Doctoral programs at U.S. universities play a critical role in the development of human resources both in the United States and abroad. This volume reports the results of an extensive study of U.S. research-doctorate programs in five broad fields: physical sciences and mathematics, engineering, social and behavioral sciences, biological sciences, and the humanities. Research-Doctorate Programs in the United States documents changes that have taken place in the size, structure, and quality of doctoral education since the widely used 1982 editions. This (...) update provides selected information on nearly 4,000 doctoral programs in 41 subdisciplines at 274 doctorate-granting institutions. This volume also reports the results of the National Survey of Graduate Faculty, which polled a sample of faculty for their views on the scholarly quality of program faculty and the effectiveness of doctoral programs in preparing research scholars/scientists. This much-anticipated update of such an essential reference will be useful to education administrators, university faculty, and students seeking authoritative information on doctoral programs. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and informed (...) consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This study builds on prior research investigating the antecedents of firm supererogation. Examining vehicle recalls in the U.S. automobile industry from 1966 to 2010 reveals that surveillance-based government enforcement programs can have widespread industry effects on a specific type of supererogatory action, firm volunteerism. Specifically, increases in government surveillance are associated with firms going beyond what is legally required of them by initiating voluntary product recalls for defects not covered in existing government regulation. Such effects are shown to be unique (...) among surveillance efforts as other government enforcement activities, such as standards-based regulation, are revealed to have a negative association with firm supererogation. (shrink)

Progressive supranuclear palsy is a movement disorder with prominent tau neuropathology. Brain diseases with abnormal tau deposits are called tauopathies, the most common of which is Alzheimer's disease. Environmental causes of tauopathies include repetitive head trauma associated with some sports. To identify common genetic variation contributing to risk for tauopathies, we carried out a genome-wide association study of 1,114 individuals with PSP and 3,247 controls followed by a second stage in which we genotyped 1,051 cases and 3,560 controls for (...) the stage 1 SNPs that yielded P ≤ 10-3. We found significant previously unidentified signals associated with PSP risk at STX6, EIF2AK3 and MOBP. We confirmed two independent variants in MAPT affecting risk for PSP, one of which influences MAPT brain expression. The genes implicated encode proteins for vesicle-membrane fusion at the Golgi-endosomal interface, for the endoplasmic reticulum unfolded protein response and for a myelin structural component. © 2011 Nature America, Inc. All rights reserved. (shrink)

These essays, first presented at a conference, “Coping with Sickness,” held in Italy in 1997, address ethical and regulatory medical issues within a historical context. Many of the essays, while addressing interesting topics, combine policy analysis and critical cultural theory. Critical cultural theory can be intellectually engaging at times but is generally irrelevant to public officials concerned with specific policy issues.Coping with Sickness is the third and final volume derived from a series of conferences cosponsored by the European Science (...) Foundation and the Euroconferences Activity of the European Union. The eight essays are organized chronologically and cover a range of disparate topics: medical practitioners and the Spanish Inquisition , the history of autopsy legislation in German since 1800 , the history of “sadism” as a medical term in the nineteenth century , folk medicine in Holland in the late nineteenth century , abortion in Weimar Germany , drug testing in Africa in the early twentieth century , comparative policies toward STDs , and the debate over brain death in Germany . As might be expected in an anthology of this sort, the quality varies considerably. Nonetheless, the subjects addressed in this volume are engaging—much to the credit of the editors.Two pieces in particular represent the range of these collected essays. In “Vacher the Ripper and the Construction of the Nineteenth‐Century Sadist,” Angus McLaren, one of the best historians writing on the history of sexuality today, explores the “discovery” of sadism in the late nineteenth century by focusing on the dramatic trial of Joseph Vacher, who was charged in 1895 for the brutal sexual murder of a woman in Champuis. He later confessed to the murder and the sexual violation of another seven females and four males. Vacher had a long history of mental illness; indeed, he had been institutionalized in July 1893 following a failed attempt at suicide that left a bullet lodged in his head. At the trial the criminologist Alexandre Lacassagne was brought in as an expert witness to testify that Vacher was not insane but an antisocial sadist, as revealed by his dabbling in anarchism, vagabondism, and homosexuality. As a consequence, Vacher was found guilty and given a death sentence.McLaren finds in this trial an example of the social construction of a new medical concept, “sadism.” The emergence of the concept of sadism, he argues, reflected a “gendered notion” of defining appropriate male and female behavior; physicians at the turn of the century believed that “civilized men were most threatened, not by excess passion, but by the enervation spawned by urban life” . The concept of sadism was also employed by doctors to enhance their own authority and to alert the public to the dangers of a male manifesting “feminine traits” and to “beat back” homosexuality.There is much interesting conjecture to McLaren's study, but what policy lessons should be drawn from this remains unclear. If every concept is actually a social construction, reflecting the social anxieties of the age, then is the fashionable concept of social construction itself socially constructed to enhance the authority of the medical historian?More interesting methodologically is Claudia Wiesemann's absorbing essay on the historical debate in Germany over “brain death.” Relying on Ulrich Beck's social theory of simple and reflexive modernization, she shows that, when confronted with complex scientific questions, the public has to decide between competing plausible scientific claims; as a result, political groups make use of scientific expertise and counterexpertise to push their favorite practical and legal solutions. (shrink)

This study examines the association between mystical experience, as captured by the Francis-Louden Mystical Orientation Scale, and psychological health, as captured by the Eysenckian three dimensional model of personality, among 329 students attending a state university in Turkey. The data reported no significant association between mystical orientation and psychoticism scores, and a small but significant positive association between mystical orientation and neuroticism scores, after controlling for sex differences. This finding suggests that there may be a small inverse (...) association between mystical experience and psychological health among students in Turkey. (shrink)

This book constitutes the strictly refereed post-workshop proceedings of the 11th International Workshop on Computer Science Logic, CSL '97, held as the 1997 Annual Conference of the European Association on Computer Science Logic, EACSL, in Aarhus, Denmark, in August 1997. The volume presents 26 revised full papers selected after two rounds of refereeing from initially 92 submissions; also included are four invited papers. The book addresses all current aspects of computer science logics and its applications and thus presents (...) the state of the art in the area. (shrink)

B a c k g r o u n d. According to the genre characteristics, the article is a form of publicizing analytical conclusions from the experience of research in the field of the philosophical Chinese studies at the National Academy of Sciences of Ukraine from 1991 to the present day. The material for understanding was supplied from the environment of scientific professional activity of prominent figures of Ukrainian philosophical Sinology from the H. Skovoroda Institute of Philosophy of the (...) NAS of Ukraine and the A. Krymskyi Institute of Oriental Studies of the NAS of Ukraine. The scientific achievements of academic Sinologists, who are leading researchers of Chinese philosophical education, science and culture from the archaic to modern times, are highlighted. They are, namely: V. Kiktenko, V. Pyrohiv, V. Hamianin, S. Kapranov, Y. Hobova and A. Usyk. M e t h o d s. The article uses an analytical approach based on the study of historical and philosophical sources. The methodological basis of the research is the main methods of historical and philosophical science: problem-categorical analysis, socio-cultural analysis and biographical analysis. At the same time, the methods of situational and contextual analysis of scientific texts are applied. R e s u l t s. Four conditional thematic vectors of the progress of academic philosophical Sinology in modern Ukraine are classified, namely the study of: 1. the history of ancient Chinese philosophy, especially Confucianism; 2. the history of Chinese philosophy in the 19th – early 21st centuries; 3) the history of Ukrainian Sinology in the 18th – early 21st centuries; 4. the history of modern foreign Sinology. The director of the A. Krymskyi Institute of Oriental Studies of the NAS of Ukraine and the head of the Ukrainian Association of Sinologists V. Kiktenko very effectively studies all these vectors, especially the last three of them. His colleagues at the institute V. Pyrohiv, V. Hamianin and Y. Hobova mainly research the first of these vectors, and primarily the history of Confucianism. Employees of the H. Skovoroda Institute of Philosophy of the NAS of Ukraine S. Kapranov and A. Usyk are also focused scientific attention on the history of Confucianism, in particular, the second of them studies social ethics and anthropology of Confucius. C o n c l u s i o n s. As a result it was established that modern domestic philosophical academic Sinology is a qualitatively new and innovative direction of Oriental studies in independent Ukraine. This discipline was formed as a result of the two-century progress of Ukrainian Chinese studies from the era of Hetmanshina until now. V. Kiktenko and his colleagues have made a significant and already internationally recognized contribution to the study of both the classical philosophical schools of Ancient China and their ideological heirs, in particular, the leaders of the PRC and the CCP from Deng Xiaoping to Xi Jinping during these thirty years. V. Kiktenko also laid the foundations for the study both of the history of Ukrainian Chinese studies and of modern foreign, primarily Western European and North American, Sinology. (shrink)

The overall objective of this research is to determine the religious perceptions and its levels of university youth and to interpret the findings from the point of view of their psychological features. This research consists of four chapter. These are: introduction, first chapter consist of discussions of the basic concepts such as religiosity, spirituality, second chapter that the data obtained from the survey was assessed the relationships with hypotheses and conclusions in which the findings were interpreted. The study’s population consists (...) of the students at the undergraduate level in faculties of the Erciyes University in 2011-2012. A questionnaire was administered on 553 students, chosen randomly in this population. The survey contains descriptive and Likert style items. As independent variables in this study, branches of science, faculty, department, class, age, gender, living environment for the longest time before coming to university, graduated high school, mother's and father's education level and the accommodation place during training have been taken. When analyzing the data, percentages, frequency distributions, descriptive statistics, analysis of variance (one-way ANOVA) and T-Tests and Chi-Square (x²) techniques were used. As a result of this research hypotheses associated with gender, age, branches of science, faculty and department were confirmed on the other hand the others were rejected. (shrink)

In a career extending over almost six decades, Nicholas Rescher has conducted researches in almost every principal area of philosophy, historical and systematic alike. In this extraordinary volume, two dozen scholars join in offering penetrating discussions of various facets of Rescher s investigations. The result is an instructively critical panorama of the many-faceted contributions of this important American philosopher. Born in Germany in 1928, Nicholas Rescher came to the U.S. at the age of nine. He is University Professor of Philosophy (...) at the University of Pittsburgh where he has also served as Chairman of the Philosophy Department and as director (and currently chairman) of the Center for Philosophy of Science. In a productive research career extending over six decades, he has established himself as a systematic philosopher of the old style. His work represents a many-sided approach to fundamental philosophical issues that weaves together threads of thought from continental idealism and American pragmatism. And apart from this larger program Rescher has made various specific contributions to logic (the conception autodescriptive systems of many-sided logic), the history of logic (the medieval Arabic theory of modal syllogistic), to the theory of knowledge (epistemetrics as a quantitative approach in theoretical epistemology), and to the philosophy of science (the theory of a logarithmic retardation of scientific progress). Rescher has also worked in the area of futuristics, and along with Olaf Helmer and Norman Dalkey is co-inaugurator of the so-called Delphi method of forecasting. Ten books about Rescher s philosophy have been published in four languages. Rescher earned his doctorate at Princeton in 1951 while still at the age of twenty-two a record for Princeton s Department of Philosophy. He has served as a President of the American Philosophical Association, of the American Catholic Philosophy Association, of the American G. W. Leibniz Society, of the C. S. Peirce Society, and of the American Metaphysical Society. He was the founder of the American Philosophical Quarterly. An honorary member of Corpus Christi College, Oxford, he has been elected to membership in the European Academy of Arts and Sciences (Academia Europaea), the Royal Society of Canada, the Institut International de Philosophie, and several other learned academies. Having held visiting lectureships at Oxford, Constance, Salamanca, Munich, and Marburg, he has been awarded fellowships by the Ford, Guggenheim, and National Science Foundations. Author of some hundred books ranging over many areas of philosophy, over a dozen of them translated from English into other languages, he is the recipient of eight honorary degrees from universities on three continents. He was awarded the Alexander von Humboldt Prize for Humanistic Scholarship in 1984, the Belgian Prix Mercier in 2005, and the Aquinas Medal of the American Catholic Philosophical Association in 2007.". (shrink)

This article develops a theoretical framework for analysing the growing public prominence, and rising influence, of transnational religious movements on the contemporary world stage, with specific reference to the case of Agudat Israel, a prominent ‘ultra-Orthodox’ Jewish organization. It first considers the place of ‘religion’ within the context of the historical emergence of the world system of modern nation-states, addressing some of the conceptual ambiguities associated with the ideas of national vs transnational religious formations. The article then provides a (...) historical sketch of the European Jewish encounter with modernity, focusing on the rise of transnational movements like Agudat Israel. Lastly, the article situates Jewish Orthodoxy within a comparative framework for the study of transnational religio-politics. The article concludes by asking whether transnational religious movements might be trapped within the instrumental logic of state governmentality they claim to oppose, and if so, with what consequences. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and informed (...) consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This is a study of the encounter with the problem of heresy in Europe between the World Wars, in Germany and among Jews above all. It is first and foremost an intellectual history, though not exclusively so, and has four related aims. It argues, first, that the advent of a heretical ideal among Jews in the interwar period marked the definitive end of a chapter in German-Jewish history that began with Moses Mendelssohn. Mendelssohn's gambit and the liberal Judaism that (...) arose in its wake proved unworkable by this time, and the arrival of avowedly heretical forms of Jewish return signaled the end of his epoch. But we also find in this period the beginnings of a search for post-liberal modes of Jewish identity in which its predecessor endured in interesting and unexpected ways. Second, the dissertation reconstructs and analyzes the two leading languages of heresy in the interwar period, the gnostic and the pantheist. The first pined for salvation from a sinful world by the grace of a wholly transcendent, extramundane and therefore absent God, or a deus absconditus , and was associated in the interwar period with the Protestant representatives of dialectical theology. The pantheist language of heresy, by contrast, contested the gnostic spirit by divinizing the world, and was associated with the interconfessional revival of Spinoza. On the strength of this contextual reconstruction, the study aims, third, to reinterpret the philosophical careers of three important twentieth-century thinkers, all of them German-Jewish emigres: Hans Jonas, whose philosophical biology made him an unproclaimed "guru" to the German Green movment; Leo Strauss, the philosopher and unwitting father of a neo-conservative revolt in American politics; and Gershom Scholem, the eminent scholar of religion and Jewish culture. The study shows how their diverse projects all had origins in their encounter with the problem of heresy in interwar Europe. Their projects had also a common end: all resurrected the ancient Greek distinction between physis and nomos , and all contested normative Judaism by coming down squarely on the side of the former as the ground for Jewish identity in particular and human being more generally. Fourth and last, the dissertation makes an argument for the abiding salience of a theological dimension to European intellectual life between the wars and beyond. If nothing else, the stories presented here should alert us to the ways in which talk about God could be adapted for talk about nature, or politics, or art, to the ways in which discourses of the divine not only endure in this worldly world of ours, but flourish. (shrink)

MARINA PAOLA BANCHETTI-ROBINO is Associate Professor and Chair of the Philosophy Department at Florida Atlantic University. Her areas of research include phenomenology, philosophy of language, philosophy of science, philosophy of mind, and zoosemiotics. Her publications have appeared in such journals as Synthese, Husserl Studies, Idealistic Studies, Philosophy East and West, and The Review of Metaphysics. She has also contributed essays to The Role of Pragmatics in Contemporary Philosophy (1997), Feminist Phenomenology (2000), and Islamic Philosophy and Occidental Phenomenology on (...) the Perennial Issue of Microcosm and Macrocosm (2006). She co-edited Philosophies of the Environment and Technology (1999) and is currently working on a book-length project entitled The Birth of Science Out of the Spirit of Myth: A Historico-Phenomenological Re-Examination of the Crisis of the European Sciences. BERNARD BOXILL was born in Saint Lucia, West Indies where he received his primary and secondary education. He studied philosophy at the University of New Brunswick, Canada and at the University of California, Los Angeles where he was awarded a doctorate in philosophy in 1971. He has published numerous articles, a book, Blacks and Social Justice (1992), and is professor of philosophy at the University of North Carolina at Chapel Hill. ED BRANDON was born and educated in England, studying philosophy and linguistics at The University of York, England, and later philosophy at The University of Oxford with the late John Mackie. After teaching in Sierra Leone and briefly in England, he went to teach philosophy of education at the University of the West Indies at Mona, Jamaica in 1978. From 1992 he has been attached to a policy unit of the Vice-Chancellery, based at the Cave Hill campus in Barbados, where he has been assisting since 2000 with a new major in philosophy. His academic work can be accessed from http://cavehill.uwi.edu/bnccde/epb/personalpage.html CAROLYN CUSICK is a doctoral candidate in the Department of Philosophy at Vanderbilt University. She is a founding member of the Phenomenology Roundtable. Her research focuses on feminist epistemology, Africana philosophy, and phenomenology. LEWIS GORDON is President of the Caribbean Philosophical Association. He is Laura H. Carnell Professor, the most distinguished chair, at Temple University, where he holds appointments in philosophy, religion, and Judaic studies and directs the Institute for the Study of Race and Social Thought and the Center for Afro-Jewish Studies. He is also Ongoing Visiting Professor of Philosophy and Government at the University of the West Indies at Mona, Jamaica. He is the author of several books, including the award-winning Her Majesty's Other Children: Sketches of Racism from a Neocolonial Age (Rowman and Littlefield, 1997), Disciplinary Decadence: Living Thought in Trying Times (Paradigm, 2006), An Introduction to Africana Philosophy (Cambridge University Press, forthcoming), and co-editor of A Companion to African-American Studies (Blackwell, 2006) and Not Only the Master's Tools: African-American Studies in Theory and Practice (Paradigm, 2005). CLEVIS HEADLEY is currently Associate Professor of Philosophy at Florida Atlantic University, director of the Ethnic Studies Certificate Program, as well as director of the Master's in Liberal Studies. Professionally, he serves as the Vice-President and Treasurer of the Caribbean Philosophical Association. Professor Headley has published widely in the areas of Critical Race Theory and Africana philosophy. He has also published in Analytic philosophy, focusing specifically on Gottlob Frege. PAGET HENRY is Professor of Sociology and Africana Studies at Brown University. He is the author of Caliban's Reason: Introducing Afro-Caribbean Philosophy, Peripheral Capitalism and Underdevelopment in Antigua, and the co-editor of C. L. R. James' Caribbean. Professor Henry also serves as the editor of the C. L. R. James Journal, and has published numerous articles on the political economy of the Caribbean as well as on African, African-American, and Afro-Caribbean philosophy. ESIABA IROBI is Associate Professor of International Theatre/Performance Studies at Ohio University, Athens. His groundbreaking book: A Theatre for Cannibals: Resisting Globalization on the Continent and Diaspora since 1441 will be published by Palgrave Macmillan, London, in 2007. He has been invited to be an External Resident Fellow at the prestigious Dartmouth College Humanities Institute for the 2007-2008 academic year. CHIKE JEFFERS is a graduate student in the Ph.D. program of the Philosophy Department at Northwestern University. His interests are in Africana philosophy, social and political philosophy, ethics, philosophy of religion and aesthetics. He is originally from Toronto, Ontario, Canada. CATHERINE JOHN is Associate Professor of African Diaspora Literary and Cultural Studies at the University of Oklahoma. Her book Clear Word and Third Sight: Folk Groundings and Diasporic Consciousness in African Caribbean Writing was co-published by Duke University Press and UWI Press in 2003. She has published several articles on Caribbean literature and culture and her current book project is entitled The Just Society and the Diasporic Imagination. She spends her summer working in Woodside, St. Mary, Jamaica helping with a summer school for children and participating in the community's emancipation celebration. KENNETH KNIES is a doctoral student in philosophy at Stony Brook University. His areas of focus are phenomenology and ancient philosophy. He is also a contributing editor for Political Affairs magazine. EDIZON LEN is a photographer and coordinator of the Fondo Documental Afro-Andino at the Universidad Andina Simòn Bolivar in Quito, Ecuador. In 2006, he was curator of the photo exhibit "The Color of the Diaspora" presented at the Cultural Center of the Catholic University of Ecuador and the University of Tennessee in Knoxville. He is currently completing his doctorate at the Universidad Andina Simòn Bolivar with a focus on Maroon thought. REKHA MENON is Associate Professor of Art History at State University of New York, Buffalo State. She is the author of Seductive Aesthetics of Post Colonialism (forthcoming). Her area of research focuses on current philosophical investigations in colonial and neocolonial aspects of Indian art, artistic/cultural practices and philosophies and their relationship to Western arts and philosophies. Her manuscripts under review are: Ashamed of Our Nakedness, Is There Ever a Naked Body? Ambivalence in Contemporary Indian Expressive Aesthetics and Insatiable Desire. MICHAEL R. MICHAU is a Ph.D. candidate in the Philosophy and Literature Program at Purdue University, and during the 2006-2007 school year, a lecturer in the Department of Comparative Studies and Department of Philosophy at Ohio State University. He is the co-founder and co-secretary of the North American Levinas Society. CHARLES W. MILLS is Distinguished Professor of Philosophy at the University of Illinois at Chicago. He works in the general area of oppositional political theory, and is the author of numerous articles and three books: The Racial Contract (Cornell University Press, 1997), Blackness Visible: Essays on Philosophy and Race (Cornell University Press, 1998), and From Class to Race: Essays in White Marxism and Black Radicalism (Rowman and Littlefield, 2003). MABOGO P. MORE is currently Associate Professor of Philosophy at the University of KwaZulu-Natal, South Africa. He has published articles on African philosophy and social and political philosophy in a number of academic journals, such as South African Journal of Philosophy, Dialogue and Universalism, Alternation, Theoria, and African Journal of Political Science. MARILYN NISSIM-SABAT, Ph.D., M.S.W. is Professor Emerita and Adjunct Professor of Philosophy, Lewis University. Dr. Nissim-Sabat is also a psychotherapist in private practice. She is the author of numerous book chapters and papers in the fields of philosophy (Husserlian phenomenology), psychoanalysis, feminism, and critical race theory. Citations of her works can be found on her website: marilynnissim-sabat.com. FREDERICK OCHIENG'-ODHIAMBO is a Senior Lecturer of Philosophy and Coordinator of the discipline at The University of the West Indies, Cave Hill, Barbados. His major research areas are African philosophy and social philosophy. He has published several articles on philosophic sagacity. IVAN PETRELLA is an Assistant Professor of Religious Studies at the University of Miami. He is author of The Future of Liberation Theology: An Argument and Manifesto (SCM Press, 2006) and editor of Latin American Liberation Theology: The Next Generation (Orbis Books, 2005) as well as co-editor of the series Reclaiming Liberation Theology (SCM Press) RICHARD PITHOUSE is a research fellow at the University of KwaZulu-Natal in Durban, South Africa. He is editor of Asinamali: University Struggles in Post-Apartheid South Africa (Africa World Press, 2006). SATHYA RAO is Assistant Professor in French translation at the Department of Modern Languages and Cultural Studies, University of Alberta, Canada. His research fields include: theory of translation, continental philosophy, postcolonial studies, discourses on Africa, and Francophone cinema and literature. He has published articles in various peer-reviewed journals and written chapters in several collective books such as: De l'Ecrit Africain a l'Oral le Phenomene Graphique Africain, Simon Battestini (Ed.) (Paris: L'Harmattan, 2006) and Thèorie-rèbellion. Un Ultimatum, Gilles Grelet (Ed.) (Paris: L'Harmattan, 2005). He has a co-edited a book on Francophone African cinema L'Afrique fait son cinema (Montreal: Memoires d'encrier, forthcoming). Sathya Rao is vice-president of the International Non-Philosophical Organisation (INPhO), member of the Canadian Association of Translatology (CATS), coordinator of the research team Poexil, and Secretary of the Caribbean Philosophical Association. He is co-founder of an online journal Alternative Francophone. CATHERINE WALSH is Professor and Director of the doctoral program in Latin American Cultural Studies at the Universidad Andina Simon Bolivar in Quito, Ecuador. Her research interests include the geopolitics of knowledge, interculturality and concerns related to the Afro-Andean Diaspora and the production of decolonial thought. Among her recent publications are Pensamiento crìtico y matriz colonial (Quito: Abya Yala, 2005), "Interculturality and the Coloniality of Power. An 'Other' Thinking and Positioning from the Colonial Difference," in Coloniality of Power, Transmodernity, and Border Thinking, R. Grosfoguel, J.D. Saldivar, and N. Maldonado-Torres (Eds.) (Durham: Duke University Press, forthcoming) and "Shifting the Geopolitics of Critical Knowledge: Decolonial Thought and Cultural Studies 'Others' in the Andes," Cultural Studies (forthcoming). KRISTIN WATERS has published widely in the areas of race and gender. Her anthology Enlightened Conversations: Women and Men Political Theorists (Blackwell, 2000) challenges political theorists to be more inclusive of race and gender in their research and teaching. Her book Black Women's Intellectual Traditions: Speaking Their Minds, co-edited with Carol Conaway (University of Vermont Press, forthcoming), addresses the varied intellectual traditions of black women's thought that spans more than two hundred years in North America. She is currently Professor of Philosophy at Worcester State College and Visiting Research Associate at Brandeis University. (shrink)

Imagining structures from the ekphrastic descriptions of the Jerusalem Temple and Temple Mount in I Kings and Ezekiel is an ancient meditation discipline, which was adopted from Jewish practices into early Christian monasticism. Though it could take various forms, ‘imagining/remembering Jerusalem’ was often practised as a devotional exercise throughout the European Middle Ages. Drawings of such an imagined character are significant to late medieval exegesis of these and related scriptural materials, particularly those associated with the commentaries of Nicholas (...) of Lyra and the collection of visual meditations known as the Speculum theologie. This chapter queries a late medieval illuminated manuscript that, in the fifteenth century, formed part of the library of St John's Hospital in Exeter, to suggest that its materials were acquired and used for scriptural study and sermon composition by scholars of the hospital and its associated school. (shrink)

States are beginning to restructure their U.S. history assessments from previous multiple-choice based assessments to include written-response questions that have higher levels of academic language demands. These higher-order thinking and analytical items pose challenges to linguistically and culturally diverse students. The purpose of the current study is to investigate how the restructuring of a U.S. history state assessment is associated with English Learners’ (ELs) achievement over time. The author incorporates 3 years of data from the Tennessee Department of Education, and (...) utilizes multi-level modeling (Hierarchical Linear Modeling) to examine and compare the association between school percentage ELs and U.S. history achievement on Tennessee's (TN) U.S. history state assessment. Findings indicate that the restructuring of the TN U.S. history state assessment in the 2015–16 school year is significantly and inversely associated with ELs’ achievement on this assessment. At the same time, there are no significant associations for the 2012–13 and the 2013–14 school years. This suggests a negative inverse association between the restructuring of the TN U.S. history state assessment and ELs’ performance. In addition, this suggests that ELs’ lack of U.S. history reading and writing ability may have contributed to the negative association. (shrink)

Understood historically, culturally, politically, geographically, or philosophically, the idea of Europe and notion of European identity conjure up as much controversy as consensus. The mapping of the relation between ideas of Europe and their philosophical articulation and contestation has never benefited from clear boundaries, and if it is to retain its relevance to the challenges now facing the world, it must become an evolving conceptual landscape of critical reflection. The Routledge Handbook of Philosophy of Europe provides an outstanding reference (...) work for the exploration of Europe in its manifold conceptions, narratives, institutions, and values. Comprising twenty-seven chapters by a group of international contributors, the Handbook is divided into three parts: • Europe of the Philosophers • Concepts and Controversies • Debates and Horizons Essential reading for students and researchers in philosophy, politics and European studies the Handbook will also be of interest to those in related disciplines such as sociology, religion, and European history and history of ideas. Darian Meacham is an Assistant Professor of Philosophy at Maastricht University, The Netherlands. He is the editor-in-chief of the Journal of the British Society for Phenomenology and the co-editor of Thinking After Europe: Jan Patočka and Politics (2016) Nicolas de Warren is Associate Professor of Philosophy and Jewish Studies at Pennsylvania State University, USA. He is the author of Husserl and the Promise of Time (2010), A Momentary Breathlessness in the Sadness of Time (2018), and Original Forgiveness (2020). (shrink)

Diabetes mellitus (DM) is a colossal burden in global health, its prevalence increases steadily throughout the world. This systematic review explores the pathophysiology and epidemiology of diabetes, which describes the interactions that implicate that is the result of the play between genetic, environmental, and lifestyle factors in the development and progression of the disease. The review also describes a plethora of pharmacological treatments available to manage diabetes, with the oral agent, insulin regimens, and new approaches to therapy. Integrating the wisdom (...) of the best clinical guidelines, those are from American diabetes association (ADA), European association for the study of diabetes (EASD), and International Diabetes Federation (IDF). Since these reviews are consistent with normative standards for evidence-based recommendations of optimal care of diabetes. The review goes further to cover technological advances in the management of diabetes. They include Continuous Glucose Monitoring, advanced insulin delivery systems, and Artificial Pancreas Systems. Such technologies hold more promising routes to better glucose control and patient quality of life. All this comes along with challenges that their deployment and maintenance that run through economic, adherence issues, and unequal access to healthcare. The future research and innovation in the battle against DM will include the application of personalized medicine and the development of advanced digital health solutions. This article will become a treasure for health professionals, researchers, and policymakers who have dedicated themselves to battling the adversities of diabetes mellitus. (shrink)

Overview * Part I: Introduction * Philip Appleman, Darwin: On Changing the Mind * Part II: Darwin’s Life * Ernst Mayr, Who Is Darwin? * Part III: Scientific Thought: Just before Darwin * Sir Gavin de Beer, Biology before the Beagle * Thomas Robert Malthus, An Essay on the Principle of Population * William Paley, Natural Theology * Jean Baptiste Pierre Antoine de Monet Lamarck, Zoological Philisophy * Charles Lyell, Principles of Geology * John Herschell, The Study of Natural Philosophy (...) * William Whewell, Astronomy and General Physics Considered with Reference to Natural Theology * Alfred Russel Wallace, On the Tendency of Varieties to Depart Indefinitely from the Original Type * Part IV: Selections from Darwin’s Work * The Voyage of the Beagle * o Chapter I. St. Jago-Cape de Verd Island o Chapter XVII. Galapagos Archipelago * On the Tendency of Species to Form Varieties; and On the Perpetuation of Varieties and Species by Natural Means of Selection * o I. Extract from an unpublished Work on Species, by C. Darwin, Esq.... o II.of Letter from C. Darwin, Esq., to Prof. Asa Gray, Boston, U.S., dated Down, September 5th, 1857 * An Historical Sketch of the Progress of Opinion on the Origin of Species, previously to the : Publication of This Work The Origin of Species * o Introduction o Chapter I. Variation under Domestication o Chapter II. Variation under Nature o Chapter III. Struggle for Existence o Chapter IV. Natural Selection o Chapter VI. Difficulties on Theory o Chapter IX. On the Imperfections of the Geological Record o Chapter XIII. Mutual Affinities of Organic Beings: Morphology: Embryology: Rudimentary Organs o Chapter XIV. Recapitulation and Conclusion * The Descent of Man * o Introduction o Chapter I. The Evidence of the Descent of Man from Some Lower Form o Chapter II. On the Manner of Development of Man from Some Lower Form o Chapter III. Comparison of the Mental Powers of Man and the Lower Animals o Chapter VI. On the Affinities and Genealogy of Man o Chapter VIII. Principles of Sexual Selection o Chapter XIX. Secondary Sexual Characters of Man o Chapter XX. Secondary Sexual Characters of Man-continued o Chapter XXI. General Summary and Conclusion * Part V: Darwin’s Influence on Science * THE VICTORIAN OPPOSITION TO DARWIN * o David L. Hull, Darwin and His Critics o Adam Sedgwick, Objections to Mr. Darwin’s Theory of the Origin of Species o Sir Richard Owen, Darwin on the Origin of Species o Fleeming Jenkin, Review of the Origin of Species * VICTORIAN SUPPORTERS OF DARWIN * o Joseph Dalton Hooker, Flora Tasmaniae o Thomas Henry Huxley, On the Relations of Man to the Lowe Animals o Charles Lyell, Principles of Geology o Alfred Russel Wallace, The Debt of Science to Darwin * DARWIN AND THE SHAPING OF MODERN SCIENCE * o Scientific Method in Evolution o National Academy of Sciences, Evolution and the Nature of Science o Richard Dawkins, Explaining the Very Improbable o Lewis Thomas, On the Uncertainty of Science o Noretta Koetge, Postmodernisms and the Problem of Scientific Literary o Richard Dawkins, Science and Sensibility o The Neo-Darwinian Synthesis o Peter Bowler, The Evolutionary Synthesis o The Human Genealogy o Adam Kuper, The Chosen Primate o Ian Tattersall, Out of Africa Again... and Again? o Stephen Jay Gould, The Human Difference o Punctuated Equilibrium o Stephen Jay Gould, [On Punctuated Equilibrium] o Niles Eldredge, The Great Stasis Debate o Rethinking Taxonomy o Kevin Padian, Darwin’s Views of Classification o David L. Hull, Cladistic Analysis o Kevin Padian and Luis M. Chiappe, Cladistics in Action: The Origin of Birds and Their Flight o Evolution as Observable Fact o James L. Gould and William T. Keeton with Carol Grant Gould, How Natural Selection Operates o Peter r. Grant, Natural Selection and Darwin’s Finches o John A. Endler, Natural Selection in the Wild * Part VI: Darwinian Patterns in Social Thought * COMPETITION AND COOPERATION * o Richard Hofstadter, The Vogue of Spencer o Andrew Carnegie, The Gospel of Wealth o Peter Kropotkin, Mutual Aid o Martin A. Nowak, Robert M. May, and Karl Sigmund, The Arithmetics of Mutual Help * NATURE AND NURTURE * o Edward O. Wilson, Sociobiology: The New Synthesis o Stephen Jay Gould, Biological Potentiality vs. Biological Determination o Barbara Ehrenreich and Janet McIntosh, The New Creationism: Biology under Attack * EVOLUTION AND GENDER * o Elizabeth Cady Stanton, The Woman’s Bible o Nancy Makepeace Tanner, On Becoming Human o Evelleen Richards, Darwin and the Descent of Woman o James Eli Adams, Woman Red in Tooth and Claw * EVOLUTION AND OTHER DISCIPLINES * o Edward O. Wilson, [On Consilience] o Randolph H. Nesse and George C. Williams, Evolution and the Origin of Disease o Steven Pinker, How the Mind Works o Steve Jones, The Set within the Skull * Part VII: Darwinian Influences in Philosophy and Ethics * John Dewey, The Influence of Darwin on Philosophy * Daniel C. Dennett, Darwin’s Dangerous Idea: Natural Selection as an Algorithmic Process * Michael Ruse Darwinian Epistemology * Thomas Henry Huxley, Evolution and Ethics * Julian Huxley, Evolutionary Ethics * Michael Ruse and Edward O. Wilson, The Evolution of Ethics * Frans de Waal, Good Natured: The Origin of Right and Wrong in Humans and Other Animals * Matt Ridley, The Origins of Virtue * Part VIII: Evolutionary Theory and Religious Theory * MAINSTREAM RELIGIOUS SUPPORT FOR EVOLUTION * o Pope John Paul II, Message to the Pontifical Academy of Sciences o Central Conference of American Rabbis, On Creationism in School Textbooks o United Presbyterian Church in the U.S.A., Evolution and Creationsim o The Lutheran World Federation, [Statement on Evolution] o The General Convention of the Episcopal Church, Resolution on Evolutionism and Creationism o Unitariuan Universalist Association, Resolution Opposing "Scientific Creationism" * FUNDAMENTALIST CREATIONISM * o Eugene C. Scott, Antievolution and Creationism in the United States o The Scopes Trial o Thomas McIver, Orthodox Jewish Creationists o Harun Yahya, [Islamic Creationism] o Seami Srila Prabhupada, [A Hare Krishna on Darwinian Evolution] o Institute for Creation Research, Tenets of Creationism o Henry M. Morris, Scientific Creationism o Thomas J. Wheeler, Review of Morris o Richard D. Sjolund and Betty McCollister, Evolution at the Grass Roots o Richard D. Sjolund, [Creationism versus Biotechnology] o Betty McCollister, [The Politics of Creationism] o Molleen Matsumara, What Do Christians Really Believe about Evolution? o National Center for Science Education, Seven Significant Court Decisions Regarding Evolution/Creation Issues * PERSONAL INCREDULITY AND ANTIEVOLUTIONISM * o Richard Dawkins, [The Argument from Personal Incredulity] o Phillip E. Johnson, Darwin on Trial o Eugenie C. Scott, Review of Johnson o Michael Behe, Darwin’s Black Box o Robert Dorit, Review of Behe o Michael Ruse, Darwin’s New Critics on Trial * SCIENTISTS’ OPPOSITION TO CREATIONISM * o American Association for the Advancement of Science, Forced Teaching of Creationist Beliefs in Public School Science Education o American Institute of Biological Sciences, Resolution Oposing Creationism in Science Courses o National Association of Biology Teachers, Statement on Teaching Evolution o National Academy of Sciences, Frequently Asked Questions about Evolution and the Nature of Science * FUNDAMENTALIST CREATIONISM AND THE VALUE OF SATIRE * o Michael Shermer, Genesis Revisted: A Scientific Creation Story o Philip Appleman, Darwin’s Ark * Part IX: Darwin and the Literary Mind * DARWIN’S LITERARY SENSIBILITY * o Charles Darwin, Autobiography o L. Robert Stevens, Darwin’s Humane Reading o George Levine, Darwin and Pain: Why Science Made Shakespeare Nauseating o Gillian Beer, Darwin’s Plots * DARWIN’S INFLUENCE ON LITERATURE * o Lionel Stevenson, Darwin among the Poets o George Levine, Darwin among the Novelists o Joseph Wood Krutch, The Tragic Fallacy o Herbert J. Muller, Modern Tragedy o Philip Appleman, Darwin-Sightings in Recent Literature. (shrink)

The paper focuses on the problem of anthropodicy in the philosophical system of Hermann Cohen and its interpretation by Jacob Gordin (1896—1947). Gordin was one of the last followers of Cohen in Russia. He developes his interpretation in the lecture “Anthropodicy”, which was given in the Philosophical Circle at the Petrograd University in December 1921. For the study of the problem of anthropodicy he was apparently inspired by the discussions at the Free Philosophical Association in 1919—1921. Gordin places Cohen’s (...) concept of man in the wide intellectual context given by the ideas of the Russian religious philosophy, German classical philosophy, Neo-Kantianism, and the West European and Jewish mysticism (cabbala). Gordin compares Cohen’s anthropodicy with Vladimir Soloviev’s one and shows that there is a similarity in their approaches. Both philosophers point out that the justification of man is possible only in form of the justification of humanity and not as for Berdyaiev in form of the justification of personality. But Gordin uses Soloviev’s concept of all-unity and Berdyaiev’s concept of creativity in order to “improve” Cohen’s conception and to reveal the contribution of a person to the justification of humanity. Stronger as Cohen Gordin connects the programm of anthropodicy with individuality and underlines the participation of the individual in creating culture. (shrink)

James E Cooper¹, Uwe Christians², Alexander C Wiseman¹¹Division of Renal Diseases and Hypertension, Transplant Center, ²iC42 Integrated Solutions in Systems Biology for Clinical Research and Development, University of Colorado Denver, Aurora, CO, USA: Everolimus is a novel target of rapamycin -I analog that has recently been approved in combination with cyclosporine A and steroids for use in the prevention of organ rejection in kidney transplant recipients. Compared with rapamycin, everolimus is characterized by a shorter half-life and improved bioavailability. Prior to (...) US Food and Drug Administration approval, a number of Phase II and III clinical trials were undertaken to evaluate the effectiveness of everolimus in combination with calcineurin inhibitors for preventing acute rejection and promoting allograft survival in kidney transplant recipients. In this report, we review the pharmacokinetic properties of everolimus, the clinical efficacy studies that led to its approval for use in kidney transplantation, as well as reported data on patient safety and tolerability associated with its use.Keywords: mTOR inhibitors, kidney transplantation, everolimus. (shrink)

In 2014, the International Association for the Psychology of Religion will have its centennial, and so will its scientific journal, the present Archive for the Psychology of Religion [ Archiv für Religionspsychologie, ARp]. This first article on IAPR's history analyses the fate of the forerunner of ARp, which was published from 1907-1913. When psychology in general began to develop as an empirical, research-based “scientific discipline” since the midst of the 19th century, the psychology of religion became a prominent application (...) of that “new” science of psychology, involving many of the founding fathers of present day psychology. Shortly after evoking these beginnings, the focus of the present article turns to the development of early scientific infrastructure for the psychology of religion. While the psychology of religion was initiated by European scholars such as Fechner and Wundt, it was the organizer of American psychology in general who started the first journal in this field, G. Stanley Hall. Through his European admirer Gustav Vorbrodt, Hall's journal may have been an inspiration to the founding of the first European journal for the psychology of religion, the German-speaking Zeitschrift für Religionspsychologie. Most likely the psychiatrist Johannes Bresler took the initiative to start this journal and had invited pastor Gustav Vorbrodt, who had already repeatedly and vigorously called for psychological study of religion, to join him as editor. Consequently, the subtitle of the journal was ‘Grenzfragen der Theologie und der Medizin [ Boundary Questions in Theology and Medicine].’ The present paper discusses both Vorbrodt's and Bresler's work in the realm of the psychology of religion, as it does the contributions of two further editors; the philosopher-historian of religion Georg Runze, an honorary professor at Berlin University, and Otto Klemm, a collaborator of Wilhelm Wundt and later the director of the latter's psychological laboratory in Leipzig and the first to hold a professorship for applied psychology. Several reasons are discussed to answer the question why the Zeitschrift für Religionspsychologie ceased publishing. Based on empirical-archival research, special attention is given to scholarly disagreements behind the transition of the Zeitschrift für Religionspsychologie to the new Archiv für Religionspsychologie. (shrink)

Hans Baron, Karl Popper, Leo Strauss and Erich Auerbach were among the many German-speaking Jewish intellectuals who fled Continental Europe with the rise of Nazism in the 1930s. Their scholarship, though not normally considered together, is studied here to demonstrate how, despite their different disciplines and distinctive modes of working, they responded polemically in the guise of traditional scholarship to their shared trauma. For each, the political calamity of European fascism was a profound intellectual crisis, requiring an intellectual (...) response which Weinstein and Zakai now contextualize, ideologically and politically. They exemplify just how extensively, and sometimes how subtly, 1930s and 1940s scholarship was used not only to explain, but to fight the political evils that had infected modernity, victimizing so many. An original perspective on a popular area of research, this book draws upon a mass of secondary literature to provide an innovative and valuable contribution to twentieth-century intellectual history. (shrink)

The Tuskegee Syphilis Study is often cited as a major reason for low research participation rates among racial/ethnic minorities. We use data from a random-digit-dial telephone survey of 510 African Americans and 253 Latinos drawn from low income Los Angeles neighborhoods to investigate associations between knowledge of the study and endorsement of HIV/aids conspiracy theories. Results indicate African Americans were significantly more likely than Latinos to endorse HIV/aids conspiracy theories and were more aware of the study. Nevertheless, few Americans and (...) Latinos had ever heard of Syphilis Study suggesting that awareness is not a major factor in low participation rates. (shrink)

Background: Funding organisations and research ethics committees should play a part in strengthening attention to gender equality in clinical research. In the research policy of European Union , funding measures have been taken to realise this, but such measures are lacking in the EU policy regarding RECs.Objective: To explore how RECs in Austria, Germany, Ireland, The Netherlands and Sweden deal with gender equality issues by asking two questions: Do existing procedures promote representation of women and gender expertise in the (...) committee? How are sex and gender issues dealt with in protocol evaluation?Methods: Two RECs were selected from each country. Data were obtained through interviews with key informants and content analysis of relevant documents .Results: All countries have rules to ensure the presence of women on RECs; gender expertise is not required. Drug study protocols are carefully evaluated, sometimes on a formal basis, as regards the inclusion of women of childbearing age. The reason for excluding either one of the sexes or including specific groups of women or making a gender-specific risk–benefit analysis are investigated by some RECs. Such measures are, however, neither defined in the regulations nor integrated in review tools.Conclusions: The RECs investigated in five European member states are found to pay limited attention to gender equality in their working methods and, in particular in protocol evaluation. Policy and regulations of EU are needed to strengthen attention to gender equality in the work of RECs. (shrink)

Objectives To conduct an independent evaluation of the first phase of the Health Foundation’s Safer Patients Initiative (SPI), and to identify the net additional effect of SPI and any differences in changes in participating and non-participating NHS hospitals. Design Mixed method evaluation involving five substudies, before and after design. Setting NHS hospitals in the United Kingdom. Participants Four hospitals (one in each country in the UK) participating in the first phase of the SPI (SPI1); 18 control hospitals. Intervention The SPI1 (...) was a compound (multi-component) organisational intervention delivered over 18 months that focused on improving the reliability of specific frontline care processes in designated clinical specialties and promoting organisational and cultural change. Results Senior staff members were knowledgeable and enthusiastic about SPI1. There was a small (0.08 points on a 5 point scale) but significant (P<0.01) effect in favour of the SPI1 hospitals in one of 11 dimensions of the staff questionnaire (organisational climate). Qualitative evidence showed only modest penetration of SPI1 at medical ward level. Although SPI1 was designed to engage staff from the bottom up, it did not usually feel like this to those working on the wards, and questions about legitimacy of some aspects of SPI1 were raised. Of the five components to identify patients at risk of deterioration—monitoring of vital signs (14 items); routine tests (three items); evidence based standards specific to certain diseases (three items); prescribing errors (multiple items from the British National Formulary); and medical history taking (11 items)—there was little net difference between control and SPI1 hospitals, except in relation to quality of monitoring of acute medical patients, which improved on average over time across all hospitals. Recording of respiratory rate increased to a greater degree in SPI1 than in control hospitals; in the second six hours after admission recording increased from 40% (93) to 69% (165) in control hospitals and from 37% (141) to 78% (296) in SPI1 hospitals (odds ratio for “difference in difference” 2.1, 99% confidence interval 1.0 to 4.3; P=0.008). Use of a formal scoring system for patients with pneumonia also increased over time (from 2% (102) to 23% (111) in control hospitals and from 2% (170) to 9% (189) in SPI1 hospitals), which favoured controls and was not significant (0.3, 0.02 to 3.4; P=0.173). There were no improvements in the proportion of prescription errors and no effects that could be attributed to SPI1 in non-targeted generic areas (such as enhanced safety culture). On some measures, the lack of effect could be because compliance was already high at baseline (such as use of steroids in over 85% of cases where indicated), but even when there was more room for improvement (such as in quality of medical history taking), there was no significant additional net effect of SPI1. There were no changes over time or between control and SPI1 hospitals in errors or rates of adverse events in patients in medical wards. Mortality increased from 11% (27) to 16% (39) among controls and decreased from 17% (63) to 13% (49) among SPI1 hospitals, but the risk adjusted difference was not significant (0.5, 0.2 to 1.4; P=0.085). Poor care was a contributing factor in four of the 178 deaths identified by review of case notes. The survey of patients showed no significant differences apart from an increase in perception of cleanliness in favour of SPI1 hospitals. Conclusions The introduction of SPI1 was associated with improvements in one of the types of clinical process studied (monitoring of vital signs) and one measure of staff perceptions of organisational climate. There was no additional effect of SPI1 on other targeted issues nor on other measures of generic organisational strengthening. (shrink)

Julie Taymor is an exemplary artist who has successfully made the transition from avant-garde director of live theatre in the 1980s to become a Broadway director for Disney Corporation with The Lion King, and, more recently, a film director with Sony’s nostalgic look at the music of the Beatles in Across the Universe. Highlights of her career—spanning the latter half of the twentieth century—offer excellent examples of the changes in the economics of creativity and artistic labor for a case study (...) in cultural and aesthetic values under global capitalism. Through interviews, newspapers and financial annual reports, specific moments in Taymor’s oeuvre reveal key distinctions between cultural and intercultural values, between aesthetic and financial exchange values, and highlight themes and limitations in the legacy of the Marxist labor theory of value. (shrink)

Reincarnation is a death-specific and forward-looking philosophico-religious phenomenon that enjoys a cross-cultural appeal. It represents the theory that when the soul separates from the body at death, it informs another body for another round of earthly life. The debate on reincarnation has, so far, revolved around the reality or otherwise of reincarnation and the associated claims. In this article, we undertake a holistic and critical examination and appraisal of the key arguments underlying the reincarnation debate, with emphasis on the nature (...) and structure of reincarnation, as well as the value of reincarnation belief. The aim is to determine who gets what among the contending parties. Although oral interviews were involved in the exercise, textual and doctrinal analysis of extant literatures on reincarnation formed the predominant source of data for the research. Our finding reveals that although the phenomenon of reincarnation is bedeviled by internal contradictions and belief in it hardly justifiable, belief in it has some positive values, including coping and unifying values that could be harnessed for the well-being of people and society. These observed values of reincarnation and the attendant belief in it, the article concludes, do not constitute a conclusive proof of the reality of reincarnation.Contribution: The contributive value of this paper lies in bringing to the fore the fact that contrary to popular assumption, the notion of belief is in reality, epistemically more powerful than knowledge, at least in the context of religion. Considering that HTS Theological Studies focuses on religious issues and that ‘belief’ and ‘knowledge’ are religious concepts, we consider this paper to be suitable to its objectives. (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 (four-year period) to assess the extent of exertion of autonomy by research participants. Methods CONSORT flow charts (...) in RCTs published in New England Journal of Medicine (NEJM), The Lancet and Journal of the American Medical Association (JAMA) 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 (single centric vs. multicentric) and type of setting (developed vs. developing). Between-groups analysis was done using Chi Square, Chi Square for trend and a Crude odds ratio [95% C.I] (cOR) were calculated. Results Only 3.7% (1103/29,825) of the published articles were RCTs. Of the 1103 RCTs, only 532 (48.2%) reported consent declines. JAMA had the highest RCTs reporting consent declines (171/267.64%), 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(95% C.I): 2.27(2.23,2.32), p < 0.000001] and in single centric versus multicentric studies [cOR (95% C.I): 3.63(3.56,3.71), p < 0.0000001]. Conclusion Both authors and journal editors need to ensure better reporting of consent declines. (shrink)

Hans Baron, Karl Popper, Leo Strauss and Erich Auerbach were among the many German-speaking Jewish intellectuals who fled continental Europe with the rise of Nazism in the 1930s. Their scholarship, though not normally considered together, is studied here to demonstrate how, despite their different disciplines and distinctive modes of working, they responded polemically in the guise of traditional scholarship to their shared trauma. For each, the political calamity of European fascism was a profound intellectual crisis, requiring an intellectual (...) response which Weinstein and Zakai now contextualize, ideologically and politically. They exemplify just how extensively, and sometimes how subtly, 1930s and 1940s scholarship was used not only to explain, but to fight the political evils that had infected modernity, victimizing so many. An original perspective on a popular area of research, this book draws upon a mass of secondary literature to provide an innovative and valuable contribution to twentieth-century intellectual history. (shrink)

In this article, the author aims to demonstrate how Agamben’s concept of Homo Sacer is ideally epitomized by a soldier in war. A soldier in war holds a peculiar position, as killing of soldiers is considered neither illegal by laws nor immoral by ethics, and so a soldier is not considered to be legally or morally “guilty” in the usual sense of the word if he or she kills another soldier in war. The author analyzes the notion of Homo Sacer (...) – a figure representing a human that can be killed without the killer being punished, but at the same time someone who cannot be sacrificed – and further demonstrates that a soldier in war can be said to hold precisely such a status. The reason why a soldier cannot be sacrificed resides in the fact that he has already been “sacrificed to war” by his own society, in exchange for the safety of all other members of society. Perceiving a soldier as Homo Sacer provides a novel explanation and an additional argument for the moral symmetry of combatants, one of the pillars of non-revisionist Just War Theory, as all soldiers can be understood as persons sacrificed by their own societies. (shrink)

BackgroundVaccination against human papillomavirus (HPV) is a pivotal tool for preventing a significant cause of cervical cancer. One particular culturally recognized context associated with negative attitudes toward the HPV vaccine is the religiousness of parents. However, relatively speaking, there remains a scarcity of studies that have focused specifically on religious groups, especially non-Christian groups. PurposeTo better understand the basis for members of an ultra-Orthodox Jewish community to object to the HPV vaccine and how such objections can and cannot (...) be reduced, thereby improving cultural competence—namely, the cultural understanding and ethical addressing of HPV vaccination refusal. MethodsThis qualitative study conducted semi-structured interviews with ten Israeli ultra-Orthodox mothers who are opposed to administering the HPV vaccine to their daughters. The content analysis addressed these results and extracted the major issues arising from these particular interviews. ResultsFour main novel insights were found pertaining to the negative stance toward HPV vaccination among mothers in an ultra-Orthodox Jewish community: (a) lack of knowledge about the HPV vaccine is not part of the reasoning against it; (b) rabbinical authority might have a lesser influence than expected for the moderation of HPV vaccine refusal; (c) complicated viewpoints regarding childhood vaccination may be the larger non-moderating context for HPV vaccination refusal; and (d) cultural competence is important for the ability to change the negative attitudes toward HPV vaccination. ConclusionsThe study may improve cultural competence regarding HPV vaccination and contribute to decreasing objections to the HPV vaccine in ultra-Orthodox communities. (shrink)

The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key (...) research positions in the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT. (shrink)

ArgumentIn the 1920s the Soviet Union invested a group of talented, mostly socialist, occasionally Communist, Jewish writers and thinkers to use the power of the state to remake Jewish culture and identity. The Communist state had inherited a multiethnic empire from its tsarist predecessors and supported the creation of secular cultures for each ethnicity. These cultures would be based not on religion, but on language and culture. Soviet Jews had many languages from which to choose to be their (...) official Soviet language, but Yiddish, the vernacular of eastern European Jewry, won the battle and served as the basis of secular Soviet Jewish culture. Soviet Jewish scholars, writers, and other cultural activists remade Jewish culture by creating a usable Jewish past that fit the socialist present, reforming the “wild” vernacular of Yiddish into a modern language worthy of high culture, and transforming Jews into secular Soviet citizens. (shrink)

This book is the third volume of selected papers from the Central European Pragmatist Forum (CEPF). It deals with the general question of education, and the papers are organized into sections on Education and Democracy, Education and Values, Education and Social Reconstruction, and Education and the Self. The authors are among the leading specialists in American philosophy from universities across the U.S. and in Central and Eastern Europe. The series _Studies in Pragmatism and Values_ promotes the study of pragmatism’s (...) traditions and figures, and the explorations of pragmatic inquiries in all areas of philosophical thought. (shrink)

This article offers a critical examination of the travel diaries written by Gershom Scholem (1897–1982), a well-known pioneer scholar of Jewish mysticism and a professor at the Hebrew University of Jerusalem. In 1946, Scholem was sent to Prague on behalf of the Hebrew University to retrieve the Nazi-looted Jewish libraries from Czechoslovakia to Palestine. In recent years, at the same time as a significant rise of scholarly interest in the fate of the plundered Jewish books and manuscripts, (...) Scholem’s accounts have come to serve as a main source of information on the Jewish cultural property in the Bohemian lands. Where most of the currently available studies take his description of the Czechoslovak restitution affairs almost for granted, this article seeks to adopt a more distant approach to these materials, by undertaking a comparison with the documentation produced by the local Jewish bodies and the archival sources of the Czechoslovak authorities responsible for the management of Jewish assets. Zooming in on the encounter between Scholem and the leaders of the Jewish community in Prague, the paper points especially to the multiple misunderstandings that arose between the two parties during his visit. It then explores the difference between his and the Prague protagonists’ perspectives on the Nazi-looted Jewish cultural property. (shrink)

The concept of Europeanization has become very popular in studies of European integration and particularly in analyses on the post-communist countries undergoing extensive transformation on the road to European Union membership. Although the Europeanization process has been quite successful in the countries of Central and Eastern Europe (CEE), the same scenario has not played out in the western Balkans region. With the purpose of analysing the effectiveness and impact of the Europeanization process in the western Balkans, the (...) main subject of the paper is Bosnia and Herzegovina’s EU-related reform processes. Although Bosnia has been undergoing thorough Europeanizing reforms since the late 1990s, when the country entered the Stabilization and Association Process (SAP), it is still an unstable and dysfunctional country. That makes it the perfect case for assessing the possible shortcomings of the Europeanization process. Thus far, most scholars have concluded that domestic political elites in Bosnia are the only party responsible for Bosnia’s political deadlock. However, this paper analyses the continued Bosnian deadlock from a different perspective, trying to figure out the degree of responsibility the European Union shares in the country’s Europeanization process. Although uncooperative Bosnian political elites are to a great extent responsible for the continued political and social status quo, EU leaders are not faultless either. In fact, so far European leaders have often appeared to be deeply divided, incoherent, and short-sighted in terms of Europeanization policies in Bosnia, thus further deepening the political deadlock in the country. Therefore, we can ask whether Bosnia represents a litmus test which the EU has failed. (shrink)

Preoperative informed consent is a legal and ethical requirement that ensures patients understand a procedure, its associated risks and benefits, alternative treatment options, and potential complications to make an informed decision about their care. This cross‐sectional study evaluated the informed consent process for major orthopaedic surgeries at a tertiary hospital in Nigeria. A self‐administered questionnaire was used to collect data from 120 adult participants. Results showed that many patients do not read the consent form before signing it, and surgeons do (...) not adequately explain the alternatives to surgery, potential risks, and available anaesthetic options. Higher‐educated patients are more likely to read the consent form. Surgeons performed well in explaining the nature of the condition and prognosis, the procedure's potential benefits, and answering patients' questions. The study emphasises the need to improve the informed consent process to ensure patients understand and can make rational decisions about their healthcare. (shrink)

BackgroundCORE (Clarity and Openness in Reporting: E3-based) Reference (released May 2016 by the European Medical Writers Association [EMWA] and the American Medical Writers Association [AMWA]) is a complete and authoritative open-access user’s guide to support the authoring of clinical study reports (CSRs) for current industry-standard-design interventional studies. CORE Reference is a content guidance resource and is not a CSR Template.TransCelerate Biopharma Inc., an alliance of biopharmaceutical companies, released a CSR Template in November 2018 and recognised CORE (...) Reference as one of two principal sources used in its development.MethodsThe regulatory medical writing and statistical professionals who developed CORE Reference conducted a critical review of the TransCelerate CSR Template. We summarise our major findings and recommendations in this communication. We also re-examined and edited the Version 1 CORE Reference Terminology Table that we first published in 2016, and we present this as Version 2 in this communication.ResultsOur major critical review findings indicate that opportunities remain to refine the CSR Template structure and instructional text, enhance content clarity, add web links to referenced guidance documents, improve transparency to support the broad readership of CSRs, and develop supporting resources.The CORE Reference ‘Terminology Table’ Version 2 includes estimand as a defined term and an adaptation of the original ‘worked study example’ to incorporate the recently evolved concept of ‘estimands’.ConclusionsAs TransCelerate’s CSR Template represents an important milestone in authoring CSRs, we offer CSR authors advice and recommendations on its use, similarities, and differences with CORE Reference and advise them to consider shared interpretations between the two.RegistrationCORE Reference is registered with the EQUATOR Network. The TransCelerate CSR Template is not registered with any external organisation to the knowledge of the authors of this paper. (shrink)

Successfully explaining and replicating the complexity and generality of human and animal learning will require the integration of a variety of learning mechanisms. Here, we introduce a computational model which integrates associative learning (AL) and reinforcement learning (RL). We contrast the integrated model with standalone AL and RL models in three simulation studies. First, a synthetic grid‐navigation task is employed to highlight performance advantages for the integrated model in an environment where the reward structure is both diverse and dynamic. (...) The second and third simulations contrast the performances of the three models in behavioral experiments, demonstrating advantages for the integrated model in accounting for behavioral data. (shrink)