This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants to be permitted (...) access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

ABSTRACT This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants to be (...) permitted access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

Live donor kidney transplantation is the best treatment option for most patients with late-stage chronic kidney disease; however, the rate of living kidney donation has declined in the United States. A consensus conference was held June 5-6, 2014 to identify best practices and knowledge gaps pertaining to live donor kidney transplantation and living kidney donation. Transplant professionals, patients, and other key stakeholders discussed processes for educating transplant candidates and potential living donors about living kidney donation; efficiencies in the living donor (...) evaluation process; disparities in living donation; and financial and systemic barriers to living donation. We summarize the consensus recommendations for best practices in these educational and clinical domains, future research priorities, and possible public policy initiatives to remove barriers to living kidney donation. (shrink)

Objectives To evaluate whether the requirement of “minimal risk and burden” for paediatric research without direct benefit to the subjects compromises the ability to obtain data necessary for improving paediatric care. To provide evidence-based reflections on the EU recommendation that allows for a higher level of risk. Design and setting Systematic analysis of the approval/rejection decisions made by the Dutch Central Committee on Research involving Human Subjects (CCMO). Review methods The analysis included 165 proposals for paediatric research without direct benefit (...) that were reviewed by the CCMO between January, 2000, and July, 2007. A separate, in-depth analysis of all drug studies included 18 early phase drug studies and nine other drug studies without direct benefit. Results 11 out of 165 studies were definitively rejected because the CCMO did not regard the risk and/or burden to be minimal. In three of these 11 cases (including two early phase drug studies) the requirement of minimal risk and burden was cited as the only reason for rejection. Four other early phase drug studies also involved risks and/or burdens that were not regarded to be minimal but were nevertheless approved. Conclusions The requirement of minimal risk and burden, aiming to protect research subjects, occasionally leads to rejection of protocols. Early phase drug studies relatively often do not comply with the requirement. Committees may find ways to approve important studies that formally should be rejected, but that is not a desirable solution. The regulatory framework should be revised to make such occasional exceptions to the requirement legitimate and transparent. (shrink)

We use a new model of metarepresentational development to predict a cognitive deficit which could explain a crucial component of the social impairment in childhood autism. One of the manifestations of a basic metarepresentational capacity is a ‘ theory of mind ’. We have reason to believe that autistic children lack such a ‘ theory ’. If this were so, then they would be unable to impute beliefs to others and to predict their behaviour. This hypothesis was tested using Wimmer (...) and Perner’s puppet play paradigm. Normal children and those with Down’s syndrome were used as controls for a group of autistic children. Even though the mental age of the autistic children was higher than that of the controls, they alone failed to impute beliefs to others. Thus the dysfunction we have postulated and demonstrated is independent of mental retardation and specific to autism. (shrink)

Early last year, the GenEthics Consortium (GEC) of the Washington Metropolitan Area convened at George Washington University to consider a complex case about genetic testing for Alzheimer disease (AD). The GEC consists of scientists, bioethicists, lawyers, genetic counselors, and consumers from a variety of institutions and affiliations. Four of the 8 co-authors of this paper delivered presentations on the case. Supplemented by additional ethical and legal observations, these presentations form the basis for the following discussion.

Salutary reading for all philosophers, and not only for inductive logicians, philosophers of science and law, this important book presents an elaborate theory of inductive reasoning whose substantive features are as strikingly original as the approach is rare. First, the theory is based on concrete, real, actual, and significant instances of inductive reasoning, e.g., Karl von Frisch’s work on bees; that is, though its aim is genuinely theoretical in the sense that it engages in the proper amounts of idealization, abstraction, (...) systematization, precision, and rigor, it never loses sight of the fact that "theories in the philosophy of science, like theories in science itself, have to face up to the challenge of appropriately accredited experience within their appointed domains". Second, a central subject matter being analyzed is legal reasoning, that is, the types of proofs and arguments used by juries, judges, and lawyers in the Anglo-American system of jurisprudence, where criminal charges have to be proved beyond reasonable doubt and civil cases have to be argued on the balance of probability. Thus, in effect, Cohen’s synthesis of juridical and of scientific reasoning is an admirable example of the bridging of two "cultures." Third, and most importantly, the concept of "inductive probability," in terms of which Cohen makes sense out of his subject matter, is incommensurable with that of "mathematical probability," namely the classical calculus of chance according to which probability is measurable, additive, transitive, and obeys a multiplicational principle for conjunction and a complementational one for negation. This is not to say that "inductive probability" is a hazy, mysterious, or unstructured concept, and Cohen goes to great lengths to show that it is ordinal, modal, and formally analyzable; what it does mean is that essential types of reasoning in science and in law involve probable inferences whose probabilities are nonquantitative. Hence, though Cohen does not stress the qualitative nature of inductive probability, his book will be welcome by those who conceive of philosophy as scientia qualitatum. Specific conclusions reached by Cohen are that, in general, probability may be conceived as degree of provability, that differences in proof-rules generate different special cases of probability, that inductive probability may be viewed as the special case where the proof-rules are incomplete, that inductive probability is to inductive support as deducibility is to logical truth, and that some recent epistemological scepticism may be refuted by Cohen’s inductive logic. Finally, he sees himself in the British inductivist tradition, interpreting his predecessors as groping toward a logic of inductive support and probability rather than a methodology of discovery: from Bacon he develops the notion of eliminative induction but rejects that of induction by enumeration; Mill’s canons are analyzed as special cases of Cohen’s own "method of relevant variables," except for the method of residues, which is rejected as invalid ; he takes his critique of mathematical probability as a vindication of Hume’s thesis that "probability or reasoning from conjecture may be divided into two kinds, viz., that which is founded on chance and that which arises from causes" ; Whewell’s consilience of induction is justified ; and from Keynes, he develops the notion of the "weight" of evidence but rejects his mathematicist approach.—M. A. F. (shrink)

Intervening on causal systems can illuminate their underlying structures. Past work has shown that, relative to adults, young children often make intervention decisions that appear to confirm a single hypothesis rather than those that optimally discriminate alternative hypotheses. Here, we investigated how the ability to make informative causal interventions changes across development. Ninety participants between the ages of 7 and 25 completed 40 different puzzles in which they had to intervene on various causal systems to determine their underlying structures. Each (...) puzzle comprised a three‐ or four‐node computer chip with hidden wires. On each trial, participants viewed two possible arrangements of the chip's hidden wires and had to select a single node to activate. After observing the outcome of their intervention, participants selected a wire configuration and rated their confidence in their selection. We characterized participant choices with a Bayesian measurement model that indexed the extent to which participants selected nodes that would best disambiguate the two possible causal structures versus those that had high causal centrality in one of the two causal hypotheses but did not necessarily discriminate between them. Our model estimates revealed that the use of a discriminatory strategy increased through early adolescence. Further, developmental improvements in intervention strategy were related to changes in the ability to accurately judge the strength of evidence that interventions revealed, as indexed by participants' confidence in their selections. Our results suggest that improvements in causal information‐seeking extend into adolescence and may be driven by metacognitive sensitivity to the efficacy of previous interventions in discriminating competing ideas. (shrink)

For several decades, researchers have debated whether attention is required for consciousness or not. Throughout this time, three particular paradigms — inattentional blindness, change blindness, and the attentional blink — have been extensively used to examine this relationship. In this chapter, we highlight many of the key findings that have been discovered using these paradigms, and discuss what these findings have taught us about the role attention plays in perceptual consciousness.

Watching another person in pain activates brain areas involved in the sensation of our own pain. Importantly, this neural mirroring is not constant; rather, it is modulated by our beliefs about their intentions, circumstances, and group allegiances. We investigated if the neural empathic response is modulated by minimally-differentiating information (e.g., a simple text label indicating another’s religious belief), and if neural activity changes predict ingroups and outgroups across independent paradigms. We found that the empathic response was larger when participants viewed (...) a painful event occurring to a hand labeled with their own religion (ingroup) than to a hand labeled with a different religion (outgroup). Counterintuitively, the magnitude of this bias correlated positively with the magnitude of participants’ self-reported empathy. A multivariate classifier, using mean activity in empathy-related brain regions as features, discriminated ingroup from outgroup with 72% accuracy; the classifier’s confidence correlated with belief certainty. This classifier generalized successfully to validation experiments in which the ingroup condition was based on an arbitrary group assignment. Empathy networks thus allow for the classification of long-held, newly-modified and arbitrarily-formed ingroups and outgroups. This is the first report of a single machine learning model on neural activation that generalizes to multiple representations of ingroup and outgroup. The current findings may prove useful as an objective diagnostic tool to measure the magnitude of one’s group affiliations, and the effectiveness of interventions to reduce ingroup biases. (shrink)

The editors welcome letters from readers, although we cannot guarantee that all will be published. To ensure timeliness, correspondents must respond to an article within seven weeks and not exceed two double‐spaced pages. Letters become the property of the editors and may be edited and shortened at our discretion.

BackgroundAlthough the number of reporting guidelines has grown rapidly, few have gone through an updating process. The STARD statement (Standards for Reporting Diagnostic Accuracy), published in 2003 to help improve the transparency and completeness of reporting of diagnostic accuracy studies, was recently updated in a systematic way. Here, we describe the steps taken and a justification for the changes made.ResultsA 4-member Project Team coordinated the updating process; a 14-member Steering Committee was regularly solicited by the Project Team when making critical (...) decisions. First, a review of the literature was performed to identify topics and items potentially relevant to the STARD updating process. After this, the 85 members of the STARD Group were invited to participate in two online surveys to identify items that needed to be modified, removed from, or added to the STARD checklist. Based on the results of the literature review process, 33 items were presented to the STARD Group in the online survey: 25 original items and 8 new items; 73 STARD Group members (86 %) completed the first survey, and 79 STARD Group members (93 %) completed the second survey.Then, an in-person consensus meeting was organized among the members of the Project Team and Steering Committee to develop a consensual draft version of STARD 2015. This version was piloted in three rounds among a total of 32 expert and non-expert users. Piloting mostly led to rewording of items. After this, the update was finalized. The updated STARD 2015 list now consists of 30 items. Compared to the previous version of STARD, three original items were each converted into two new items, four original items were incorporated into other items, and seven new items were added.ConclusionsAfter a systematic updating process, STARD 2015 provides an updated list of 30 essential items for reporting diagnostic accuracy studies. (shrink)

Aim: To examine how physicians’ life stances affect their attitudes to end-of-life decisions and their actual end-of-life decision-making.Methods: Practising physicians from various specialties involved in the care of dying patients in Belgium, Denmark, The Netherlands, Sweden, Switzerland and Australia received structured questionnaires on end-of-life care, which included questions about their life stance. Response rates ranged from 53% in Australia to 68% in Denmark. General attitudes, intended behaviour with respect to two hypothetical patients, and actual behaviour were compared between all large (...) life-stance groups in each country.Results: Only small differences in life stance were found in all countries in general attitudes and intended and actual behaviour with regard to various end-of-life decisions. However, with regard to the administration of drugs explicitly intended to hasten the patient’s death , physicians with specific religious affiliations had significantly less accepting attitudes, and less willingness to perform it, than non-religious physicians. They had also actually performed PAD less often. However, in most countries, both Catholics and Protestants reported ever having made such a decision.Discussion: The results suggest that religious teachings influence to some extent end-of-life decision-making, but are certainly not blankly accepted by physicians, especially when dealing with real patients and circumstances. Physicians seem to embrace religious belief in a non-imperative way, allowing adaptation to particular situations. (shrink)

The editors welcome letters from readers, although we cannot guarantee that all will be published. To ensure timeliness, correspondents must respond to an article within seven weeks and not exceed two double‐spaced pages. Letters become the property of the editors and may be edited and shortened at our discretion.

Feelings of guilt are human emotions that may arise if a person committed an action that contradicts basic moral mores or failed to commit an action that is considered moral according to their ethical standards and values. Psychological scholarship distinguishes between altruistic guilt (AG) and deontological guilt (DG). AG results from having caused harm to an innocent victim, either by acting or failing to act, whereas DG is caused by violating a moral principle. Although physicians may be expected to experience (...) frequent feelings of guilt in their demanding and intensive work, it is surprising to find that this issue has not been explored in the professional literature on medical ethics. To that end, we conducted a qualitative study that included personal in-depth interviews with Sunni Muslim gynaecologists. These doctors provide underground infertility care and perform religiously forbidden treatments involving sex selection and gamete donation. They opened their hearts and spoke about the emotionally taxing pangs of conscience they suffer. Analysing their narratives led us to characterize their feelings of guilt as DG. We discuss the causes for their plight and the way they cope with it, compare DG to the concept of moral distress, and call for future research on clinicians’ feelings of guilt and pangs of conscience. (shrink)

In 2004 a survey was conducted in the member states of the European Union designed to gain greater insight into the views on control strategies for foot and mouth disease, classical swine fever, and avian influenza with respect to the epidemiological, economic and social-ethical consequences of each of these animal diseases. This article presents the results of the social-ethical survey. A selection of stakeholders from each member state was asked to prioritize issues for the prevention and control of these diseases. (...) A majority of stakeholders chose preventive measures as the preferred issue. An analysis was done to determine whether there were differences in views expressed by stakeholders from member states with a history of recent epidemics and ones without such a history, and whether there were regional differences. There were no differences between member states with or without a history of recent epidemics. There were indeed regional differences between the priority orders from Northern and Southern Europe on the one hand, and from Eastern Europe on the other. (shrink)

One hypothesis concerning the human dorsal anterior cingulate cortex (ACC) is that it functions, in part, to signal the occurrence of conflicts in information processing, thereby triggering compensatory adjustments in cognitive control. Since this idea was first proposed, a great deal of relevant empirical evidence has accrued. This evidence has largely corroborated the conflict-monitoring hypothesis, and some very recent work has provided striking new support for the theory. At the same time, other findings have posed specific challenges, especially concerning the (...) way the theory addresses the processing of errors. Recent research has also begun to shed light on the larger function of the ACC, suggesting some new possibilities concerning how conflict monitoring might fit into the cingulate's overall role in cognition and action. (shrink)

Digital medicine is a medical treatment that combines technology with drug delivery. The promises of this combination are continuous and remote monitoring, better disease management, self-tracking, self-management of diseases, and improved treatment adherence. These devices pose ethical challenges for patients, providers, and the social practice of medicine. For patients, having both informed consent and a user agreement raises questions of understanding for autonomy and informed consent, therapeutic misconception, external influences on decision making, confidentiality and privacy, and device dependability. For providers, (...) digital medicine changes the relationship where trust can be verified, clinicians can be monitored, expectations must be managed, and new liability risks may be assumed. Other ethical questions include direct third-party monitoring of health treatment, affordability, and planning for adverse events in the case of device malfunction. This article seeks to lay out the ethical landscape for the implementation of such devices in patient care. (shrink)

Background: While religious faith remains one of the most significant features of human life, little is known about its relationship to ordinary belief at the level of the brain. Nor is it known whether religious believers and nonbelievers differ in how they evaluate statements of fact. Our lab previously has used functional neuroimaging to study belief as a general mode of cognition, and others have looked specifically at religious belief. However, no research has compared these two states of mind directly. (...) Methodology/Principal Findings: We used functional magnetic resonance imaging to measure signal changes in the brains of thirty subjects - fifteen committed Christians and fifteen nonbelievers - as they evaluated the truth and falsity of religious and nonreligious propositions. For both groups, and in both categories of stimuli, belief was associated with greater signal in the ventromedial prefrontal cortex, an area important for self-representation, emotional associations, reward, and goal-driven behavior. This region showed greater signal whether subjects believed statements about God, the Virgin Birth, etc. or statements about ordinary facts. A comparison of both stimulus categories suggests that religious thinking is more associated with brain regions that govern emotion, self-representation, and cognitive conflict, while thinking about ordinary facts is more reliant upon memory retrieval networks. Conclusions/Significance: While religious and nonreligious thinking differentially engage broad regions of the frontal, parietal, and medial temporal lobes, the difference between belief and disbelief appears to be content-independent. Our study compares religious thinking with ordinary cognition and, as such, constitutes a step toward developing a neuropsychology of religion. However, these findings may also further our understanding of how the brain accepts statements of all kinds to be valid descriptions of the world. © 2009 Harris et al. (shrink)

This rich collection will introduce students of philosophy and politics to the contemporary critical literature on the classical social contract political thinkers Thomas Hobbes , John Locke , and Jean-Jacques Rousseau . A dozen essays and book excerpts have been selected to guide students through the texts and to introduce them to current scholarly controversies surrounding the contractarian political theories of these three thinkers.

Although a great deal of literature has looked at how individuals respond to stigma, far less has been written about how professional groups address challenges to their self-perception as abiding by clear moral standards. In this paper, we ask how professional group members maintain a positive self-perception in the face of moral stigma. Drawing on pragmatic and cultural sociology, we claim that professional communities hold narratives that link various aspects of the work their members perform with specific understanding of the (...) common good. These narratives allow professionals to maintain a shared view of their work as benefitting society and to perceive themselves as moral individuals. As a case study, we focus on the advertising industry, which has long been stigmatized as complicit in exploitative capitalist mechanisms and cultural degradation. We draw on nine total months of fieldwork and seventy-four interviews across three US advertising agencies. We find that advertising practitioners use narratives to present their work as contributing to the common good, depicting themselves as moral individuals who care about others in the process. We analyze three prevalent narratives: the account-driven narrative, which links moral virtue to caring for clients; the creative-driven narrative, which ties caring to the production of meaningful advertisements; and the strategic-driven narrative, which sees caring in finding meaningful relationships for consumers and brands. (shrink)

The death of Imre Lakatos on February 2, 1974 was a personal and philosophical loss to the worldwide circle of his friends, colleagues and students. This volume reflects the range of his interests in mathematics, logic, politics and especially in the history and methodology of the sciences. Indeed, Lakatos was a man in search of rationality in all of its forms. He thought he had found it in the historical development of scientific knowledge, yet he also saw rationality endangered everywhere. (...) To honor Lakatos is to honor his sharp and aggressive criticism as well as his humane warmth and his quick wit. He was a person to love and to struggle with. PAUL K. FEYERABEND ROBERT S. COHEN MARX W. WARTOFSKY TABLE OF CONTENTS Preface VII JOHN WORRALL / Imre Lakatos : Philosopher of Mathematics and Philosopher of Science JOSEPH AGASSI / The Lakatosian Revolution 9 23 D. M. ARMSTRONG / Immediate Perception w. W. BAR TLEY, III/On Imre Lakatos 37 WILLIAM BERKSON / Lakatos One and Lakatos Two: An Appreciation 39 I. B. COHEN / William Whewell and the Concept of Scientific Revolution 55 L. JONATHAN COHEN / How Can One Testimony Corroborate Another? 65 R. S. COHEN / Constraints on Science 79 GENE D'AMOUR/ Research Programs, Rationality, and Ethics 87 YEHUDA ELKANA / Introduction: Culture, Cultural System and Science 99 PA UL K. (shrink)