The Giving Voice to Values pedagogy and curriculum is described as an example of a powerful leverage point in the integration of business ethics and values-driven leadership across the business curriculum. GVV is post-decision-making in that it identifies an ethical course of action and asks practitioners to identify who are the parties involved and what’s at stake for them; what are the main arguments to be countered; and what levers that can be used to influence those who are in disagreement. (...) The internalization of GVV’s constructs allows faculty to comfortably raise and endorse ethics as part of the natural order of business decision-making because the stakes of doing so have been normalized. Methods for introducing and using GVV in undergraduate through MBA courses are given. An illustration is given for economics courses. (shrink)

With increasing complexity in the evolving structure of work in organizations, employees’ preferences for working from home (WFH) relative to working on-site can lead to systematic differences in perceived career implications. An emerging tension associated with WFH versus work-at-work is whether this locational divide is associated with concerns over career progression, especially among racial minorities. Here, we seek to determine whether Black employees, relative to their White counterparts, have more concerns over career progression relating to WFH compared with their on-site (...) colleagues. From a sample of employees in the May 2021 cross-section of the Survey of Working Arrangements and Attitudes (SWAA), we find that relative to higher (lower) income White employees, higher (lower) income Black WFH employees have significantly higher (lower) concerns over career progression than their on-site counterparts. These findings speak both to the nontrivial choices employees may be forced to make as the structure of work continues to evolve and consequences for racial inequality. (shrink)

: C.S. Peirce defines mathematics in two ways: first as "the science which draws necessary conclusions," and second as "the study of what is true of hypothetical states of things" (CP 4.227–244). Given the dual definition, Peirce notes, a question arises: Should we exclude the work of poietic hypothesis-making from the domain of pure mathematical reasoning? (CP 4.238). This paper examines Peirce's answer to the question. Some commentators hold that for Peirce the framing of mathematical hypotheses requires poietic genius but (...) is not scientific work. I propose, to the contrary, that although Peirce occasionally seems to exclude the poietic creation of hypotheses altogether from pure mathematical reasoning, Peirce's position is rather that the creation of mathematical hypotheses is poietic, but it is not merely poietic, and accordingly, that hypothesis-framing is part of mathematical reasoning that involves an element of poiesis but is not merely poietic either. Scientific considerations also inhere in the process of hypothesis-making, without excluding the poietic element. In the end, I propose that hypothesis-making in mathematics stands between artistic and scientific poietic creativity with respect to imaginative freedom from logical and actual constraints upon reasoning. (shrink)

Among multiple legal challenges to the Patient Protection and Affordable Care Act (PPACA) is the premise that PPACA's “individual mandate” (requiring all individuals to obtain health insurance by 2014 or face civil penalties) is inviolate of Congress' interstate commerce powers because Congress lacks the power to regulate commercial “inactivity.” Several courts initially considering this argument have rejected it, but federal district courts in Virginia and Florida have concurred, leading to numerous appeals and prospective review of the United States Supreme Court. (...) Despite creative arguments, the dispositive constitutional question is not whether Congress' interstate commerce power extends to commercial inactivity. Rather, it is whether Congress may regulate individual decisions with significant economic ramifications in the interests of protecting and promoting the public's health. This article offers a counter-interpretation of the scope of Congress' interstate commerce power to regulate in furtherance of the public's health. (shrink)

Despite historic efforts to enact the Patient Protection and Affordable Care Act in 2010, national health reform is threatened by multiple legal challenges grounded in constitutional law. Premier among these claims is the premise that PPACA’s “individual mandate” is constitutionally infirm. Attorneys General in Virginia and Florida allege that Congress’ interstate commerce powers do not authorize federal imposition of the individual mandate because Congress lacks the power to regulate commercial “inactivity.” Stated simply, Congress cannot regulate individuals who choose not to (...) obtain health insurance because they are not engaged in a commercial venture. Several courts initially considering this argument have rejected it, but two federal district courts in Virginia and Florida have concurred, leading to numerous appeals and the near promise of United States Supreme Court review. (shrink)

This paper reviews the literature concerning the neural correlates of the self, the relationship between self and memory and the profile of memory impairments in Alzheimer’s disease and explores the relationship between the preservation of the self and anosognosia in this condition. It concludes that a potential explanation for anosognosia in AD is a lack of updating of personal information due to the memory impairments characteristic of this disease. We put forward the hypothesis that anosognosia is due in part to (...) the “petrified self.”. (shrink)

It is often assumed that engaging in a one‐on‐one dialogue with a tutor is more effective than listening to a lecture or reading a text. Although earlier experiments have not always supported this hypothesis, this may be due in part to allowing the tutors to cover different content than the noninteractive instruction. In 7 experiments, we tested the interaction hypothesis under the constraint that (a) all students covered the same content during instruction, (b) the task domain was qualitative physics, (c) (...) the instruction was in natural language as opposed to mathematical or other formal languages, and (d) the instruction conformed with a widely observed pattern in human tutoring: Graesser, Person, and Magliano's 5‐step frame. In the experiments, we compared 2 kinds of human tutoring (spoken and computer mediated) with 2 kinds of natural‐language‐based computer tutoring (Why2‐Atlas and Why2‐AutoTutor) and 3 control conditions that involved studying texts. The results depended on whether the students' preparation matched the content of the instruction. When novices (students who had not taken college physics) studied content that was written for intermediates (students who had taken college physics), then tutorial dialogue was reliably more beneficial than less interactive instruction, with large effect sizes. When novices studied material written for novices or intermediates studied material written for intermediates, then tutorial dialogue was not reliably more effective than the text‐based control conditions. (shrink)

Barresi & Moore assume an equivalence between ontogenetic and evolutionaiy transformations of social understanding. The mechanisms of evolution allow for novel structures to arise, both through terminal addition and through the onset of novel pathways at time points that precede the end points of ancestral pathways. Terminal addition may not be the appropriate model for the evolution of human object-directed imitation, intermodal equivalence, or joint attention.

Hibbing et al. argue that the liberal–conservative continuum is (a) universal and (b) grounded in psychological differences in sensitivity to negative stimuli. Our commentary argues that both claims overlook the importance of context. We review evidence that the liberal–conservative continuum is far from universal and that ideological differences are contextually flexible rather than fixed.

Why do people act morally – when they do? Moral philosophers and psychologists often assume that acting morally in the absence of incentives or sanctions is a product of a desire to uphold one or another moral principle (e.g., fairness). This form of motivation might be called moral integrity because the goal is to actually be moral. In a series of experiments designed to explore the nature of moral motivation, colleagues and I have found little evidence of moral integrity. We (...) have found considerable evidence of a different form of moral motivation, moral hypocrisy. The goal of moral hypocrisy is to appear moral yet, if possible, avoid the cost of being moral. To fully reach the goal of moral hypocrisy requires self-deception, and we have found evidence of that as well. Strengthening moral integrity is difficult. Even effects of moral perspective taking – imagining yourself in the place of the other (as recommended by the Golden Rule) – appear limited, further contributing to the moral masquerade. (shrink)

Moral hypocrisy is motivation to appear moral yet, if possible, avoid the cost of actually being moral. In business, moral hypocrisy allows one to engender trust, solve the commitment problem, and still relentlessly pursue personal gain. Indicating the power of this motive, research has provided clear and consistent evidence that, given the opportunity, many people act to appear fair (e.g., they flip a coin to distribute resources between themselves and another person) without actually being fair (they accept the flip only (...) if it favors themselves). New evidence also indicates the power of moral hypocrisy in a situation more obviously relevant to business, resource allocation when one party has information about relative resource value that the other does not. Characteristics of modern business situations likely to encourage moral hypocrisy are outlined. We conclude that moral hypocrisy is not only a pragmatic virtue in modern business but is also fast becoming a prescriptive one. (shrink)

“Tell me," Wittgenstein once asked a friend, "why do people always say, it was natural for man to assume that the sun went round the earth rather than that the earth was rotating?" His friend replied, "Well, obviously because it just looks as though the Sun is going round the Earth." Wittgenstein replied, "Well, what would it have looked like if it had looked as though the Earth was rotating?” What would it have looked like if we looked at all (...) sciences from the viewpoint of Wittgenstein’s philosophy? Wittgenstein is undoubtedly one of the most influential philosophers of the twentieth century. His complex body of work has been analysed by numerous scholars, from mathematicians and physicists, to philosophers, linguists, and beyond. This volume brings together some of his central perspectives as applied to the modern sciences and studies the influence they may have on the thought processes underlying science and on the world view it engenders. The contributions stem from leading scholars in philosophy, mathematics, physics, economics, psychology and human sciences; all of them have written in an accessible style that demands little specialist knowledge, whilst clearly portraying and discussing the deep issues at hand. (shrink)

BackgroundPreprint usage is growing rapidly in the life sciences; however, questions remain on the relative quality of preprints when compared to published articles. An objective dimension of quality that is readily measurable is completeness of reporting, as transparency can improve the reader’s ability to independently interpret data and reproduce findings.MethodsIn this observational study, we initially compared independent samples of articles published in bioRxiv and in PubMed-indexed journals in 2016 using a quality of reporting questionnaire. After that, we performed paired comparisons (...) between preprints from bioRxiv to their own peer-reviewed versions in journals.ResultsPeer-reviewed articles had, on average, higher quality of reporting than preprints, although the difference was small, with absolute differences of 5.0% [95% CI 1.4, 8.6] and 4.7% [95% CI 2.4, 7.0] of reported items in the independent samples and paired sample comparison, respectively. There were larger differences favoring peer-reviewed articles in subjective ratings of how clearly titles and abstracts presented the main findings and how easy it was to locate relevant reporting information. Changes in reporting from preprints to peer-reviewed versions did not correlate with the impact factor of the publication venue or with the time lag from bioRxiv to journal publication.ConclusionsOur results suggest that, on average, publication in a peer-reviewed journal is associated with improvement in quality of reporting. They also show that quality of reporting in preprints in the life sciences is within a similar range as that of peer-reviewed articles, albeit slightly lower on average, supporting the idea that preprints should be considered valid scientific contributions. (shrink)

In recent years, there has been an increasing interest in the development of well-founded conceptual models for Service Management, Accounting Information Systems and Financial Reporting. Economic ex- changes are a central notion in these areas and they occupy a prominent position in frameworks such as the Resource-Event Action (REA) ISO Standard, service core ontologies (e.g., UFO-S) as well as financial stan- dards (e.g. OMG’s Financial Industry Business Ontology - FIBO). We present a core ontology for economic exchanges inspired by a (...) recent view on this phenomenon. According to this view, economic exchanges are based on an agreement on the actions that the agents are committed to perform. This view enables a unified treatment of economic exchanges, regardless the object of the transaction. We ground our core ontology on the Unified Foundational Ontology (UFO), discussing its formal and conceptual aspects, instantiating it as a reusable OntoUML model, and confronting it with the REA standard and the UFO-S service ontology. (shrink)

Given its non-invasive nature, there is increasing interest in the use of transcutaneous vagus nerve stimulation across basic, translational and clinical research. Contemporaneously, tVNS can be achieved by stimulating either the auricular branch or the cervical bundle of the vagus nerve, referred to as transcutaneous auricular vagus nerve stimulation and transcutaneous cervical VNS, respectively. In order to advance the field in a systematic manner, studies using these technologies need to adequately report sufficient methodological detail to enable comparison of results between (...) studies, replication of studies, as well as enhancing study participant safety. We systematically reviewed the existing tVNS literature to evaluate current reporting practices. Based on this review, and consensus among participating authors, we propose a set of minimal reporting items to guide future tVNS studies. The suggested items address specific technical aspects of the device and stimulation parameters. We also cover general recommendations including inclusion and exclusion criteria for participants, outcome parameters and the detailed reporting of side effects. Furthermore, we review strategies used to identify the optimal stimulation parameters for a given research setting and summarize ongoing developments in animal research with potential implications for the application of tVNS in humans. Finally, we discuss the potential of tVNS in future research as well as the associated challenges across several disciplines in research and clinical practice. (shrink)

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)

Is the view supported that consciousness is a mysterious phenomenon and cannot succumb, even with much effort, to the standard methods of cognitive science? The lecture, using the analogy of the magician’s praxis, attempts to highlight a strong but little supported intuition that is one of the strongest supporters of this view. The analogy can be highly illuminating, as the following account by LEE SIEGEL on the reception of her work on magic can illustrate it: “I’m writing a book on (...) magic”, I explain, and I’m asked, “Real magic?” By real magic people mean miracles, thaumaturgical acts, and supernatural powers. “No”, I answer: “Conjuring tricks, not real magic”. Real magic, in other words, refers to the magic that is not real, while the magic that is real, that can actually be done, is not real magic. I suggest that many, e.g., DAVID CHALMERS has perpetrated the same feat of conceptual sleight-of-hand in declaring to the world that he has discovered “The Hard Problem” of consciousness. It is, however, possible that what appears to be the Hard Problem is simply the large bag of tricks that constitute what CHALMERS calls the Easy Problems of Consciousness. These all have mundane explanations, requiring no revolutions in physics, no emergent novelties. I cannot prove that there is no Hard Problem, and CHALMERS cannot prove that there is. He can appeal to your intuitions, but this is not a sound basis on which to found a science of consciousness. The “magic” of consciousness, like stage magic, defies explanation only so long as we take it at face value. Once we appreciate all the non-mysterious ways in which the brain can create benign “userillusions”, we can begin to imagine how the brain creates consciousness. (shrink)

Given its non-invasive nature, there is increasing interest in the use of transcutaneous vagus nerve stimulation across basic, translational and clinical research. Contemporaneously, tVNS can be achieved by stimulating either the auricular branch or the cervical bundle of the vagus nerve, referred to as transcutaneous auricular vagus nerve stimulation and transcutaneous cervical VNS, respectively. In order to advance the field in a systematic manner, studies using these technologies need to adequately report sufficient methodological detail to enable comparison of results between (...) studies, replication of studies, as well as enhancing study participant safety. We systematically reviewed the existing tVNS literature to evaluate current reporting practices. Based on this review, and consensus among participating authors, we propose a set of minimal reporting items to guide future tVNS studies. The suggested items address specific technical aspects of the device and stimulation parameters. We also cover general recommendations including inclusion and exclusion criteria for participants, outcome parameters and the detailed reporting of side effects. Furthermore, we review strategies used to identify the optimal stimulation parameters for a given research setting and summarize ongoing developments in animal research with potential implications for the application of tVNS in humans. Finally, we discuss the potential of tVNS in future research as well as the associated challenges across several disciplines in research and clinical practice. (shrink)

After decades of persistent work by researchers in many fields, building foundations and patiently filling in details, the gigantic jigsaw puzzle of consciousness is beginning to come into focus. As large assemblies fall into place with a gratifying convergence of details drawn from different disciplines, the pace is quickening. Everybody wants to be in on the delicious task of describing what the Big Picture is going to look like, predicting the outlines before the mopping up operations confirm them. Well, not (...) quite everybody. There are also those who dislike what they see happening: consciousness is turning out to be "just" a great big jigsaw puzzle. What? No cosmic revolutions in quantum physics? No Impenetrable Mysteries? Bummer! (shrink)

N-methyl-d-aspartate receptor (NMDAR) dysfunction plays a crucial role in schizophrenia, leading to impairments in cognitive coordination. NMDAR agonists (e.g., glycine) ameliorate negative and cognitive symptoms, consistent with NMDAR models. However, not all types of cognitive coordination use NMDAR. Further, not all aspects of cognitive coordination are impaired in schizophrenia, suggesting the need for specificity in applying the cognitive coordination construct.

"An immensely valuable and detailed analysis of foreign, mainly American, assistance to Latin American higher education, To Export Progress provides an understanding of the 'what' and the 'why' of foreign aid to a key sector. This book will be a classic in its field." —Philip G. Altbach, Monan Professor of Higher Education, Boston College "Professor Daniel C. Levy, a leading authority in the field of higher education and the nonprofit sector in Latin America, once again has opened an otherwise (...) neglected field through his carefully researched and reported study of philanthropic support for university reform in the region. Drawing on a wealth of archival material, documentary evidence, interviews, and first hand experience with the actors and agencies involved, To Export Progress illuminates the vision and ideals inspiring international agencies, as much as the realities they confronted in deciding on grants and loans policy, from the 1960s to the 1980s. The book is strongly recommended for scholars and students of international education, for Latin American experts, and for philanthropic managers and educational administrators in the developing world." —Jorge Balan, Senior Program Officer for Higher Education, The Ford Foundation. In this study of the attempts to export the modern Western university, its ideas, and its form to the Third World, Daniel C. Levy examines the development assistance provided by the Ford Foundation, the U.S. Agency for International Development, and the Inter-American Development Bank and their relations with local partners in Latin America in the 1960s and 1970s. Levy considers the funders, how they selected partners, which countries and institutions were favored, and to what effect. Based on meticulous research and careful analysis, the book provides a detailed look at philanthropic assistance to the region during the era of modernization and development in Latin America. (shrink)

Perhaps we can all agree that in order for intelligent activity to be produced by embodied nervous systems, those nervous systems have to have things in them that are about other things in the following minimal sense: there is information about these other things not just present but usable by the nervous system in its modulation of behavior. (There is information about the climatic history of a tree in its growth rings--the information is present, but not usable by the tree.) (...) The disagreements set in when we start trying to characterize what these things-aboutthings are--are they "just" competences or dispositions embodied somehow (e.g., in connectionist networks) in the brain, or are they more properly mental representations, such as sentences in a language of thought, images, icons, maps, or other data structures? And if they are "symbols", how are they "grounded"? What, more specifically, is the analysis of the aboutness that these things must have? Is it genuine intentionality or mere as if intentionality? These oft-debated questions are, I think, the wrong questions to be concentrating on at this time, even if, "in the end", they make sense and deserve answers. These questions have thrived in the distorting context provided by two ubiquitous idealizing assumptions that we should try setting aside: an assumption about how to capture content and an assumption about how to isolate the vehicles of content from the "outside" world. (shrink)

Back and forth swings the pendulum. It is remarkable that Baars can claim that “many scientists now feel that radical behaviorists tossed out the baby with the bathwater” while not being able to see that his own efforts threaten to be an instance of the complementary overshooting–what we might call covering a nice clean baby with dualistic dirt . Yes indeed, radical behaviorism of Skinner’s variety fell from grace some years ago, with the so-called cognitive revolution, to be replaced by (...) a sort of cognitivistic behaviorism that has plenty of room for inner processes, for talking to yourself, for mental imagery, for hunches, feelings, pains, dreams, beliefs and hopes and expectations, but only so long as these are understood to be physical (“informational” or “computational”) processes that could be accomplished by the machinery of the brain. It is an interesting speculative question whether William James would have been a wholehearted cognitivist, or whether he would have insisted that what he meant by the stream of consciousness had to be sharply distinguished from the streams of mere information-manipulation discernible in the activities of cortical subsystems, etc., etc. Making a home for consciousness in the brain, for a distinction between unconscious information-transformations and conscious ones, for instance, is now the work of many hands in many fields (See, e.g., Dennett, 2001, and the other essays in the special issue of Cognition devoted to the cognitive neuroscience of consciousness). The main methodological principle of this research is one shared with the radical behaviorists: only intersubjectively accessible data are to be admitted in this natural science of consciousness. If that allegiance, by itself , counts as ‘behaviorism,” then we should all be behaviorists, and indeed the very researchers Baars cites (Singer, Ericsson and Simon, Hilgard, Crick, and Edelman) scrupulously and unapologetically are behaviorists in this minimal sense. They interview their subjects, under controlled conditions, and take their reports seriously–but not as infallible guides to their subjects’ subjectivity.. (shrink)

We present a one per cent measurement of the cosmic distance scale from the detections of the baryon acoustic oscillations in the clustering of galaxies from the Baryon Oscillation Spectroscopic Survey, which is part of the Sloan Digital Sky Survey III. Our results come from the Data Release 11 sample, containing nearly one million galaxies and covering approximately 8500 square degrees and the redshift range 0.2 < z < 0.7. We also compare these results with those from the publicly released (...) DR9 and DR10 samples. Assuming a concordance Λ cold dark matter cosmological model, the DR11 sample covers a volume of 13 Gpc3 and is the largest region of the Universe ever surveyed at this density. We measure the correlation function and power spectrum, including density-field reconstruction of the BAO feature. The acoustic features are detected at a significance of over 7σ in both the correlation function and power spectrum. Fitting for the position of the acoustic features measures the distance relative to the sound horizon at the drag epoch, rd, which has a value of rd,fid = 149.28 Mpc in our fiducial cosmology. We find DV = at z = 0.32 and DV = at z = 0.57. At 1.0 per cent, this latter measure is the most precise distance constraint ever obtained from a galaxy survey. Separating the clustering along and transverse to the line of sight yields measurements at z = 0.57 of DA = and H =. Our measurements of the distance scale are in good agreement with previous BAO measurements and with the predictions from cosmic microwave background data for a spatially flat CDM model with a cosmological constant. © 2014 The Author Published by Oxford University Press on behalf of the Royal Astronomical Society. (shrink)

2021 marks Dylan's 80th birthday and his 60th year in the music world. It invites us to look back on his career and the multitudes that it contains. Is he a song and dance man? A political hero? A protest singer? A self-portrait artist who has yet to paint his masterpiece? Is he Shakespeare in the alley? The greatest living exponent of American music? An ironsmith? Internet radio DJ? Poet (who knows it)? Is he a spiritual and religious parking meter? (...) Judas? The voice of a generation or a false prophet, jokerman, and thief? Dylan is all these and none. The essays in this book explore the Nobel laureate’s masks, collectively reflecting upon their meaning through time, change, movement, and age. They are written by wonderful and diverse set of contributors, all here for his 80th birthday bash: celebrated Dylanologists like Michael Gray and Laura Tenschert; recording artists such as Robyn Hitchcock, Barb Jungr, Amy Rigby, and Emma Swift; and 'the professors’ who all like his looks: David Boucher, Anne Margaret Daniel, Ray Monk, Galen Strawson, and more. Read it on your toaster! (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been an assertion that women have been (...) inadequately represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

It was, until recently, accepted that the two classes of acetylcholine (ACh) receptors are distinct in an important sense: muscarinic ACh receptors signal via heterotrimeric GTP binding proteins (G proteins), whereas nicotinic ACh receptors (nAChRs) open to allow flux of Na+, Ca2+, and K+ ions into the cell after activation. Here we present evidence of direct coupling between G proteins and nAChRs in neurons. Based on proteomic, biophysical, and functional evidence, we hypothesize that binding to G proteins modulates the activity (...) and signaling of nAChRs in cells. It is important to note that while this hypothesis is new for the nAChR, it is consistent with known interactions between G proteins and structurally related ligand‐gated ion channels. Therefore, it underscores an evolutionarily conserved metabotropic mechanism of G protein signaling via nAChR channels.Also watch the Video Abstract. (shrink)

It was, until recently, accepted that the two classes of acetylcholine (ACh) receptors are distinct in an important sense: muscarinic ACh receptors signal via heterotrimeric GTP binding proteins (G proteins), whereas nicotinic ACh receptors (nAChRs) open to allow flux of Na+, Ca2+, and K+ ions into the cell after activation. Here we present evidence of direct coupling between G proteins and nAChRs in neurons. Based on proteomic, biophysical, and functional evidence, we hypothesize that binding to G proteins modulates the activity (...) and signaling of nAChRs in cells. It is important to note that while this hypothesis is new for the nAChR, it is consistent with known interactions between G proteins and structurally related ligand‐gated ion channels. Therefore, it underscores an evolutionarily conserved metabotropic mechanism of G protein signaling via nAChR channels.Also watch the Video Abstract. (shrink)