BackgroundThe U.S. Food and Drug Administration traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, we convened (...) a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.ResultsThe team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.FundingThe development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation. (shrink)

Preparing the Next Generation of Oral Historians is an invaluable resource to educators seeking to bring history alive for students at all levels. Filled with insightful reflections on teaching oral history, it offers practical suggestions for educators seeking to create curricula, engage students, gather community support, and meet educational standards. By the close of the book, readers will be able to successfully incorporate oral history projects in their own classrooms.

When I say ‘pain’, it is clearly a singular phenomenon. Yet if I ask for an example, you can provide many varying instances that confound the idea of its singularity. How can a pinprick be of the same thing as depression or grief? This study maintains the singularity of pain by exploring the process and structure of its experience to account for its variance and its subjectivity. Heidegger’s Being and Time provides the pathway to achieving this, where we comprehend how (...) pain’s myriad manifestations, and their inherent subjectivity, relate to our way of Being – the meaningful horizon through which we encounter pain. The study comes to tie the process of encountering pain with a structure that suffering provides, which explains both the variance and the subjectivity of the pain experience. This can then be mapped onto individual experiences of a singular phenomenon to understand how they arose and what has conditioned them. (shrink)

These studies examined whether having thoughts related to an event before it occurs leads people to infer that they caused the event— even when such causation might otherwise seem magical. In Study 1, people perceived that they had harmed another person via a voodoo hex. These perceptions were more likely among those who had first been induced to harbor evil thoughts about their victim. In Study 2, spectators of a peer’s basketball-shooting performance were more likely to perceive that they had (...) influenced his success if they had first generated positive visualizations consistent with that success. Observers privy to those spectators’ visualizations made similar attributions about the spectators’ influence. Finally, addi- tional studies suggested that these results occur even when the thought-about outcome is viewed as unwanted by the thinker and even in field settings where the relevant outcome is occurring as part of a live athletic competition. (shrink)

This study surveys the internal audit department of a large financial services organization. Respondents were challenged to recognize and evaluate ethical and unethical situations often encountered in practice. Four key demographic variables were investigated: gender, age, years of employment and peer group influence. For the most part, respondents view themselves as more ethical than their peers. There does appear to be a gender effect suggesting females' ability to identify ethical behavior better than their male counterparts. This study contributes to the (...) extant literature in that it has explored a previously unexplored profession, namely, the internal auditing profession. (shrink)

Recent research in moral psychology highlights the role of emotion and intuition in moral judgment. In the wake of these findings, the role and significance of moral reasoning remain uncertain. In this article, we distinguish among different kinds of moral reasoning and review evidence suggesting that at least some kinds of moral reasoning play significant roles in moral judgment, including roles in abandoning moral intuitions in the absence of justifying reasons, applying both deontological and utilitarian moral principles, and counteracting automatic (...) tendencies toward bias that would otherwise dominate behavior. We argue that little is known about the psychology of moral reasoning and that it may yet prove to be a potent social force. (shrink)

Anyone teaching in theological schools or university departments of religion in the West should be struck by two related factors which seem to influence the attitude and thinking, of today's students. The first is the preoccupation with ‘experience’, while the second is the openness toward Eastern religious insights as well as their meditation techniques. In this paper, the writer intends to reflect on these two factors both as the causes and the effects of the significant change that has taken place (...) in Western man's world of meaning in our time. (shrink)

The design argument for God’s existence was critically assessed when in the growth of modern science the cognitive value of teleological categories was called into question. In recent discussions dealing with anthropic principles there has appeared a new version of the design argument, in which cosmic design is described without the use of teleological terms. The weak anthropic principle (WAP), a most critical version of all these principles, describes the fine-tuning of physical parameters necessary to the genesis of carbon-based life. (...) Consequently, a new version of the philosophical design argument can be developed on the basis of the weak anthropic principle.(edited). (shrink)

This paper develops analogies concerning the evolution of dissipative structures in nonequilibrium thermodynamics to interpret irrational human behavior in which one finds a lack of correspondence between the invested means and the consequences observed. In an attempt to positively explain the process of cooperation between the free human person and interacting God, I use philosophical categories of Whitehead's process philosophy in an aesthetic model that opposes composition and performance in a musical symphony. Certainly, the essence of human freedom can be (...) expressed in neither thermodynamical nor aesthetic terms. The models proposed can, however, facilitate our understanding of the mutual relations between God's action in the world and the drama of human free choice of moral evil. (shrink)

So-called grand or paradigmatic theories—structural functionalism, psychoanalysis, Marxism, rational-choice theory—provide their proponents with a conceptual vocabulary and syntax that allows for the classification and configuring of wide ranges of phenomena. Advocates for any particular “analytical grammar” are accordingly prone to conflating the internal coherence of their paradigm—its integrated complex of definitions, axioms, and inferences—with a corresponding capacity for representational verisimilitude. The distinction between Theory-as-heuristic and Theory-as-imposition is of course difficult to negotiate in practice, given that empirical observation and measurement are (...) not entirely “theory neutral” or independent of prior analytical conceptualization. Nonetheless, the scientific cogency of any theory is ultimately evaluated by the substantive realism of its foundational assumptions and categorical designations; that is, the accuracy with which it identifies and tracks the determinant properties and processes of the phenomena to be explicated. The paradigm of sociocultural evolutionism—despite extensive revamping by contemporary proponents—does not carry warrant in this regard, as its recourse to an analytical grammar fashioned and derived from another discipline raises doubts about its empirical veridicality. This article revisits the contentious issue of remodeling social phenomena in accordance with biological categories and offers both a theoretical and a substantive critique of the “selectionist” paradigm. The transdisciplinary program of historical social science is affirmed by way of counterpoint. (shrink)

THE SAME PHILOSOPHICAL IDEAS often become the object of extremely diverse opinions. When Leibniz presented his idea of "possible worlds," Voltaire used the occasion for an ironic comment on "metaphysico-theologo-cosmology," whereas for P. L. M. de Maupertuis it was an idea that inspired his important discoveries in the domain of mathematical analysis of dynamic systems. Similar differences of opinion appear today in discussions on the so-called Anthropic Principle. Unequivalent variants of this principle state the existence of close links between the (...) appearance of carbon-based life and the cosmological structure of the universe, between the laws of cosmic evolution and values of physical constants. Many authors question the philosophical significance of the Anthropic Principle, regarding the principle as the product of arbitrary speculations. Their philosophical opponents try to show that certain versions of the principle, which do not go beyond generalization of empirical data, provide grounds for solid teleological assertions claiming that the appearance of the human observer is the goal of cosmic evolution. (shrink)

Post-abortion care research is increasingly being conducted in low- and middle-income countries to help reduce the high burden of unsafe abortion. This study aims to help address the evidence gap about ethical challenges that researchers in LMICs face when carrying out PAC research with adolescents. Employing an explorative qualitative approach, the study identified several ethics challenges encountered by PAC researchers in Zambia, including those associated with seeking ethics and regulatory approvals at institutional and national levels. Persistent stigma around abortion and (...) community perceptions that PAC studies encourage adolescents to seek abortion affected adolescents’ right to exercise their autonomy and to make decisions as well as exposed adolescents to social stigmatization risks. Challenges with recruitment was reported to result in abandoning of studies, thereby undermining development of PAC services that are more responsive to adolescent needs. Training needs identified included knowledge of best practices for conducting and disseminating PAC research. Strategies for addressing the ethical challenges included trust building and using less value-laden terminology when seeking permission and consent. It is essential to the future of PAC research in Zambia and globally that these important challenges be addressed through the development of comprehensive ethics guidance. (shrink)

Interpreting John Paul II's message to the Pontifical Academy of Sciences in the context of the new scientific discoveries concerning the mitochondrial DNA, one can argue that the human species emerged in Africa some 200,000 years ago. The very problem of the emergence of the human soul in the process of biological evolution represents a subject outside the cognitive competence of science. Attempts can be undertaken to explain this issue in the epistemological perspective of philosophy and theology. In traditional versions (...) of evolutionary theism, God* s interaction in nature was interpreted in causal categories when deterministic dependences were stressed in the process of evolutionary growth. In new proposals, God's presence in an evolving nature has been explained in categories of potentialities and propensities built by God into an evolving Nature. Consequently, in this approach God could be conceived not as a Paleyan designer but rather as a composer unfolding the possibilities hidden in His creation. The future of the evolutionary process depends not only on cosmic physical determinants; it depends to a large extent on the quality of cooperation of human actions with the influence of the Divine Creator. Accordingly, the shape of human culture, as well as the state of moral consciousness of Homo sapiens, should be taken into consideration to discuss the future evolution of the human species. /// Interpretando a mensagem do Papa João Paulo II à Academia Pontifícia das Ciências no contexto das novas descobertas científicas referentes ao DNA mitocondrial, o autor do artigo considera ser possível defender que a espécie humana surgiu em África há cerca de 200 000 anos. Mas o problema da emergência da alma humana no contexto do processo da evolução biológica representa um assunto que está fora da competência cognitiva da ciência. Contudo é possível realizar tentativas no sentido de explicar esta questão na perspectiva epistemológica da filosofia e da teologia. Nas versões tradicionais do teísmo evolutivo, a interacção de Deus com a natureza era interpretada segundo categorias causais quando as dependências deterministicas eram sublinhadas no processo do desenvolvimento evolutivo. No contexto de novas propostas interpretativas, a presença de Deus na ordem evolutiva tem sido explicada em termos das potencialidades e das propensidades induzidas por Deus na Natureza em evolução. Consequentemente, segundo esta abordagem Deus poderia ser concebido não como sábio projectista de que fala William Paley, mas antes como um compositor fazendo vir ao de cima as possibilidades escondidas na sua própria criação. O futuro do processo evolutivo depende não apenas das determinantes físicas do cosmos; ele depende em larga medida da qualidade da cooperação das acções humanas com a influência do Criador. Neste sentido, o artigo defende que a forma da cultura humana, bem como o estado da consciência moral do homo sapiens deve ser tido em consideração em ordem a se poder discutir a evolução futura da espécie humana. (shrink)

Interpreting John Paul II's message ca the Pontifical Academy of Sciences in the context of the new scientific discoveries concerning the mitochondrial DNA, one can argue that the human species emerged in Africa some 200,000 years ago. The very problem of the emergence of the human soul in the process of biological evolution represents a subject outside the cognitive competence of science. Attempts can be undertaken to explain this issue in the epistemological perspective of philosophy and theology. In traditional versions (...) of evolutionary theism, God's interaction in nature was interpreted in causal categories when deterministic dependence were stressed in the process of evolutionary growth. In new proposals, God's presence in an evolving nature has been explained in categories of potentialities and propensities built by God into an evolving Nature. Consequently, in this approach God could be conceived not as a Paleyan designer but rather as a composer unfolding the possibilities hidden in His creation. The future of the evolutionary process depends not only on cosmic physical determinants; it depends to a large excent on the quality of cooperation of human actions with the influence of the Divine Creator. Accordingly, the shape of human culture, as well as the state of moral consciousness of Homo sapiens, should be taken into consideration to discuss the future evolution of the human species. (shrink)

In 1981 S. W. Hawking and J. Hartle presented a quantum mechanical description of the early stages of possible cosmological evolution. Their proposal was interpreted by many authors as a pattern of cosmic creation from nothing in which no divine Creator is needed. In this approach, physically defined “nothing” was identified both with the empty set of set theory and with metaphysical nothingness. After defining philosophical presuppositions implicitly assumed in Hawking's paper, one discovers that this alleged nothingness has all properties (...) of the philosophically conceived Logos accepted by Hellenic philosophers of the Neoplatonic tradition. Consequently, Hawking's theory of creation remains consistent with Christian theism, and its only theological opponents can be found among defenders of Samuel Clark's God of scientific gaps. (shrink)

IN DEBATES CONCERNING the relationship between basic principles of Whiteheadian process philosophy and the classical doctrine of substance, one can distinguish at least three types of essentially different approaches to the discussed issue: Process metaphysics implies definitive rejection of substantialist categories of traditional philosophy, and introduces a radically new perspective in which notions of flux and change replace the former categories of enduring substances and relative immutability of individual subjects. Whitehead's approach to the traditional doctrine of substance results in a (...) strong critique of it but not in total rejection. Certain elements of the Aristotelian and Cartesian legacy must be critically revised, but they cannot be eliminated from a rational interpretation of nature. Their implicit presence in Whiteheadian interpretative schemes substantiates the opinion that process metaphysics introduces a reformed version of the doctrine of substance. In spite of explicit critique of the concept of substance found in Whitehead's texts, the same texts implicitly presuppose the necessity of reference to certain substantialist categories. Whitehead himself did not always formally recognize such a necessity; his metaphysical assertions, however, provide an objective basis for developing a modified theory of substance. (shrink)

Goering and colleagues (2017) acknowledge closed-loop neural devices have the potential to undermine agency. Indeed, the authors observe that “the agent using the device may . . . sometimes doubt whether she is the author of her action, given that the device may operate in ways that are not transparent to her” (65). Still, the authors ultimately argue that closed-loop neural devices may be construed as supporting agency, especially when we view agency from a relational perspective. The reason? We often (...) manifest our agency in relation with others. For example, family and close friends sometimes step in to support us in setting and achieving our aims. In a similar way, then, the authors argue that “we can imagine [a closed-loop] device stepping in to support the user in achieving her aim” (67). Closed-loop neural devices, in other words, can be construed as supporting one’s agency in much the same way as other people can be seen as supporting one’s agency. The authors thus conclude that when we view agents from a relational perspective, closed-loop neural devices may be viewed as supporting rather than undermining agency. I largely agree with the authors’ conclusion. I also believe, however, that their discussion can be clarified by distinguishing three kinds of agency and viewing closed-loop neural devices from the perspective of each. By thinking carefully about agency, we can see more clearly the ways in which it is undermined by closed-loop neural devices, as well as the way in which these devices may support agency. (shrink)

In the late 1970s and the 1980s, a number of radical left political theorists focused their philosophical attention on the relevance of ancient atomism, revitalizing a tradition that went back to Karl Marx's work on his dissertation. This essay looks at the uses of atomism by two thinkers in particular, Jacques Rancière and Alain Badiou, in order to see how their discussions of and references to ancient materialism help to shed light on their fundamental disagreements about the nature of community (...) and equality. First, this paper argues that what Badiou and Rancière most obviously share in their assessments of atomism is a negative judgment regarding the post-swerve constitution of the world, while what most obviously distinguishes their positions is their differing judgments regarding the preswerve rain of the atoms in the void. Becoming clear both about how Badiou and Rancière respond to what comes before and after the atomistic swerve helps to clarify an implicit response on Rancière’s part to what has become Badiou’s chief objection to Rancière’s political theory. Second, this paper argues that the fact that Badiou assesses both what comes before and what comes after the swerve as negative, while Rancière assesses only what comes after the swerve as negative, makes clear that their most essential point of difference concerns the status of the swerve that mediates between before and after. Working through the complexities of Badiou’s analysis of the swerve and uncovering Rancière’s extremely subtle analysis of the swerve helps to clarify a major aspect of what has become Rancière’s chief criticism of Badiou’s conception of philosophy. (shrink)

Ce texte présente le contexte politico-symbolique qui a imprégné la jeunesse de l’auteur au Liban et qui a vu naître sa passion des mathématiques. Il décrit la révolution de ses modes de représentations provoquée par l’éclatement de la guerre civile libanaise, et cela, au contact du milieu intellectuel et politique français. Cela donna corps à son engagement dans un domaine particulier des mathématiques, la « théorie des jeux ». Il introduit brièvement le cadre conceptuel de cette théorie en vue de (...) l’analyse du conflit, et la façon dont il fut étendu pour y inclure les configurations politiques instables. Il livre enfin des lignes directrices pour une modélisation applicable à la condition particulière du Liban et à la récurrence de ses crises structurelles. (shrink)

The Bush administration's military war on terrorism is a blunt, ineffective, and unjust response to the threat posed to innocent civilians by terrorism. Decentralized terrorist networks can only be effectively fought by international cooperation among police and intelligence agencies representing diverse nation‐states, including ones with predominantly Islamic populations. The Bush administration's allegations of a global Islamist terrorist threat to the national interests of the United States misread the decentralized and complex nature of Islamist politics. Undoubtedly there exists a “combat fundamentalist” (...) element within Islamism. But the threat posed to U.S. citizens by Islamist terrorism neither necessitates nor justifies as a response massive military invasions of other nations. Not only does the Bush administration's war on alleged “terrorist states” violate the doctrine of just war, but in addition these wars arise from a new, unilateral, imperial foreign‐policy doctrine of “preventive wars.” Such a doctrine will isolate the United States from international institutions and long‐standing allies. The weakening of these institutions and alliances will only weaken the ability of the international community to deter terrorism. (shrink)

Are conspiracy theory beliefs pathological? That depends on what is meant by "pathological." This paper begins by unpacking that ill-defined and value-laden term before making the case that widespread conspiracy theory belief should not be conceptualized through the “othering’ perspective of individual psychopathology. In doing so, it adopts a phenomenological perspective to argue that conspiracy theory beliefs can be reliably distinguished from paranoid delusions based on falsity, belief conviction, idiosyncrasy, and self-referentiality. A socio-epistemic model is then presented that characterizes the (...) broader phenomenon of conspiracy theory belief as a product of a sick society plagued by epistemic mistrust and vulnerability to misinformation that is ubiquitous in today’s post-truth world. Finally, it is proposed that for individuals, the harmfulness of conspiracy theory belief is less related to belief content as it is to belief conviction and degree of self-relevant consequentiality. Staging conspiracy theory belief in terms of ideological commitment offers a conceptual framework to estimate behavioral risks and test hypotheses about the effectiveness of interventions along a continuum of belief conviction and associated socio-epistemic dynamics. Interventions should target not only individuals, but the dysfunctional social conditions that give rise to the pervasive and enduring phenomenon of conspiracy theory belief. (shrink)