beyond just the workplace. Summary: A stronger articulation of occupational health practice with advocacy for prevention should be an ethical norm. Ethical codes should ideally harmonize and balance individual and community needs so as to provide stronger moral authority guidelines. There is a need to consider an African Charter on Bioethics as complementary and strengthening of existing codes for the region. (shrink)

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Volume 19, Issue 9, September 2019, Page 32-34.

Statements of the core ethical and professional responsibilities of medical professionals are incomplete in ways that threaten fundamental goals of medicine. First, in the absence of explicit guida...

International codes of ethics play an important role in guiding professional practice in developing countries. In the occupational health setting, codes developing by international agencies have substantial import on protecting working populations from harm. This is particularly so under globalisation which has transformed processes of production in fundamental ways across the globe. As part of the process of revising the Ethical Code of the International Commission on Occupational Health, an African Working Group addressed key challenges for the relevance and cogency (...) of an ethical code in occupational health for an African context through an iterative consultative process. (shrink)

The debate over when medical research may be performed in developing countries has steered clear of the broad issues of social justice in favor of what seem more tractable, practical issues. A better approach will reframe the question of justice in international research in a way that makes explicit the links between medical research, the social determinants of health, and global justice.

Recent debates over the use of sham surgery as a control for studies of fetal tissue transplantation for Parkinson’s disease have focused primarily on rival interpretations of the US federal regulations governing human-subjects research. Using the core ethical and methodological considerations that underwrite the equipoise requirement, we nd strong prima facie reasons against using sham surgery as a control in studies of cellular-based therapies for Parkinson’s disease and more broadly in clinical research. Additionally, we believe that these reasons can be (...) generalized to apply to the use of other placebo controls that carry signi cant risks of positive harms in and of themselves. As a result, our arguments are centrally relevant to the emerging drive to subject therapies with a surgical component to the same rigorous standards of evaluation as those governing the approval of new pharmaceuticals. (shrink)

There is considerable enthusiasm about the prospect that artificial intelligence (AI) will help to improve the safety and efficacy of health services and the efficiency of health systems. To realize this potential, however, AI systems will have to overcome structural problems in the culture and practice of medicine and the organization of health systems that impact the data from which AI models are built, the environments into which they will be deployed, and the practices and incentives that structure their development. (...) This perspective elaborates on some of these structural challenges and provides recommendations to address potential shortcomings. (shrink)

La mayoría de interpretaciones sobre la noción de comunidad en Hannah Arendt, han pasado por alto el esfuerzo por parte de la autora de deslindarse de lo que ella considera -la tradición de la filosofía política-. Arendt encuentra que dicha tradición ha sido incapaz de reconocer la pluralidad y contingencia propias de los asuntos humanos. Este libro se propone buscar en el pensamiento de la autora una posible noción de Comunidad que conciba la pluralidad como -ley de la tierra-, y (...) vea en la acción esa puesta en escena de dicha pluralidad. (shrink)

Recent claims that artificial intelligence (AI) systems demonstrate “emergent abilities” have fueled excitement but also fear grounded in the prospect that such systems may enable a wider range of parties to make unprecedented advances in areas that include the development of chemical or biological weapons. Ambiguity surrounding the term “emergent abilities” has added avoidable uncertainty to a topic that has the potential to destabilize the strategic landscape, including the perception of key parties about the viability of nonproliferation efforts. To avert (...) these problems in the future, scientists, developers, policymakers, and other parties should take credible steps to strengthen the health of the scientific ecosystem around AI. (shrink)

In “The Real Problem With Equipoise,” Chiong (2006) raises two distinct, but interrelated issues concerning the concept of equipoise. The first deals with the role of equipoise in evaluating intern...

This study examines urban agriculture (UA) in Sacramento, California (USA), the nation's self-branded “Farm-to-Fork Capital,” in order to highlight UA’s distinct yet entangled roots. The study is based on 24 interviews with a diverse array of UA leaders, conducted as part of a five-year transdisciplinary study of UA in Sacramento. In it, we unearth three primary “taproots” of UA projects, each with its own historical legacies, normative visions, and racial dynamics. In particular, we examine UA projects with “justice taproots,” “health (...) taproots,” and “market taproots.” We use this analysis to understand how different kinds of UA projects are embedded in racial capitalism in ways that transform relationships between people, the city, and food systems. Unearthing these entangled roots helps illuminate UA’s underlying politics, showing how these roots grow in both competitive and symbiotic ways within the soil matrix of racial capitalism. We argue that these roots interact differently with racial capitalism, creating disparities in their growth trajectories. In particular, UA projects associated with the justice taproot are historically underrepresented and undervalued. However, we argue that there are some prospects for building alliances between the UA movement’s three roots, and that these are both promising and problematic. (shrink)

It is useful to be reminded that Spain produced, according to several estimates, about 10,000 plays during its literary Golden Age. Indeed, one of the many positive results from this enterprising b...

Research ethics is often said to have been born of scandal. Whether or not this is true of the field in general, it does seem to be the case for much of the literature on the ethics of international research. But in When Experiments Travel: Clinical Trials and the Global Search for Human Subjects, the anthropologist Adriana Petryna sets out to portray not scandal, but the routine offshoring of clinical trials. Through gripping interviews and detailed case studies, she follows the (...) lifecycle of international research, tracing its connections to health systems, legal systems, and entitlement programs. She also provides a glimpse into the complex social relations on which the research process depends, allowing her reader to see the way the labor is divided, the responsibilities delegated, the risks shifted, and decisions with far-reaching social consequences shaped by a spectrum of market, regulatory, and cultural influences. (shrink)

This article argues that lingering uncertainty about the normative foundations of research ethics is perpetuated by two unfounded dogmas of research ethics. The first dogma is that clinical research, as a social activity, is an inherently utilitarian endeavor. The second dogma is that an acceptable framework for research ethics must impose constraints on this endeavor whose moral force is grounded in role-related obligations of either physicians or researchers. This article argues that these dogmas are common to traditional articulations of the (...) equipoise requirement and to recently articulated alternatives, such as the non-exploitation approach. Moreover, important shortcomings of these approaches can be traced to their acceptance of these dogmas. After highlighting these shortcomings, this article illustrates the benefits of rejecting these dogmas by sketching the broad outlines of an alternative called the "integrative approach" to clinical research. (shrink)

The “fair benefits” approach to international research is designed to produce results that all can agree are fair without taking a stand on divisive questions of justice. But its appealing veneer of collaboration masks ambiguities at both a conceptual and an operational level. An attempt to put it into practice would look a lot like an auction, leaving little reason to think the outcomes will satisfy even minimal conditions of fairness.

Regulators rely on clinical trials for drug approval and labeling decisions. Health systems and clinicians rely on the evidence from trials to determine treatment, and patients rely on it to decide which courses of care to undertake. Many of these stakeholders presume that the careful review of individual studies is enough to address the ethical and scientific questions that arise in clinical trials. In what follows, however, we demonstrate that explicit consideration of trial portfolios—series of trials that are interrelated by (...) a common set of objectives—is crucial. the ethical acceptability and evidentiary probity of individual trials can change depending on the characteristics of the portfolios in which they are embedded. Second, how trial portfolios are composed, how well they are coordinated, and how efficiently they use information determines the balance of risks and benefits they present as well as their different prospects for generating socially valuable information; these three factors also raise distinct questions of justice. (shrink)

The prevailing discourse around AI ethics lacks the language and formalism necessary to capture the diverse ethical concerns that emerge when AI systems interact with individuals. Drawing on Sen and Nussbaum’s capability approach, we present a framework formalizing a network of ethical concepts and entitlements necessary for AI systems to confer meaningful benefit or assistance to stakeholders. Such systems enhance stakeholders’ ability to advance their life plans and well-being while upholding their fundamental rights. We characterize two necessary conditions for morally (...) permissible interactions between AI systems and those impacted by their functioning, and two sufficient conditions for realizing the ideal of meaningful benefit. We then contrast this ideal with several salient failure modes, namely, forms of social interactions that constitute unjustified paternalism, coercion, deception, exploitation and domination. The proliferation of incidents involving AI in high-stakes domains underscores the gravity of these issues and the imperative to take an ethics-led approach to AI systems from their inception. (shrink)

ABSTRACT:The judgments of conscientious and informed experts play a central role in two elements of clinical equipoise. The first, and most widely discussed, element involves ensuring that no participant in a randomized trial is allocated to a level of treatment that everyone agrees is substandard. The second, and less often discussed, element involves ensuring that trials are likely to generate social value by producing the information necessary to resolve a clinically meaningful uncertainty or disagreement about the relative merits of a (...) set of interventions. The distribution of judgments in expert communities can take many forms, each with important implications for whether a trial satisfies one or both elements of clinical equipoise. In this article we use a graphical approach to represent three ways in which expert community uncertainty can vary: by spread, modality, and skew. Understanding these different distributions of expert judgment has three important implications: it helps to make operational the requirement of social value, it shows that some conditions for initiating studies to promote social value diverge from common assumptions about clinical equipoise, and it has important implications for how trials should be designed and monitored, and what patients should be told during informed consent. (shrink)

Global debates in approaches to HIV/AIDS control have recently moved away from a uniformly strong human rights-based focus. Public health utilitarianism has become increasingly important in shaping national and international policies. However, potentially contradictory imperatives may require reconciliation of individual reproductive and other human rights with public health objectives. Current reproductive health guidelines remain largely nonprescriptive on the advisability of pregnancy amongst HIV-positive couples, mainly relying on effective counselling to enable autonomous decision-making by clients. Yet, health care provider values and (...) attitudes may substantially impact on the effectiveness of nonprescriptive guidelines, particularly where social norms and stereotypes regarding childbearing are powerful, and where providers are subjected to dual loyalty pressures, with potentially adverse impacts on rights of service users. Data from a study of user experiences and perceptions of reproductive and HIV/AIDS services are used to illustrate a rights analysis of how reproductive health policy should integrate a rights perspective into the way services engage with HIV-positive persons and their reproductive choices. The analysis draws on recognised tools developed to evaluate health policies for their human rights impacts and on a model developed for health equity research in South Africa to argue for greater recognition of agency on the part of persons affected by HIV/AIDS in the development and content of policies on reproductive choices. We conclude by proposing strategies that are based upon a synergy between human rights and public health approaches to policy on reproductive health choices for persons with HIV/AIDS. (shrink)

Abstract:This paper considers novel ethical issues pertaining to near-future artificial intelligence (AI) systems that seek to support, maintain, or enhance the capabilities of older adults as they age and experience cognitive decline. In particular, we focus on smart assistants (SAs) that would seek to provide proactive assistance and mediate social interactions between users and other members of their social or support networks. Such systems would potentially have significant utility for users and their caregivers if they could reduce the cognitive load (...) for tasks that help older adults maintain their autonomy and independence. However, proactively supporting even simple tasks, such as providing the user with a summary of a meeting or a conversation, would require a future SA to engage with ethical aspects of human interactions which computational systems currently have difficulty identifying, tracking, and navigating. If SAs fail to perceive ethically relevant aspects of social interactions, the resulting deficit in moral discernment would threaten important aspects of user autonomy and well-being. After describing the dynamic that generates these ethical challenges, we note how simple strategies for prompting user oversight of such systems might also undermine their utility. We conclude by considering how near-future SAs could exacerbate current worries about privacy, commodification of users, trust calibration and injustice. (shrink)