Using mobile health research as an extended example, this article provides an overview of when the Common Rule “applies” to a variety of activities, what might be meant when one says that the Common Rule does or does not “apply,” the extent to which these different meanings of “apply” matter, and, when the Common Rule does apply, how it applies.

In this consensus report by a diverse group of academics who conduct and/or are concerned about social and behavioral genomics (SBG) research, the authors recount the often‐ugly history of scientific attempts to understand the genetic contributions to human behaviors and social outcomes. They then describe what the current science—including genomewide association studies and polygenic indexes—can and cannot tell us, as well as its risks and potential benefits. They conclude with a discussion of responsible behavior in the context of SBG research. (...) SBG research that compares individuals within a group according to a “sensitive” phenotype requires extra attention to responsible conduct and to responsible communication about the research and its findings. SBG research (1) on sensitive phenotypes that (2) compares two or more groups defined by (a) race, (b) ethnicity, or (c) genetic ancestry (where genetic ancestry could easily be misunderstood as race or ethnicity) requires a compelling justification to be conducted, funded, or published. All authors agree that this justification at least requires a convincing argument that a study's design could yield scientifically valid results; some authors would additionally require the study to have a socially favorable risk‐benefit profile. (shrink)

Many feel the Common Rule treats an unwieldy range of activities identically under the monolithic label "human subjects research." Past objections centering on the conflation of biomedical and behavioral research have gained new currency with the increase in biobanking and Internet-based research. A more nuanced approach to research is overdue. Regulation will no doubt remain a major component of any new approach. But in some research contexts, investigators and subjects should be permitted to reach voluntary, informed agreements about certain aspects (...) of their relationship.Consider the National Institutes of Health's new "Guidelines for Human Stem Cell Research."1 The guidelines owe their existence to the NIH's .. (shrink)

Many assumed that the Obama administration would usher in a sea change from the previous administration by expanding NIH support for human embryonic stem cell (hESC) research and reducing the patchwork of state and federal regulations that currently governs it. This article examines the extent to which NIH’s new Guidelines are likely to accomplish these goals.

As a recent special report in the Hastings Center Report demonstrates, many bioethicists are rethinking the way we regulate both biomedical research and clinical practice, as well as the sharp boundary that the field has assumed can and should exist between them. Such a rethinking is long overdue. There is surely a meaningful normative distinction between activities whose expected risk‐benefit profile is and is not “reasonable” for participants (to echo the language in the Common Rule—the core set of human research (...) guidelines found in many federal regulations). But neither the research‐practice distinction nor the criteria underlying it—the intention of the actor, whether the activity is “systematic,” and whether its results are “generalizable”—closely track good and bad outcomes for research participants and patients or justify either the bureaucratic, paternalistic licensing system that governs human subjects research or the comparatively lax governance of medical practice. The specious distinction between research and practice is especially ripe for dismantling in light of the embarrassing fact that evidence‐based medicine remains more aspiration than reality. (shrink)

Bioethicists frequently call for empirical researchers to engage participants and community members in their research, but don't themselves typically engage community members in their normative research. In this article, we describe an effort to include members of the public in normative discussions about the risks, potential benefits, and ethical responsibilities of social and behavioral genomics (SBG) research. We reflect on what might—and might not— be gained from engaging the public in normative scholarship and on lessons learned about public perspectives on (...) the risks and potential benefits of SBG research and the responsible conduct and communication of such research. We also provide procedural lessons for others in bioethics who are interested in engaging members of the public in their research. (shrink)

Since 2011, the research community had waited with bated breath as regulators contemplated for the first time bringing secondary research with nonidentifiable biospecimens under the Common Rule and dramatically tightening the criteria for waiving consent to biospecimen research. After considerable pushback from both researchers and patients and amid rumors of intractable disagreement among Common Rule agencies, the Final Rule published on the last day of President Obama's administration left out these troubling changes, and there was a collective sigh of relief. (...) Relief is appropriate, but celebration premature: researchers have little reason to avail themselves of the new broad consent option offered in the Final Rule, and the question of whether biospecimens ought to be treated as inherently identifiable has merely been postponed. (shrink)

Hastings Center Report, Volume 52, Issue 1, Page 51-58, January/February 2022.

Researchers and practitioners are increasingly using machine‐generated synthetic data as a tool for advancing health science and practice, by expanding access to health data while—potentially—mitigating privacy and related ethical concerns around data sharing. While using synthetic data in this way holds promise, we argue that it also raises significant ethical, legal, and policy concerns, including persistent privacy and security problems, accuracy and reliability issues, worries about fairness and bias, and new regulatory challenges. The virtue of synthetic data is often understood (...) to be its detachment from the data subjects whose measurement data is used to generate it. However, we argue that addressing the ethical issues synthetic data raises might require bringing data subjects back into the picture, finding ways that researchers and data subjects can be more meaningfully engaged in the construction and evaluation of datasets and in the creation of institutional safeguards that promote responsible use. (shrink)

Researchers and practitioners are increasingly using machine-generated synthetic data as a tool for advancing health science and practice, by expanding access to health data while—potentially—mitigating privacy and related ethical concerns around data sharing. While using synthetic data in this way holds promise, we argue that it also raises significant ethical, legal, and policy concerns, including persistent privacy and security problems, accuracy and reliability issues, worries about fairness and bias, and new regulatory challenges. The virtue of synthetic data is often understood (...) to be its detachment from the data subjects whose measurement data is used to generate it. However, we argue that addressing the ethical issues synthetic data raises might require bringing data subjects back into the picture, finding ways that researchers and data subjects can be more meaningfully engaged in the construction and evaluation of datasets and in the creation of institutional safeguards that promote responsible use. (shrink)

L'Histoire s'accélère aujourd'hui à un rythme inégalé. Jamais les réponses d'hier, ou même d'aujourd'hui, n'ont semblé à ce point problématiques à ceux qui les vivent, et parfois en souffrent. Mais à quelle logique répond cette historicité qui est notre lot quotidien? Si l'Histoire ne répond à aucune finalité ultime qu'on puisse dégager, contrairement à ce que pensaient Hegel et Marx, est-ce à dire que rien ne peut expliquer les variations historiques? L'Europe connaît actuellement une grande crise, voire un déclin, provoqué (...) par les deux guerres mondiales. La démographie, l'inventivité, la mort des élites, la compétitivité, la création, tout semble faire question. Connaîtrons-nous le même destin que celui de la Grèce, après les guerres fratricides décrites par Thucydide? Ou celui de l'Europe centrale après la guerre de Trente Ans? Tout cela pose la seule vraie question : qu'est-ce que l'Histoire? Le livre de Michel Meyer permet, grâce à la philosophie du questionnement qui lui est associée (la problématologie), de fonder une nouvelle approche de l'Histoire et d'analyser les gouffres auxquels elle livre ceux qui ont à la vivre de plus en plus violemment. (shrink)

La réalité est au centre du débat en science comme en philosophie. De l'infiniment petit à l'infiniment grand, de la mécanique quantique à la relativité, les conceptions s'affrontent, et parfois se complètent. Que peut nous dire le philosophe sur ces questions? Pour y répondre, Michel Meyer a développé une approche nouvelle, la problématologie ou théorie du questionnement. Le savant interroge le réel, se livre à des expériences qui sont des mises à l'épreuve d'alternatives, tout comme l'homme de la rue (...) affronte le réel, qui n'est jamais donné, en l'interrogeant également. Mais en quoi consiste une pensée qui ne se mesure plus à l'aune du jugement, mais au questionnement dont il est issu? Michel Meyer élabore ici une systématisation de l'interrogativité, qui oblige à repenser les catégories aussi bien que les principes de l'esprit humain qui servent à concevoir la réalité scientifique mais aussi quotidienne. La réalité n'est pas tant un contenu, toujours variable d'époque à époque, qu'une fonction, celle qui permet de maintenir la différence entre nos questions, voire nos souhaits, et les réponses qui s'en détachent, pour valoir comme telles. (shrink)

After decades of neglect, positive emotion is now the focus of a rich, diverse, and rapidly growing field. Basic research has advanced understanding of positive emotions’ neural mechanisms, nonverbal expression, and implications for cognition and motivation, with increasing appreciation of positive emotion differentiation, as well as cultural and contextual moderators of positive emotions’ effects. Much research has also addressed ways positive emotions can be leveraged to improve the human condition, and the mechanisms by which interventions have beneficial effects. As always, (...) new knowledge raises more questions, and we still have a long way to go before the promise of this field can be fully realized. This comment reviews major developments in positive emotion science and offers recommendations for the future. (shrink)

Awe has been defined as an emotional response to perceptually vast stimuli that overwhelm current mental structures, yet facilitate attempts at accommodation. Four studies are presented showing the information-focused nature of awe elicitors, documenting the self-diminishing effects of awe experience, and exploring the effects of awe on the content of the self-concept. Study 1 documented the information-focused, asocial nature of awe elicitors in participant narratives. Study 2 contrasted the stimulus-focused, self-diminishing nature of appraisals and feelings associated with a prototypical awe (...) experience with the self-focused appraisals and feelings associated with pride. Study 3 found that dispositional awe-proneness, but not dispositional joy or pride, was associated with low Need for Cognitive Closure, and also documented a relationship between dispositional awe and increased emphasis on membership in “universal” categories in participants’ self-concepts. Study 4 replicated the self-concept finding from Study 3 using experimentally elicited awe. Implications for future work on awe are discussed. (shrink)

Physiologically accurate mouse models of cancer are critical in the pre‐clinical development of novel cancer therapies. However, current standardized animal‐housing temperatures elicit chronic cold‐associated stress in mice, which is further increased in the presence of tumor. This cold‐stress significantly impacts experimental outcomes. Data from our lab and others suggest standard housing fundamentally alters murine physiology, and this can produce altered immune baselines in tumor and other disease models. Researchers may thus underestimate the efficacy of therapies that are benefitted by immune (...) responses. A potential mediator, norepinephrine, also underlies stress pathways common in mice and humans. Therefore, research into mechanisms connecting cold‐stress and norepinephrine signaling with immune depression in mice could highlight new combination therapies for humans to simultaneously target stress while stimulating anti‐tumor immunity. (shrink)

Previously conducted research has determined that physiological and psychophysiological communications evident during pregnancy are vital to the bond formed prenatally. These innate biological responses are further enhanced through psychophysiological factors, such as maternal prenatal stress, which attest to the essential communication between a mother and child in maternal–fetal attachment. A consideration of these factors is necessary with the increase in assisted reproductive technology, such as in vitro fertilization, surrogacy, and elective cesarean section, as this may affect the development of the (...) maternal–fetal bond. It would be of benefit to the child, the mother, and every society to seek a more complete understanding of the intricate maternal–fetal bond, as the first friendship developed at the beginning of human life. (shrink)

Studies suggest that emotional complexity—the experience of positive and negative emotion in response to the same event—is unusual in Western samples. However, recent research finds that the co-occurrence of positive and negative emotion during unstructured situations is more common among East Asians than Westerners, consistent with theories emphasising the prevalence of dialectical folk epistemology in East-Asian culture. The present study builds upon previous research by examining Asian- and European-Americans' experience of a particular positive emotion—love—and a situationally appropriate negative emotion during (...) four structured laboratory conversations with their romantic partner. Among Asian Americans, love and the experience of negative emotion were typically less negatively correlated during these conversations than was true for European Americans. (shrink)

Comparative psychology assesses cognitive abilities and capacities of non-human animals and humans. Based on performance differences and similarities in various species in cognitive tests, it is inferred how their minds work and reconstructed how cognition might have evolved. Critically, such species comparisons are only valid and meaningful if the tasks truly capture individual and inter-specific variation in cognitive abilities rather than contextual variables that might affect task performance. Unlike in human test psychology, however, cognitive tasks for non-human primates (and most (...) other animals) have been rarely evaluated regarding their measurement validity. We review recent studies that address how non-cognitive factors affect performance in a set of commonly used cognitive tasks, and if cognitive tests truly measure individual variation in cognitive abilities. We find that individual differences in emotional and motivational factors primarily affect performance via attention. Hence, it is crucial to systematically control for attention during cognitive tasks to obtain valid and reliable results. Aspects of test design, however, can also have a substantial effect on cognitive performance. We conclude that non-cognitive factors are a minor source of measurement error if acknowledged and properly controlled for. It is essential, however, to validate and eventually re-design several primate cognition tasks in order to ascertain that they capture the cognitive abilities they were designed to measure. This will provide a more solid base for future cognitive comparisons within primates but also across a wider range of non-human animal species. (shrink)

Non-fiction graphic novels about illness and death created by patients and their loved ones have much to teach all readers. However, the bond of empathy made possible in the comic form may have special lessons for healthcare providers who read these texts and are open to the insights they provide.

When testing primates with cognitive tasks, it is usually not considered that subjects differ markedly in terms of emotional reactivity toward the experimenter, which potentially affects a subject’s cognitive performance. We addressed this issue in common marmosets (Callithrix jacchus), a monkey species in which males tend to show stronger emotional reactivity in testing situations, whereas females have been reported to outperform males in cognitive tasks. In a two-phase experiment, we first quantified the emotional reactivity of 14 subjects toward four different (...) experimenters performing a standardized behavioral action sequence and then assessed whether and how it affected the subjects’ participation and performance in a subsequent object permanence task. A test session was terminated if a subject refused to make a choice in four consecutive trials. Highly emotionally aroused individuals, particularly males, were less likely to participate in the cognitive task and completed fewer trials. However, whenever they did participate and were attentive to the task, their performance was not affected. Our results suggest that differences in emotional reactivity toward an experimenter have no major impact on cognitive performance if strict criteria are applied on when to abandon a test session and if performance is corrected for attention to the test procedure. Furthermore, they suggest that the reported sex differences in cognitive performance in marmosets may be owing to motivational and attentional factors, rather than a difference in cognitive ability per se. (shrink)

This dissertation urges philosophers to reevaluate how they frame the question of the rationality of moral action. Its motivation is the thought that approaches to the question have suffered from mistakes in the relata. On the part of theories of practical reason, philosophers adopt an inadequate theory of action. On the part of moral theory, philosophers hold narrow conceptions of moral worth. As a result, not only have we failed to vindicate the thought that the moral agent acts well, our (...) conception of moral action invites the charge of remoteness from human life. ;In response, I propose we abandon some dogmas of moral psychology. My rethinking proceeds, negatively, by rejecting desire-based instrumentalist accounts of practical rationality and, positively, from renewed attention to virtuous action, a focus some suggest might counteract the remoteness of which morality's critics complain. I attend to the virtue of true friendship to defend non-instrumental conceptions of moral psychology and practical rationality that bring both into closer contact with commonsense norms of admirable action as they bear on what agents have reason to do. ;Chapter 1 introduces desire-based instrumentalism as the theory proponents claim is best suited to avoid the problem of the alienation of practical reason. I argue their claim does not survive scrutiny. ;In Chapter 2 I distinguish between explicit desiderative content and desiderative framing versions of desire-based instrumentalism. I argue the former is false to the content of deliberation and that arguments from the nature of intentional action fail to support the latter. ;Chapter 3 examines the evaluatively non-detachable quality of the descriptions under which actions performed out of friendship are intentional. I develop an account of virtuous action as nonteleologically ally motivated action understood in terms not of what it brings about but of its expressive quality. I argue action's expressive quality is key to assessing moral worth and rationality. ;Chapter 4 develops my account of virtuous agents' reasons for acting and asks what earns expressive action its claim to rationality. I argue certain actions inherit their rationality by expressing dispositions to regulate practical attitudes , dispositions themselves rationally assessable. (shrink)

The presence of general intelligence poses a major evolutionary puzzle, which has led to increased interest in its presence in nonhuman animals. The aim of this review is to critically evaluate this question and to explore the implications for current theories about the evolution of cognition. We first review domain-general and domain-specific accounts of human cognition in order to situate attempts to identify general intelligence in nonhuman animals. Recent studies are consistent with the presence of general intelligence in mammals (rodents (...) and primates). However, the interpretation of a psychometricgfactor as general intelligence needs to be validated, in particular in primates, and we propose a range of such tests. We then evaluate the implications of general intelligence in nonhuman animals for current theories about its evolution and find support for the cultural intelligence approach, which stresses the critical importance of social inputs during the ontogenetic construction of survival-relevant skills. The presence of general intelligence in nonhumans implies that modular abilities can arise in two ways, primarily through automatic development with fixed content and secondarily through learning and automatization with more variable content. The currently best-supported model, for humans and nonhuman vertebrates alike, thus construes the mind as a mix of skills based on primary and secondary modules. The relative importance of these two components is expected to vary widely among species, and we formulate tests to quantify their strength. (shrink)

Understanding positive emotions' shared and differentiating features can yield valuable insight into the structure of positive emotion space and identify emotion states, or aspects of emotion states, that are most relevant for particular psychological processes and outcomes. We report two studies that examined core relational themes (Study 1) and expressive displays (Study 2) for eight positive emotion constructs—amusement, awe, contentment, gratitude, interest, joy, love, and pride. Across studies, all eight emotions shared one quality: high positive valence. Distinctive core relational theme (...) and expressive display patterns were found for four emotions—amusement, awe, interest, and pride. Gratitude was associated with a distinct core relational theme but not an expressive display. Joy and love were each associated with a distinct expressive display but their core relational themes also characterised pride and gratitude, respectively. Contentment was associated with a distinct expressive display but not a core relational theme. The implications of this work for the study of positive emotion are discussed. (shrink)

Drug repurposing is a strategy of identifying new potential uses for already existing drugs. Many researchers adopted this method to identify treatment or prevention during the COVID-19 pandemic. However, despite the considerable number of repurposed drugs that were evaluated, only some of them were labeled for new indications. In this article, we present the case of amantadine, a drug commonly used in neurology that attracted new attention during the COVID-19 outbreak. This example illustrates some of the ethical challenges associated with (...) the launch of clinical trials to evaluate already approved drugs. In our discussion, we follow the ethics framework for prioritization of COVID-19 clinical trials proposed by Michelle N Meyer and colleagues (2021). We focus on four criteria: social value, scientific validity, feasibility, and consolidation/collaboration. We claim that launching amantadine trials was ethically justified. Although the scientific value was anticipated to be low, unusually, the social value was expected to be high. This was because of significant social interest in the drug. In our view, this strongly supports the need for evidence to justify why the drug should not be prescribed or privately accessed by interested parties. Otherwise, a lack of evidence-based argument could enhance its uncontrolled use. With this paper, we join the discussion on the lessons learned from the pandemic. Our findings will help to improve future efforts to decide on the launch of clinical trials on approved drugs when dealing with the widespread off-label use of the drug. (shrink)

Derrida's work testifies to the problematic state of contemporary thought. Questioning Derrida offers new explorations into Derrida's contribution to philosophy. Presenting contributions from prominent philosophers worldwide, this book explores many aspects of Derrida's philosophical perspective. With contributors commenting on a particular topic or defending alternative viewpoints, this book examines the work of Plato, Hegel, Aristotle, Heidegger and also the philosophy of science. Focusing on 'problematology' - a conception of philosophy as questioning - the contributors explore this new way of 'doing' (...) philosophy. Including a concluding chapter from Derrida himself, this book presents Derrida in question and Derrida and his answers and opens new debate for readers across the fields of philosophy and literature, particularly those exploring the work of Derrida, issues in continental philosophy, and the theory of questioning. (shrink)

English summary: Theater allows people to examine important problems with sufficient distance in order to judge fairly without feeling directly implicated. Michel Meyer offers a much needed history of theater, from its earliest Greek beginnings, through the Middle Ages, Enlightenment, to the absurd works of Beckett or Sartre, while remembering the context of other supporting arts. French description: Le theatre est, avec l'epopee, la plus ancienne forme de litterature en Occident. Son but est de creer de la distance avec (...) des situations problematiques, liees au pouvoir, au divin, aux dilemmes moraux, afin de permettre au spectateur de faire le bon jugement sans se sentir directement implique. Michel Meyer envisage toutes les theories du theatre, a commencer par celle d'Aristote, qui se sont succede jusqu'a aujourd'hui et les confronte a l'histoire meme du theatre. Eschyle, Sophocle, Euripide, Aristophane, Marlowe, Machiavel, Shakespeare, Racine et le theatre classique francais, le theatre baroque espagnol, le romantisme, le realisme, d'Ibsen a Tchekhov et a Pirandello, comme le theatre de l'absurde, avec Ionesco, Beckett ou Sartre, tout est etudie, articule, et remis en perspective. La rationalite dans l'histoire du theatre est clairement mise en evidence, sans jamais negliger ce que le theatre doit ou apporte aux autres arts les plus proches, comme l'opera. Michel Meyer offre ici une synthese spectaculaire et une erudition sans precedent sur le phenomene theatre en un ouvrage court et percutant, plein d'idees nouvelles. (shrink)

Ce traité élabore de nouveaux fondements pour repenser la philosophie. Il intègre les grandes révolutions scientifiques du XXe siècle, comme la psychanalyse, la relativité et la mécanique quantique.

Contemporary or postmodern thought is based on the lack of foundation. The impossibility of having a principle for philosophy has become a position of principle. As a result, rhetoric has taken over. Content has given way to the priority of form. Michel Meyer's book aims at showing that philosophy as foundational is possible and necessary, and that rhetoric can flourish alongside, but the conception of reason must be changed. Questioning rather than answering must be considered as the guiding principle. (...) What the author calls "problematology" is not only the study of questioning but also the analysis of the reasons why it has been repressed throughout the history of philosophy. Since Socrates, philosophers and scientists have reasoned by asking questions and by trying to solve them. Questioning has been the unthematized foundation of philosophy and thought at large. Philosophers, however, have preferred another norm, granting privilege to the answers and thereby repressing the questions into the realm of the preliminary and unessential. They have not considered their discursive practice as being based upon some question-answer complex, but exclusively on the results they call propositions. Meyer argues that propositions ensue from corresponding questions, and not the other way around. Anthropology, ontology, reasoning, and language thus receive a new interpretation in the problematological conception of philosophy, a conception in which questions and problems are thematized afresh. The theory of language in everyday use, in argumentation, or in literary analysis receives a full and decisive treatment here, making Meyer's question-view one of the leading theories in contemporary thought, alongside his rhetoric for which he is already well known. (shrink)

For the passions represent a force of excess and lawlessness in humanity that produces troubling, confusing paradoxes.In this book, noted European philosopher Michel Meyer offers a wide-ranging exegesis, the first of its kind, that ...

Michel Meyer offers a new beginning for philosophy rooted in a theory of questioning that he calls "problematology." Meyer argues that a new beginning is necessary in order to resituate philosophy, science, and linguistic analysis, and he proposes a global view of rationality by returning to the nature of questioning itself. For Meyer, philosophy does not solve problems or give answers but instead shows how propositions are related to a whole field of questions that give them meaning. (...) Reason is identified not with answers but with the question-answer process. Meyer pursues this new theory of reason and meaning in a critique of Western philosophy from Socrates, Plato, and Aristotle through Heidegger, Wittgenstein, and Foucault. He provides a detailed analysis of Descartes' notion of radical doubt and demonstrates its implications for the subsequent philosophical tradition that ignored the questioning process while pursuing an unshakable foundation for knowledge. Meyer argues that recent work in rhetoric points toward a theory of radical questioning and claims that the methods of rhetoric and argumentation must be turned back on philosophy itself in order to recover the original significance of metaphysics as the science of ultimate questions. (shrink)