The historical background of the discovery of adverse health effects of medicines, food additives, pesticides, and other chemicals is reviewed, and the development of national and international regulations and testing procedures to protect the public against the toxic effects of these drugs and chemicals is outlined. Ethical considerations of the safety evaluation of drugs and chemicals by human experimentation and animal toxicity studies, ethical problems associated with clinical trials, with the falsification of clinical and toxicological data, and with inadequate experimental (...) methodology, are reviewed, and the ethics of the marketing of drugs and their post-marketing surveillance, are similarly considered. These ethical problems are illustrated with many specific examples, including the drugs neoarsphenamine, chloramphenicol, thalidomide, diethyl stilboestrol and benoxaprofen. (shrink)

The historical background of the discovery of adverse health effects of medicines, food additives, pesticides, and other chemicals is reviewed, and the development of national and international regulations and testing procedures to protect the public against the toxic effects of these drugs and chemicals is outlined. Ethical considerations of the safety evaluation of drugs and chemicals by human experimentation and animal toxicity studies, ethical problems associated with clinical trials, with the falsification of clinical and toxicological data, and with inadequate experimental (...) methodology, are reviewed, and the ethics of the marketing of drugs and their post-marketing surveillance, are similarly considered. These ethical problems are illustrated with many specific examples, including the drugs neoarsphenamine, chloramphenicol, thalidomide, diethyl stilboestrol and benoxaprofen. (shrink)

The critical issues facing the human community population growth, sustained development, threats to the environment, the arms race, the ethical/philosophical challenges in light of advances in science and technology, and our very survival as a species require a multidisciplinary approach grounded in a clear understanding of human behavior. Fifty-one scholars from 11 countries representing 19 disciplines met at Delphi, Greece, to discuss and debate why we do what we do to ourselves and our world. Out of this vigorous exchange emerged (...) the Delphi Society for long-term study of patterns of human behavior. This book offers a unique international perspective on global human problems. (shrink)

This paper proposes research propositions to study on MMOG and MUD addictions based on their causes – flow state and social interaction. Though previous studies relate MMOG addictions to Internet addictions based on social interactions, this study after examining the underlying theories of Use and Gratification The-ory and Flow Theory concludes that what cause MMOG addiction is flow experience not social interaction. On the other hand, the cause of MUD addiction is social interaction. After proposing the propositions of MUD and (...) MMOG addiction causes, this study provides possible impacts of such addictions based on the reasoning between the two theories and two online game addictions. (shrink)

Many office workers use computers and the Internet not only to get their daily jobs done but also to deal with their personal businesses. Therefore employers nowadays monitor their employees electronically to prevent the misuse of the company resources. The use of electronic monitoring in organizations causes issues of trust and privacy. This study is dedicated to developing a conceptual model on the two issues under electronic monitoring. Control, considered as the essence of the definition of privacy as well as (...) the foundation of the control model in the theory of procedural justice, plays an important role to people’s privacy concerns and trust. People’s perceived‐self, as essential in the group‐value model in the theory of procedural justice and in the cultural studies, also plays an important role to people’s privacy concerns and trust. This study presents research hypotheses on trust and privacy under electronic surveillance based on the two models of the theory of procedural justice, social identity theory, and cultural studies. (shrink)

The story of the greatest of all philosophical friendships—and how it influenced modern thought David Hume is widely regarded as the most important philosopher ever to write in English, but during his lifetime he was attacked as “the Great Infidel” for his skeptical religious views and deemed unfit to teach the young. In contrast, Adam Smith was a revered professor of moral philosophy, and is now often hailed as the founding father of capitalism. Remarkably, the two were best friends (...) for most of their adult lives, sharing what Dennis Rasmussen calls the greatest of all philosophical friendships. The Infidel and the Professor is the first book to tell the fascinating story of the friendship of these towering Enlightenment thinkers—and how it influenced their world-changing ideas. The book follows Hume and Smith’s relationship from their first meeting in 1749 until Hume’s death in 1776. It describes how they commented on each other’s writings, supported each other’s careers and literary ambitions, and advised each other on personal matters, most notably after Hume’s quarrel with Jean-Jacques Rousseau. Members of a vibrant intellectual scene in Enlightenment Scotland, Hume and Smith made many of the same friends, joined the same clubs, and were interested in many of the same subjects well beyond philosophy and economics—from psychology and history to politics and Britain’s conflict with the American colonies. The book reveals that Smith’s private religious views were considerably closer to Hume’s public ones than is usually believed. It also shows that Hume contributed more to economics—and Smith contributed more to philosophy—than is generally recognized. Vividly written, The Infidel and the Professor is a compelling account of a great friendship that had great consequences for modern thought. (shrink)

BackgroundThere is increasing need for peer reviewers as the scientific literature grows. Formal education in biostatistics and research methodology during residency training is lacking. In this pilot study, we addressed these issues by evaluating a novel method of teaching residents about biostatistics and research methodology using peer review of standardized manuscripts. We hypothesized that mentored peer review would improve resident knowledge and perception of these concepts more than non-mentored peer review, while improving review quality.MethodsA partially blinded, randomized, controlled multi-center study (...) was performed. Seventy-eight neurology residents from nine US neurology programs were randomized to receive mentoring from a local faculty member or not. Within a year, residents reviewed a baseline manuscript and four subsequent manuscripts, all with introduced errors designed to teach fundamental review concepts. In the mentored group, mentors discussed completed reviews with residents. Primary outcome measure was change in knowledge score between pre- and post-tests, measuring epidemiology and biostatistics knowledge. Secondary outcome measures included level of confidence in the use and interpretation of statistical concepts before and after intervention, and RQI score for baseline and final manuscripts.ResultsSixty-four residents (82%) completed initial review with gradual decline in completion on subsequent reviews. Change in primary outcome, the difference between pre- and post-test knowledge scores, did not differ between mentored (−8.5%) and non-mentored (−13.9%) residents (p = 0.48). Significant differences in secondary outcomes (using 5-point Likert scale, 5 = strongly agree) included mentored residents reporting enhanced understanding of research methodology (3.69 vs 2.61; p = 0.001), understanding of manuscripts (3.73 vs 2.87; p = 0.006), and application of study results to clinical practice (3.65 vs 2.78; p = 0.005) compared to non-mentored residents. There was no difference between groups in level of interest in peer review (3.00 vs 3.09; p = 0.72) or the quality of manuscript review assessed by the Review Quality Instrument (RQI) (3.25 vs 3.06; p = 0.50).ConclusionsWe used mentored peer review of standardized manuscripts to teach biostatistics and research methodology and introduce the peer review process to residents. Though knowledge level did not change, mentored residents had enhanced perception in their abilities to understand research methodology and manuscripts and apply study results to clinical practice. (shrink)

Dennis H. Wrong postulates sociological theory’s origins in the asking of general questions about man and society. Th e answers lose their meaning if they are elaborated without reference to the questions, as has been the case in much contemporary theory. An example is the Hobbesian question of how men become tractable to social controls. Th e two-fold answer of contemporary theory is that man „internalizes“ social norms and seeks a favorable self-image by conforming to the „expectations“ of others. (...) Such a model of man denies the very possibility of his being anything but a thoroughly socialized being and thus denies the reality of the Hobbesian question. Th e Freudian view of man, on the other hand, which sociologists have misrepresented, sees man as a social though never a fully socialized creature. Wrong claims that sociologists need to develop a more complex, dialectical conception of human nature instead of relying on an implicit conception that is tailor-made for special sociological problems. (shrink)

Unfounded—conspiracy and health—beliefs about COVID-19 have accompanied the pandemic worldwide. Here, we examined cross-nationally the structure and correlates of these beliefs with an 8-item scale, using a multigroup confirmatory factor analysis. We obtained a two-factor model of unfounded (conspiracy and health) beliefs with good internal structure (average CFI = 0.98, RMSEA = 0.05, SRMR = 0.04), but a high correlation between the two factors (average latent factor correlation = 0.57). This model was replicable across 50 countries (total N = 13,579), (...) as evidenced by metric invariance between countries (CFI = 0.96, RMSEA = 0.06, SRMS = 0.07) as well as scalar invariance across genders (CFI = 0.98, RMSEA = 0.04, SRMS = 0.03) and educational levels (CFI = 0.98, RMSEA = 0.04, SRMS = 0.03). Also, lower levels of education, more fear of COVID-19, and more cynicism were weakly associated with stronger conspiracy and health beliefs. The study contributes to knowledge about the structure of unfounded beliefs, and reveals the potential relevance of affective (i.e., fear of COVID-19) and cognitive (i.e., cynicism) factors along with demographics, in endorsing such beliefs. In summary, we obtained cross-cultural evidence for the distinctiveness of unfounded conspiracy and health beliefs about COVID-19 in terms of their structure and correlates. (shrink)

Unfounded—conspiracy and health—beliefs about COVID-19 have accompanied the pandemic worldwide. Here, we examined cross-nationally the structure and correlates of these beliefs with an 8-item scale, using a multigroup confirmatory factor analysis. We obtained a two-factor model of unfounded (conspiracy and health) beliefs with good internal structure (average CFI = 0.98, RMSEA = 0.05, SRMR = 0.04), but a high correlation between the two factors (average latent factor correlation = 0.57). This model was replicable across 50 countries (total N = 13,579), (...) as evidenced by metric invariance between countries (CFI = 0.96, RMSEA = 0.06, SRMS = 0.07) as well as scalar invariance across genders (CFI = 0.98, RMSEA = 0.04, SRMS = 0.03) and educational levels (CFI = 0.98, RMSEA = 0.04, SRMS = 0.03). Also, lower levels of education, more fear of COVID-19, and more cynicism were weakly associated with stronger conspiracy and health beliefs. The study contributes to knowledge about the structure of unfounded beliefs, and reveals the potential relevance of affective (i.e., fear of COVID-19) and cognitive (i.e., cynicism) factors along with demographics, in endorsing such beliefs. In summary, we obtained cross-cultural evidence for the distinctiveness of unfounded conspiracy and health beliefs about COVID-19 in terms of their structure and correlates. (shrink)

Tuberculosis (TB) is a potentially fatal infectious disease that, in Aotearoa New Zealand (NZ), inequitably affects Asian, Pacific, Middle Eastern, Latin American, and African (MELAA), and Māori people. Medical research involving genome sequencing of TB samples enables more nuanced understanding of disease strains and their transmission. This could inform highly specific health interventions. However, the collection and management of TB isolate samples for research are currently informed by monocultural biomedical models often lacking key ethical considerations. Drawing on a qualitative kaupapa (...) Māori–consistent study, this paper reports on preliminary discussions with groups of Māori, Pacific, and Afghan people in NZ, whose communities have been harmed by TB and TB stigma. Participants’ discussions highlight key concerns and meanings that ought to inform the development of guidelines and a more robust consultative process for the governance of how TB isolate samples are collected and used both retrospectively and in future research. We argue for ethical processes to be culturally nuanced and community-generated, flexible and meaningful, and situated in relation to the physical and symbolic effects of TB. We discuss the significance of Indigenous data sovereignty, rights, and kāwanatanga (governorship) in shaping a multicultural data sovereignty model. (shrink)

Identity, Morality, and Threat offers a critical examination of the social psychological processes that generate outgroup devaluation and ingroup glorification as the source of conflict. Daniel Rothbart and Karyna Korostelina bring together essays analyzing the causal relationship between escalating violence and opposing images of the Self and Other.

This is a study of the political theory of the Enlightenment, focusing on four leading eighteenth-century thinkers: David Hume, Adam Smith, Montesquieu and Voltaire. Dennis C. Rasmussen calls attention to the particular strand of the Enlightenment these thinkers represent, which he terms the 'pragmatic Enlightenment'. He defends this strand of Enlightenment thought against both the Enlightenment's critics and some of the more idealistic Enlightenment figures who tend to have more followers today, such as John Locke, Immanuel Kant and Jeremy (...) Bentham. Professor Rasmussen argues that Hume, Smith, Montesquieu and Voltaire exemplify an especially attractive type of liberalism, one that is more realistic, moderate, flexible, and contextually sensitive than most other branches of this tradition. (shrink)

Just north of the Arctic Circle sits Kotzebue, a town of the Inupiat people that has endured for over a century. In this compelling visual essay, Dennis Witmer captures scenes on its Front Street, the main thoroughfare whose buildings have evolved from the sod huts of Native cultures to permanent wood and concrete edifices. From front yards with parked snow machines to townspeople peacefully strolling down sidewalks, the striking black-and-white images in Front Street, Kotzebue offer a thought-provoking view of (...) life in the Arctic and people’s methods of coexisting with the brutality of nature. (shrink)

If the morphology of baseball is similar to that of the fairy tale, it is obviously not because baseball is a form of narrative art. As my title suggests, insofar as baseball resembles literature at all in the way it manifests itself, it is clearly much closer to drama. Baseball takes place within a fixed, carefully delimited space that may be improvised but is reserved specifically for the purpose wherever the game is institutionalized. It is an ensemble performance carried out (...) by specially trained "players" in front of an audience for whom the occasion is a festive event that occurs as a suspension of ordinary life. It possesses a plot that develops in a limited period of time from initial situation through complication to denouement and has a relatively large number of dramatis personae who are sent into the playing area at a given moment in order to perform specific roles. Dennis Porter, associate professor of French and comparative literature at the University of Massachusetts, Amherst, has published widely on nineteenth- and twentieth-century French and English novels. He is currently an NEH fellow and is working on two books: one on plot and ideology in the novel, the other, The Alibi of Crime, on detective fiction. (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)

Wittgenstein's distinction between understanding and interpretation is fundamental to the account of meaning in _Philosophical Investigations. In his discussion of rule-following, Wittgenstein explicitly rejects the idea that understanding or grasping a rule is a matter of interpretation. Wittgenstein explains meaning and rule-following in terms of action, rejecting both realist and Cartesian accounts of the mental. I argue that in his effort to employ Wittgenstein's views on meaning and rule-following, Professor Morawetz embraces the position Wittgenstein rejects. In the course of (...) making his case for law as a "deliberative practice", Professor Morawetz embraces interpretation as a fundamental element of human practices, thereby taking up precisely the view Wittgenstein rejects. (shrink)

Professor Vickers extracts two or three sentences out of a long article I wrote on a completely different topic and misreads them, attributing to me statements I never made and positions I have explicitly argued against. When Francis Bacon used the metaphor of rape to refer to the Baconian natural philosopher's relationship to nature, which he did relatively infrequently, he invoked the classical, "heroic" sense of rape as the act whereby gods and heroes found dynasties and empires, as in (...) the rape of the Sabine women, the rape of Europa, and the rape of the daughters of Leucippus. (shrink)

The article deals, on the one hand, with a legal conflict between a musical performer/arranger, Mike Batt, and the estate of a composer of avant-garde music, John Cage, over copyright. It is also concerned with the field of intertextuality – how meaning is created in a text or in a work of art, whether it is visual, musical or verbal, through allusions and quotations to previous texts or works of art. The controversy, which did not reach the courts because of (...) a pre-trial settlement, was over an author’s rights to silence, or, as in this case, a silent piece of music. The central issue discussed is the way in which silence may be considered – if at all, to be protectable. (shrink)

What are the assumptions and tasks hidden in contemporary calls to "overcome" the metaphysical tradition? Reflecting upon the internal contradictions of the notions of "tradition" and "finiteness," Dennis J. Schmidt offers novel insights into how philosophy must relate to its traditions if it is to retain a vital sense of the plurality of "edges" that constitute its finiteness. He does this through a close examination of issues found in the work of Hegel and Heidegger, two philosophers who made the (...) ideas of both tradition and finiteness the center of their concern.Schmidt begins by asking how Heidegger can claim to have destroyed metaphysics despite Hegel's claim to have perfected its possibilities. Systematically following the development of Heidegger's critique of Hegel, Schmidt generates a dialogue between them. The topic of that dialogue is the nature of finiteness as it is articulated in time, nothing, the dialectical and hermeneutical circles, and in the notions of experience, work, technology, history, and preSocratic thought.Beginning with Heidegger's critique of Hegel in Being and Time, Schmidt's strategy is to disclose the complexities of philosophical discourse about the finite by drawing out the proximities between Hegel and Heidegger. The dialogue that results presents novel portraits of both philosophers. It also reveals that Heidegger's early, unacknowledged failure to separate himself from the Hegelian dialectic is the motive behind many of the turns and decisions of his later career.In concluding, Schmidt offers an interpretation of the wider significance of the results of that dialogue, and connects his study to other contemporary discussions of postmodernism. He expands upon the idea of the plurality of edges opened by finiteness, arguing that philosophy only understands its own past and future once it recognizes the meaning of its own finiteness.Dennis J. Schmidt is Associate Professor of Philosophy at the State University of New York at Binghamton. The Ubiquity of the Finite is included in the series Studies in Contemporary German Social Thought, edited by Thomas McCarthy. (shrink)

Ethics Introduced: Readings in Moral Philosophy in an anthology that provides students with foundational knowledge in moral philosophy by exposing them to a variety of classical and contemporary readings in ethical theory and application. The anthology is divided into four parts. In Part 1, students learn about meta-ethics and question the status of moral truths through selections by Nietzsche, Ruth Benedict, and Smith. In Part 2, the question of what we should value most is addressed through readings on hedonism, Aristotelian (...) Virtue Ethics, Confucianism, and Buddhism. Part 3 focuses on normative ethics, diving into theories such as egoism, divine command theory, utilitarianism, Kantianism, care ethics, and more. Part 4 rounds out the anthology by helping students think through moral problems and contemporary controversies. Readings in this section address death and dying, abortion, war, treatment of animals and the environment, and the nature of moral obligations to people in need. Throughout the text, each reading is supported by an introduction, study questions, and suggestions for further reading and exploration to inspire critical thinking and additional analysis. Ethics Introduced is ideal for introductory ethics courses and can also be used in comparative religion, philosophy, and humanities courses. Dennis Arjo earned his B.A. in philosophy from the University of California, Santa Cruz, M.A. in philosophy from University of Colorado, and Ph.D. in philosophy from the University of California, Santa Barbara. He is a professor of philosophy at Johnson County Community College, where he teaches introduction to philosophy, ethics, ancient philosophy, and Asian philosophy. Omar Conrad earned his B.A. in sociology, his M.A. in sociology, and his M.A. in philosophy from the University of Kansas. He is a professor of philosophy at Johnson County Community College, where he teaches introduction to philosophy, ethics, logic and critical thinking, and philosophy of religion. Dawn Gale earned her B.A. in philosophy and psychology from the University of Wisconsin, Madison, her graduate certificate in women and gender studies, and her M.A. in philosophy from the University of Kansas. She is a professor of philosophy at Johnson County Community College, where she teaches introduction to philosophy, ethics, environmental ethics, and logic and critical thinking. (shrink)

ABSTRACT In this wide-ranging interview Professor Douglas V. Porpora discusses a number of issues. First, how he became a Critical Realist through his early work on the concept of structure. Second, drawing on his Reconstructing Sociology, his take on the current state of American sociology. This leads to discussion of the broader range of his work as part of Margaret Archer’s various Centre for Social Ontology projects, and on moral-macro reasoning and the concept of truth in political discourse.

I very much enjoyed reading and thinking about Krister Bykvist's interesting and carefully written paper. My comments will not be criticisms. I will not challenge the conclusions the paper draws about the complicated examples of conflicts between preferences that it discusses. For example, I will not attempt to defend any of the views criticized in section IV of the paper. And I agree with the positive solution presented in section V, when that solution is characterized in the broadest possible way. (...) In cases where a choice that I must make now will create one or the other of two possible future ‘selves’ whose preferences would conflict over the question of which choice I should make, prudence tells me to create the self that will experience a higher level of well-being or welfare. (shrink)

Education, Religion and Society celebrates the career of Professor John Hull of the University of Birmingham, UK, the internationally renowned religious educationist who has also achieved worldwide fame for his brilliant writings on his experience, mid-career, of total blindness. In his outstanding career he has been a leading figure in the transformation of religious education in English and Welsh state schools from Christian instruction to multi-faith religious education and was the co-founder of the International Seminar on Religious Education and (...) values. John Hull has also made major contributions to the theology of disability and the theological critique of the "money culture." This volume brings together leading international scholars to honour John Hull's contribution, with a focus on furthering scholarship in the areas where he has been active as a thinker. The book offers a critical appreciation of his contribution to religious education and practical theology, and goes on to explore the continuing debate about the role of religious education in promoting international understanding, intercultural education and human rights education. A possible basis for integrating Islamic education into Western education is suggested and the contribution of the philosophy of religion to pluralistic religious education is outlined. The contributors also deal with issues relating to indoctrination, racism and relationship in Christian religious aspects, and examines aspects of the the theology of social exclusion and disability. (shrink)

The paper looks at the establishment of religion clause in the First Amendment to the US Constitution, and cases, e.g. Brown v. Gilmore, followed by Croft v. Perry and Sherman v. Koch, cases that relate to the concept of the “moment of silence” in educational institutions in which it was claimed that such events constitute a breach of the establishment clause. Courts have been inconsistent in their decision-making, which may indicate a lack of transparency not only in the interpretation of (...) the relevant phrase in the Constitution but also in the judicial interpretation of the “three-pronged test” with regard to “excessive entanglement” as laid out in Lemon v. Kurtzman of 1971. The paper discusses the “moment of silence” within the framework of a model of silence in which this type of silence would be labeled as either textual or situational silence. (shrink)

I begin, in Parts I-III, by presenting the details of the Baker and Hacker/community consensus debate over the nature of rule-following in the later Wittgenstein. In Part IV this philosophical debate is related to the law through the argument that there is both an internal and an external element to rule-following in law. I here assert one of the principal claims of my position: viz., that legal argument is directed at constructing the point of law. Part V introduces the distinction (...) between the formal and the material elements of a concept. As I shall show in detail, form is a heuristic for illuminating conceptual understanding. In Part VI, I move on to provide several examples in support of the form/matter distinction. Part VI also provides arguments in support of the proposition that understanding is internal to a practice and thus not necessarily coextensive with regularity in behavior. Parts VII-IX examine relevant claims made by Wittgenstein and their application to law. Finally, Parts X-XI sketch and illustrate my ultimate claim, a narrative approach to law. (shrink)