Ethical oversight of clinical research is one of the primary means of ensuring that human subjects are protected from the natural bias of researchers and research institutions in favor of experimentation. At a minimum, effective oversight should ensure that risks are minimized and reasonable in relation to anticipated benefits, protect vulnerable subjects from potential coercion or undue influence, ensure full and informed consent, and promote the equitable distribution of the risks and benefits of research. Because these assessments often involve value (...) judgments for which there are no agreed-upon objective standards, we rely on deliberative procedures thought to have the greatest likelihood of producing the right or best outcomes. Concerns about the potential for improperly functioning IRBs to waste scarce human and institutional resources and impede biomedical progress have motivated a surge in empirical research assessing their procedures and outcomes. Yet within this literature, there has been minimal attention paid to the social scientific evidence regarding how individuals and deliberating groups make decisions, nor how those data might inform IRB practice. This essay seeks to fill that gap, locating recent empirical data on IRB composition and process within the context of data regarding what I call “deliberative pathologies,” or instances when deliberation fails to live up to one or more aspect of the deliberative ideal because of systematic biases in the ways participants interact. The paper goes on to make evidence-based recommendations to reduce the vulnerability of IRB deliberations to the kinds of pathologies discussed and indicate directions for future research. (shrink)

The author replies to a letter to the editor from Felicitas Sofia Holzer concerning Wenner’s article “The Social Value Requirement in Research: From the Transactional to the Basic Structure Model of Stakeholder Obligations,” in the Hastings Center Report’s January‐February 2019 issue.

Patient-funded trials are gaining traction as a means of accelerating clinical translation. However, such trials sidestep mechanisms that promote rigor, relevance, efficiency, and fairness. We recommend that funding bodies or research institutions establish mechanisms for merit review of patient-funded trials, and we offer some basic criteria for evaluating PFT protocols.

It has long been taken for granted that clinical research involving human subjects is ethical only if it holds out the prospect of producing socially valuable knowledge. Recently, this social value requirement has come under scrutiny, with prominent ethicists arguing that the social value requirement cannot be substantiated as an ethical limit on clinical research, and others attempting to offer new support. In this paper, I argue that both criticisms and existing defenses of the social value requirement are predicated on (...) what I call the “transactional model of stakeholder obligations”. I go on to problematize this framework, and to introduce an alternative framework for conceptualizing ethical obligations within clinical research. In defending this framework, which I call the “basic structure model of stakeholder obligations”, I also demonstrate how it provides a stronger grounding for the social value requirement that is not vulnerable to critiques grounded in the transactional model. (shrink)

Relational autonomy theorists attempt to accommodate social embeddedness within a conception of autonomy. These attempts are conceptually messy, at best, and category errors, at worst. Rejecting the liberal conception of autonomy due to feminist concerns is more helpfully answered by the neorepublican notion of freedom as nondomination. The conception of freedom as nondomination captures the values that motivate the relational turn in moral and political theory and does so in a conceptually neater way than attempting to accommodate those concerns in (...) our accounts of autonomy. (shrink)

Kripke-style models with two accessibility relations, one intuitionistic and the other modal, are given for analogues of the modal systemK based on Heyting's prepositional logic. It is shown that these two relations can combine with each other in various ways. Soundness and completeness are proved for systems with only the necessity operator, or only the possibility operator, or both. Embeddings in modal systems with several modal operators, based on classical propositional logic, are also considered. This paper lays the ground for (...) an investigation of intuitionistic analogues of systems stronger thanK. A brief survey is given of the existing literature on intuitionistic modal logic. (shrink)

Many tasks in statistical and causal inference can be construed as problems of entailment in a suitable formal language. We ask whether those problems are more difficult, from a computational perspective, for causal probabilistic languages than for pure probabilistic (or “associational”) languages. Despite several senses in which causal reasoning is indeed more complex—both expressively and inferentially—we show that causal entailment (or satisfiability) problems can be systematically and robustly reduced to purely probabilistic problems. Thus there is no jump in computational complexity. (...) Along the way we answer several open problems concerning the complexity of well-known probability logics, in particular demonstrating the ${\exists \mathbb {R}}$ -completeness of a polynomial probability calculus, as well as a seemingly much simpler system, the logic of comparative conditional probability. (shrink)

Ethicists have long recognized that two necessary features of ethical research are scientific validity and social value. Yet despite a significant literature surrounding the validity component of this dictate, until recently there has been little attention paid to unpacking what the social value component might require. This article introduces a framework for assessing the social value of research, and in particular, for determining whether a given research program is likely to have significant social value of the kind necessary to fulfill (...) the social value requirement. The article goes on to illustrate how this framework can provide a clearer account of the responsiveness requirement, an ethical dictum that is oft-repeated but whose content and value as a guideline in international research remains contested. Although I introduce this conception of social value in the context of the responsiveness requirement, the account offered can, and is intended to, stand alone as a tool for the assessment of the social value of research. As such it can be usefully applied to discussions about the value of comparative effectiveness trials, the assessment of the continued proliferation of me-too drugs and the research done to develop them, the demand for public access to study-generated data, and persistent deficits in the publication of negative results. (shrink)

Within bioethics as well as in broader clinical practice, support for transgender and gender‐questioning adolescent access to pubertal suppression has often relied heavily on the desire to prevent risky, self‐destructive, and suicidal behavior. We argue that framing justifications for access to puberty suppression in this way can actually be harmful to both individual patients as well as to the broader trans population. This justification for access to care makes such access precarious, limits its scope, and introduces perverse incentives to the (...) patient population that is being served. We go on to offer an alternative, positive defense of access to puberty‐blocking treatment for transgender youth grounded in the child's right to an open future. We argue that decisions related to pubertal suppression are both importantly weighty and potentially irreversible, and show why this justification is preferable to so‐called “informed consent” approaches. (shrink)

Quantification is particularly seductive in times of global uncertainty. Not surprisingly, numbers, indicators, categorizations, and comparisons are central to governmental and popular response to the COVID-19 pandemic. This essay draws insights from critical data studies, sociology of quantification and decolonial thinking, with occasional excursion into the biomedical domain, to investigate the role and social consequences of counting broadly defined as a way of knowing about the virus. It takes a critical look at two domains of human activity that play a (...) central role in the fight against the virus outbreak, namely medical sciences and technological innovation. It analyzes their efforts to craft solutions for their user base and explores the unwanted social costs of these operations. The essay argues that the over-reliance of biomedical research on “whiteness” for lab testing and the techno-solutionism of the consumer infrastructure devised to curb the social costs of the pandemic are rooted in a distorted idea of a “standard human” based on a partial and exclusive vision of society and its components, which tends to overlook alterity and inequality. It contends that to design our way out of the pandemic, we ought to make space for distinct ways of being and knowing, acknowledging plurality and thinking in terms of social relations, alterity, and interdependence. (shrink)

In light of the growth in the conduct of international clinical research in developing populations, this paper seeks to explore what is owed to developing world communities who host international clinical research. Although existing paradigms for assigning and assessing benefits to host communities offer valuable insight, I criticize their failure to distinguish between those benefits which can justify the conduct of research in a developing world setting and those which cannot. I argue that the justification for human subjects research is (...) fundamentally grounded in the social value of knowledge, and that this value is context-dependent in a manner which should inform our ethical evaluation of the conduct of research in specific settings. I propose a new framework for the assessment of research benefits assigned to developing world host communities, a natural implication of which is to limit the types of research projects which may permissibly be conducted in developing world settings. (shrink)

This paper examines the moral force of exploitation in developing world research agreements. Taking for granted that some clinical research which is conducted in the developing world but funded by developed world sponsors is exploitative, it asks whether a third party would be morally justified in enforcing limits on research agreements in order to ensure more fair and less exploitative outcomes. This question is particularly relevant when such exploitative transactions are entered into voluntarily by all relevant parties, and both research (...) sponsors and host communities benefit from the resulting agreements. I show that defenders of the claim that exploitation ought to be permitted rely on a mischaracterization of certain forms of interference as unjustly paternalistic and two dubious empirical assumptions about the results of regulation. The view I put forward is that by evaluating a system of constraints on international research agreements, rather than individual transaction-level interference, we can better assess the alternatives to permitting exploitative research agreements. (shrink)

Recent discussion of the alleged adverse consequences of space colonization by Phil Torres in this journal is critically assessed. While the concern for suffering risks should be part of any strategic discussion of the cosmic future of humanity, the Hobbesian picture painted by Torres is largely flawed and unpersuasive. Instead, there is a very real risk that the skeptical arguments will be taken too seriously and future human flourishing in space delayed or prevented.

The thesis analyzes the position of Albanian women in the first decade of socialist rule in Montenegro, during which women became full members of society. The efforts of the communist authorities t...

As a philosopher, legal ethicist, and expert in international criminal law, David Luban was uniquely positioned to challenge the morality and legality of the Bush administration's coercive interrog...

A partir del análisis del ambientalismo desde las perspectivas que brindan diferentes discursos sobre desarrollo sostenible, los autores argumentan que, en un nivel de aplicación local, en comunidades y proyectos específicos, se pueden generar nichos de sostenibilidad, pese a que reconocen la extrema dificultad de este desafío; comparan viejas y nuevas propuestas para alcanzar la sostenibilidad, tales como: el desarrollo sostenible, el capitalismo natural, el decrecimiento sostenible o el ecologismo de los pobres. Por último, presentan dos casos con particularidades diferentes, (...) en los que comunidades pobres se resisten a la Raubwirtschaft o economía industrial de rapiña dominante, al buscar la construcción de nichos de sostenibilidad desde una perspectiva local y de comunalidad, mediante el ordenamiento comunitario territorial, la gobernanza democrática y la planeación participativa. (shrink)

Volume 19, Issue 9, September 2019, Page 60-62.

The aim of this study was to empirically investigate differences in role expectations, among the stakeholders involved, about the devolved personnel management role of front-line managers. In particular, we researched the role expectation differences between FLMs, their middle managers, and Human Resource practitioners. In total, nineteen semi-structured interviews have been conducted involving eleven FLMs, eight middle managers, and two HR practitioners working at the same Dutch hospital. Most discovered role expectation differences were related to how FLMs should execute their HR (...) tasks. FLMs were often uncertain if their role enactment met those of their middle managers and/or HR practitioners, herewith indicating role stress. Our findings underline the importance of paying attention to role expectations’ differences in aligning components of the HRM-performance relationship. Future research could include the role expectations of other important stakeholders, such as: subordinates and top management. The outcomes of this empirical work are translated into four interventions to diminish FLMs’ role stress. (shrink)

This article approaches the paradigm shift of datafication from the perspective of civil society. Looking at how individuals and groups engage with datafication, it complements the notion of “data politics” by exploring what we call the “contentious politics of data”. By contentious politics of data we indicate the bottom-up, transformative initiatives interfering with and/or hijacking dominant processes of datafication, contesting existing power relations or re-appropriating data practices and infrastructure for purposes distinct from the intended. Said contentious politics of data is (...) articulated in an array of practices of data activism taking a critical stance towards datafication. In data activism, data as mediators take a central role, both as part of an action repertoire or as objects of struggle in their own right. Leveraging social movement studies and science and technology studies, this theoretical essay argues that data activism can be mapped along two analytical dimensions: “data as stakes” vs. “data as repertoires”, and “individual practice vs. collective action”. Mapping action repertoires and tactics along these axes allows us to chart the potential emergence of a political data subject at the intersection of these two dimensions. This furthers our understanding of people’s engagement with data in relation to other forms of activism and existing work in social movement studies. It also helps us interpreting potential trajectories of contemporary social movements, as they increasingly interface with data, devices and platforms. (shrink)

Pratt, Zion, and Loff (2012) correctly point out that most international clinical research (ICR) is not intended to address the vast inequities in access to health care between developed and develo...

A growing proportion of clinical research funded by pharmaceutical companies, high-income country research agencies, and not-for-profit funders is conducted in low- and middle-income settings. Disparities in wealth and access to healthcare between the populations where new interventions are often tested and those where many of them are ultimately marketed raise concerns about exploitation. This chapter examines several ethical requirements frequently advanced as mechanisms for protecting research subjects in underserved communities from exploitation and evaluates the effectiveness of those mechanisms as responses (...) to exploitation worries. It goes on to highlight where the conceptual frameworks relied upon by research ethicists must be improved if we are to fully understand the nature of the moral claims and obligations that arise in research conducted in underserved communities. (shrink)

The main goals of this work are: Ethical and social aspects of policy, contemporary liberal democratic structures, morality in political decision-making, human rights and their individual conceptions, political-philosophical ideas, function of a social-scientific education, selected aspects of security policy, environmental policy, eco-social market economy and religion and law.

Con el repunte de la literatura nacional durante la República Restaurada, Justo Sierra adoptó la pauta romántica y liberal que propugnaba Altamirano en órganos de difusión como El Renacimiento. Luego, con la llegada de Porfirio Díaz al poder, la literatura de Sierra se orientó al positivismo. En este artículo se estudia cómo se produjo el cambio del Sierra "romántico" al Sierra "positivista".

The paper reconsiders the Weber Thesis of a linkage between Calvinism and capitalism. It first restates this sociological Thesis in terms of the Calvinist doctrine of predestination as its theological core and premise in virtue of being treated as the crucial religious factor of the spirit of modern capitalism. Consequently, it proposes that the Weber Thesis’ validity and consistency depends on that doctrine, succeeding or failing as a sociological theory with the latter depending on whether or not it is unique (...) in theological terms, as well as economic-social consequences. For that purpose, it reexamines and compares the Calvinist doctrine of predestination with the pre-Calvinist versions and infers that it is basically identical to or compatible with these. It then draws the implications for the Weber Thesis in respect of the degree of its validity or consistence. It concludes that the Weber Thesis likely is fail as a sociological-economic theory with the Calvinist doctrine of predestination to the extent that the latter is its theological ground and revealed not to be unique and new theologically and probably in terms of its societal effects. (shrink)

Kenneth Kai-chung Yung’s Chinese Émigré Intellectuals and Their Quest for Liberal Values in the Cold War presents the philosophical and political development of Chinese intellectuals who fled the mainland after the Communist takeover in 1949. Focusing on Yin Haiguang 殷海光, Zhang Junmai 張君勱, and Xu Fuguan 徐復觀, the author provides a comparative account and comprehensive overview of the many facets of intellectual discourse among Chinese post-war philosophers and public intellectuals.Yung’s book is structured into five chapters. While the first two chapters (...) introduce the reader to the general trends and historical circumstances of the post-war intellectual sphere, the ensuing chapters... (shrink)