Background and rationaleWhen deception is used, a conflict ensues between the need to use it to answer a research question scientifically whilst protecting the participants’ autonomy simultaneously...

The community representative plays a very important role in an institutional review board but there is sparse data about their understanding of their role in an IRB. This study was conducted to assess perceptions of community members serving on IRBs of one region in India. A validated questionnaire was administered to community members of IRBs in a prospective cross-sectional study. The questions related to demography, perceptions of their role in the IRB, experiences while serving on the IRBs, difficulties faced by (...) them, and suggestions to improve their contributions. Of the 56 IRBs contacted, all 15 of the public institutions shared details of their community members, while only 26 of the 41 IRBs of private institutions responded. When questioned about why they joined the IRB, one third of the respondents said either that there was “no specific reason” for joining or that they accepted the invitation to serve on the insistence of other members of the IRBs or the head of their institution. All except one felt that community members were needed for optimal functioning. Six participants said that they did not review informed consent documents, and 10 were unaware that their presence was vital for quorum to be met. Twenty-eight said they participated actively in meetings and did not feel intimidated by the presence of clinicians. Twelve reported difficulties in understanding medical terminologies in ICDs. Although the majority of participants were aware about their role in an IRB, some did not review important documents such as ICDs. Restricted participation by private hospital IRBs was a striking observation in our study. There is a need to define eligibility criteria and develop targeted training modules for community members to ensure their effective contribution to effective oversight of clinical research. (shrink)

Background and rationale Several factors that motivate individuals to participate in non-therapeutic studies have been identified. This study was conducted as limited data is available regarding these motivations from developing countries. Methods This was a single-centre study conducted over 4 months in which a questionnaire was administered to 102 healthy participants and 16 patient participants who had earlier taken part in non-therapeutic studies at our centre. Descriptive statistics and univariate analysis were used to analyse data. Results The most common motivation (...) among healthy participants was financial reward (65%) followed by altruism, free medical check up, curiosity and personal health benefit. Patient participants, however, most commonly said they consented to take part in the trial as they were ‘invited to participate by the treating physician’ (88%). In comparison with the patient participants, healthy participants were more likely to be satisfied with the financial reward (p=0.02), and recommend participation in studies to friends or relatives (p=0.0013). Conclusions The most common motivating factor to participate in non-therapeutic studies appears to be different for healthy participants (financial reward) and patient participants (invitation to participate by the physician). Participants also felt that adequate information and care was given to them during the trial, and that they would participate in future clinical studies, and would also recommend such studies to their friends. (shrink)

Objective To evaluate the questions asked during the informed consent process by adult and adolescent participants as well as their parents in five interventional regulatory studies conducted at our center from 2018 to 2019. Methods The study protocol was approved by Institutional Ethics Committee [EC/OA-116/2019]. Consent narratives in the source documents for the studies were evaluated. Questions asked were classified as per Indian Council of Medical Research’s guidelines. We evaluated total number of questions, nature of questions and whether there was (...) an association between education, gender, phase of trials, physician taking consent and number questions being asked. Results A total of five studies that had N = 297 consent narratives were evaluated. Narratives of n = 284 adult participants/Guardians and of n = 13 children were analysed. A total of 374 questions were asked of which children asked only 10 questions. A total of 131/284 of the participants did not ask any question. Among the participants who asked questions, the majority132/171 participants asked about risks related to investigational products followed by questions related to study procedures 83/171. Participants/guardians with higher education and those who consented for Phase III studies asked significantly more questions. Conclusion A majority of the queries were related to the risks associated with the investigational products. Educational status and the Phase of the trial were found to be significantly associated with the number of questions being asked. (shrink)

Background: As there is little Indian data about severity, frequency and types of research related injuries, costs involved and policies regarding compensation, this study was conducted to review the present Indian scenario. Methods: The study was carried out in three parts; a questionnaire-based survey, in-depth interviews, and a review of informed consent and insurance documents of projects submitted to three ethics committees. Results: 47% of investigators were either unaware of, or had not understood, the legal requirements and depended on sponsors (...) to manage these issues, whereas 74% of ethics committee members were aware of the requirements. Although 40% of investigators, 30% of ethics committee members and all sponsors had policies to manage compensation issues, these were mainly to provide immediate free medical care or reimbursement of expenses incurred for the acute management of an adverse event. Compensation for loss of time/wages, death, physical disability or long term incapacitation was not included. A review of informed consent and insurance documents showed that compensation issues were inadequately discussed, with only insurance certificates submitted to ethics committees. Conclusion: In India, there are no uniform policies and investigators are largely unaware of their responsibilities. Therefore, there is an urgent need to draft national guidelines regarding compensation for research injuries of research participants and highlight the responsibilities of each stakeholder. Potential research injuries should be categorised based on risk assessment, severity and seriousness of the injury. Further, it would be necessary to have arbitration committees to determine the extent of compensation. Training and awareness workshops for those involved in clinical research, including research participants, is also needed. (shrink)

Background Informed consent confers upon participants the right to decline or accept participation in a study in equal measure. Consent declines can be used as a potential metric to assess the adequacy of the informed consent process. Limited literature is available on the reporting of consent declines in Clinical Research. We evaluated randomized controlled trials published in three high-impact factor journals for consent declines to assess the extent of exertion of autonomy by research participants. Methods CONSORT flow charts in RCTs (...) published in New England Journal of Medicine, The Lancet and Journal of the American Medical Association between 2012 and 2015 were evaluated. The total and per journal proportion of RCTs reporting consent declines was calculated. Percentage of consent declines was also compared based on number of centers and type of setting. Between-groups analysis was done using Chi Square, Chi Square for trend and a Crude odds ratio [95% C.I] were calculated. Results Only 3.7% of the published articles were RCTs. Of the 1103 RCTs, only 532 reported consent declines. JAMA had the highest RCTs reporting consent declines, the Lancet [129,150/781,924, 16.5%] had the most participants declining consent. Difference was significant using Chi square for linear trend [ p < 0.00001]. Consent decline rate was higher in developed countries relative to developing countries [cOR: 2.27, p < 0.000001] and in single centric versus multicentric studies [cOR : 3.63, p < 0.0000001]. Conclusion Both authors and journal editors need to ensure better reporting of consent declines. (shrink)

The Bhagavadgita: A Biography. By Richard H. Davis. Lives of Great Religious Books. Princeton: Princeton University Press, 2015. Pp. xii + 243. $24.95.

This book explores 'efficacious intimacy' as an embodied concept of worldmaking, and a framework for studying belief practices in religious and political domains. The study of how beliefs make and manifest power through their sociality and materiality can reveal who, or what, is considered effective in a particular socio-cultural context. The chapters feature case studies drawn from diverse religious and political contexts in Asia, Africa, and the Americas, and explore practices ranging from ingesting sacred water to resisting injustice. In doing (...) so, the authors analyze emotions and affects, and how they influence dynamics of proximity and distance. Taking an innovative approach to the topic of intimacy, the book offers a fascinating examination of how life-worlds are constructed by material practices. It will be of interest to scholars of anthropology, religion, and material culture. (shrink)

This collection addresses a post-WWII shift in the hierarchy of scientific explanations, where the highest goal moves from reductionism towards some ...

For the theorists of crisis, the revolutionary state comes into existence through violence, and due to its inability to provide an authoritative katechon (restrainer) against internal and external violence, it perpetuates violence until it self-destructs. Writing during extreme economic depression and growing social and political violence, the crisis theorists––Joseph de Maistre, Juan Donoso Cortés, and Carl Schmitt––each sought to blame the chaos of their time upon the Janus-faced postrevolutionary ideals of liberalism and socialism by urging a return to pre-revolutionary moral (...) and religious values. They are united by three counterrevolutionary principles, all of which are purported to remedy revolutionary violence: traditional constitutional fidelity, the philosophy of the decision, and opposition to bourgeois liberalism. This essay is followed by the first complete English translation and publication of Donoso’s letter of October 24, 1851, which contains Donoso’s only reference to the “discussing class,” a political entity later popularized by Schmitt in his 1922 work Political Theology. (shrink)

Critical study of Saptapadārthī, work on the fundamentals of Vaiśeṣika and Nyaya school in Hindu philosophy by Śivāditya, 11th century.

In much of the current academic and public discussion, conspiracy theories are portrayed as a negative phenomenon, linked to misinformation, mistrust in experts and institutions, and political propaganda. Rather surprisingly, however, philosophers working on this topic have been reluctant to incorporate a negatively evaluative aspect when either analyzing or engineering the concept conspiracy theory. In this paper, we present empirical data on the nature of the concept conspiracy theory from five studies designed to test the existence, prevalence and exact form (...) of an evaluative dimension to the ordinary concept conspiracy theory. These results reveal that, while there is a descriptive concept of conspiracy theory, the predominant use of conspiracy theory is deeply evaluative, encoding information about epistemic deficiency and often also derogatory and disparaging information. On the basis of these results, we present a new strategy for engineering conspiracy theory to promote theoretical investigations and institutional discussions of this phenomenon. We argue for engineering conspiracy theory to encode an epistemic evaluation, and to introduce a descriptive expression—such as ‘conspiratorial explanation’—to refer to the purely descriptive concept conspiracy theory. (shrink)

Bioethics has paid surprisingly little attention to the special problems faced by women and to feminist analyses of current health care issues other than ...

This volume provides a philosophical introduction to and analysis of the study of metaphor. By proceeding from the concrete analysis of complex metaphors, White is able to identify a range of features which are incompatible with standard accounts of the way words function in metaphor.

The spiritual geography of Russian cosmism. General characteristics ; Recent definitions of cosmism -- Forerunners of Russian cosmism. Vasily Nazarovich Karazin (1773-1842) ; Alexander Nikolaevich Radishchev (1749-1802) ; Poets: Mikhail Vasilyevich Lomonosov, (1711-1765) and Gavriila Romanovich Derzhavin (1743-1816) ; Prince Vladimir Fedorovich Odoevsky (1803-1869) ; Aleksander Vasilyevich Sukhovo-Kobylin (1817-1903) -- The Russian philosophical context. Philosophy as a passion ; The destiny of Russia ; Thought as a call for action ; The totalitarian cast of mind -- The religious and spiritual (...) context. The kingdom of god on earth ; Hesychasm: two great Russian saints ; The Third Rome ; Pre-Christian antecedents -- The Russian esoteric context. Early searches for "deep wisdom" ; Popular magic ; Higher magic in the time of Peter the Great ; Esotericism after Peter the Great ; Theosophy and anthroposophy -- Nikolai Fedorovich Fedorov (1829-1903), the philosopher of the common task ; The one idea ; The unacknowledged prince ; The village teacher ; First disciple: Dostoevsky and Tolstoy ; The Moscow librarian ; Last years: Askhabad: the only portrait -- The "common task" ; Esoteric dimensions of the "common task" ; Fedorov's legacy: projectivism, delo, regulation -- The religious cosmists. Vladimir Sergeevich Solovyov (1853-1900) ; Sergei Nikolaevich Bulgakov (1871-1944) ; Pavel Aleksandrovich Florensky (1882-1937) ; Nikolai Aleksandrovich Berdyaev (1874-1948) -- The scientific cosmists. Konstantin Edouardovich Tsiolkovsky (1857-1935) ; Vladimir Ivanovich Vernadsky (1863-1945) ; Alexander Leonidovich Chizhevsky (1897-1964) ; Vasily Feofilovich Kuprevich (1897-1969) -- Promethean theurgy. Life-creation ; Cultural immortalism ; God-building ; Re-aiming the arrows of Eros ; Technological utopianism ; Occultism -- Fedorov's twentieth century followers. Nikolai Pavlovich Peterson (1844-1919) and Vladimir Aleksandrovich Kozhevnikov (1852-1917) ; Svyatogor and the biocosmists ; New wine and the universal task ; Alexander Konstantinovich Gorsky (1886-1943) and Nikolai Alexandrovich Setnitsky (1888-1937) ; Valerian Nikolaevich Muravyov (1885-1932) ; Vasily Nikolaevich Chekrygin (1897-1922) -- Cosmism and its offshoots today. The N.F. Fedorov museum-library ; The Tsiolkovsky museum and Chizhevsky center ; ISRICA - Institute for Scientific Research in Cosmic Anthropoecology ; Lev Nikolaevich Gumilev (1912-1992) and neo-eurasianism ; The hyperboreans ; Scientific immortalism: Igor Vishev, Danila Medvedev ; Conclusions about the Russian cosmists. (shrink)

Much discussion about experimental philosophy and philosophical methodology has been framed in terms of the reliability of intuitions, and even when it has not been about reliability per se, it has been focused on whether intuitions meet whatever conditions they need to meet to be trustworthy as evidence. But really that question cannot be answered independently from the questions, evidence for what theories arrived at by what sorts of inferences? I will contend here that not just philosophy's sources of evidence, (...) but also its inferential resources, are in great need of closer examination. (shrink)

Linguistic anthropologists have studied emotion in societies around the world for several decades. This article defines the discipline, introduces its general relevance to emotion theory, then presents five of the most important contributions linguistic anthropology has made to the study of emotion.

Arguably no concept is more fundamental to science than that of causality, for investigations into cases of existence, persistence, and change in the natural world are largely investigations into the causes of these phenomena. Yet the metaphysics and epistemology of causality remain unclear. For example, the ontological categories of the causal relata have been taken to be objects (Hume 1739), events (Davidson 1967), properties (Armstrong 1978), processes (Salmon 1984), variables (Hitchcock 1993), and facts (Mellor 1995). (For convenience, causes and effects (...) will usually be understood as events in what follows.) Complicating matters, causal relations may be singular (Socrates’s drinking hemlock caused Socrates’s death) or general (Drinking hemlock causes death); hence the relata might be tokens (e.g., instances of properties) or types (e.g., types of events) of the category in question. Other questions up for grabs are: Are singular causes metaphysically and/or epistemologically prior to general causes or vice versa (or neither)? What grounds the intuitive asymmetry of the causal relation? Are macro-causal relations reducible to micro-causal relations? And perhaps most importantly: Are causal facts (e.g., the holding of causal relations) reducible to non-causal facts (e.g., the holding of certain spatiotemporal relations)? (shrink)

In this paper I argue that both defence and criticism of the claim that humans act ‘under the guise of the good’ neglects the metaphysical roots of the theory. I begin with an overview of the theory and its modern commentators, with critics noting the apparent possibility of acting against the good, and supporters claiming that such actions are instances of error. These debates reduce the ‘guise of the good’ to a claim about intention and moral action, and in so (...) doing have become divorced from the theory's roots in classical and medieval philosophy. Aristotle and Aquinas’ ‘guise of the good’ is primarily a metaphysical claim resting on the equivalence between actuality and goodness, from which conclusions about moral action are derived. I show the reasoning behind their theory and how it forms the basis for the claims about intention and action at the centre of the modern debate. Finally, I argue that the absence of its original foundation is apparent in recent attacks on the ‘guise of the good’. It is unsurprising that modern action theory and ethics have not always been able to comfortably accommodate the ‘guise of the good’; they are only telling half of the story. (shrink)

Twentieth-century developments in quantum physics, together with an emerging science of consciousness, have created the need for a new cosmology, or model of the universe. The theory of process contained in THE REFLEXIVE UNIVERSE places consciousness within the context of contemporary science. One of the central themes of this extraordinary work is that each successive organization of matter, from fundamental particles in physics to living organisms, expresses a particular stage in the evolution of mind. Starting with the photon, the basic (...) unit of light, and moving through atomic physics, molecular chemistry, the morphology of plants and animals and finally to levels of human evolution, Young develops his theory in vivid step-by-step detail. Consciousness, in his point of view, is not isolated from the material universe. It exists in a continuum, one in which physical and nonphysical realms can be linked and the teachings of mythology and religion can be integrated. To order: FAX: 415-883-9280; e-mail: [email protected]; or write: Anodos Foundation, c/o Publishers Services, P.O. Box 2510, Novato, CA 94948. Visa and MasterCard only. Trade STOP orders 40% plus postage. (shrink)

Studien zur Wissenschaftsgeschichte und Wissenschaftssystematik im 19. Jahrhundert Josef M. Werle. Drittes Kapitel Argumente zugunsten der Zukunft der Philosophie II: Wissenschaftsgeschichtliche und wissenschaftssystematische ...

This article aims to contribute to the application of ethical frameworks to public health policy. In particular, the article considers the use of the Nuffield Council on Bioethics stewardship model, as an applied framework for the evaluation of evidence within public health policymaking. The ‘Stewardship framework’ was applied to a policy proposal to restrict marketing of food and beverages to children. Reflections on applying the stewardship model as a framework are provided. The article concludes that the questions used to apply (...) the stewardship model usefully introduced ethical considerations into the evidence review. However, the real value will likely come from the type of policy process within which the framework is used, identifying competing value positions and capturing local value requirements. (shrink)