The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was formed over 20 years ago with a goal of harmonizing research regulations among the European Union, United States, and Japan. Harmonization was intended to speed approval of pharmaceuticals, avoid unnecessary repetition of studies, and ensure protection of research participants. This paper examines United States, European Union, and ICH pediatric research regulations in five domains: parental permission, assent/dissent, payment, risk/benefit and inclusion of disabled children/wards (...) of state. The purpose is to examine similarities and differences among the regulations to help investigators, policy makers and the public to understand what each regulatory framework can learn from the others. Additionally, the paper suggests philosophical differences in how these entities view pediatric research which may serve as barriers to harmonization in the future. (shrink)

The Food and Drug Administration and the European Medicines Agency have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use as a (...) mechanism for harmonizing clinical research regulations. The intent of harmonization was to improve patients’ “access to new drugs, to prevent unnecessary global development delays and to avoid animal and human study duplications” through policy reconciliation.FDA/EMA efforts at collaboration call for a reassessment of past harmonization efforts: to what extent are ICH member policies already synchronized and to what extent can they be harmonized in the future? This paper will focus on these questions through the lens of pediatric investigation. (shrink)

Objective: Contemporary ethical accounts of the patient-provider relationship emphasise respect for patient autonomy and shared decision making. We sought to examine the relative influence of involvement in decisions, confidence and trust in providers, and treatment with respect and dignity on patients’ evaluations of their hospital care.Design: Cross-sectional survey.Setting: Fifty one hospitals in Massachusetts.Participants: Stratified random sample of adults discharged from a medical, surgical, or maternity hospitalisation between January and March, 1998. Twelve thousand six hundred and eighty survey recipients responded.Main outcome (...) measure: Respondent would definitely be willing to recommend the hospital to family and friends.Results: In a logistic regression analysis, treatment with respect and dignity 3.4, 99% confidence interval 2.8 to 4.2) and confidence and trust in providers were more strongly associated with willingness to recommend than having enough involvement in decisions . Courtesy and availability of staff , continuity and transition , attention to physical comfort , and coordination of care were also significantly associated with willingness to recommend.Conclusions: Confidence and trust in providers and treatment with respect and dignity are more closely associated with patients’ overall evaluations of their hospitals than adequate involvement in decisions. These findings challenge a narrow emphasis on patient autonomy and shared decision making, while arguing for increased attention to trust and respect in ethical models of health care. (shrink)

The examination of the notion of science from a sociological perspective has begun to transform the attitudes to science traditionally upheld by historians and philosophers.

A recent commentary defends 1) the concept of 'brain arrest' to explain what brain death is, and 2) the concept that death occurs at 2–5 minutes after absent circulation. I suggest that both these claims are flawed. Brain arrest is said to threaten life, and lead to death by causing a secondary respiratory then cardiac arrest. It is further claimed that ventilation only interrupts this way that brain arrest leads to death. These statements imply that brain arrest is not death (...) itself. Brain death is a devastating state that leads to death when intensive care, which replaces some of the brain's vital functions such as breathing, is withdrawn and circulation stops resulting in irreversible loss of integration of the organism. Circulatory death is said to occur at 2–5 minutes after absent circulation because, in the context of DCD, the intent is to not attempt reversal of the absent circulation. No defense of this weak construal of irreversible loss of circulation is given. This means that paents in identical physiologic states are dead (in the DCD context) or alive (in the resuscitation context); the current state of death (at 2–5 minutes) is contingent on a future event (whether there will be resuscitation) suggesting backward causation; and the commonly used meaning of irreversible as 'not capable of being reversed' is abandoned. The literature supporting the claim that autoresuscitation does not occur in the context of no cardiopulmonary resuscitation is shown to be very limited. Several cases of autoresuscitation are summarized, suggesting that the claim that these cases are not applicable to the current debate may be premature. I suggest that brain dead and DCD donors are not dead; whether organs can be harvested before death from these patients whose prognosis is death should be debated urgently. (shrink)

Corporate sustainability can be defined as organizations’ commitment to profitability, environment, and social well-being. This study uses a transactional culture analysis of CS reporting practices to explain why some Indian organizations conform to voluntary CS reporting guidelines and others do not. The literature contains two different perspectives on culture, defined broadly as a set of values that guide people’s behavior at a given time. Most past studies typically use national culture to explain differences in CS practices across nations. This concept (...) embeds corporate cultures within the larger national culture, neglecting intranation diversity. Conversely, according to the transactional culture approach used in this study, cultures are plural and independent of geoethnic boundaries, and emerge through social transactions. TCA encourages multilevel explorations of complex social phenomena. Since CS reporting preferences are the outcome of ongoing transactions among organizational stakeholders across different levels, TCA is more appropriate for this study. Since this application requires an understanding of social accountability, the authors use Mary Douglas’s Cultural Framework, a transactional framework of social accountability. A qualitative exploration of six Indian organizations using DCF reveals different dominant forms of social accountability in these organizations: either alone or as paired hybrids. Consequently, each organization prioritizes different stakeholders and reacts differently to voluntary CS reporting guidelines. Identifying the dominant form or forms of social accountability in their organizations and understanding their underlying reasons for resisting voluntary CS guidelines enables managers to secure better collaboration for their CS initiatives. (shrink)

Whether it would take one decade or several centuries, many agree that it is possible to create a *superintelligence*---an artificial intelligence with a godlike ability to achieve its goals. And many who have reflected carefully on this fact agree that our best hope for a "friendly" superintelligence is to design it to *learn* values like ours, since our values are too complex to program or hardwire explicitly. But the value learning approach to AI safety faces three particularly philosophical puzzles: first, (...) it is unclear how any intelligent system could learn its final values, since to judge one supposedly "final" value against another seems to require a further background standard for judging. Second, it is unclear how to determine the content of a system's values based on its physical or computational structure. Finally, there is the distinctly ethical question of which values we should best aim for the system to learn. I outline a potential answer to these interrelated puzzles, centering on a "miktotelic" proposal for blending a complex, learnable final value out of many simpler ones. (shrink)

Over the last century, psychoanalysis has transformed the ways in which we think about our relationships with others. Psychoanalytic concepts and methods, such as the unconscious and dream analysis, have greatly impacted on social, cultural and political theory. Reinterpreting the ways in which geography has explored people's mental maps and their deepest feelings about places, The Body and the City outlines a new cartography of the subject. Mapping key coordinates of meaning, identity and power across the sites of body and (...) city, author Steve Pile explores a wide range of critical thinking, particularly the work of Lefebvre, Freud and Lacan to present a pathbreaking psychoanalysis of space. (shrink)

This is the first book to undertake an applied postmedia and philosophical approach to the work of Felix Guattari. It provides a way to understand philosophically issues in contemporary technology, social life and consumer culture in Asia.

This book introduces the history of third way ideology, surveys its various contrasting forms and locates it within the context of a recurrent crisis of modern European ideologies.

An affirmative answer is given to the question quoted in the title.

Some patients who have been diagnosed as “dead by neurologic criteria” continue to exhibit certain brain functions, most commonly, neuroendocrine functions. This preservation of neurologic function after the diagnosis of “brain death” or “brainstem death” is an ongoing source of controversy and concern in the medical, bioethics, and legal literatures. Most obviously, if some brain function persists, then it is not the case that all functions of the entire brain have ceased and hence, declaring such a patient to be “dead” (...) would be a false positive, in any nation with so-called “whole brain death” laws. Furthermore, and perhaps more concerning, the preservation of any brain function necessarily entails the preservation of some amount of brain perfusion, thereby raising the concern as to whether additional areas of neural tissue may remain viable, including areas in the brainstem. These and other considerations cast significant doubt on the reliability of diagnosing either “brain death” or “brainstem death.”. (shrink)

Comics writer and artist Frank Miller reinvented Batman, bringing greater emotional, moral, and political depth to the character. This chapter considers Batman’s ethics and politics, examining his rejection of utilitarianism, his embrace of the will to power, his Kantian dilemma when dealing with the Joker, and the distinction to be drawn between Miller’s own libertarianism and Bruce Wayne’s Bat-Libertarianism.

The essays complement one another to provide a tour of the complexities and richness of contemporary modes of critique.

French philosopher Bernard Stiegler’s teacher, the great Jacques Derrida, when speaking of the nature of the life of Aristotle, questioned the need for biography and anecdote. Philosophy excludes b...

Here presented are three singular, philosophical perspectives on the Delhi student protests which took place in 2019 and 2020, before the coronavirus pandemic. The writers hail from India, England...

Steve Awodey and Erich H. Reck. Completeness and Categoricity: 19th Century Axiomatics to 21st Century Senatics.

This paper examines the affective disorders plaguing many young people and the problem of attention-deficit hyperactivity disorder in particular. It aims to define the limits of the critique of British educationalist Sir Ken Robinson in terms of his philosophy of ‘creativity’ through a consideration of the ideas of French philosopher Bernard Stiegler, especially the notions of ‘industrial temporal objects’ and stupidity. It makes the case for adopting elements of each distinct research paradigm as a prolegomena to forging a social critique (...) of capitalist-dominated, market-led educational institutions. The former, it will be seen, identifies some of the problems facing teachers in terms of the use and application of technology, the false divide between arts and the humanities, but falls short of explaining the root of the structural and psychic malaise in neo-liberal regimes regarding classroom breakdown in general. The latter, despite the apocalyptic tone of some his pronouncements provides an update and radicalization of Deleuze’s societies of control thesis in terms of what Stiegler designates ‘uncontrollable societies’. Stiegler, it will be seen, presents a critique of technology that is all the more pressing in an age in which the loss of expectation in the lives of young people can lead to a corresponding fall off or destruction in ‘deep attention’. I want to test the hyperbole of Stiegler’s assertion that young people today suffer from a ‘colossal’ attention deficit disorder of unprecedented scale and magnitude. (shrink)

Uses examples from physics, philosophy, and Zen teachings to describe a purely objective style of perception.

A systematic outline of how the environmental crisis is transforming political theory's fundamental concepts.

We are living in and beyond two massive changes in the world, both of which must be addressed by education, the caretaker of memory. First is the geological era of the Anthropocene—a crisis...

Medical ethics assumes a clear boundary between clinical research and clinical medicine: one produces knowledge for the benefit of future patients, while the other provides optimal care to individuals right now. It also assumes that the two cannot be integrated without sacrificing the needs of the current patient to those of future patients. But integration could allow us to provide better care to everyone, now and in the future.

In this riveting collection, which he has been working on for twenty-five years, Pyke presents 100 black-and-white portraits of contemporary philosophers, ...

My intention is to consider Bernard Stiegler’s concept of ‘journeys of knowledge’. Open Humanities Press, 2020) and to explore how one might rethink the knowledge-creating potentialities of information itself. This has become all the more apparent in the time of lockdowns, physical distancing during the pandemic but the primary purpose of the paper is to look at the distinction between knowledge/information and the role of the teacher in using technology pharmacologically to safeguard the savoirs and to stem the proletarianization of (...) knowledge or stupidity as such. The point is that the pandemic is bringing home the question of the role of the teacher, the role of the school and the necessity of the co-production and co-creation of knowledge. It seems essential to understand the concept of ‘journeys of knowledge’ in the time of the pandemic as students are left at home without a journey to voyage upon. As such, there is a lack of futurally-bound collective protentions, an absence of any vision projection into the future. What is there in the concept of ‘journeys of knowledge’ that demonstrates how to use the Internet in bifurcatory ways, to produce what Stiegler calls negentropic knowledge or new forms of knowledge, or what I want to designate as experiments with truth-telling. What does it mean to produce negentropic knowledge without the teacher to guide, curate and care? With the above in mind, and by writing out of the wound of thinking, it is by rethinking the concept of curation in a different way that it is hoped one can contribute to educational research to produce unheard-of bifurcations of knowledge, to invoke Deleuze’s sense of the incomprehensible and Stiegler’s sense of the impossible, the improbable and the incalculable in educational concerns, to pave a path out of the aporia of the present—a present which is without decision and epoch. (shrink)

This paper explores the implications of libertarianism for welfare policy. There are two central arguments. First, the paper argues that if one adopts a libertarian framework, it makes most sense to be a Lockean right-libertarian. Second, the paper argues that this form of libertarianism leads to the endorsement of a fairly extensive set of redistributive welfare programs. Specifically, the paper argues that Lockean right-libertarians are committed to endorsing welfare programs under which the receipt of benefits is conditional on meeting a (...) work requirement, and also endorsing some form of publicly funded jobs of last resort for potential welfare recipients. (shrink)

Standard epistemology takes it for granted that there is a special kind of value: epistemic value. This claim does not seem to sit well with act utilitarianism, however, since it holds that only welfare is of real value. I first develop a particularly utilitarian sense of “epistemic value”, according to which it is closely analogous to the nature of financial value. I then demonstrate the promise this approach has for two current puzzles in the intersection of epistemology and value theory: (...) first, the problem of why knowledge is better than mere true belief, and second, the relation between epistemic justification and responsibility. (shrink)

This brief article is intended to introduce the reader to the field of algebraic set theory, in which models of set theory of a new and fascinating kind are determined algebraically. The method is quite robust, applying to various classical, intuitionistic, and constructive set theories. Under this scheme some familiar set theoretic properties are related to algebraic ones, while others result from logical constraints. Conventional elementary set theories are complete with respect to algebraic models, which arise in a variety of (...) ways, including topologically, type-theoretically, and through variation. Many previous results from topos theory involving realizability, permutation, and sheaf models of set theory are subsumed, and the prospects for further such unification seem bright. (shrink)

At first glance a Russian anarchist’s revolutionary address to the youth of his day made in the late 19th century and the address to youth made by a contemporary French philosopher may appear to have little in common as their context and era are ostensibly very different. How would Petr Kropotkin’s address be understood in our time? Are Kropotkin’s concerns the same as those raised by Bernard Stiegler? Could Kropotkin speak of universal concerns, a sense of elevation and sublimation not (...) governed, undermined or circumvented by digital relations, calculation or algorithmic determination? I find a mutual concern with the coming into maturity of youth, but, I am concerned that as we are passing through an epochal and revolutionary transformation driven by digital and cognitive capitalism and in our toxic and crisis-ridden milieu, Kropotkin’s rhetoric would inevitably fall on deaf ears? Is his rhetoric on revolution anachronistic? How would his rhetoric be crafted for a youth seemingly indifferent to the plight of fellow brethren? Is it conceivable that the humanist-inflected prospects of youth so vaunted by Kropotkin have now been devastated by the inhuman and nihilistic tendencies of the so-called miscreant, ‘blank generation’ as described by Stiegler? True, while it is difficult to calibrate the vision of youth affirmed in Kropotkin with the fear of youth in Stiegler, and, despite differences in episteme, tradition and political orientation, both thinkers I think are concerned with the trials and tribulations of youth and both hold out the prospect of the not-yet of youth, of the coming into being of the maturity of youth, of Aufklärung. It is this shared focus I wish to examine further. (shrink)

Scholarly debate over faux-snuff’s content has predominantly focused on realism and affect. This paper seeks to offer an alternative interpretation, examining what faux-snuff’s form reveals about self. Faux-snuff is typically presented from a first-person perspective, and as such is foundationally invested in the killer’s experiences as they record their murder spree. First then, I propose that the simulated-snuff form reifies self-experience in numerous ways. Faux-snuff’s characteristic formal attributes capture the self’s limited, fractured qualities, for example. Second, I contend that the (...) faux-snuff film’s singular focus lays bare the killer-self. The killer’s identity is principally constituted by the murders they commit. Resultantly, faux-snuff’s victims necessarily affirm the killer qua killer in the moment of murder. However, homicide eradicates the victim. Victims thus vanish in the moment they become the killer’s counter-identity. Consequently, the mock-snuff film centralises not only killing, but also the killer’s self-abnegation. Simulated-snuff’s repeated murders are a compulsive process of becoming in which the killer-self is both reified and erased. Despite presenting events through the killer’s eyes then, the simulated-snuff film can never provide access to the killer. The killer is an absent-presence that also acts as a constant reminder that the viewer is profoundly distanced from the action depicted, despite its apparent immediacy. In sum, faux-snuff commonly combines first-person form with relentless violent content. That melding leads me to scrutinize the apparently absolute binary oppositions at the heart of self-conception. By nature of their approach, these films routinely expose the tipping points between victim/killer, self/other, and life/death. In doing so, simulated-snuff catalyses questions about the self in general, and about our own selves in particular. (shrink)

In thinking the passage from the “all-human cerebrum” to what one might call the contemporary “all-too-human” cerebrum in neo-liberal societies and beyond to the “all-too-transhuman” cerebrum in the cybernetic society, in contrasting Wells’s idea of a new world order with the dystopia of the disordering un-world, in considering the prospects of a “world brain” faced with the realities of the “global mnemotechnical system”, in highlighting the differences between the global and authoritarian instrument of “control” in Wells and the descriptions of (...) the control society by Deleuze, and finally, in critiquing the “unifying of the general intelligence services of the world” in Wells and the capturing of the “general intellect”, this paper maps the contemporary prospects of the “world brain” against the backdrop of the worldweariness of the present. (shrink)

The recent discovery of an interpretation of constructive type theory into abstract homotopy theory suggests a new approach to the foundations of mathematics with intrinsic geometric content and a computational implementation. Voevodsky has proposed such a program, including a new axiom with both geometric and logical significance: the Univalence Axiom. It captures the familiar aspect of informal mathematical practice according to which one can identify isomorphic objects. While it is incompatible with conventional foundations, it is a powerful addition to homotopy (...) type theory. It also gives the new system of foundations a distinctly structural character. (shrink)

One of the central ethical tenets of research in developing countries is the sponsor's obligation to benefit host participants and communities. Two known models of benefits provision dominate the ethical discourse of research in developing countries. The first model, known as the “reasonable availability,” endorses the obligation to provide interventions proven to be effective at the end of a study. This contrasts with the second model, known as “fair benefits,” which endorses other forms of benefits that host communities may deem (...) as fair beyond those derived directly from the study's findings. This paper explores a third benefit model consistent with the writings of the Human Hereditary and Health in Africa research initiative. The H3Africa—a North-South collaborative initiative predicated by U.S. National Institutes of Health, the Wellcome Trust and the African Society of Human Genetics upholds a benefit model that endorses capacity building as the primary obligation of its research agenda. This is evident by the endorsement of mechanisms to strengthen capacity building in its research projects. While capacity building remains a plausible means of improving the expertise, quality and independence of research in Africa, sustainable measures are needed to realizing the full potential for African-led research on the continent. (shrink)

The shift away from paternalistic decision-making and toward patient-centered, shared decision-making has stemmed from the recognition that in order to practice medicine ethically, health care professionals must take seriously the values and preferences of their patients. At the same time, there is growing recognition that minor and seemingly irrelevant features of how choices are presented can substantially influence the decisions people make. Behavioral economists have identified striking ways in which trivial differences in the presentation of options can powerfully and predictably (...) affect people's choices. Choice-affecting features of the decision environment that do not restrict the range of choices or significantly alter the incentives have come to be known as “nudges.” Although some have criticized conscious efforts to influence choice, we believe that clinical nudges may often be morally justified. The most straightforward justification for nudge interventions is that they help people bypass their cognitive limitations—for example, the tendency to choose the first option presented even when that option is not the best for them—thereby allowing people to make choices that best align with their rational preferences or deeply held values. However, we argue that this justification is problematic. We argue that, if physicians wish to use nudges to shape their patients’ choices, the justification for doing so must appeal to an ethical and professional standard, not to patients’ preferences. We demonstrate how a standard with which clinicians and bioethicists already are quite familiar—the best-interest standard—offers a robust justification for the use of nudges. (shrink)