In Grimes v. Kennedy Krieger Institute (KKI), the Maryland Court of Appeals, while noting that U.S. federal regulations include risk standards for pediatric research, endorses its own risk standards. The Grimes case has implications for the debate over whether the minimal risk standard should be interpreted based on the risks in the daily lives of most children (the objective interpretation) or the risks in the daily lives of the children who will be enrolled in a given study (the subjective interpretation). (...) The court's use of the objective interpretation to block studies like the KKI study protects individual children who are worse off than the average child. Unfortunately, this approach also may block research intended to improve the lives of these same individuals. A similar dilemma arises in the context of multinational research, suggesting that a "modified objective standard," proposed to address this dilemma in the multinational setting, may offer a framework for addressing the dilemma in the context of pediatric research as well. (shrink)

Die gängige Unterscheidung zwischen 'Modellen von etwas' und 'Modellen für etwas' basiert weitgehend auf der Zuordnung der einen zu den Wissenschaften, der anderen zu den Künsten und den entwerfenden Disziplinen. Diese Aufteilung hält einer näheren Untersuchung nicht Stand. Zudem hat sie die Einsicht vereitelt, dass und wie Forschen und Entwerfen im Modell ineinander verflochten sind.

Although informed consent is important in clinical research, questions persist regarding when it is necessary, what it requires, and how it should be obtained. The standard view in research ethics is that the function of informed consent is to respect individual autonomy. However, consent processes are multidimensional and serve other ethical functions as well. These functions deserve particular attention when barriers to consent exist. We argue that consent serves seven ethically important and conceptually distinct functions. The first four functions pertain (...) principally to individual participants: (1) providing transparency; (2) allowing control and authorization; (3) promoting concordance with participants' values; and (4) protecting and promoting welfare interests. Three other functions are systemic or policy focused: (5) promoting trust; (6) satisfying regulatory requirements; and (7) promoting integrity in research. Reframing consent around these functions can guide approaches to consent that are context sensitive and that maximize achievable goals. (shrink)

Net‐risk pediatric research encompasses interventions and studies that pose risks and do not offer a compensating potential for clinical benefit. These interventions and studies are central to efforts to improve pediatric clinical care. Yet critics argue that it is unethical to expose children to research risks for the benefit of unrelated others. While a number of ethical justifications have been proposed, none have received widespread acceptance. This leaves funders with uncertainty over whether they should support and institutional review boards with (...) uncertainty over whether they should approve net‐risk pediatric research. To try to answer these questions, this article describes a justification that I previously proposed and considers two objections to it. This analysis reveals that the opportunity to contribute to a valuable project can justify exposing children to risks even though some trials turn out to be valueless and others turn out to be harmful. It follows that, to protect pediatric participants, institutional review boards need to assess whether trials have the potential to collect socially valuable information and whether they are likely to enroll and retain a sufficient number of participants. (shrink)

Guidelines around the world require children to provide assent for their participation in most research studies. Yet, little further guidance is provided on how review committees should implement this requirement, including which children are capable of providing assent and when the requirement for assent may be waived on the grounds that the research offers participating children the potential for important clinical benefit. The present paper argues that the assent requirement is supported by the importance of allowing children who are capable (...) to make their own decisions. This suggests children are capable of assent when they become able to understand the research in question. While development varies across individual children, existing data suggest most children develop this ability by approximately age 14. Until instruments are developed to assess the assent capacity of individual children, this age should be used as the threshold for assent. In addition, the importance of protecting children from harm suggests that the sustained dissent of all children, including those who are unable to provide assent, should be respected. While the assent requirement may be waived when research participation offers the potential for important medical benefit that is unavailable outside the research context, analysis suggests that children’s sustained dissent should be respected in all cases. (shrink)

In this clear and accessible book, Gernot Bohme places philosophical ethics in the context of our individual and social lives. Arguing against the conception of ethics as a body of knowledge, Bohme defines morality as a matter of 'serious questions'. In the case of an individual, a serious question is one that determines that person's mode of living. In the case of society, a serious question is one that shapes our social norms. In Ethics in Context, Bohme explores the (...) key areas of moral living and moral discourse. He examines some of the urgent issues affecting society today, such as the moral implications of reproductive technology, man's mastery over nature and the right of citizenship. This book is a lucid and engaging guide to ethics, which will be of great interest to students of philosophy and, indeed, to all those interested in the subject. (shrink)

Recently, there has been renewed interest in so-called evidence-based policy making. Enticed by the grand promises of Big Data, public officials seem increasingly inclined to experiment with more data-driven forms of governance. But while the rise of Big Data and related consequences has been a major issue of concern across different disciplines, attempts to develop a better understanding of the phenomenon's historical foundations have been rare. This short commentary addresses this gap by situating the current push for numerical evidence within (...) a broader socio-political context, demonstrating how the epistemological claims of Big Data science intersect with specific forms of trust, truth, and objectivity. We conclude by arguing that regulators' faith in numbers can be attributed to a distinct political culture, a representative democracy undermined by pervasive public distrust and uncertainty. (shrink)

The philosophical literature would have us believe that the conservative view on abortion is based on the claim that the fetus is a person from the time of conception. Given the widespread acceptance of this analysis, it comes as something of a surprise to learn that it conflicts with a number of major arguments offered in support of the conservative view. I argue, in the present paper, that a careful examination of these inconsistencies establishes that the personhood analysis is mistaken: (...) the conservative view is based on the natural process of fetal development, not the personhood of the fetus. (shrink)

The threat-advantage hypothesis that threatening or negative faces can be discriminated preattentively has often been tested in the visual search paradigm with schematic stimuli. The results have been heterogeneous, suggesting that the choice of particular stimuli have profound effects on search efficiency. Because this conclusion is hampered by differences in experimental procedure, I selected examples from past literature and presented replicas of stimulus pairs (schematic positive and negative faces) in a within-participants design. Although there was a consistent advantage for angry-face (...) targets, search efficiency varied between 8 and 35 ms/item, yielding no clear evidence for the threat-advantage hypothesis. Furthermore, search efficiency for negative- and positive-face targets was highly correlated over stimulus pairs, which implies that whatever complicates the search for the negative face of a pair also complicates the search for the positive face. This results pattern argues against the hypothesised preattentive detector. (shrink)

ABSTRACT Moral hazards are ubiquitous. Green ones typically involve technological fixes: Environmentalists often see ‘technofixes’ as morally fraught because they absolve actors from taking more difficult steps toward systemic solutions. Carbon removal and especially solar geoengineering are only the latest example of such technologies. We here explore green moral hazards throughout American history. We argue that dismissing (solar) geoengineering on moral hazard grounds is often unproductive. Instead, especially those vehemently opposed to the technology should use it as an opportunity to (...) expand the attention paid to the underlying environmental problem in the first place, actively invoking its opposite: ‘inverse moral hazards’. (shrink)

Guidelines for health research focus on protecting individual research subjects. It is also vital to protect the communities involved in health research. In particular, a number of studies have been criticized on the grounds that they exploited host communities. The present paper attempts to address these concerns by providing an analysis of community exploitation and, based on this analysis, determining what safeguards are needed to protect communities in health research against exploitation. (edited).

Cognitive and biological theories of emotion consider surprise as an emotional response to unexpected events. Four experiments examined the latency and the duration of one behavioural component of surprise: The interruption of ongoing action. Participants were presented with an unannounced visual event—the appearance of new perceptual objects—during the execution of a continuous action—a rapid alternate finger tapping—which allowed a precise measurement of the latency, and the duration of an action interruption induced by the surprising event. Of the participants, 78% interrupted (...) the tapping with a mean latency of 214 ms and a mean duration of 995 ms. Variations of the number and perceptual heterogeneity of the new objects revealed that the perceptual analysis of the surprising event contributes significantly to the interruption duration. (shrink)

The standard approach to treatment decision making for incapacitated patients often fails to provide treatment consistent with the patient’s preferences and values and places significant stress on surrogate decision makers. These shortcomings provide compelling reason to search for methods to improve current practice. Shared decision making between surrogates and clinicians has important advantages, but it does not provide a way to determine patients’ treatment preferences. Hence, shared decision making leaves families with the stressful challenge of identifying the patient’s preferred treatment (...) option. To address this concern, the present paper proposes to incorporate the use of a “Patient Preference Predictor” (PPP) into the shared decision-making process between surrogates and clinicians. A PPP would predict which treatment option a given incapacitated patient would most likely prefer, based on the individual’s characteristics and information on what treatment preferences are correlated with these characteristics. Use of a PPP is likely to increase the chances that incapacitated patients are treated consistent with their preferences and values and might reduce the stress and burden on their surrogates. Including a PPP in the shared decision-making process therefore has the potential to realize important ethical goals for making treatment decisions for incapacitated patients. The present paper justifies this approach on conceptual and normative grounds. (shrink)

A primary goal of clinical practice is to respect patient autonomy. To promote this goal for patients who have lost the ability to make their own decisions, commentators recommend that surrogates make their treatment decisions based on the substituted judgment standard. This standard is commonly interpreted as directing surrogates to make the decision the patient would have made in the circumstances, if the patient were competent. However, recent commentators have argued that this approach—attempting to make the decision the patient would (...) have made if competent—is theoretically problematic, practically infeasible, and ignores the interests of the patient9s family and loved ones. These commentators conclude that the substituted judgment standard should be revised significantly, or abandoned altogether. While this response would avoid the cited problems, it also would require substantial changes to clinical practice and would raise significant problems of its own. The present paper thus considers the possibility that the criticisms do not point to problems with the substituted judgment standard itself; instead, they point to problems with the way it is most commonly interpreted. This analysis suggests that the substituted judgment standard need not be dramatically revised or abandoned. Instead, it should be interpreted in a way that effectively promotes respect for the autonomy of incompetent patients. The ‘endorsed life’ interpretation described here helps clinicians and surrogates to achieve this important goal. To clarify this approach, we explain how it differs from three other recently proposed alternatives to the standard interpretation of the substituted judgment standard. (shrink)

Die zentrale Rolle des Gedächtnisses in der Entwicklung von Lebewesen wurde von Biologen wie Ernst Haeckel, Ewald Hering und Jakob von Uexküll erkannt, wobei zwischen einem Artgedächtnis und einem individuellen Gedächtnis unterschieden wird. Ersteres ist für die Aufrechterhaltung und Weiterentwicklung einer artspezifischen Erscheinungsform verantwortlich, letzteres gestaltet die Erinnerung an individuelle Erfahrungen. Im vorliegenden Band werden die Vorstellungen dieser Biologen mit Ideen der Philosophen G.W.F. Hegel, Alfred N. Whitehead, John Dewey, Ernst Cassirer, Henri Bergson und Reto L. Fetz in einer kohärenten (...) Theorie der Organismen, die auch den Menschen und seine Geschichte umfasst, aufeinander abgestimmt. (shrink)

The properties of the phosphate uptake system of the cyanobacterium Anacystis nidulans have been studied during the transition from a phosphate-deficient non-growing state to a non-deficient growing state. In the phosphate-deficient state the high affinity phosphate transport system in the cell membrane is extremely adaptive. As a result of these adaptive features the phosphate transport system cannot be described by determinate, fixed parameters, because the transport system is influenced by the measurement of the uptake process itself. When the growing state (...) has been initiated by a persisting phosphate pulse, the transport system rapidly loses its adaptive features and can then be characterized by determinate parameters that remain unchanged for a long period of time, even if no uptake occurs in that time. Depending on the amount of phosphate stored during a pulse the cell makes a choice between slow or fast growth. In the latter case the light harvesting and energy converting machinery is completely reorganized before growth commences. Thereby the components of this machinery conform to each other and to the stable properties of the phosphate transport system. It is suggested that the mutual adjustment of these adaptive energy converting subunits is guided by attractors that function as the final cause for the development of the whole system.An application of this model to an analysis of the selforganization of aquatic ecosystems is discussed. (shrink)

Using a generalized conception of experience, from which all features characteristic for higher animals (such as consciousness and thought) have been removed, allowed relating experience to adaptive processes in lower organisms. The temporal vector character of every current experience, containing as well memories of past experiences as intentions for future activities, can then be found in the adaptive response of cyanobacteria to alterations in phosphate supply, particularly in energetic manifestations of this phenomenon. A possible analogy between adaptive events as the (...) “atomic units” of physiological adaptation and Whitehead's actual occasion of experience is discussed. (shrink)

In an everyday private practice setting, regularly also existential topics will emerge from doctor-patient encounters. These are often questions of coping with life and lifestyle. To enable a thorough discussion of such topics, an implicit, and sometimes also explicit reference to a philosophical background is needed. Philosophical concepts to be used in this realm are discussed. An individual patient-doctor interaction is used as an example to demonstrate the doctor’s choice of hermeneutical and phenomenological philosophical concepts.

In an everyday private practice setting, regularly also existential topics will emerge from doctor-patient encounters. These are often questions of coping with life and lifestyle. To enable a thorough discussion of such topics, an implicit, and sometimes also explicit reference to a philosophical background is needed. Philosophical concepts to be used in this realm are discussed. An individual patient-doctor interaction is used as an example to demonstrate the doctor’s choice of hermeneutical and phenomenological philosophical concepts.

It has recently been proposed to incorporate the use of a “Patient Preference Predictor” (PPP) into the process of making treatment decisions for incapacitated patients. A PPP would predict which treatment option a given incapacitated patient would most likely prefer, based on the individual’s characteristics and information on what treatment preferences are correlated with these characteristics. Including a PPP in the shared decision-making process between clinicians and surrogates has the potential to better realize important ethical goals for making treatment decisions (...) for incapacitated patients. However, developing and implementing a PPP poses significant practical challenges. The present paper discusses these practical challenges and considers ways to address them. (shrink)

ABSTRACTTo build a process model of the understanding of conditionals we extract a common core of three semantics of if-then sentences: the conditional event interpretation in the coherencebased probability logic, the discourse processingtheory of Hans Kamp, and the game-theoretical approach of Jaakko Hintikka. The empirical part reports three experiments in which each participant assessed the probability of 52 if-then sentencesin a truth table task. Each experiment included a second task: An n-back task relating the interpretation of conditionals to working memory, (...) a Bayesian bookbag and poker chip task relating the interpretation of conditionals to probability updating, and a probabilistic modus ponens task relating the interpretation of conditionals to a classical inference task. Data analysis shows that the way in which the conditionals are interpreted correlates with each of the supplementary tasks. The results are discussed within the process model proposed in the introduction. (shrink)

This essay raises a philosophical question concerning the language of Life Theory. It aims to prove the assumption that in contrast to Life Science, which today is connected to neuroscience and biotechnology, a theory that comprehends “life itself” must exceed the computerized mathematics of modern materialistic positivism. For this purpose, the conceptual possibility of such a theory is analysed from the perspective of 20th century philosophy of life. Beginning with Henri Bergson, who developed an immanent concept of life“from within itself” (...) in L’évolution créatrice, the analysis turns to Alain Badiou, whose fundamental onto-phenomenology of being is summed up in Logiques des mondes by answering the question “what is it to live”. The comparison between the two philosophies exposes the conditions of a Life Theory that encompasses, beyond the results of the digitalizable language translated from the neurons of the human brain, the uncountable and unpredictable aspects of living and being alive. These conditions are: an ethics of universality, a differential philosophy of time, and a concept of independent novelty enforced by the aesthetics of subjective creation. (shrink)

Summary This paper attempts to distinguish the methods of the constitution of a realm of scientific objects from the methods of their mathematical representation. In its investigations into the procedures for forming quantitative concepts analytical philosophy of science has thematized the numerical representation of empirical relational systems (metricizing). It is the task of an historical epistemology to identify the methods and historical processes through which relams of phenomena have been made representable in such a way (quantification). In preparing such investigations (...) conceptual distinctions are made, in particular between quantities and scales. (shrink)

During the recent Ebola epidemic, some commentators and stakeholders argued that it would be unethical to carry out a study that withheld a potential treatment from affected individuals with such a serious, untreatable disease. As a result, the initial trials of experimental treatments did not have control arms, despite important scientific reasons for their inclusion. In this paper, we consider whether the duty to rescue entails that it would be unethical to withhold an experimental treatment from patient-participants with serious diseases (...) for which there are no effective treatments, even when doing so is scientifically necessary to test the effectiveness of the treatment. We argue that the duty to rescue will rarely apply. The context of medical research also throws new light on the content of the duty to rescue, since the interests of future patients—who stand to benefit from the fruits of medical research—are relevant to whether the duty applies. (shrink)

The author asks about the conceptual tools which would enable a critique of contemporary capitalism without falling back to Utopianism and its historically-discredited theses. With the help of paired categories like community–society, human dignity–self-awareness, need–desire, Gernot Böhme portrays the deficiencies of contemporary Western social reality, e.g. the steadily exhausting reserves of the highly-bureaucratised welfare state system, the rapidly mounting differences in income, or the negative moral and psychological effects of unemployment and the so-called precariat. Böhme presents his critique of (...) “aesthetic capitalism,” which does not satisfy human needs in the Marxist sense but rather the aesthetically-refined consumer desires of today’s affluent societies, in reference to the views of contemporary critical theory authorities. (shrink)

When patients cannot make their own treatment decisions, surrogates typically step in to do it for them. Surrogate decision‐making is far from ideal, of course, as the surrogate may not know what the patient prefers or what best promotes her interests. One way to improve it would be to arm surrogates with information about what patients in similar circumstances tend to prefer, allowing them to make empirically grounded predictions about what their patient would want.

It is widely held that individuals who are unable to provide informed consent should be enrolled in clinical research only when the risks are low, or the research offers them the prospect of direct benefit. There is now a rich literature on when the risks of clinical research are low enough to enroll individuals who cannot consent. Much less attention has focused on which benefits of research participation count as ‘direct’, and the few existing accounts disagree over how this crucial (...) concept should be defined. This disagreement raises concern over whether those who cannot consent, including children and adults with severe dementia, are being adequately protected. The present paper attempts to address this concern by considering first what additional protections are needed for these vulnerable individuals. This analysis suggests that the extant definitions of direct benefits either provide insufficient protection for research subjects or pose excessive obstacles to appropriate research. This analysis also points to a modified definition of direct benefits with the potential to avoid these two extremes, protecting individuals who cannot consent without blocking appropriate research. (shrink)

The U.S. Federal regulations allow institutional review boards (IRBs) to approve non-beneficial pediatric research when the risks are a minor increase over minimal, provided that the research is likely to develop generalizable knowledge about the subjects' disorder or condition. This “subjects' condition” requirement is quite controversial; commentators have argued for a variety of interpretations. Despite this considerable disagreement in the literature, there have not been any attempts to apply principles of legal interpretation to determine how the subjects' condition requirement should (...) be understood. (shrink)