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)

Charity governance is undergoing a crisis of confidence. In this paper, we suggest an alternative approach to how governance could be perceived and conceptualized by considering the ethical notions of governance embedded in religious enquiry, with a specific focus on the Islamic perspective of governance. We firstly develop an ethical framework for charity governance, utilizing insight from the Islamic perspective. Secondly, we undertake an empirical study to assess the experience of governance within Islamic charity organizations. Our theoretical framework provides a (...) comprehensive approach to viewing organizational governance with an emphasis on governance as a mechanism for working towards social justice and the public good. However, our empirical findings reveal an ‘ethical gap’ between the ideals of the Islamic Ethical Framework and the reality of governance practice within Muslim charity organizations. We consider the implications of these findings and outline avenues for future research. (shrink)

This study described the relationships between academic class and student moral sensitivity and reasoning and between curriculum design components for ethics education and student moral sensitivity and reasoning. The data were collected from freshman (n = 506) and senior students (n = 440) in eight baccalaureate nursing programs in South Korea by survey; the survey consisted of the Korean Moral Sensitivity Questionnaire and the Korean Defining Issues Test. The results showed that moral sensitivity scores in patient-oriented care and conflict were (...) higher in senior students than in freshman students. Furthermore, more hours of ethics content were associated with higher principled thinking scores of senior students. Nursing education in South Korea may have an impact on developing student moral sensitivity. Planned ethics content in nursing curricula is necessary to improve moral sensitivity and moral reasoning of students. (shrink)

This study examines the participation strategies of an environmental non-governmental organization (NGO) in community-based conservation (CBC) initiatives in the developing country context of Pakistan. We use local Pakistani concepts and terms to interpret and narrate our study. Drawing on the micro-mobilization literature, our analysis embeds a situated analysis of the_ ‘biradari’_ (kinship) structures that pervade Pakistani social and cultural milieu. We shed light on the importance of various gatekeepers in providing access and ongoing support for CBC initiatives, suggesting NGOs must (...) navigate complex cultural and social structures to manage participation in developing country contexts. Here our findings point to the importance of local knowledge not just in articulating community needs but also in articulating participation strategies. Furthermore, even though ‘elite’ structures have the potential to jeopardize equitable participation and project long-term sustainability, our analysis suggests interacting and gaining ‘_bharosa’_ (trust) of communities’ via these structures is critical to participation. While previous research has called into doubt the efficacy of CBC in advancing conservation, we suggest that frequent and culturally atoned engagement is a must for environmental NGOs working in socially entrenched developing nations. Our research brings to light the complex ethical terrain navigated by environmental NGOs in CBC projects, illuminating the inherent potential for both empowering and subjugating outcomes. (shrink)

Papers presented by three scholars from Asia, Africa and Europe, at a seminar held at the Hague Academy of International Law, Netherlands.

This article explores the uptake and circulation of ‘transgender’ in academic and philanthropic institutions, as a way of taking seriously Robyn Wiegman’s call for a divergentist approach. In so doing, the article aims to demonstrate the intimate entanglements between non-profit and academic spheres and identity knowledges therein. Taken together, both contexts reveal the messiness and complexities of institutionality, not only as a lived reality for individuals such as philanthropy professionals and academics, but also as an object of study itself.

ABSTRACT Chapter 4, verse 34 of the Qur'an permits husbands to physically discipline recalcitrant wives. Modern Muslims who find this husbandly privilege discomfiting often rely on Muhammad's prophetic practice to mitigate the meaning of this verse. In light of Muhammad's example of never hitting his own wives, as found in one prophetic report, they reinterpret the verse as restricting and/or voiding a husband's right to physically discipline his wife. This essay provides a critical and expository survey of prophetic reports related (...) to the husbandly privilege to physically discipline wives. The essay argues that the modernists are correct in positing that Muhammad's prophetic practice was to morally censure husbands who hit their wives. However, taken as a whole, it is impossible to ignore that Muhammad's example also unilaterally upheld physical discipline as a husband's marital right. (shrink)

CONTEMPORARY MUSLIM SCHOLARS WHO SEEK TO RECONCILE GENDER egalitarian values with the premodern patriarchal Islamic tradition face a dilemma. Because the two values—gender egalitarianism and patriarchy—are fundamentally at odds with each other, scholars must choose one to privilege over the other. If the premodern Islamic tradition is privileged, then the ideal of gender egalitarianism is compromised. However, favoring gender egalitarian values at the expense of the premodern Islamic tradition leads to the loss of authority within the believing community. This essay (...) explores the options available to Muslim scholars as they negotiate the egalitarian—authoritative dilemma in the context of the Qur'anic exegesis of the husbandly privilege to discipline wives in Qur'an 4:34. (shrink)

In this article, I explore the geopoetics of Scott Walker’s lyrics and sonics, where the term geopoetics is construed as a concern with the geographical, geological, ecological and cosmological in...

The project of inquiring into the history of our morals is premised upon the idea that some of our deeply held moral convictions might have emerged through a complicated historical process, rather than, say, through a process of rational deliberation. Were that the case, our philosophical efforts to properly understand our present moral conceptions, as well as our efforts to criticize them, would certainly profit from serious attention to the history of our morals. Jesse Prinz notes, however, that there are (...) several different genealogical methods we could employ in pursuit of this project of historicizing morals.1 Prinz focuses upon three such methods—utilitarian genealogies (such as the ones offered by... (shrink)

South Asian English fiction, in recent decades, has significantly manifested its deepest concern for history and its relevance in the contemporary global scenario. The last couple of years have noticed the publication of many English novels by Indian and Pakistani authors that in fact belong to the very genre of postmodern historiographic metafiction. In fact, postmodern fiction writers usually deviate from the traditional representation of past events. The current study examines the way history writing is reconfigured in the selected postmodern (...) novel. In these novels, the writers retell the traditional history through innovative narrative techniques and multiplicity of the views that de-centralize the conventional history. The present research attempts to explore Amitav Gosh’s The Glass Palace and Kamila Shamsie’s Burnt Shadows as historiographic metafiction, that is a sub-genre of postmodern fiction. The study focuses on the selected texts to explore how these novels transform the traditional history through the incorporation of magic realism, intertextuality and self-reflexivity. This research is qualitative and descriptive, while the textual analysis has been used as a research method. The theoretical concept of Linda Hutcheon is incorporated in this current study that ends with findings and recommendations for future research. (shrink)

Ibn al-ʻArabī, 1165-1240; views on freedom; Sufism; Islamic philosophy.

With the advent of social media and increase in networked publics, context collapse has emerged as a critical topic in the discussion of imagined audiences and blurring of the private and the public. The meshing of social contexts portends problematic issues as messages inadvertently reach unimagined audiences causing shame and leading to loss of ‘face’. In this article, we specifically study the impact of context collapse on some celebrities ‘who had it all’ yet, lost ‘it some’ to the world of (...) networked public. The article examines celebrities sharing identity information across multiple contexts and explores situations of lost fame when ‘face’ is threatened, usage falters and breaks some of the well-established norms of interactivity. It concludes that lack of prudence in separating social contexts, loss of ‘face’ and social approval can dampen online celebrity presence. It proposes the use of ‘polysemy’ to simultaneously appeal to audiences from different contexts. (shrink)

Thriving is a psychological state in which individuals experience a sense of vitality and a sense of learning. Thriving come from relational connections with others, and is deeply rooted in social systems. Theoretical literature suggests that thriving occurs in the presence of decision-making discretion, broad information sharing, and a climate of trust. However, no study has investigated these environmental factors empirically. Using a multiple-studies approach, we established valid and reliable scale for each of these environmental factors using experimental vignettes, confirmed (...) the association of decision-making discretion, broad information sharing and climate of trust with thriving, and identified the role of self-determination theory in determining these relationships. Our analysis was based on data collected from 512 Indian management students across five studies. The results indicate significant difference in thriving for high vs. low level for decision-making discretion, broad information sharing and climate of trust. The relationship of these environmental factors with thriving is mainly due to the fulfillment of the need for competence. Competence partially mediates the relationship of decision-making discretion with thriving, and fully mediates the relationship of broad information sharing and climate of trust with thriving. Autonomy, although positively related with the environmental factors, does not lead to thriving. Practical implications, limitations and research avenues are discussed. (shrink)

Contrary to Vaesen's argument that humans are unique with respect to nine cognitive capacities essential for tool use, we suggest that although such cognitive processes contribute to variation in tool use, it does not follow that these capacities arenecessaryfor tool use, nor that tool use shaped cognition per se, given the available data in cognitive neuroscience and behavioral biology.

We are developing the Neurological Disease Ontology (ND) to provide a framework to enable representation of aspects of neurological diseases that are relevant to their treatment and study. ND is a representational tool that addresses the need for unambiguous annotation, storage, and retrieval of data associated with the treatment and study of neurological diseases. ND is being developed in compliance with the Open Biomedical Ontology Foundry principles and builds upon the paradigm established by the Ontology for General Medical Science (OGMS) (...) for the representation of entities in the domain of disease and medical practice. Initial applications of ND will include the annotation and analysis of large data sets and patient records for Alzheimer’s disease, multiple sclerosis, and stroke. (shrink)

The University of Michigan conference “Where Religion, Policy, and Bioethics Meet: An Interdisciplinary Conference on Islamic Bioethics and End-of-Life Care” in April 2011 addressed the issue of brain death as the prototype for a discourse that would reflect the emergence of Islamic bioethics as a formal field of study. In considering the issue of brain death, various Muslim legal experts have raised concerns over the lack of certainty in the scientific criteria as applied to the definition and diagnosis of brain (...) death by the medical community. In contrast, the medical community at large has not required absolute certainty in its process, but has sought to eliminate doubt through cumulative diagnostic modalities and supportive scientific evidence. This has recently become a principal model, with increased interest in data analysis and evidence-based medicine with the intent to analyze and ultimately improve outcomes. Islamic law has also long employed a systematic methodology with the goal of eliminating doubt from rulings regarding the question of certainty. While ample criticism of the scientific criteria of brain death (Harvard criteria) by traditional legal sources now exists, an analysis of the legal process in assessing brain death, geared toward informing the clinician’s perspective on the issue, is lacking. In this article, we explore the role of certainty in the diagnostic modalities used to establish diagnoses of brain death in current medical practice. We further examine the Islamic jurisprudential approach vis-à-vis the concept of certainty (yaqīn). Finally, we contrast the two at times divergent philosophies and consider what each perspective may contribute to the global discourse on brain death, understanding that the interdependence that exists between the theological, juridical, ethical, and medical/scientific fields necessitates an open discussion and active collaboration between all parties. We hope that this article serves to continue the discourse that was successfully begun by this initial interdisciplinary endeavor at the University of Michigan. (shrink)

This paper is devoted to the study of some subvarieties of the variety Qof Q-Heyting algebras, that is, Heyting algebras with a quantifier. In particular, a deeper investigation is carried out in the variety Q 3 of three-valued Q-Heyting algebras to show that the structure of the lattice of subvarieties of Qis far more complicated that the lattice of subvarieties of Heyting algebras. We determine the simple and subdirectly irreducible algebras in Q 3 and we construct the lattice of subvarieties (...) (Q 3 ) of the variety Q 3. (shrink)

Traditional Chinese commentators rightly see that understanding Zhuangzi's way with words is the presupposition for understanding Zhuangzi at all. They are not sure, however, if Zhuangzi's words are super-effective or pure nonsense. I consider Zhuangzi's experience with language, and then turn to Heidegger's word of being to see if it may throw light on Zhuangzi's way of saying. I argue that a conversation between Heidegger and Zhuangzi on language is possible, but only by expanding Heidegger's notion of Gestell and through (...) a destruction of the dominant Confucian discourse that obscures Zhuangzi's way of saying. (shrink)

Efforts to build research capacity and capability in low and middle income countries (LMIC) has progressed over the last three decades, yet it confronts many challenges including issues with communicating or even negotiating across different cultures. Implementing global research requires a broader understanding of community engagement and participatory research approaches. There is a considerable amount of guidance available on community engagement in clinical trials, especially for studies for HIV/aids, even culturally specific codes for recruiting vulnerable populations such as the San (...) or Maori people. However, the same cannot be said for implementing research in global health. In an effort to build on this work, the Pakistan Institute of Living and Learning and University College London in the UK sought to better understand differences in beliefs, values and norms of local communities in Pakistan. In particular, they have sought to help researchers from high income countries (HIC) understand how their values are perceived and understood by the local indigenous researchers in Pakistan. To achieve this end, a group discussion was organised with indigenous researchers at Pakistan Institute of Living and Learning. The discussion will ultimately help inform the development of a cultural protocol for researchers from HIC engaging with communities in LMIC. This discussion revealed five common themes; (1) religious principles and rules, (2) differing concepts of and moral emphasis on autonomy and privacy, (3) importance of respect and trust; (4) cultural differences (etiquette); (5) custom and tradition (gift giving and hospitality). Based on the above themes, we present a preliminary cultural analysis to raise awareness and to prepare researchers from HIC conducting cross cultural research in Pakistan. This is likely to be particularly relevant in collectivistic cultures where social interconnectedness, family and community is valued above individual autonomy and the self is not considered central to moral thinking. In certain cultures, HIC ideas of individual autonomy, the notion of informed consent may be regarded as a collective family decision. In addition, there may still be acceptance of traditional professional roles such as ‘doctor knows best’, while respect and privacy may have very different meanings. (shrink)

We present readings, by Jewish, Christian and Muslim women scholars, of `difficult' texts from three scriptural traditions, viz. Ephesians 5.21-33, Sura' 4.32-35 and Genesis 30.1-26. All three texts concern marriage and point in different ways to the erasure of women's significance or agency, and we ask what happens when women read such texts as scripture. Our readings were developed in conversation with one another, following the developing practice of `Scriptural Reasoning', and they suggest ways in which the texts and their (...) feminist readers can `correct' and challenge each other. We propose that feminist biblical hermeneutics and inter-traditional scriptural reasoning can be mutually informative, with both practices seeking to take embodied difference seriously and to allow unresolved critical questions to arise in reading. (shrink)

Writing from a scientifically and philosophically informed perspective, the authors provide a critical overview of the conceptual difficulties encountered in many current neuroscientific and psychological theories.

Hubert Dreyfus has argued that cases of absorbed bodily coping show that there is no room for self-awareness in flow experiences of experts. In this paper, I argue against Dreyfus’ maxim of vanishing self-awareness by suggesting that awareness of agency is present in expert bodily action. First, I discuss the phenomenon of absorbed bodily coping by discussing flow experiences involved in expert bodily action: merging into the flow; immersion in the flow; emergence out of flow. I argue against the claim (...) that flow experience does not involve an awareness of agency for each of these features, while conceding that fluent agency does not involve self-awareness in the thetic sense. I challenge the assumption that the awareness of fluent agency must be understood in terms of a thetic awareness of agency. Instead, I develop an Anscombean account of the awareness of fluent agency in terms of the phenomenal character of knowing one’s aims. I respond to the challenge that if an Anscombean account of the awareness of agency is to succeed, then agents must be able to answer Anscombean questions. I consider the objection that awareness of agency is not a form of self-awareness by outlining an account of self-awareness as self-synthesis that is distinct from self-perception and self-ascription, but which makes room for self-awareness in expert bodily action. (shrink)

Collected for the first time in a single volume are essays which examine the developments in three fundamental biological disciplines - embryology, evolutionary biology, and genetics. These disciplines were in conflict for much of the twentieth century and the essays in this collection examine key methodological problems within these disciplines and the difficulties faced in overcoming the conflicts between them. Burian skilfully weaves together historical appreciation of the settings within which scientists work, substantial knowledge of the biological problems at stake (...) and the methodological and philosophical issues faced in integrating biological knowledge drawn from disparate sources. The final chapter describes what recent findings in development biology and genetics can tell us about the history and development of animals. Written in a clear, accessible style this collection should appeal to students and professionals in philosophy of science, and the philosophy and history of biology. (shrink)

This study investigates the effect of inclusive leadership on innovation performance with a mediating role of employee innovation behavior and the moderating role of psychological empowerment. Supervisors and employees of Saudi manufacturing firms are the participants of this study. This study used a quantitative research technique with a cross-sectional approach and a self-administrative survey questionnaire to collect the data. The data were analyzed by using the Smart PLS 3 software. The results depict that inclusive leadership has a significant positive impact (...) on the firm’s innovation performance. Employees’ innovation behavior has a significant mediating effect on the association of inclusive leadership and innovation performance. Findings revealed that PE has an important moderating role in the association of inclusive leadership and innovation performance. The findings of this study contribute to the body of knowledge by finding that inclusive leadership has a significant effect on the firm’s innovative performance and PE is crucial to enhance innovation performance. (shrink)