No man can live without ideas, for every human action, internal or external, is of necessity enacted by virtue of certain ideas. In these ideas a man believes; they guide his actions, and ultimately his whole life. Study of these ideas and principles is one of the distinctive tasks of the history of philosophy. But were we to restrict the field of interest of the history of philosophy to a mere detached academic "cataloguing" of past ideas, the history of philosophy (...) itself would have joined long ago the interminable line of barren catalogued ideas. The study of the wisdom of past ages, however, is very much alive. Not only is it alive, but in the words ot Wilhelm Dilthey: "What man is, he learns through history. "l Thus, the culture of every generation is inevitably related, whether thetically or antithetically, to the previous one, and the politi cal and economic struggles of any present are always the consequences of an earlier and perhaps even fiercer battle of ideas. I t is imperative to know the history of the philosophies that nourish the present if we wish to know ourselves and the world about us. The Socratic call to self-knowledge is as indispensable a condition of a truly human existence today as it was in the fifth century B. C. (shrink)

In this study, we examine investor and firm response to the California Transparency in Supply Chains Act of 2010. The CTSCA requires large retail and manufacturing firms to disclose efforts to eradicate slavery and human trafficking from their supply chains and is a rare example of mandated corporate social responsibility disclosure. Based on a sample of 105 retail companies subject to the CTSCA, we find a significant negative market reaction to the passing of the CTSCA. Furthermore, we find that the (...) reaction is significantly more negative for larger firms and companies facing greater supply chain risks, suggesting that investors place a negative value on exposure to legitimacy threats in the social domain. With respect to company disclosure response, we document relatively high compliance with the legislation, although we also find that the disclosure response appeared to be more symbolic than substantive in nature. Finally, our analysis indicates that both disclosure choice and disclosure extensiveness were significantly higher for the high-supply chain risk companies, suggesting that the response was influenced by concerns with strategic legitimation. Overall, the limited quality of disclosure suggests that, without additional rules and guidance, mandates alone may not lead to meaningful social disclosure. (shrink)

In amblyopia, abnormal visual experience during development leads to an enduring loss of visual acuity in adulthood. Physiological studies in animal models suggest that intracortical GABAergic inhibition may mediate visual deficits in amblyopia. To better understand the relationship between visual cortical γ-aminobutyric acid (GABA) and perceptual suppression in persons with amblyopia (PWA), we employed magnetic resonance spectroscopy (MRS) to quantify GABA levels in both PWA and normally-sighted persons (NSP). In the same individuals, we obtained psychophysical measures of perceptual suppression for (...) a variety of ocular configurations. In PWA, we found a robust negative correlation between the depth of amblyopia (the difference in visual acuity between the amblyopic and non-amblyopic eyes) and GABA concentration that was specific to visual cortex and was not observed in a sensorimotor cortical control region. Moreover, lower levels of visual cortical GABA were associated with weaker perceptual suppression of the fellow eye by the amblyopic eye and stronger suppression of the amblyopic eye by the fellow eye. Taken together, our findings provide evidence that intracortical GABAergic inhibition is an important component of the pathology of human amblyopia and suggest possible therapeutic interventions to restore vision in the amblyopic eye through enhancement of visual cortical GABAergic signaling in PWA. (shrink)

We propose a framework for analyzing the development, operation and failure to survive of all things, living, non-living or organized groupings. This framework is a sequence of developments that improve survival capability. Framework processes range from origination of any entity/system, to the development of increased survival capability and development of life-forms and organizations that use intelligence. This work deals with a series of developmental changes that arise from the uncovering of emergent properties. The framework is intended to be general, but (...) we see a potential to apply it to scientific topics such as the exploration of the origin of life or the search for life beyond Earth, and to understand some biological issues in evolution and symbiosis, and also to apply to social systems that do not seem to be operating well, to determine their problems and correct them. (shrink)

This volume offers the first English language collection of academic essays on the post-Holocaust thought of Jean Améry, a Jewish-Austrian-Belgian essayist, journalist and literary author. Comprehensive in scope and multi-disciplinary in orientation, contributors explore central aspects of Améry's philosophical and ethical position, including dignity, responsibility, resentment, and forgiveness.

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.

The paper attempts to provide a basis for exploring the continued relevance of Catholic social teaching to business ethics, byinterpreting the historic development of a Catholic work ethic and the traditions of Catholic social teaching in light of contemporary discussions of economic globalization, notably those of Robert Reich and Peter Drucker. The paper argues that the Catholic work ethic and the Church’s tradition of social teaching has evolved dynamically in response to the structural changes involved in the history of modern (...) economic development, and thus is well poised to speak to the ethical challenges implicit in the advent of a knowledge-based society. In order to test this thesis, the author sketches an approach to the ethical challenge of corporate downsizing that he believes illustrates the continued relevance of Catholic social teaching to business ethics. (shrink)

Hong Kong is undergoing two overlapping crises: social unrest over anti-government protests, and COVID-19. The media has linked these events in both objective and subjective ways. While some liken the social unrest to COVID-19, others do the opposite. This is an intriguing real-world instance of source-target reversibility with interchangeable source and target resulting in two apt variants. This paper reports a survey study of the links between crisis perceptions and the aptness of metaphor variants. Participants (N = 93) rated 30 (...) matched items on the effects of both crises on trust in governance, interpersonal relations, the economy, physical/mental health, and Hong Kong’s future. This determined, for each participant, a correlation coefficient reflecting perceived structural similarity, and absolute/raw difference scores reflecting perceived substantive similarity of the crises. They then explained which (or neither) of two constructed headlines depicting the SOCIAL UNREST as COVID-19 or COVID-19 as the SOCIAL UNRESTwas more apt. Logistic regression analyses showed that i) metaphor aptness was predictable from structural but not substantive similarity, and ii) the worse crisis was preferred as source domain, but only for its more experientially concrete aspects. The study exemplifies socio-culturally situated’ theoretical investigation and how metaphor research can shed light on crisis perceptions. (shrink)

N. Maxwell (1985) has claimed that special relativity and "probabilism" are incompatible; "probabilism" he defines as the doctrine that "the universe is such that, at any instant, there is only one past but many alternative possible futures". Thus defined, the doctrine is evidently prerelativistic as it depends on the notion of a universal instant of the universe. In this note I show, however, that there is a straightforward relativistic generalization, and that therefore Maxwell's conclusion that the special theory of relativity (...) should be amended is unwarranted. I leave open the question whether or not probabilism (or the related doctrine of the flow of time) is true, but argue that the special theory of relativity has no fundamental significance for this question. (shrink)

The significance of A. N. Whitehead’s contribution to 20th century metaphysics has become widely recognized. The focus on the novelty of his process ontology, however, has led to a view that isolates him from the mainstream of the tradition of Western philosophy. Hence, it is often overlooked that on the methodological level Whitehead is a pragmatist, whose much quoted indebtedness to William James is reflected in the project of his speculative metaphysics. A detailed analysis of the respective theories of truth (...) and knowledge in James and Whitehead illustrates their common methodological approach and allows us to assess the role of Whiteheadian thinking within the pragmatist tradition. James advances a form of epistemic conservatism that supplements the pragmatic idea of a concept’s cash-value with the demand for internal consistency. New beliefs have to fit in the totality of all previously accepted convictions in order to become accepted as true. James argues his case on three levels – a psychological, an epistemological and a pragmatic one – and develops a theory of truth that comprises an empirical and a rational dimension. Whitehead takes up this two-sided approach, but modifies the idea of genetic consistency into that of systematic coherence. The fundamental concepts of an ontological theory must not be isolated from each other to allow for a cosmology which is both rational and satisfies the pragmatic test of applicability. With the close relation of James and Whitehead in mind, the latter can be identified as the ‘missing link’ that bridges the gap between the so-called classical pragmatism and its more analytic versions as advanced by Quine, Lewis and Rescher. (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)

This essay examines Nancey Murphy's commitment to downward causation and develops a critique of that notion based upon the distinction between the causal relevance of a higher‐level event and its causal efficacy. I suggest the following: (1) nonreductive physicalism lacks adequate resources upon which to base an assertion of real causal power at the emergent, supervenient level; (2) supervenience's nonreductive nature ought not obscure the fact that it affirms an ontological determination of higher‐level properties by those at the lower level; (...) and (3) the notion of divine self‐renunciation, while consonant with Murphy's claim of supervenient, divine action, is nonetheless problematic. Throughout, I claim that the question of the causal efficacy of a level is logically independent from the assertion of its conceptual or nomological nonreducibility. (shrink)

Erziehung und Bildung stehen im Blickpunkt gesellschaftlicher, politischer und wissenschaftlicher Diskussion. Dem brisanten Thema stellt sich seit jeher auch die Philosophie. Ein moderner Klassiker der Erziehungs- und Bildungsphilosophie ist Alfred North Whitehead. In den vorliegenden Essays, die nun erstmals in deutscher Sprache erscheinen, befaßt sich der berühmte Philosoph mit zentralen Aspekten der Wissensvermittlung und Denkorganisation, dem Anspruch an Bildungsinstitutionen, mathematisch-naturwissenschaftlichen Herausforderungen sowie der Kultivierung von Ideen. Die Texte verbinden sich zu einer Erziehungs- und Bildungskonzeption, die den Lernenden als einen mit (...) seiner Umwelt interagierenden Organismus versteht und nichts an Aktualität eingebüßt hat. (shrink)

N- and O-linked glycan structures of cell surface and secreted glycoproteins serve a variety of functions related to cell–cell communication in systems affecting development and disease. The more sophisticated N-glycan biosynthesis pathway of metazoans diverges from that of yeast with the appearance of the medial-Golgi β-N-acetylglucosaminyltransferases (GlcNAc-Ts). Tissue-specific regulation of medial- and trans-Golgi glycosyltransferases contribute structural diversity to glycoproteins in metazoans, and this can affect their molecular properties including localization, half-life, and biological activity. Null mutations in glycosyltransferase genes positioned later (...) in the biosynthetic pathway disrupt expression of smaller subsets of glycan structures and are progressively milder in phenotype. In this review, we examine data on targeted mutations affecting glycosylation in mice and congenital mutations in man, with a view to understanding the molecular functions of glycan structures as modulators of glycoprotein activity. Finally, pathology associated with the expression of GlcNAc-Ts in cancer and diabetes-induced cardiac hypertrophy suggest that inhibitors of these enzymes may have therapeutic value. BioEssays 21:412–421, 1999. © 1999 John Wiley & Sons, Inc. (shrink)

Recent scholarship in intellectual humility (IH) has attempted to provide deeper understanding of the virtue as personality trait and its impact on an individual's thoughts, beliefs, and actions. A limitations-owning perspective of IH focuses on a proper recognition of the impact of intellectual limitations and a motivation to overcome them, placing it as the mean between intellectual arrogance and intellectual servility. We developed the Limitations-Owning Intellectual Humility Scale to assess this conception of IH with related personality constructs. In Studies 1 (...) (n= 386) and 2 (n = 296), principal factor and confirmatory factor analyses revealed a three-factor model – owning one's intellectual limitations, appropriate discomfort with intellectual limitations, and love of learning. Study 3 (n = 322) demonstrated strong test-retest reliability of the measure over 5 months, while Study 4 (n = 612) revealed limitations-owning IH correlated negatively with dogmatism, closed-mindedness, and hubristic pride and positively with openness, assertiveness, authentic pride. It also predicted openness and closed-mindedness over and above education, social desirability, and other measures of IH. The limitations-owning understanding of IH and scale allow for a more nuanced, spectrum interpretation and measurement of the virtue, which directs future study inside and outside of psychology. (shrink)

The ability to reason independently from one's own goals or beliefs has long been recognised as a key characteristic of the development of formal operational thought. In this article we present the results of a study that examined the correlates of this ability in a group of 10-year-old children ( N = 61). Participants were presented with conditional and relational reasoning items, where the content was manipulated such that the conclusion to the arguments were either congruent, neutral, or incongruent with (...) beliefs, and either logically valid or logically invalid. Participants also received a measure of working memory capacity (the counting span task) and a measure of inhibitory control (the stop signal task). Indices of belief bias and logical reasoning on belief-based problems were predicted independently by both measures. In contrast logical reasoning on belief neutral problems was predicted by working memory alone. The findings suggest that executive functions play a key role in the development of children's ability to decontextualise their thinking. (shrink)

Anger, indignation, guilt, rumination, victim compensation, and perpetrator punishment are considered primary responses associated with justice sensitivity. However, injustice and high JS may predispose to further responses. We had N = 293 adults rate their JS, 17 potential responses toward 12 unjust scenarios from the victim’s, observer’s, beneficiary’s, and perpetrator’s perspectives, and several control variables. Unjust situations generally elicited many affective, cognitive, and behavioral responses. JS generally predisposed to strong affective responses toward injustice, including sadness, pity, disappointment, and helplessness. It (...) impaired trivialization, victim-blaming, or justification, which may otherwise help cope with injustice. It predisposed to conflict solutions and victim compensation. Particularly victim and beneficiary JS had stronger effects in unjust situations from the corresponding perspective. These findings add to a better understanding of the main and interaction effects of unjust situations from different perspectives and the JS facets, differences between the JS facets, as well as the links between JS and behavior and well-being. (shrink)

In this collection, a leading sociologist brings his distinctive method of social criticism to bear on some of the most significant ideas, political and social events, and thinkers of the late twentieth century. In the first section, the author examines several concepts that have figured prominently in recent political-ideological controversies: capitalism, rationality, totalitarianism, power, alienation, left and right, and cultural relativism/ multiculturalism. He considers their origins, historical shifts in their meaning and the myths surrounding them, and their resonance beyond their (...) formal definitions. The second section highlights the author's lifelong interest in the relation of intellectuals to social classes and institutions. The author assesses the notion of a 'New Class', considers the implications for class structure of the increasing centring of intellectual life in the university, and assesses the relation of sociology to professional jargon. (shrink)

When it originated in the late 19th century, psychometrics was a field with both a scientific and a social mission: psychometrics provided new methods for research into individual differences, and at the same time, these psychometric instruments were considered a means to create a new social order. In contrast, contemporary psychometrics - due to its highly technical nature and its limited involvement in substantive psychological research - has created the impression of being a value-free discipline. In this article, we develop (...) a contrasting characterization of contemporary psychometrics as a value-laden discipline. We expose four such values: that individual differences are quantitative (rather than qualitative), that measurement should be objective in a specific sense, that test items should be fair, and that utility of a model is more important than its truth. Our goal is not to criticize psychometrics for employing these values, but rather to bring them into the open and to show that these values are not inevitable and are in need of systematic evaluation. (shrink)

This book represents a considerable revision and expansion of Public Choice II. Six new chapters have been added, and several chapters from the previous edition have been extensively revised. The discussion of empirical work in public choice has been greatly expanded. As in the previous editions, all of the major topics of public choice are covered. These include: why the state exists, voting rules, federalism, the theory of clubs, two-party and multiparty electoral systems, rent seeking, bureaucracy, interest groups, dictatorship, the (...) size of government, voter participation, and political business cycles. Normative issues in public choice are also examined including a normative analysis of the simple majority rule, Bergson–Samuelson social welfare functions, the Arrow and Sen impossibility theorems, Rawls's social contract theory and the constitutional political economy of Buchanan and Tullock. (shrink)

Abstract: Contemporary analytic philosophers of the “reactive attitudes” tend to share a simple conception of guilt as “self-directed blame”—roughly, an “unpleasant affect” felt in combination with, or in response to, the thought that one has violated a moral requirement, evinced substandard “quality of will,” or is blameworthy. I believe that this simple conception is inadequate. As an alternative, I offer my own theory of guilt’s logic and its connection to morality. In doing so, I attempt to articulate guilt’s defining thought (...) or proposition through an extended investigation and analysis of guilt’s many competing metaphors, which I trace from the Hebrew Bible to the New Testament to Shakespeare to contemporary vernacular. My interpretation of this literary genealogy offers a way to understand guilt’s seemingly disparate metaphors in terms of a single master-image that illuminates our self-conceptions and our relationship to morality. I conclude by making a very brief start toward a moral vindication of guilt against the backdrop of Nietzschean and Freudian analyses that explicitly call guilt’s place in a healthy social and personal life into question. I suggest that once guilt’s logic is made explicit, we can see that it makes sense of, honors, and addresses some of our deepest aspirations and needs. (shrink)