Abstract:Human and animal research both operate within established standards. In the United States, criticism of the human research environment and recorded abuses of human research subjects served as the impetus for the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and the resulting Belmont Report. The Belmont Report established key ethical principles to which human research should adhere: respect for autonomy, obligations to beneficence and justice, and special protections for vulnerable individuals and (...) populations. While current guidelines appropriately aim to protect the individual interests of human participants in research, no similar, comprehensive, and principled effort has addressed the use of (nonhuman) animals in research. Although published policies regarding animal research provide relevant regulatory guidance, the lack of a fundamental effort to explore the ethical issues and principles that should guide decisions about the potential use of animals in research has led to unclear and disparate policies. Here, we explore how the ethical principles outlined in the Belmont Report could be applied consistently to animals. We describe how concepts such as respect for autonomy and obligations to beneficence and justice could be applied to animals, as well as how animals are entitled to special protections as a result of their vulnerability. (shrink)

The devastating impact of the national opioid epidemic has given rise to hundreds of lawsuits. This article details the extremely broad range of legal claims, compares the opioid cases to other public health litigation efforts, including tobacco, and describes the special mechanism — a multidistrict litigation — through which more than 700 opioid-related cases have been consolidated thus far, with settlement almost certain to follow.

How far does a researcher’s responsibility extend when an incidental finding is identified? Balancing pertinent ethical principles such as beneficence, respect for persons, and duty to rescue is not always straightforward, particularly in neuroimaging research where empirical data that might help guide decision making are lacking. We conducted a systematic survey of perceptions and preferences of 396 investigators, research participants, and Institutional Review Board members at our institution. Using the partial entrustment model as described by Richardson, we argue that our (...) data supports universal reading by a neuroradiologist of all research MRI scans for incidental findings and providing full disclosure to all participants. (shrink)

This is a comprehensive review of the psychological literature on wisdom by leading experts in the field. It covers the philosophical and sociocultural foundations of wisdom, and showcases the measurement and teaching of wisdom. The connection of wisdom to intelligence and personality is explained alongside its relationship with morality and ethics. It also explores the neurobiology of wisdom, its significance in medical decision-making, and wise leadership. How to develop wisdom is discussed and practical information is given about how to instil (...) it in others. The book is accessible to a wide readership and includes virtually all of the major theories of wisdom, as well as the full range of research on wisdom as it is understood today. It takes both a basic-science and applied focus, making it useful to those seeking to understand wisdom scientifically, and to those who wish to apply their understanding of wisdom to their own work. (shrink)

The COVID-19 pandemic laid bare systemic inequities shaped by social determinants of health (SDoH). Public health agencies, legislators, health systems, and community organizations took notice, and there is currently unprecedented interest in identifying and implementing programs to address SDoH. This special issue focuses on the role of medical-legal partnerships (MLPs) in addressing SDoH and racial and social inequities, as well as the need to support these efforts with evidence-based research, data, and meaningful partnerships and funding.

Here is Lukcs among his friends, lovers, and peers in those important years before 1918, when he converted to Communism and Marxism at the age of thirty-nine.

On December 15, 2011, a final report was issued by the Committee on the Use of Chimpanzees in Biomedical and Behavioral Research, which had been convened by the U. S. Institute of Medicine (IOM) in collaboration with National Research Council (NRC) of the National Academies. Within a month of its release, this report was designated by Wired Science one of the “top scientific discoveries of 2011” (Wired Science Staff 2011). The ad hoc Committee responsible for this report was formed at (...) the request of the National Institutes of Health (NIH) in response to congressional inquiry that had been prompted by expressions of public concern.1 The issues addressed in the report are profoundly ethical, despite NIH’s .. (shrink)

Specialists and primary care physicians play an integral role in treating the twin epidemics of pain and addiction. But inadequate access to specialists causes much of the treatment burden to fall on primary physicians. This article chronicles the differences between treatment contexts for both pain and addiction — in the specialty and primary care contexts — and derives a series of reforms that would empower primary care physicians and better leverage specialists.

In the relatively short time since 2006—when Theoretical Medicine and Bioethics published an issue on moral issues relevant to the use of nonhuman animals in research [1]—significant changes have occurred for nonhuman animals in many quarters. Public sentiment, new policy initiatives, and scientific studies of nonhuman animals’ capacities have all influenced the ways in which nonhuman animals are perceived and treated in research. Today, a large body of information is available for use in decision making about the acceptability of using (...) nonhuman animals in research. The articles in this issue assess how moral argument and empirical studies stand to guide animal research policies and practices in future years.Many in bioethics have come to regard issues of animal research as a subfield of research ethics, bringing it closer to human research ethics. Animal ethics, like public health ethics, has struggled for recognition in bioethics. As the contributions to this issue show, some in bioe. (shrink)

The first set of case studies on animal use, this volume offers a thorough, up-to-date exploration of the moral issues related to animal welfare. Its main purpose is to examine how far it is ethically justifiable to harm animals in order to benefit mankind. An excellent introduction provides a framework for the cases and sets the background of philosophical and moral concepts underlying the subject. Sixteen original, previously unpublished essays cover controversies associated with the human use of animals in a (...) broad range of contexts, including biomedical, behavioral, and wildlife research, cosmetic safety testing, education, the food industry, commerce, and animal use as pets and in religious practices. Scientific research is accorded the closest scrutiny. The authors represent a wide range of expertise within their specialized areas of research--physiology, public policy, ethics, philosophy, law, veterinary science, and psychology. The careful analysis of each case makes it possible to elevate the discourse beyond over-simplified positions, and to demonstrate the complexity of the issues. The Human Use of Animals will be welcomed by students and faculty in law, philosophy, ethics, public policy, religion, medicine, and veterinary medicine. It will also interest activists in the animal protection movement, and members of animal protection organizations and Institutional Animal Care and Use Committees. (shrink)

A long history of research has revealed many neurophysiological changes and concomitant behavioral impacts of sleep deprivation, sleep restriction, and circadian rhythms. Little research, however, has been conducted in the area of computational cognitive modeling to understand the information processing mechanisms through which neurobehavioral factors operate to produce degradations in human performance. Our approach to understanding this relationship is to link predictions of overall cognitive functioning, or alertness, from existing biomathematical models to information processing parameters in a cognitive architecture, leveraging (...) the strengths from each to develop a more comprehensive explanation. The integration of these methodologies is used to account for changes in human performance on a sustained attention task across 88 h of total sleep deprivation. The integrated model captures changes due to time awake and circadian rhythms, and it also provides an account for underlying changes in the cognitive processes that give rise to those effects. The results show the potential for developing mechanistic accounts of how fatigue impacts cognition, and they illustrate the increased explanatory power that is possible by combining theoretical insights from multiple methodologies. (shrink)

Modern science’s ability to produce, store, and analyze big datasets is changing the way that scientific research is practiced. Philosophers have only begun to comprehend the changed nature of scientific reasoning in this age of “big data.” We analyze data-focused practices in biology and climate modeling, identifying distinct species of data-centric science: phenomena-laden in biology and phenomena-agnostic in climate modeling, each better suited for its own domain of application, though each entail trade-offs. We argue that data-centric practices in science are (...) not monolithic because the opportunities and challenges presented by big data vary across scientific domains. (shrink)

The spacing effect is among the most widely replicated empirical phenomena in the learning sciences, and its relevance to education and training is readily apparent. Yet successful applications of spacing effect research to education and training is rare. Computational modeling can provide the crucial link between a century of accumulated experimental data on the spacing effect and the emerging interest in using that research to enable adaptive instruction. In this paper, we review relevant literature and identify 10 criteria for rigorously (...) evaluating computational models of the spacing effect. Five relate to evaluating the theoretic adequacy of a model, and five relate to evaluating its application potential. We use these criteria to evaluate a novel computational model of the spacing effect called the Predictive Performance Equation. Predictive Performance Equation combines elements of earlier models of learning and memory including the General Performance Equation, Adaptive Control of Thought—Rational, and the New Theory of Disuse, giving rise to a novel computational account of the spacing effect that performs favorably across the complete sets of theoretic and applied criteria. We implemented two other previously published computational models of the spacing effect and compare them to PPE using the theoretic and applied criteria as guides. (shrink)

Robustness with respect to climate models is often considered by philosophers of climate science to be a crucial issue in determining whether and to what extent the projections of the Earth’s future climate that models yield should be trusted. Parker (2011) and Lloyd (2009, 2015) have introduced influential accounts of robustness for climate models with seemingly conflicting conclusions. I argue that Parker and Lloyd are characterizing distinct notions of robustness and providing complementary insights. Confidence, if warranted, need be by virtue (...) of causally consistent climate models rather than by agreement upon projections by a diverse range of models. (shrink)

It is correctly asserted that the intensity of the current debate over the use of animals in biomedical research is unprecedented. The extent of expressed animosity and distrust has stunned many researchers. In response, researchers have tended to take a strategic defensive posture, which involves the assertion of several abstract positions that serve to obstruct resolution of the debate. Those abstractions include the notions that the animal protection movement is trivial and purely anti-intellectual in scope, that all science is good (...) (and some especially so), and the belief that an ethical consensus can never really be reached between the parties. (shrink)

Debriefing is a standard ethical requirement for human research involving the use of deception. Little systematic attention, however, has been devoted to explaining the ethical significance of debriefing and the specific ethical functions that it serves. In this article, we develop an account of debriefing as a tool of moral accountability for the prima facie wrong of deception. Specifically, we contend that debriefing should include a responsibility to promote transparency by explaining the deception and its rationale, to provide an apology (...) to subjects for infringing the principle of respect for persons, and to offer subjects an opportunity to withdraw their data. We also present recommendations concerning the discussion of deception in scientific articles reporting the results of research using deception. (shrink)

Although gender differences in attitudes toward animal research have been reported in the literature for some time, exploration into the nature of these differences has received less attention. This article examines gender differences in responses to a survey of attitudes toward the use of animals in research. The survey was completed by college students and consisted of items intended to tap different issues related to the animal research debate. Results indicated that women were more likely than men to support tenets (...) of the animal protection movement. Likewise, women were more likely than men to favor increased restrictions on animal use and were more concerned than men about the suffering of research animals. Analysis of item contents suggested that women endorsed items reflecting a general caring for animals, were more willing than men to make personal sacrifices such as giving up meat and medical benefits in an effort to protect animals, and were more likely than men to question the use of animals in research on scientific grounds. Men, on the other hand, tended to emphasize the potential benefits arising from the use of animals in research. (shrink)

Firearm injury in the United States is a public health crisis in which physicians are uniquely situated to intervene. However, their ability to mitigate harm is limited by a complex array of laws and regulations that shape their role in firearm injury prevention. This piece uses four clinical scenarios to illustrate how these laws and regulations impact physician practice, including patient counseling, injury reporting, and the use of court orders and involuntary holds. Unintended consequences on clinical practice of laws intended (...) to reduce firearm injury are also discussed. Lessons drawn from these cases suggest that physicians require more nuanced education on this topic, and that policymakers should consult front-line healthcare providers when designing firearm policies. (shrink)

To function well in an unpredictable environment using unreliable components, a system must have a high degree of robustness. Robustness is fundamental to biological systems and is an objective in the design of engineered systems such as airplane engines and buildings. Cognitive systems, like biological and engineered systems, exist within variable environments. This raises the question, how do cognitive systems achieve similarly high degrees of robustness? The aim of this study was to identify a set of mechanisms that enhance robustness (...) in cognitive systems. We identify three mechanisms that enhance robustness in biological and engineered systems: system control, redundancy, and adaptability. After surveying the psychological literature for evidence of these mechanisms, we provide simulations illustrating how each contributes to robust cognition in a different psychological domain: psychomotor vigilance, semantic memory, and strategy selection. These simulations highlight features of a mathematical approach for quantifying robustness, and they provide concrete examples of mechanisms for robust cognition. (shrink)

Since 1985, the US Animal Welfare Act and Public Health Service policy have required that researchers using nonhuman primates in biomedical and behavioral research develop a plan “for a physical environment adequate to promote the psychological well-being of primates.” In pursuing this charge, housing attributes such as social companionship, opportunities to express species-typical behavior, suitable space for expanded locomotor activity, and nonstressful relationships with laboratory personnel are dimensions that have dominated the discussion. Regulators were careful not to direct a specific (...) set of prescriptions (i.e., engineering standards) for the attainment of these goals, but to leave the design of the programs substantially up to “professional judgment” at the local level. Recently, however, the Institute of Medicine, in its path-finding 2011 report on the necessity of chimpanzee use in research, bypassed this flexible and contingent concept, and instead, required as a central precondition that chimpanzees be housed in “ethologically appropriate” environments. In so doing, obligations of ethical treatment of one great ape species were elevated above the needs of some research. The evolution and significance of this change are discussed. (shrink)

Palliative care and medical-legal partnership are complementary disciplines dedicated to integrating care to treat the whole patient and intervening before a legal or medical issue is at a crisis point. In this paper, we discuss the founding and operations of the Yale Palliative Medical Legal Partnership, give examples of typical cases, explain special considerations in this area of law, and propose areas for further research.

This article examines five different Medical-Legal Partnerships associated with Yale Law School in New Haven, Connecticut to illustrate how MLP addresses the social determinants of poor health. These MLPs address varied and distinct health and legal needs of unique patient populations, including: 1) children; 2) immigrants; 3) formerly incarcerated individuals; 4) patients with cancer in palliative care; and 5) veterans. The article charts a research agenda to create the evidence base for quality and evaluation metrics, capacity building, sustainability, and best (...) practices; it also focuses specifically on a research agenda that identifies the value of the lawyers in MLP. Such a focus on the “L” has been lacking and is overdue. (shrink)

The next steps in health reform, like all such efforts before it, will have to engage the issue of American health care federalism – the relationship between the federal and state governments in the realm of health law and policy. Since its enactment in 2010, the Patient Protection and Affordable Care Act has offered a robust example of modern federalism and revealed new complexities. This article recounts the findings of our five-year study of the federalist and nationalist features of ACA (...) implementation. Contrary to the claims of ACA opponents that the law marked a federal “takeover,” the ACA's governance structures have advanced rather than suppressed state power. But we also found that the advances in state power occurred seemingly independently of the statute's structural arrangements; that is, the ACA's nationalist and federalist features both enhanced state power over health policy. These findings raise questions about whether cherished American federalism values are unique to federalist structures; they also raise the question of what exactly health care federalism is for, and why we continue to design health policy with federalism front and center. It is not clear that enhanced state power has brought better health policy. If it has not, is federalism for its own sake worth the trade-off? (shrink)

In a broad-based study of experiences in psychological research, 65 undergraduates participating in a wide range of psychological experiments were interviewed in depth. Overall findings demonstrated that participants hold varying views, with only 32% of participants characterizing their experiences as completely positive. Participants' descriptions of their debriefing experiences suggest substantial variability in the content, format, and general quality of debriefing practices. Just over 40% of the debriefing experiences were viewed favorably. Positive debriefing experiences were described as including a thorough explanation (...) of the study and detailed information concerning the broader relevance of the experiment to the field of psychology. The most common complaint, characterizing 28.8% of the responses, was that the debriefing was unclear and that insufficient information was provided. Participants' views of psychological research and the discipline of psychology were also elicited. Results are discussed in terms of ethical and methodological implications. (shrink)

Reconstructing Popper's research programme for the Human Sciences, Noretta Koertge (Inquiry, Vol. 18 [1975]) has given a deductive?nomological account of explanations of actions by means of a Rationality Principle. It is argued here that such a Rationality Principle is fundamentally redundant. Neither is it logically necessary in order to deduce a cognitive action?explanandum, nor can it be given a semantic non?empty interpretation, at least not within Koertge's own syllogism. Any attempt to save the Rationality Principle as unfalsifiablc but nevertheless indispensable (...) for action explanations is rejected in the light of possible alternative action explanations by empirical and therefore in principle falsifiable psychological laws. (shrink)

The federal government is funding a sea change in health care by investing in interventions targeting social determinants of health, which are significant contributors to illness and health inequity. This funding power has encouraged states, professional and accreditation organizations, health care entities, and providers to focus heavily on social determinants. We examine how this shift in focus affects clinical practice in the fields of oncology and emergency medicine, and highlight potential areas of reform.

In lieu of an abstract, here is a brief excerpt of the content:FDA Releases Draft Guidance on Regulation of Genetically Engineered AnimalsJohn P. Gluck (bio) and Mark T. Holdsworth (bio)On 18 September 2008, the U.S. Food and Drug Administration (FDA) issued a draft set of guidelines for those involved in developing genetically engineered animals with heritable recombinant DNA (rDNA) constructs and is requesting comment from industry and the public about their content. The document does not impose new regulations but details (...) how existing laws and regulations apply to genetically engineered (GE) animals and offers advice to developers on how to negotiate the laws in the most efficient and productive manner. The draft guidance document is not legally enforceable at this juncture, but the guidelines are recommendations reflecting the FDA's "current thinking on a topic."The modification of GE animals being developed for commercialization, which are the focus of the document, fall into six categories: modifications intended to (1) enhance food quality—e.g., faster growing fish and meats with better nutritional profiles; (2) improve animal health via increased resistance to disease—e.g., mastitis in dairy cattle and Bovine Spongiform Encephalopathy (BSE); (3) create so-called "biopharm" animals capable of producing therapeutic products such as insulin, clotting factors, and tissues for human transplantation; (4) reduce the barriers to human animal interaction—e.g., hypoallergenic pets; (5) develop valid animal models of human disease—e.g., Parkinson's disease, Lesh-Nyhan's syndrome, and cancer; and (6) improve production of industrial or consumer products such as fiber. The timing of the guidelines coincides with the FDA's belief in an expected boon in the number of GE animals approaching the stage of commercialization.The FDA's involvement in the approval process emerges from the new animal drug provisions of the Federal Food Drug and Cosmetic Act and the definition of what constitutes a drug. The Act defines a new animal drug as "an article (other than food) intended to affect the structure or any function of the body of... animals." A rDNA construct intended to affect the structure or function of an animal meets the definition of a new animal drug, regardless of whether the resulting GE animals are intended for human food or the production of pharmaceuticals or any other substances. [End Page 393]Before proceeding to a review of the draft guidelines, it is important briefly to set the controversies around GE animals in historical and ethical context.The Ethical DebateFrom its inception, the intentional genetic modification or genetic engineering of molecules, plants, and animals by the techniques of gene splicing has consistently elicited strong responses from both the scientific community and the public. There are some data to suggest that although the concerns of scientists fall primarily into the category of possible biohazards, those of the public also reflect great concern about the intrinsic moral issues, such as whether there is something fundamentally wrong with this line of work, making it a form of forbidden knowledge (see, e.g., Gaskell 1997). When news of Paul Berg's attempts in 1970 to graft the primate tumor virus (SV 40) onto the intestinal tract bacteria Escherichia coli for the purpose of studying how normal cells may be transformed into cancerous cells was shared with colleagues, he was strongly encouraged to reflect on the potential public health risks if somehow the altered bacteria broke containment and entered the environment. Thanks to Berg's leadership, these concerns soon resulted in conferences held in Asilomar, California, and New Hampton, New Hampshire, where the ethical responsibilities of microbiologists involved in this research were discussed. These initial discussions resulted in what has come to be known as "The Moratorium Letter" (Shattuck 1996) published in the journal Science in 1974. This letter, signed by 11 leaders in the field, actually recommended restrictions on several types of experiments that were considered to be particularly risky and stated "that adherence to our major recommendations will entail postponement or possibly abandonment of certain types of scientifically worthwhile experiments" (Berg 1974). An international conference on the issues came to similar conclusions about the need for a research moratorium for the sake of public safety. Recommendations arising from conference participants led to the formation of the National Institutes... (shrink)

Successfully explaining and replicating the complexity and generality of human and animal learning will require the integration of a variety of learning mechanisms. Here, we introduce a computational model which integrates associative learning (AL) and reinforcement learning (RL). We contrast the integrated model with standalone AL and RL models in three simulation studies. First, a synthetic grid‐navigation task is employed to highlight performance advantages for the integrated model in an environment where the reward structure is both diverse and dynamic. The (...) second and third simulations contrast the performances of the three models in behavioral experiments, demonstrating advantages for the integrated model in accounting for behavioral data. (shrink)

Né vers 1600 en Italie, l'opéra encourait les foudres de Marcello dès 1720. L'ouverture des salles au public, les nécessités commerciales et le vedettariat l'avaient éloigné des idéaux qui présidèrent à sa naissance. L'opuscule de Benedetto Marcello aborde, sur le ton de la dérision et de la satire, tous les aspects de l'opéra, du livret à la musique, en passant par les chanteurs, les compositeurs, les directeurs de théâtre, la mise en scène, etc. Le texte méritait une nouvelle traduction française (...) (la dernière datait de la fin du dix-neuvième siècle), plus précise et plus complète, car le savant compositeur de l'Estro poetico-armonico y déploie une verve irrésistible, proche de celle dont se servira Carlo Goldoni dans l'imprésario de Smyrne. Cette satire représente l'étincelle qui allait embraser le flambeau de la réforme par le biais du comte Francesco Algarotti (1712-1764) poète et écrivain. Son Essai sur l'Opéra en musique contient en effet tous les points importants sur lesquels Calzabigi et Gluck allaient asseoir leur reconstruction : choix du livret, rôle de la poésie et de la musique, rôle des chanteurs, du compositeur, moyens et contrôle artistiques des productions. La traduction française qu'un fit Chastellux en 1773, nonobstant sa finesse et son élégance, fait pourtant figure de " belle infidèle ". Force nous était donc d'élaborer là encore une nouvelle traduction de ce texte fondateur. A côté de ces deux grands titres, nous avons réuni un dossier important d'écrits émanant des acteurs de la réforme : Métastase, Angiolini, Calzabigi, Gluck et Du Roullet. (shrink)

Maimonides real opinion regarding it. Then, as now, the Aristotelian theory of an eternal material universe seemed more plausible to many people than did the Biblical view of creation exnihilo. While creation is the orthodox view in both Judaism and Christianity, the tension between those two explanatory models goes back a long way. 1 Referring to the heretical views of Elisha ben Abuya, in the early Talmudic period, David Hartman argues as follows.