Researchers designing a clinical trial may be aware of disputed evidence of serious risks from previous studies. These researchers must decide whether and how to describe these risks in their model informed consent document. They have an ethical obligation to provide fully informed consent, but does this obligation include notice of controversial evidence? With ACCORD as an example, we describe a framework and criteria that make clear the conditions requiring inclusion of important controversial risks. The ACCORD model consent document did (...) not include notice of prior trials with excess death. We develop and explain a new standard labeled risk in equipoise. We argue that our approach provides an optimal level of integrity to protect the informational needs of the reasonable volunteers who agree to participate in clinical trials. We suggest language to be used in a model consent document and the informed consent discussion when such controversial evidence exists. (shrink)

When the COVID-19 surge hit New York City hospitals, the Division of Medical Ethics at Weill Cornell Medical College, and our affiliated ethics consultation services, faced waves of ethical issues sweeping forward with intensity and urgency. In this article, we describe our experience over an eight-week period (16 March through 10 May 2020), and describe three types of services: clinical ethics consultation (CEC); service practice communications/interventions (SPCI); and organizational ethics advisement (OEA). We tell this narrative through the prism of time, (...) describing the evolution of ethical issues and trends as the pandemic unfolded. We delineate three phases: anticipation and preparation, crisis management, and reflection and adjustment. The first phase focused predominantly on ways to address impending resource shortages and to plan for remote ethics consultation, and CECs focused on code status discussions with surrogates. The second phase was characterized by the dramatic convergence of a rapid increase in the number of critically ill patients, a growing scarcity of resources, and the reassignment/ redeployment of staff outside their specialty areas. The third phase was characterized by the recognition that while the worst of the crisis was waning, its medium- and long-term consequences continued to pose immense challenges. We note that there were times during the crisis that serving in the role of clinical ethics consultant created a sense of dis-ease as novel as the coronavirus itself. In retrospect we learned that our activities far exceeded the familiar terrain of clinical ethics consultation and extended into other spheres of organizational life in novel ways that were unanticipated before this pandemic. To that end, we defined and categorized a middle level of ethics consultation, which we have termed service practice communication intervention (SPCI). This is an underappreciated dimension of the work that ethics consult services are capable of in times of crisis. We believe that the pandemic has revealed the many enduring ways that ethics consultation services can more robustly contribute to the ethical life of their institutions moving forward. (shrink)

Patient autonomy, as exercised in the informed consent process, is a central concern in bioethics. The typical bioethicist's analysis of autonomy centers on decisional capacity—finding the line between autonomy and its absence. This approach leaves unexplored the structure of reasoning behind patient treatment decisions. To counter that approach, we present a microeconomic theory of patient decision-making regarding the acceptable level of medical treatment from the patient's perspective. We show that a rational patient's desired treatment level typically departs from the level (...) yielding an absence of symptoms, the level we call ideal. This microeconomic theory demonstrates why patients have good reason not to pursue treatment to the point of absence of physical symptoms. We defend our view against possible objections that it is unrealistic and that it fails to adequately consider harm a patient may suffer by curtailing treatment. Our analysis is fruitful in various ways. It shows why decisions often considered unreasonable might be fully reasonable. It offers a theoretical account of how physician misinformation may adversely affect a patient's decision. It shows how billing costs influence patient decision-making. It indicates that health care professionals' beliefs about the ‘unreasonable’ attitudes of patients might often be wrong. It provides a better understanding of patient rationality that should help to ensure fuller information as well as increased respect for patient decision-making. (shrink)

Patient noncompliance with physician prescriptions, especially in nonsymptomatic chronic diseases, is frequently characterized in the literature as harmful and economically costly (Miller 1997).1 Nancy Houston Miller views patient noncompliance as harmful because noncompliance can result in continued or new health problems leading to hospital admissions. Further, she places the annual monetary cost of noncompliance at $100 billion.Patient noncompliance with prescribed treatment is considered the least understood form of health behavior (Coons 2001). Despite the plethora of attention in journal articles, the (...) issue of noncompliance remains unresolved even in terms of understanding the main correlates to .. (shrink)

The case of Twin B involves the decision to send a newborn to a less intensive Level 2 special care nursery (SCN) than to the Level 3 neonatal intensive care unit (NICU) that is considered optimal by the physician. The physician’s acceptance of the transfer is against the child’s best interest and is due to parental convenience. In analyzing the case, we reject the best interest standard. Our rejection is partly supported by the views of Douglas Diekema, John Hardwig, (...) and Lannie Ross. Instead of the best interest standard, we offer and defend an approach we base on a microeconomic analysis of externalities, such as those involved with automobile emissions. This extends our previously presented general microeconomic approach to patient decision-making. It provides a clearer way to evaluate situations, like those of Twin B, in which burdens faced by family members may be used to determine the appropriate level of treatment for a decisionally incapable patient. (shrink)

The Global Forum on Bioethics in Research (GFBR) served as a global platform for debate on ethical issues in international health research between 1999 and 2008, bringing together research ethics experts, researchers, policy makers and community members from developing and developed countries. In total, nine GFBR meetings were held on six continents. Work is currently underway to revive the GFBR. This paper describes the purpose and history of the GFBR and presents key elements for its reinstatement, future functioning and sustainability. (...) Potential participants and sponsors are encouraged to contribute actively to the future of this unique international research ethics event. (shrink)

Volume 19, Issue 11, November 2019, Page 78-80.

Annotation. A new translation of Schelling's Die Philosophie der Kunst, 1859 with extensive commentary by the translator, Douglas W. Stott. Annotation copyrighted by Book News, Inc., Portland, OR.

We posit that the weight a person assigns a moral principle is not stable between ideal, or un-contextual assessments and the weight the same moral principle is allocated when applied in a contextual dilemma. Second, we postulate that past behavior is the best predictor of future behavior or judgment. Results indicate that the importance of moral principles is dynamic and that patterned moral behavior is a significant predictor of moral judgments.

The rise of neurotechnologies, especially in combination with artificial intelligence (AI)-based methods for brain data analytics, has given rise to concerns around the protection of mental privacy, mental integrity and cognitive liberty – often framed as “neurorights” in ethical, legal, and policy discussions. Several states are now looking at including neurorights into their constitutional legal frameworks, and international institutions and organizations, such as UNESCO and the Council of Europe, are taking an active interest in developing international policy and governance guidelines (...) on this issue. However, in many discussions of neurorights the philosophical assumptions, ethical frames of reference and legal interpretation are either not made explicit or conflict with each other. The aim of this multidisciplinary work is to provide conceptual, ethical, and legal foundations that allow for facilitating a common minimalist conceptual understanding of mental privacy, mental integrity, and cognitive liberty to facilitate scholarly, legal, and policy discussions. (shrink)

People with early-to-mid stage dementia frequently attend groups that provide opportunities for socialising and engaging in group activities, such as quizzes. This article uses conversation analysis to investigate the interactional strategies that the staff use to initiate and keep these quizzes ‘on track’, and what they orient to as impediments and facilitators of quiz progression. Specifically, we outline how staff deal with incorrect or ‘non-answers’, and what happens when players have their own goals or ‘projects’ that do not align with (...) staff members’ orientations to the overarching activity completion. We reflect on the tensions that arise between doing interactional work to progress through the quiz, and how that goal can conflict with attending to the needs or wishes expressed by the person living with dementia, potentially resulting in threats to the ‘face’ of the quiz players. Data are taken from a corpus of 10 quizzes recorded in 4 different group settings in England. (shrink)

Peter Abelard (1079–1142 ce) was the most wide‐ranging philosopher of the twelfth century. He quickly established himself as a leading teacher of logic in and near Paris shortly after 1100. After his affair with Heloise, and his subsequent castration, Abelard became a monk, but he returned to teaching in the Paris schools until 1140, when his work was condemned by a Church Council at Sens. His logical writings were based around discussion of the “Old Logic”: Porphyry's Isagoge, aristotle'S Categories and (...) On Interpretation and boethius'S textbook on topical inference. They comprise a freestanding Dialectica (“Logic”; probably c.1116), a set of commentaries (known as the Logica [Ingredientibus], c. 1119) and a later (c. 1125) commentary on the Isagoge (Logica Nostrorum Petititoni Sociorum or Glossulae). In a work Abelard called his Theologia, issued in three main versions (between 1120 and c.1134), he attempted a logical analysis of trinitarian relations and explored the philosophical problems surrounding God's claims to omnipotence and omniscience. The Collationes (“Debates,” also known as “Dialogue between a Christian, a Philosopher and a Jew”; probably c.1130) present a rational investigation into the nature of the highest good, in which the Christian and the Philosopher (who seems to be modeled on a philosopher of pagan antiquity) are remarkably in agreement. The unfinished Scito teipsum (“Know thyself,” also known as the “Ethics”; c.1138) analyses moral action. (shrink)

Each contributor to this book has used personal experience as the basis from which to frame his individual sociological perspectives. Because they have personalized their work, their accounts are real, and recognizable as having come from 'real' persons, about 'real' experiences. There are no objectively-distanced disembodied third person entities in these accounts. These writers are actual people whose stories will make you laugh, cry, think, and want to know more.

Philosophy is shaped by life and life is shaped by philosophy. This is reflected in The Philosophical I, a collection of 16 autobiographical essays by prominent philosophers.

One of the challenging problems in large scale cyber-argumentation platforms is that users often engage and focus only on a few issues and leave other issues under-discussed and under-acknowledged. This kind of non-uniform participation obstructs the argumentation analysis models to retrieve collective intelligence from the underlying discussion. To resolve this problem, we developed an innovative opinion prediction model for a multi-issue cyber-argumentation environment. Our model predicts users’ opinions on the non-participated issues from similar users’ opinions on related issues using intelligent (...) argumentation techniques and a collaborative filtering method. Based on our detailed experimental results on an empirical dataset collected using our cyber-argumentation platform, our model is 21.7% more accurate, handles data sparsity better than other popular opinion prediction methods. Our model can also predict opinions on multiple issues simultaneously with reasonable accuracy. Contrary to existing opinion prediction models, which only predict whether a user agrees on an issue, our model predicts how much a user agrees on the issue. To our knowledge, this is the first research to attempt multi-issue opinion prediction with the partial agreement in the cyber-argumentation platform. With additional data on non-participated issues, our opinion prediction model can help the collective intelligence analysis models to analyze social phenomena more effectively and accurately in the cyber argumentation platform. (shrink)

In face of the multiple controversies surrounding the DSM process in general and the development of DSM-5 in particular, we have organized a discussion around what we consider six essential questions in further work on the DSM. The six questions involve: 1) the nature of a mental disorder; 2) the definition of mental disorder; 3) the issue of whether, in the current state of psychiatric science, DSM-5 should assume a cautious, conservative posture or an assertive, transformative posture; 4) the role (...) of pragmatic considerations in the construction of DSM-5; 5) the issue of utility of the DSM – whether DSM-III and IV have been designed more for clinicians or researchers, and how this conflict should be dealt with in the new manual; and 6) the possibility and advisability, given all the problems with DSM-III and IV, of designing a different diagnostic system. Part 1 of this article took up the first two questions. Part 2 took up the second two questions. Part 3 now deals with Questions 5 & 6. Question 5 confronts the issue of utility, whether the manual design of DSM-III and IV favors clinicians or researchers, and what that means for DSM-5. Our final question, Question 6, takes up a concluding issue, whether the acknowledged problems with the earlier DSMs warrants a significant overhaul of DSM-5 and future manuals. As in Parts 1 & 2 of this article, the general introduction, as well as the introductions and conclusions for the specific questions, are written by James Phillips, and the responses to commentaries are written by Allen Frances. (shrink)

In the conclusion to this multi-part article I first review the discussions carried out around the six essential questions in psychiatric diagnosis – the position taken by Allen Frances on each question, the commentaries on the respective question along with Frances’ responses to the commentaries, and my own view of the multiple discussions. In this review I emphasize that the core question is the first – what is the nature of psychiatric illness – and that in some manner all further (...) questions follow from the first. Following this review I attempt to move the discussion forward, addressing the first question from the perspectives of natural kind analysis and complexity analysis. This reflection leads toward a view of psychiatric disorders – and future nosologies – as far more complex and uncertain than we have imagined. (shrink)

Pancreatitis is a complex, progressively destructive inflammatory disorder. Alcohol was long thought to be the primary causative agent, but genetic contributions have been of interest since the discovery that rare PRSS1, CFTR and SPINK1 variants were associated with pancreatitis risk. We now report two associations at genome-wide significance identified and replicated at PRSS1-PRSS2 and X-linked CLDN2 through a two-stage genome-wide study. The PRSS1 variant likely affects disease susceptibility by altering expression of the primary trypsinogen gene. The CLDN2 risk allele is (...) associated with atypical localization of claudin-2 in pancreatic acinar cells. The homozygous CLDN2 genotype confers the greatest risk, and its alleles interact with alcohol consumption to amplify risk. These results could partially explain the high frequency of alcohol-related pancreatitis in men. © 2012 Nature America, Inc. All rights reserved. (shrink)

The four coauthors describe the twenty-five-year history of efforts of the Council of Learned Societies in Education (CLSE) to represent the interests of the social foundations of education in the National Council for Accreditation of Teacher Education (NCATE), including the evolution of CLSE into the Council for the Social Foundations of Education and its recent departure from NCATE after a quarter century of successful involvement. The coauthors, each personally supportive of foundational involvement in national accreditation, delineate advantages gained by both (...) CLSE and NCATE during the quarter century of involvement, while also describing concerns and arguments that have led to the current disassociation of the Council for Social Foundations of Education (CSFE) fromNCATE. The article concludes with suggestions for the future and the coauthors' hope that this history and chronicle will provide incentive for reinvolvement of the foundations in national accreditation circles. (shrink)

The excellent quality and depth of the various essays make [the book] an invaluable resource....It is likely to become essential reading in its field.—CHOICE.

In face of the multiple controversies surrounding the DSM process in general and the development of DSM-5 in particular, we have organized a discussion around what we consider six essential questions in further work on the DSM. The six questions involve: 1) the nature of a mental disorder; 2) the definition of mental disorder; 3) the issue of whether, in the current state of psychiatric science, DSM-5 should assume a cautious, conservative posture or an assertive, transformative posture; 4) the role (...) of pragmatic considerations in the construction of DSM-5; 5) the issue of utility of the DSM - whether DSM-III and IV have been designed more for clinicians or researchers, and how this conflict should be dealt with in the new manual; and 6) the possibility and advisability, given all the problems with DSM-III and IV, of designing a different diagnostic system. Part I of this article will take up the first two questions. With the first question, invited commentators express a range of opinion regarding the nature of psychiatric disorders, loosely divided into a realist position that the diagnostic categories represent real diseases that we can accurately name and know with our perceptual abilities, a middle, nominalist position that psychiatric disorders do exist in the real world but that our diagnostic categories are constructs that may or may not accurately represent the disorders out there, and finally a purely constructivist position that the diagnostic categories are simply constructs with no evidence of psychiatric disorders in the real world. The second question again offers a range of opinion as to how we should define a mental or psychiatric disorder, including the possibility that we should not try to formulate a definition. The general introduction, as well as the introductions and conclusions for the specific questions, are written by James Phillips, and the responses to commentaries are written by Allen Frances. (shrink)

In face of the multiple controversies surrounding the DSM process in general and the development of DSM-5 in particular, we have organized a discussion around what we consider six essential questions in further work on the DSM. The six questions involve: 1) the nature of a mental disorder; 2) the definition of mental disorder; 3) the issue of whether, in the current state of psychiatric science, DSM-5 should assume a cautious, conservative posture or an assertive, transformative posture; 4) the role (...) of pragmatic considerations in the construction of DSM-5; 5) the issue of utility of the DSM - whether DSM-III and IV have been designed more for clinicians or researchers, and how this conflict should be dealt with in the new manual; and 6) the possibility and advisability, given all the problems with DSM-III and IV, of designing a different diagnostic system. Part I of this article took up the first two questions. Part II will take up the second two questions. Question 3 deals with the question as to whether DSM-V should assume a conservative or assertive posture in making changes from DSM-IV. That question in turn breaks down into discussion of diagnoses that depend on, and aim toward, empirical, scientific validation, and diagnoses that are more value-laden and less amenable to scientific validation. Question 4 takes up the role of pragmatic consideration in a psychiatric nosology, whether the purely empirical considerations need to be tempered by considerations of practical consequence. As in Part 1 of this article, the general introduction, as well as the introductions and conclusions for the specific questions, are written by James Phillips, and the responses to commentaries are written by Allen Frances. (shrink)