For centuries medical schools in Britain and elsewhere had a fairly static curriculum based on what might be called the 'three Rs' of medicine, and consequently had to make room for new subjects as the need arose in a fashion which was sometimes makeshift. However, Southampton University has only had a medical school for six years, and therefore their course on medical ethics and legal medicine was carefully integrated into the curriculum after some preliminary experiments carried out by a subcommittee (...) which is continually reviewing the situation. Medical ethics has now a definite place in the fourth year, preceded by an introduction to ethical problems encountered in medicine in the first year. Not only do members of the medical faculty participate in this teaching but also members of the faculties of law and the arts. (shrink)

Two fundamental business ethics issues that repeatedly surface in the academic literature relate to business's role in the development of public policy [Suarez, S. L.: 2000, Does Business Learn? (The University of Michigan Press, Ann Arbor, MI); Roberts, R. W. and D. D. Bobek: 2004, Accounting, Organizations and Society 29(5-6), 565-590] and its role in responsibly managing the natural environment [Newton, L.: 2005, Business Ethics and the Natural Environment (Blackwell Publishing, Oxford)]. When studied together, researchers often examine if, and how, (...) corporations influence environmental policy decisions. Drawing from literatures on corporate political activity, corporate social and environmental performance, and corporate environmental disclosure, we develop and empirically examine two research questions concerning the relations between corporate political expenditures, environmental performance, and environmental disclosure. The questions are: (1) Do corporations that are poorer environmental performers spend more on political activities than their better-performing counterparts? (2) Is there an association between corporations' spending on political activities and the extent of their financial report environmental disclosures? We investigated these questions through analyses of data we gathered on a sample consisting of 119 U.S. environmentally sensitive firms for the 2001-2002 election cycle. After controlling for firm size and specific industry effects, our tests reveal a significant, inverse relationship between firm environmental performance and political spending. This is consistent with the notion that U.S. firms with relatively poorer environmental performance records engage more intensely in corporate political activities as part of their overall strategic management of their relationship with the state. In addition, a significant and positive association between the amount of political spending and the extent of environmental disclosure suggests that environmental disclosure and political spending are both proactive, complementary tactics to strategically manage public policy pressure. If corporations' strategies are intentionally designed to unreasonably limit their environmental responsibilities or to misrepresent firm environmental performance, then we argue that these activities reflect a significant lapse in ethical conduct. (shrink)

Das Ritual der Aštu : Rekonstruktion und Tradition eines hurritisch-hethitischen Rituals aus Boğazköy/Ḫattuša. By Susanne Görke. Culture and History of the Ancient Near East, vol. 40. Leiden: Brill, 2010. Pp. xvii + 365. $179.

Influences on the perception of affordances (i.e., opportunities for actions) have been primarily studied by manipulating the functional morphology of the body. However, affordances are not just determined by the functional morphology of the perceiver, but also by the physiological state of the perceiver. States of anxiety have been shown to lead to marked changes in individuals’ physiological state and their behaviour. To assess the influence of emotional state on affordance perception, the perception of action capabilities in near space was (...) examined after participants completed an anxiety-provoking task. Anxiety was induced immediately prior to tasks that assessed participants' perceived reaching ability in Experiment 1, grasping ability in Experiment 2, and the ability to pass their hands through apertures in Experiment 3. Results indicated that those participants who experienced changes in anxiety underestimated their reaching, grasping, and passing ability compared to non-anxious participants. In other words, anxious participants were more conservative in their estimations of their action capabilities. These results suggest that anxiety influences the perception for affordances in near space and are consistent with the notion that anxiety induces withdrawal behaviours. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Lord Nottingham and the Conscience of EquityDennis R. KlinckI. Introduction"There is nothing more in our Mouths than Conscience," wrote John Sharp in the 1680s, echoing a sentiment that had been expressed before in the seventeenth century.1 Indeed, one modern writer has observed, uncontroversially, that that century "can justly be called the Age of Conscience."2 Among the foci of this preoccupation one can identify such topics as moral and religious (...) casuistry and "liberty of conscience." My focus in this paper is somewhat different: conscience as a criterion of judgment in the Court of Chancery—the court of equity—and particularly its meaning for Heneage Finch, Lord Nottingham, successively Lord Keeper and Lord Chancellor from 1673 to 1682, a seminal figure in the history of English equity.The intimate connection of conscience with the equitable jurisdiction [End Page 123] is a commonplace,3 and certain aspects of it have been quite thoroughly studied.4 A central problem that has been identified with resort to conscience as a criterion of legal judgment is its subjective and hence ostensibly arbitrary nature. This concern goes back a long way. Thomas Audley, in 1526, argued that conscience was an uncertain ground of law because "it depended upon the 'arbitrament' of one man, the chancellor alone."5 The author of The Replication of a Serjeant at the Laws of England similarly raised the complaint of "divers men, divers conscience."6 No doubt the most remembered comment of this sort is John Selden's that the spaciousness of chancellors' consciences might vary as much as the length of their respective feet, so that equitable adjudication on the basis of conscience was "a roguish thing."7 Nottingham himself balked at the idea that justice might be dispensed according to the kind of conscience that amounted only to "the pleasure of a Court which took upon itself to be purely arbitrary."8Indeed, as the father of systematic equity,9 Nottingham apparently devoted himself to the project, undertaken in some measure by certain of his predecessors,10 of making the jurisdiction regular. He repeatedly makes this [End Page 124] point. In the case just cited, he observes that "equity itself would cease to be Justice if the rules and measures of it were not certain and known" and that "conscience" has to be "dispensed by the rules of science" (639). "Rules," "measures," and "science" are by-words of his preoccupation. Elsewhere, he asserts that "if equity be tied to no rule... everything becomes arbitrary."11At the same time, he did not abandon conscience as a kind of touchstone of equity. He refers to it repeatedly, and often speaks of Chancery as a "court of conscience,"12 as if this was a perfectly natural way of describing it. So the question becomes: how did he reconcile the tendency towards arbitrariness thought to be implicit in "conscience" with the ruled, measured, scientific system that he sought to develop? Or putting the question slightly differently: how did he understand or limit the notion of "conscience" so as to make it compatible with the "regular equity" to which he aspired?What appears to have been a crucial distinction for Nottingham in this regard was that between private conscience and public, or perhaps civic, conscience. In the Prolegomena, he says that "there is a twofold conscience, viz. conscientia politica et civilis, et conscientia naturalis et interna" and that "[m]any things are against inward and natural conscience, which cannot be reformed by the regular and political administration of equity" (194). He makes the point again in "the great case" of Cook v. Fountain: "With such a conscience which is only naturalis et interna this Court hath nothing to do; the conscience by which I am to proceed is merely civilis et politica, and tied to certain measures...."13 As Yale points out, this distinction was not new with Nottingham. The distinction between the forum internum and the forum externum was venerable;14 an anonymous Elizabethan case distinguishes between matters of conscience in which equity will intervene and those that must be left to the party's own moral judgment;15 Francis Bacon recognized, at least as alternatives, a party... (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)

Throughout the Old Testament, the stories, laws, and songs not only teach a way of life that requires individuals to be moral, but they demonstrate how. In biblical studies, character ethics has been one of the fastest-growing areas of interest. Whereas ethics usually studies rules of behavior, character ethics focuses on how people are formed to be moral agents in the world. This book presents the most up-to-date academic work in Old Testament character ethics, covering topics throughout the Torah, the (...) Prophets, and the Writings, in addition to the use of the Bible in the modern world. In addition to Carroll and Lapsley, contributors are Denise M. Ackermann, Cheryl B. Anderson, Samuel E. Balentine, William P. Brown, Walter Brueggemann, Thomas B. Dozeman, Bob Ekblad, Jose Rafael Escobar R., Theodore Hiebert, Kathleen O'Connor, Dennis T. Olson, J. David Pleins, Luis R. Rivera Rodriguez, J. J. M. Roberts, and Daniel L. Smith-Christopher. (shrink)

We argue that neural networks for semantic cognition, as proposed by Rogers & McClelland (R&M), do not acquire semantics and therefore cannot be the basis for a theory of semantic cognition. The reason is that the neural networks simply perform statistical categorization procedures, and these do not require any semantics for their successful operation. We conclude that this has severe consequences for the semantic cognition views of R&M.

This article suggests a way to circumvent some of the problems that follow from the lack of consensus on a definition of emotion (Izard, 2010; Kleinginna & Kleinginna, 1981) and emotion regulation (Cole, Martin, & Dennis, 2004) by adopting a conceptual framework based on discrete emotions theory and focusing on specific emotions. Discrete emotions theories assume that neural, affective, and cognitive processes differ across specific emotions and that each emotion has particular motivational and regulatory functions. Thus, efforts at regulation should (...) target the specific dysregulated emotions. The positive effects of emotion regulation are more likely to be optimized when they result from or lead to emotion utilization—the constructive use of the energy of emotion arousal. Effective processes for regulation differ for basic emotions and emotion schemas. This article identifies neural systems that facilitate emotion experiences and emotion regulation processes. It considers the implications of the developmental change from basic emotions to emotion schemas, and also briefly discusses the effects of interventions on changes in emotion knowledge, emotion regulation, and social and emotional competence. (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 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)

Mit dem Transzendentalismus entsteht ab 1830 die erste Philosophietradition der USA. Überzeugungen und Theorien müssen sich R. W. Emerson, H. D. Thoreau, M. Fuller folgend in der Lebenspraxis bewähren und können keine überzeitliche Geltung beanspruchen. Damit bereiten sie den Boden für den Pragmatismus und vermessen Politik, Ethik, Pädagogik neu.

Greek text, english translation and commentary on the surviving fragments of Empedocles (fragments as known in 1981, does not include more recent finds).

The problem of foreknowledge and freedom presents a challenge to the defender of traditional Western theism. Nelson Pike has argued that the existence of an essentially omniscient God who possesses foreknowledge is incompatible with human freedom. Pike's opponents in this matter, among whom is Alvin Plantinga, argue that no incompatibility has yet been shown. I shall develop the view that neither Pike nor his opponents have conclusively settled the question whether foreknowledge and freedom are compatible. Furthermore there is a reason (...) why the issue has not been, and may never be, conclusively settled: it is an inherently paradoxical issue. To aid in demonstrating this point I shall discuss a modified version of a paradox that has come to be known as Newcomb's Problem. (shrink)

WHILE THERE IS AGREEMENT AMONG MANY (BUT NOT ALL) THEOLOGIANS AND PHILOSOPHERS THAT A MIRACULOUS EVENT SHOULD BE CONCEIVED IN OPPOSITION TO THE NATURAL ORDER, THERE IS DISAGREEMENT ABOUT WHY THIS OPPOSITION MUST BE PRESENT. IN THIS PAPER I EXAMINE ANTONY FLEW’S EXPLANATION OF HOW AND WHY MIRACLES AND NATURE ARE OPPOSED, SUGGESTING THAT HIS ACCOUNT IS, AS IT STANDS, PROBLEMATICAL AND IN NEED OF REVISION. I ARGUE THAT IF MIRACLES ARE TO BE THOUGHT OF AS SUPERNATURAL INTERVENTIONS INTO THE (...) NATURAL WORLD, AND HENCE IT IS THOUGHT APPROPRIATE TO SPEAK OF THEM AS PHYSICALLY IMPOSSIBLE, THEN ONE MUST DEFINE THE PHYSICALLY IMPOSSIBLE IN TERMS OF WHAT CAN BE EXPLAINED ONLY BY REFERENCE TO SUPERNATURAL FORCE, RATHER THAN IN TERMS OF WHAT IS LOGICALLY INCONSISTENT WITH LAWS OF NATURE. (shrink)

Writing from a scientifically and philosophically informed perspective, the authors provide a critical overview of the conceptual difficulties encountered in many current neuroscientific and psychological theories.

In this paper I interrogate the notion of `debunking conspiracy theories’, arguing that the term `debunk’ carries with it pejorative implications, given that the verb `to debunk’ is commonly understood as `to show the wrongness of a thing or concept’. As such, the notion of `debunking conspiracy theories’ builds in the notion that such theories are not just wrong but ought to be shown as being wrong. I argue that we should avoid the term `debunk’ and focus on investigating conspiracy (...) theories. Looking at recent research work in epistemology on conspiracy theory, I argue that the best way to avoid talk of `debunking’ conspiracy theories is by working with a non-pejorative definition of `conspiracy theory’, and forming communities of inquiry which allow us to investigate the warrant of such theories without the prejudice associated with working with a pejorative definition. (shrink)

Polyhedral functions provide a model for an important class of problems that includes both linear programming and applications in data analysis. General methods for minimizing such functions using the polyhedral geometry explicitly are developed. Such methods approach a minimum by moving from extreme point to extreme point along descending edges and are described generically as simplicial. The best-known member of this class is the simplex method of linear programming, but simplicial methods have found important applications in discrete approximation and statistics. (...) The general approach considered in this text, first published in 2001, has permitted the development of finite algorithms for the rank regression problem. The key ideas are those of developing a general format for specifying the polyhedral function and the application of this to derive multiplier conditions to characterize optimality. Also considered is the application of the general approach to the development of active set algorithms for polyhedral function constrained problems and associated Lagrangian forms. (shrink)

A remarkable feature of the philosophical work on conspiracy theory theory has been that most philosophers agree there is nothing inherently problematic about conspiracy theories (AKA the thesis of particularism). Recent work, however, has challenged this consensus view, arguing that there really is something epistemically wrong with conspiracy theorising (AKA generalism). Are particularism and generalism incompatible? By looking at just how much particularists and generalists might have to give away to make their theoretical viewpoints compatible, I will argue that particularists (...) can accept many of the concerns that motivate generalism because generalism can never be about ‘all’ conspiracy theories without being either ahistorical or apolitical. In the end generalist critiques are best seen as useful guidelines or considerations for the appraising of particular conspiracy theories. (shrink)

This study investigates the market reaction to corporate press releases announcing donations to the relief effort following the December, 2004 tsunami in Southeast Asia. Based on a sample of 79 U.S. companies, results indicate a statistically significant positive 5-day cumulative abnormal return. While differences in the timing of the press releases do not appear to have influenced market reactions, the amount of the donations did. Overall, the results appear to support Godfrey’s (Academy of Management Review 30, 777–798; 2005) assertion that (...) philanthropic giving must be perceived as being a genuine manifestation of the firm’s underlying social responsiveness in order to increase firm value. (shrink)

THE ESSAY "OF MIRACLES," IN ADDITION TO BEING ONE OF THE MOST PROVOKING SECTIONS OF HUME’S WRITINGS, IS ALSO ONE OF THE MOST WIDELY MISUNDERSTOOD. HUME CLAIMS HIS ARGUMENT IS SIMILAR TO AN ARGUMENT OF ARCHBISHOP TILLOTSON, AND I EXPLORE THE PARALLEL BETWEEN THE TWO ARGUMENTS IN DETAIL. FUNDAMENTAL TO BOTH IS THE CONCEPT OF EVIDENTIAL IMPOSSIBILITY: A PROPOSITION, P, IS EVIDENTIALLY IMPOSSIBLE IF AND ONLY IF ALLEGED EVIDENCE FOR THE TRUTH OF P WOULD NOT BE EVIDENCE FOR P, WERE (...) THE TRUTH OF P ESTABLISHED. I ARGUE THAT HUME’S CLAIM, WHICH IS THAT PROPOSITIONS ASSERTING THE EXISTENCE OF MIRACLES ARE EVIDENTIALLY IMPOSSIBLE, IS ONE WHICH IS NOT ACCEPTABLE, BUT FOR REASONS OTHER THAN THOSE THAT ARE USUALLY GIVEN. (shrink)

Conspiracy theories and conspiracy theorists have been accused of a great many sins, but are the conspiracy theories conspiracy theorists believe epistemically problematic? Well, according to some recent work, yes, they are. Yet a number of other philosophers like Brian L. Keeley, Charles Pigden, Kurtis Hagen, Lee Basham, and the like have argued ‘No!’ I will argue that there are features of certain conspiracy theories which license suspicion of such theories. I will also argue that these features only license a (...) limited suspicion of these conspiracy theories, and thus we need to be careful about generalising from such suspicions to a view of the warrant of conspiracy theories more generally. To understand why, we need to get to the bottom of what exactly makes us suspicious of certain conspiracy theories, and how being suspicious of a conspiracy theory does not always tell us anything about how likely the theory in question is to be false. (shrink)

This paper critiques a recent article in this journal in terms of its use of persuasive techniques. The central issue of the original article by Miles, Munilla and Covin and this paper is whether there should be a change in intellectual property rights to address the needs of impoverished people who are HIV positive or have full blown AIDS and the countries that do not have the means to buy AIDS medication in the absence of subsidies. This paper argues that (...) patents are state sanctioned monopolies that worked effectively for nearly a century. However, new circumstances and a globally interdependent world represent a new environment calling for an adjustment in the conventional public policy premises underlying patents. Most of the meaning and complexity of this issue is lost to the persuasive techniques of the original article. (shrink)

Conspiracy theories are often portrayed as unwarranted beliefs, typically supported by suspicious kinds of evidence. Yet contemporary work in Philosophy argues provisional belief in conspiracy theories is—at the very—least understandable (because conspiracies occur) and if we take an evidential approach—judging individual conspiracy theories on their particular merits—belief in such theories turns out to be warranted in a range of cases. Drawing on this work, I examine the kinds of evidence typically associated with conspiracy theories, showing that the evidential problems typically (...) associated with conspiracy theories are not unique to such theories. As such, if there is a problem with the conspiracy theorist’s use of evidence, it is one of principle: is the principle which guides their use of evidence somehow in error? I argue that whatever we might think about conspiracy theories generally, there is no prima facie case for a scepticism of conspiracy theories based purely on their use of evidence. (shrink)

Although data sharing is one of the primary measures proposed to improve the integrity and quality of published research, studies show it remains the exception not the rule. The current study examines the availability of data in papers reporting the results of analyses of empirical data from original research in high-impact addiction journals. Thirteen high-impact journals with data sharing policies were selected from those included in the substance abuse category of the 2018 Clarivate Analytics’ Journal Citation Report. The first 10 (...) full or short original research reports that included empirical data in the most recent complete issue of each journal were electronically searched and reviewed for reference to where their data can be obtained and for a formal data sharing statement. Only eight of the 130 papers contained a data sharing statement in their text or supplementary online materials, and just one contained a direct link to the data analyzed. Data sharing was rare in the 13 high-impact addiction journals reviewed. The nature of the data reported in addiction journals might partly explain this. Currently, data sharing is not a procedure likely to improve the quality and integrity of published addiction research. (shrink)

In a recent comment on H.L.A. Hart’s ‘Postscript’ to The Concept of Law, Ronald Dworkin claims that the meaning of legal and political concepts may be understood by analogy to the meaning of natural kind concepts like ‘tiger’, ‘gold’ and ‘water’. This article questions the efficacy of Dworkin’s claims by challenging the use of natural kinds as the basis for a semantic theory of legal and political concepts. Additionally, in matters of value there is no methodological equivalent to the scientific (...) method. Thus, there is little hope of finding hidden essences to explain the meaning of legal and political concepts. Finally, even if there are natural kinds, Dworkin’s arguments for their efficacy in jurisprudence are problematic and unpersuasive. The problem for Dworkin is that his embrace of natural kinds undermines the ‘fit’ side of the fit/justification model of adjudication that lies at the heart of his theory of law. (shrink)

Concern about the integrity of empirical research has arisen in recent years in the light of studies showing the vast majority of publications in academic journals report positive results, many of these results are false and cannot be replicated, and many positive results are the product of data dredging and the application of flexible data analysis practices coupled with selective reporting. While a number of potential solutions have been proposed, the effects of these are poorly understood and empirical evaluation of (...) each would take many years. We propose that methods from the systems sciences be used to assess the effects, both positive and negative, of proposed solutions to the problem of declining research integrity such as study registration, Registered Reports, and open access to methods and data. In order to illustrate the potential application of systems science methods to the study of research integrity, we describe three broad types of models: one built on the characteristics of specific academic disciplines; one a diffusion of research norms model conceptualizing researchers as susceptible, “infected” and recovered; and one conceptualizing publications as a product produced by an industry comprised of academics who respond to incentives and disincentives. (shrink)

This textbook offers a unique and accessible approach to ethical decision-making for practicing pharmacists and student pharmacists. Unlike other texts, it gives clear guidance based on the fundamental principles of moral philosophy, explaining them in simple language and illustrating them with abundant clinical examples and case studies. The strength of this text is in its emphasis on normative ethics and critical thinking, and that there is truly a best answer in the vast majority of cases, no matter how complex. The (...) authors place high trust in a pharmacist’s moral judgment. This teaches the reader how to think, based on ethical principles, not necessarily what to think. This means navigating between the two extremes of overly theoretical and excessively prescriptive. The cogent framework given in this text uses the language of competing duties, identifying the moral principles at stake that create duties for the pharmacist. This is the balancing act of normative ethics, and of deciding which duties should prevail in a given clinical situation. This work presents a clear-cut pathway for resolving ethical dilemmas encountered by pharmacists, based on foundational principles and critical thinking. Presents a clear-cut pathway for resolving the ethical dilemmas encountered by pharmacists, based on foundational principles and critical thinking. Jon E. Sprague, RPh, PhD, Director of Science and Research for the Ohio Attorney General. (shrink)

This volume offers the first-ever complete English translation of Leibniz’s Dissertatio De Arte Combinatoria together with a critical edition of the original Latin text on fa...