The unbridled use of modern medical skills and technology in preserving life at all costs has stimulated interest in expressing a 'right to die' by the legally competent patient who is anxious to protect his autonomy. Some recent decisions by American courts are seen to threaten this 'right to die' of competent patients and imply that legally incompetent patients including children should not have this right under any circumstances, even when expressed on their behalf by guardians, nearest relatives or parents. (...) It is argued that this is contrary to 'natural justice' as viewed by most people. It should be possible to develop procedures which are protective of the basic 'right to life' of the incompetent yet will recognise circumstances where they could be allowed to die. This paper was presented at the 1983 annual conference of the London Medical Group, 'Human Rights in Medicine'. (shrink)

The human major histocompatibility complex (MHC), on the short arm of chromosome 6, represents one of the most extensively characterised regions of the human genome. This ∼4 Mb segment of DNA contains genes encoding the polymorphic MHC class I and class II molecules which are involved in antigen presentation during an immune response. Recently the whole of the MHC has been cloned in cosmids and/or yeast artificial chromosomes (YACs) and large portions have been characterised for the presence of novel genes. (...) Many unrelated genes, both housekeeping and tissue specific, have been identified and the gene density in some regions is now approaching one gene every few kilobases. Some of the novel genes encode proteins involved in the intracellular processing and transport of antigens that are presented by MHC class I molecules. Others, however, have no obvious role in the immune response. The MHC is located in the chromosome band 6p21.3 which is a Giemsa (G)‐light band. The detection of such a large number of functional genes (at least 70) in this region is compatible with the idea that both housekeeping and tissue‐specific genes are localised predominantly in G‐light bands. (shrink)

Cell line immortalisation is a growing component of African genomics research and biobanking. However, little is known about the factors influencing consent to cell line creation and immortalisation in African research settings. We contribute to addressing this gap by exploring three questions in a sample of Xhosa participants recruited for a South African psychiatric genomics study: First, what proportion of participants consented to cell line storage? Second, what were predictors of this consent? Third, what questions were raised by participants during (...) this consent process? 760 Xhose people with schizophrenia and 760 controls were matched to sex, age, level of education and recruitment region. We used descriptive statistics to determine the proportion of participants who consented to cell line creation and immortalization. Logistic regression methods were used to examine the predictors of consent. Reflections from study recruiters were elicited and discussed to identify key questions raised by participants about consent. Approximately 40% of participants consented to cell line storage. The recruiter who sought consent was a strong predictor of participant’s consent. Participants recruited from the South African Eastern Cape, and older participants, were more likely to consent; both these groups were more likely to hold traditional Xhosa values. Neither illness nor education were significant predictors of consent. Key questions raised by participants included two broad themes: clarification of what cell immortalisation means, and issues around individual and community benefit. These findings provide guidance on the proportion of participants likely to consent to cell line immortalisation in genomics research in Africa, and reinforce the important and influential role that study recruiters play during seeking of this consent. Our results reinforce the cultural and contextual factors underpinning consent choices, particularly around sharing and reciprocity. Finally, these results provide support for the growing literature challenging the stigmatizing perception that people with severe mental illness are overly vulnerable as a target group for heath research and specifically genomics studies. (shrink)

BackgroundCommunity engagement within biomedical research is broadly defined as a collaborative relationship between a research team and a group of individuals targeted for research. A Community Advisory Board is one mechanism of engaging the community. Within genomics research CABs may be particularly relevant due to the potential implications of research findings drawn from individual participants on the larger communities they represent. Within such research, CABs seek to meet instrumental goals such as protecting research participants and their community from research-related risks, (...) as well as intrinsic goals such as promoting the respect of participants and their community. However, successful community engagement depends on the degree to which CABs legitimately represent and engage with communities targeted for research. Currently, there is little literature describing the use of CABs in genomics research taking place in developing countries, and even less in the field of genomics research relating to mental illness. The aim of this article is to describe and consider the contributions made by a researcher-driven, population-specific CAB in a genomics of schizophrenia research project taking place in South Africa, from the perspective of the research team.DiscussionFour broad discussion topics emerged during the CAB meetings namely: 1) informed consent procedures, 2) recruitment strategies, 3) patient illness beliefs and stigma experiences, and 4) specific ethical concerns relating to the project. The authors consider these discussions in terms of their contributions to instrumental and intrinsic goals of community engagement.SummaryThe CAB gave valuable input on the consent processes and materials, recruitment strategies and suggested ways of minimizing the potential for stigma and discrimination. All of these contributions were of an instrumental nature, and helped improve the way in which the research took place. In addition, and perhaps more importantly, the CAB made a unique and important contribution relating to intrinsic functions such as promoting the respect and dignity of research participants and their community. This was particularly evident in ensuring sensitivity and respect of the community’s traditional beliefs about schizophrenia and its treatment, and in this way promoting a respectful relationship between the research team and the participants. (shrink)

Sports medicine clinicians face conflicts of interest in providing medical care to athletes. Using a survey of college football players, this study evaluates whether athletes are aware of these conflicts of interest, whether these conflicts affect athlete trust in their health care providers, or whether conflicts or athletes' trust in stakeholders are associated with athletes' injury reporting behaviors.

Nanomedicine is yielding new and improved treatments and diagnostics for a range of diseases and disorders. Nanomedicine applications incorporate materials and components with nanoscale dimensions where novel physiochemical properties emerge as a result of size-dependent phenomena and high surface-to-mass ratio. Nanotherapeutics and in vivo nanodiagnostics are a subset of nanomedicine products that enter the human body. These include drugs, biological products, implantable medical devices, and combination products that are designed to function in the body in ways unachievable at larger scales. (...) Nanotherapeutics andin vivonanodiagnostics incorporate materials that are engineered at the nanoscale to express novel properties that are medicinally useful. These nanomedicine applications can also contain nanomaterials that are biologically active, producing interactions that depend on biological triggers. Examples include nanoscale formulations of insoluble drugs to improve bioavailability and pharmacokinetics, drugs encapsulated in hollow nanoparticles with the ability to target and cross cellular and tissue membranes and to release their payload at a specific time or location, imaging agents that demonstrate novel optical properties to aid in locating micrometastases, and antimicrobial and drug-eluting components or coatings of implantable medical devices such as stents. (shrink)

Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially (...) in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. Semi-structured interviews with key stakeholders, across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications. (shrink)

Drug Safety Communications are used by the Food and Drug Administration to inform health care providers, patients, caregivers, and the general public about safety issues related to FDA-approved drugs. To assess patient knowledge of the messaging contained in DSCs related to the sleep aids zolpidem and eszopiclone, we conducted a large, cross-sectional patient survey of 1,982 commercially insured patients selected by stratified random sampling from the Optum Research Database who had filled at least two prescriptions for either zolpidem or eszopiclone (...) between July 1, 2012 and June 30, 2013. Among the 594 respondents, two-thirds reported hearing generally about drug safety information prior to starting a new drug, with the remaining one-third “rarely” or “never” hearing such information. Providers and pharmacists were primary sources of drug safety information. Two-thirds of zolpidem users and half of eszopiclone users reported having heard about the related DSC messages, ability to accurately identify the major factual messages was limited. Respondents reacted to new drug safety information about their sleep aids by reporting that they would want to learn about alternative ways to help them sleep and seek out more information about the safety of their specific sleeping pill. Opportunities may exist for the FDA to work with providers and pharmacies to help ensure the DSC information is more widely received and is more fully understood by those taking the affected medications. (shrink)

The conflicts of interest that may arise in relationships between academic researchers and industry continue to prompt controversy. The bulk of attention has focused on financial aspects of these relationships, but conflicts may also arise in the legal obligations that faculty acquire through consulting contracts. However, oversight of faculty members' consulting agreements is far less vigorous than for financial conflicts, creating the potential for faculty to knowingly or unwittingly contract away important rights and freedoms. Increased regulation could prevent this, but (...) it is unclear what forms of oversight universities view as feasible and effective. In this article, we report on a Delphi study to evaluate several approaches for oversight of consulting agreements by medical schools. The panel was comprised of 11 senior administrators with responsibility for oversight of faculty consulting relationships. We found broad agreement among panelists regarding the importance of institutional oversight to protect universities' interests. There was strong support for two specific approaches: providing educational resources to faculty and submitting consulting agreements for institutional review. Notwithstanding the complexities of asserting authority to regulate private consulting agreements between faculty members and companies, medical school administrators reached consensus that several approaches to improving institutional oversight are feasible and useful. (shrink)

BackgroundRandomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their methodology in (...) a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data.MethodsThe development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial “long list” of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the “long list” and generate a “short list” of key items. In phase 4, these items will serve as the basis for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline.DiscussionDevelopment of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data. (shrink)

Background: Notwithstanding near-universal agreement on the theoretical importance of truthfulness, empirical research has documented gaps between ethical norms and physician behaviors. Although prior research has explored situations in which physicians may not be truthful with patients, it has focused on contexts within specialty practice. In this article, we report on a qualitative study of truthfulness in primary care. Methods: We conducted a qualitative study during December 2014–March 2015 involving both focus groups and in-depth, semistructured interviews with 32 primary care physicians (...) from the Boston, MA, and Baltimore, MD, metro areas in three specialties: internal medicine, family practice, and pediatrics. Interviews and focus groups were led using a semistructured guide, which explored situations in which primary care physicians find it difficult to be honest with patients; factors shaping truthfulness; and rationales for truthful and untruthful communication. Results: While physicians described outright lying to patients as rare, other deviations from truthfulness were not uncommon, including slanting and deliberately withholding information. Physicians described a range of factors as influencing truthfulness, from patient-level characteristics such as educational background to societal considerations including avoiding unnecessary tests and procedures. Physicians described truthfulness as an ethical requirement, deviations from which required further justification. Perceived justifications included promoting patient well-being and avoiding harm. Conclusions: Our results suggest a potential need to augment opportunities for training in “everyday ethics” challenges, such as the appropriateness of deception in response to patient requests for inappropriate tests or pain medications. Furthermore, they indicate that, in various circumstances encountered in primary care, physicians perceive other moral duties as potentially in conflict with the duty of truthfulness. Further ethical analysis should focus on identifying when deviations from complete truthfulness do and do not serve patients' interests, to guide physicians in striking a reasonable balance among principles of medical ethics that may conflict with one another. (shrink)

Essays by Rudolf Bernoulli, Martin Buber, C. M. von Cammerloher, T. W. Danzel, Friedrich Heiler, C. G. Jung, C. Kerényi, John Layard, Fritz Meier, Max Pulver, Erwin Rousselle, and Heinrich Zimmer. With an introduction by Mircea Eliade.

— No 1, mars : S. Chollet et D. Valentin, Le degré d’expertise a-t-il une influence sur la perception olfactive ? Quelques éléments de réponse dans le domaine du vin ; G. Molina et J.-M. Fabre, Norme et contexte : influence d’une dichotomisation du matériel et de l’évaluation sur la contextualisation de jugements catégoriels ; S. Nicolas, J. Ségui..

This book is a collection of essays in honor of Radoslav A. Tsanoff, Chairman of the Department of Philosophy at Rice University for forty years. Besides a tribute to Tsanoff written by J. S. Fulton, there are ten essays written by distinguished philosophers, each considering a topic in his field of interest. Virgil Aldrich discusses the importance of language in an essay entitled "Self-Consciousness." An examination of the new in art and an attempt to explicate its value and rationale is (...) presented by Van Meter Ames; illustrative material is drawn from such sources as contemporary film, pop art and chance music. In "Social Science and Social Norms" Clifford Barrett discusses the relevance of facts and norms in systematic considerations of social scientists. C. P. Snow's concept of two cultures is examined by A. Cornelius Benjamin in "Philosophy and the Cultures." Other essays presented are "Philosophy and Common Sense" by George Boas, "Conscience and Conscientiousness" by A. Campbell Garnett, "Criteria for Ideas of God" by C. Hartshorne, and "Sovereignty and the Idea of Republic" by C. W. Hendel. Charles Morris examines the common themes of the pragmatic movement, discussing such fields as epistemology, axiology and cosmology, and such philosophers as Peirce, Dewey, Mead and Lewis. In the concluding essay G. R. Morrow discusses Plato's views about a God and the many gods of the Greek pantheon. This book is a loose collection of papers, lacking any single theme or determinate relation between the essays presented; each essay, however, is competently handled and is interesting in its own right.—E. M. (shrink)

Donald T. Campbell argued that the organization of university departments shaped the boundaries among specialties. This article extends his argument in two ways. First, specialties are also shaped by other institutions, such as sponsors and learned societies. Second, the intersection among specialties is shaped by the complexity of the problems that research addresses. Specialization of research is a way to deal with the complexity of nature. One way of doing this is to erect specialties that focus on different aspects (...) of nature, and which do not overlap in subject matter. This view is the basis of Campbell’s “fish-scale” model of relations among specialties, and assumes that nature is descriptively complex in the sense of William C. Wimsatt . But specialties often overlap and are thus interactively complex as well. Here I argue that a kind of interactive complexity—collaborative complexity—arises when research on a problem must take the not-yet-established contents of multiple specialties into account. Such compound problems are exemplified by attempts to explain historical particulars, such as particular adaptations in single species, e.g., masculinization in Spotted Hyenas. (shrink)

When we dream, it is often assumed, we are isolated from the external environment. It is also commonly believed that dreams can be, at times, accurate, convincing replicas of waking experience. Here I analyse some of the implications of this view for an enactive theory of conscious experience. If dreams are, as described by the received view, “inactive”, or “cranially envatted” whilst replicating the experience of being awake, this would be problematic for certain extended conscious mind theories. Focusing specifically on (...) Alva Noë’s enactive view, according to which the vehicles of perceptual experience extend beyond the brain, I argue that dreams are a quandary. Noë’s view is that dreaming is consistent with enactivism because even if dreams are inactive and shut off from the external environment, they are not “full-blown” perceptual consciousness, and also, there is some reason to reject the inactive claim. However, this view rests on an unjustified and reductive account of dreams which is not supported... (shrink)

Inasmuch as a good many of the Australian philosophers one would like to see included are not represented, and some of the contributors are no longer teaching in Australia, the title of this volume is somewhat misleading. It contains an introduction by Alan Donagan and the following original essays: J. Passmore, "Russell and Bradley"; L. Goddard, "The Existence of Universals"; B. Ellis, "An Epistemological Concept of Truth"; P. Herbst, "Fact, Form, and Intentionality"; M. Deutscher, "A Causal Account of Inferring"; D. (...) M. Armstrong, "Colour-Realism and the Argument from Microscopes"; K. Campbell, "Colours"; C. B. Martin, "People"; M. C. Bradley, "Two Arguments Against the Identity Thesis"; D. H. Monro, "Mill's Third Howler"; G. Schlesinger, "The Passage of Time." Though the essays are original and admirable, there does not seem to be anything distinctively Australian, rather than American or British, about their contents. Perhaps the most enlightening fact about them is that neither the Andersonian tradition of Sydney nor the Wittgensteinian tradition of Melbourne which dominated the Australian philosophical scene in the early 1950's is pre-eminent any longer, or even in evidence.--A. B. M. (shrink)

A significant proportion of conservationists' work is directed towards efforts to save disappearing species. This relies upon the belief that species extinction is undesirable. When justifications are offered for this belief, they very often rest upon the assumption that extinction brought about by humans is different in kind from other forms of extinction. This paper examines this assumption and reveals that there is indeed good reason to suppose current anthropogenic extinctions to be different in kind from extinctions brought about at (...) other times or by other factors. Having considered – and rejected – quantity and rate of extinction as useful distinguishing factors, four alternative arguments are offered, each identifying a way in which anthropogenic extinction is significantly different from other forms of extinction, even mass extinction: (1) Humans are a different kind of natural cause from other causes of extinction; (2) Extinctions brought about by humans are uniquely persistent; (3) Anthropogenic extinctions are effectively random whereas past mass extinctions are rule-bound; (4) The impact of the current anthropogenic extinction event differs from the impact of other extinction events of the past, such that future recovery may not follow past patterns. Together, these four arguments suggest that the present-day extinction event brought about by humans may be unprecedented and that we cannot clearly extrapolate from past to present recovery from extinctions. Although insufficient as justification for the claim that present-day extinctions are undesirable, the arguments provide some ammunition for conservationists' conviction that species extinction – in which humans play an accelerating role – ought to be prevented. (shrink)

The world is not on track to achieve Agenda 2030—the approach chosen in 2015 by all UN member states to engage multiple stakeholders for the common goal of sustainable development. The creation of the 17 Sustainable Development Goals (SDGs) arguably offered a new take on sustainable development by adopting hybrid and principle-based governance approaches, where public, private, not for profit and knowledge-institutions were invited to engage around achieving common medium-term targets. Cross-sector partnerships and multi-stakeholder engagement for sustainability have consequently taken (...) shape. But the call for collaboration has also come with fundamental challenges to meaningful engagement strategies—when private enterprises try to establish elaborate multi-stakeholder configurations. How can the purpose of businesses be mitigated through multi-stakeholder principle-based partnerships to effectively serve the purpose of a common sustainability agenda? In selecting nine scholarly contributions, this special issue aims at advancing this discourse. To stimulate further progress in business studies, this introductory essay, furthermore, identifies three pathways for research on multi-stakeholder engagement processes in support of the Decade of Action along three coupling lines: multi-sector alignment (relational coupling), operational perception alignment (cognitive coupling) and goal and strategic alignment (material coupling). (shrink)