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)

Medical research is widely thought to have a fundamentally therapeutic orientation, in spite of the fact that clinical research is thought to be ethically distinct from medical care. We need an entirely new conception of clinical research ethics—one that looks to science instead of the doctor‐patient relationship.

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)

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)

BackgroundTo determine whether the public and scientists consider common arguments in support of animal research convincing.MethodsAfter validation, the survey was sent to samples of public, Amazon Mechanical Turk, a Canadian city festival and children’s hospital), medical students, and scientists. We presented questions about common arguments to justify the moral permissibility of AR. Responses were compared using Chi-square with Bonferonni correction.ResultsThere were 1220 public [SSI, n = 586; AMT, n = 439; Festival, n = 195; Hospital n = 107], 194/331 medical (...) student, and 19/319 scientist [too few to report] responses. Most public respondents were <45 years, had some College/University education, and had never done AR. Most public and medical student respondents considered ‘benefits arguments’ sufficient to justify AR; however, most acknowledged that counterarguments suggesting alternative research methods may be available, or that it is unclear why the same ‘benefits arguments’ do not apply to using humans in research, significantly weakened ‘benefits arguments’. Almost all were not convinced of the moral permissibility of AR by ‘characteristics of non-human-animals arguments’, including that non-human-animals are not sentient, or are property. Most were not convinced of the moral permissibility of AR by ‘human exceptionalism’ arguments, including that humans have more advanced mental abilities, are of a special ‘kind’, can enter social contracts, or face a ‘lifeboat situation’. Counterarguments explained much of this, including that not all humans have these more advanced abilities [‘argument from species overlap’], and that the notion of ‘kind’ is arbitrary [e.g., why are we not of the ‘kind’ ‘sentient-animal’ or ‘subject-of-a-life’?]. Medical students were more supportive of AR at the end of the survey.ConclusionsResponses suggest that support for AR may not be based on cogent philosophical rationales, and more open debate is warranted. (shrink)

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...

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

By tracing the genealogy of Lawrence Ferlinghetti's outlandish notion of the fourth person singular and its appropriation in The Logic of Sense, several keys concepts in Deleuze's thought such as the nonpersonal and pre-individual subjectivity can be rendered clearer to the understanding. While there is poetic licence in the use of the term by Ferlinghetti, the fourth person singular is heuristic for exploring the notion of free indirect speech and, more speculatively, the ideas of impersonal death and suicide. The fourth (...) person singular is thus a trope that sheds light on the ideas of humour, irony, lightness and becoming ‘without a verb’ in Deleuze's thought. Under close scrutiny is what Ferlinghetti designates as the ‘cool’ eyes of the fourth person singular. We shall work to differentiate these from so-called mad, Dada-esque ‘unblinking’ eyes. We shall ask how the poet in ‘obscenely seeing’ the impossible possibility of life can envision – perspicaciously – the immanent sense of death-in-life. From what standpoint does the poet gain access to the real? To consider this fully it is necessary to follow the Deleuzian interpretation of singularities as true transcendental events so as to clarify what gives life a ‘non-personal power, above individuals’. (shrink)

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)

John Dupr argues that 'scientific imperialism' can result in 'misguided' science being considered acceptable. 'Misguided' is an explicitly normative term and the use of the pejorative 'imperialistic' is implicitly normative. However, Dupr has not justified the normative dimension of his critique. We identify two ways in which it might be justified. It might be justified if colonisation prevents a discipline from progressing in ways that it might otherwise progress. It might also be justified if colonisation prevents the expression of important (...) values in the colonised discipline. This second concern seems most pressing in the human sciences. (shrink)

There is a growing perception among economists that their field is becoming increasingly irrelevant due to its disregard for reality. Critical realism addresses the failure of mainstream economics to explain economic reality and proposes an alternative approach. This book debates the relative strengths and weaknesses of critical realism, in the hopes of developing a more fruitful and relevant socio-economic ontology and methodology. With contributions from some of the leading authorities in economic philosophy, it includes the work of theorists critical of (...) this approach. In the first part, contributors develop and deepen economics as a realist social theory by considering the work of individuals, various schools of thought, socio- economic phenomena and methodology. In the second part, contributors weigh the strengths and weaknesses of critical realism. (shrink)

When the policies and activities of one country or generation harm both other nations and later generations, they constitute serious injustices. Recognizing the broad threat posed by anthropogenic climate change, advocates for an international climate policy development process have expressly aimed to mitigate this pressing contemporary environmental threat in a manner that promotes justice. Yet, while making justice a primary objective of global climate policy has been the movement's noblest aspiration, it remains an onerous challenge for policymakers. -/- Atmospheric Justice (...) is the first single-authored work of political theory that addresses this pressing challenge via the conceptual frameworks of justice, equality, and responsibility. Throughout this incisive study, Steve Vanderheiden points toward ways to achieve environmental justice by exploring how climate change raises issues of both international and intergenerational justice. In addition, he considers how the design of a global climate regime might take these aims into account. Engaging with the principles of renowned political philosopher John Rawls, he expands on them by factoring in the needs of future generations. Vanderheiden also demonstrates how political theory can contribute to reaching a better understanding of the proper human response to climate change. By showing how climate policy offers insights into resolving contemporary controversies within political theory, he illustrates the ways in which applying normative theory to policy allows us to better understand both. -/- Thoroughly researched and persuasively argued, Atmospheric Justice makes an important step toward providing us with a set of carefully elaborated first principles for achieving environmental justice. (shrink)

If nothing else, the twelve papers assembled in this volume should lay to rest the idea that the interesting debates about the nature of science are still being conducted by "internalists" vs. "externalists,"" rationalists" vs. "arationalists, n or even "normative epistemologists" vs. "empirical sociologists of knowledge. " Although these distinctions continue to haunt much of the theoretical discussion in philosophy and sociology of science, our authors have managed to elude their strictures by finally getting beyond the post-positivist preoccupation of defending (...) a certain division of labor among the science studies disciplines. But this is hardly to claim that our historians, philosophers, sociologists, and psychologists have brought about an "end of ideology," or even an "era of good feelings," to their debates. Rather, they have drawn new lines of battle which center more squarely than ever on practical matters of evaluating and selecting methods for studying science. To get a vivid sense of the new terrain that was staked out at the Yearbook conference, let us start by meditating on a picture. The front cover of a recent collection of sociological studies edited by one of us (Woolgar 1988) bears a stylized picture of a series of lined up open books presented in a typical perspective fashion. The global shape comes close to a trapezium, and is composed of smaller trapeziums gradually decreasing in size and piled upon each other so as to suggest a line receding in depth. The perspective is stylized too. (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.

Can an event’s blameworthiness distort whether people see it as intentional? In controversial recent studies, people judged a behavior’s negative side effect intentional even though the agent allegedly had no desire for it to occur. Such a judgment contradicts the standard assumption that desire is a necessary condition of intentionality, and it raises concerns about assessments of intentionality in legal settings. Six studies examined whether blameworthy events distort intentionality judgments. Studies 1 through 4 show that, counter to recent claims, intentionality (...) judgments are systematically guided by variations in the agent’s desire, for moral and nonmoral actions alike. Studies 5 and 6 show that a behavior’s negative side effects are rarely seen as intentional once people are allowed to choose from multiple descriptions of the behavior. Specifically, people distinguish between “knowingly” and “intentionally” bringing about a side effect, even for immoral actions. These studies suggest that intentionality judgments are unaffected by a behavior’s blameworthiness. (shrink)

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.

Classic statements of research ethics advise against permitting physician-investigators to obtain consent for research participation from patients with whom they have preexisting treatment relationships. Reluctance about “dual-role” consent reflects the view that distinct normative commitments govern physician–patient and investigator–participant relationships, and that blurring the research–care boundary could lead to ethical transgressions. However, several features of contemporary research demand reconsideration of the ethics of dual-role consent. Here, we examine three arguments advanced against dual-role consent: that it creates role conflict for the (...) physician-investigator; that it can compromise the voluntariness of the patient-participant’s consent; and that it promotes therapeutic misconceptions. Although these concerns have merit in some circumstances, they are not dispositive in all cases. Rather, their force—and the ethical acceptability of dual-role consent—varies with features of the particular study. As research participation more closely approximates usual care, it becomes increasingly acceptable, or even preferable, for physicians to seek consent for research from their own patients. It is time for a more nuanced approach to dual-role consent. (shrink)

This paper is the first in a two-part series in which we discuss several notions of completeness for systems of mathematical axioms, with special focus on their interrelations and historical origins in the development of the axiomatic method. We argue that, both from historical and logical points of view, higher-order logic is an appropriate framework for considering such notions, and we consider some open questions in higher-order axiomatics. In addition, we indicate how one can fruitfully extend the usual set-theoretic semantics (...) so as to shed new light on the relevant strengths and limits of higher-order logic. (shrink)

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)

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...

Steve Coutinho explores in detail the fundamental concepts of Daoist thought as represented in three early texts: the _Laozi_, the _Zhuangzi_, and the _Liezi_. Readers interested in philosophy yet unfamiliar with Daoism will gain a comprehensive understanding of these works from this analysis, and readers fascinated by ancient China who also wish to grasp its philosophical foundations will appreciate the clarity and depth of Coutinho's explanations. Coutinho writes a volume for all readers, whether or not they have a background (...) in philosophy or Chinese studies. A work of comparative philosophy, this volume also integrates the concepts and methods of contemporary philosophical discourse into a discussion of early Chinese thought. The resulting dialogue relates ancient Chinese thought to contemporary philosophical issues and uses modern Western ideas and approaches to throw new interpretive light on classical texts. Rather than function as historical curiosities, these works act as living philosophies in conversation with contemporary thought and experience. Coutinho respects the multiplicity of Daoist philosophies while also revealing a distinctive philosophical sensibility, and he provides clear explanations of these complex texts without resorting to oversimplification. (shrink)

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)

An exploration of the production, transmission, and mutation of affective tonality—when sound helps produce a bad vibe.

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

Improvisation is ubiquitous in life. It deserves, we suggest, to occupy a more central role in cognitive science. In the current paper, we take the case of jazz improvisation as a rich model domain from which to explore the nature of improvisation and expertise more generally. We explore the activity of the jazz improviser against the theoretical backdrop of Dreyfus’s account of expertise as well as of enactivist and 4E accounts of cognition and action. We argue that enactivist and 4E (...) accounts provide a rich source of insights on improvisation that go beyond Dreyfus’s notion of skilled coping, for example, through the central enactivist notion of “sense-making”. At the same time, however, we see improvisation also as suggesting an extension of enactivist theory. We see expert improvisers, in music and in life, as walking on a path of open-ended expansion of their mindful experiential relation with their doing. At the heart of an improviser’s expertise, we propose, lies a form of “higher-level inner sense-making” that spontaneously creates novel forms of agentive goal-directedness in the moment. Our account thus supplants Dreyfus’s idea of the ego-less absorbed expert by that of a mindful improviser enacting spontaneous expressions of herself, in music or in life. (shrink)

We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.

A Brief History of Analytic Philosophy: From Russell to Rawls presents a comprehensive overview of the historical development of all major aspects of analytic philosophy, the dominant Anglo-American philosophical tradition in the twentieth century. Features coverage of all the major subject areas and figures in analytic philosophy - including Wittgenstein, Bertrand Russell, G.E. Moore, Gottlob Frege, Carnap, Quine, Davidson, Kripke, Putnam, and many others Contains explanatory background material to help make clear technical philosophical concepts Includes listings of suggested further readings (...) Written in a clear, direct style that presupposes little previous knowledge of philosophy. (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)

: Medical research is widely thought to have a fundamentally therapeutic orientation, in spite of the fact that clinical research is thought to be ethically distinct from medical care. We need an entirely new conception of clinical research ethics—one that looks to science instead of the doctor-patient relationship.

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

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)

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)