In 2005 the new Governor of Puerto Rico appointed a panel of experts to evaluate the healthcare system of Puerto Rico and make recommendations. Among other things, the panel recommended the creation of an advisory board on bioethics for the commonwealth of Puerto Rico.

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)

Postcolonial theory has yielded productive methodologies with which to examine an institution such as the John Rylands Library. This paper reinterprets aspects of the Library‘s history, especially its collecting practices, using Bhabha‘s concept of hybridity. The Library‘s founder, Enriqueta Rylands, embodied hybridity and colonial talking back in her remarkable trajectory from a Catholic upbringing in Cuba, via her conversion to Nonconformity and her marriage to Manchester‘s most successful cotton manufacturer, to her usurpation of the cultural hegemony in purchasing spectacular aristocratic (...) collections for her foundation. Hybridity was embedded in many other aspects of the Library‘s development: it was established as a public library with a board of governors but its collections were largely shaped by Enriqueta‘s tastes and interests; it was independent until 1972, while maintaining very close links to the University of Manchester; it has always fulfilled a dual remit of addressing the research needs of scholars and attracting wider audiences; and it is simultaneously a library of printed books and manuscripts, an archive repository, and a gallery of visual materials. (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)

In lieu of an abstract, here is a brief excerpt of the content:Monroe RememberedAesthetics: Problems in the Philosophy of Criticism on Its Fiftieth AnniversaryPeter Kivy (bio)When I proposed this symposium for the 2008 annual meeting of the American Society for Aesthetics, the title "Monroe Remembered" already in place, it was with the intention of commemorating not just the philosopher but the man as well. All who were privileged to know him personally—particularly those, like myself, just beginning their careers as philosophers (...) of art—will always remember not only the keen-edged mind of the true philosopher but the kindness and consideration of the true teacher as well. In all the years that I knew Monroe Beardsley, he never responded in anger or annoyance to any question asked of him, no matter how stupid or silly it was. Nor did he ever fail to offer assistance to any young aspirant. He was, in the best sense of the word, a "gentleman," with emphasis on the gentle. It was one of the great experiences of my life to have known him.But the other purpose of this symposium, and the principal one, is to commemorate Monroe Beardsley's work as a philosopher of art. For it is very hard to imagine that the philosophy of art, and the American Society for Aesthetics, would have prospered, as soon and as successfully as they did, were it not for Beardsley's philosophical presence in person and in his magnum opus, which is the subject of this symposium.It is altogether appropriate, for two reasons, that the papers comprising the Beardsley symposium be published in the pages of the Journal of Aesthetic Education. First, Beardsley and his book were mainly instrumental in the education of a whole new generation of philosophers of art in the 1960s who changed the face of the discipline in America and Britain. And second, no one interested in the implications for education of art and the aesthetic can afford not to be acquainted with Beardsley's imposing contribution to our understanding of both. It is our hope that the present papers will help to make this apparent and be a fitting tribute to Beardsley—both the man and his work. [End Page 1]Peter Kivy Peter Kivy is Board of Governors Professor of Philosophy at Rutgers University and a past president of the American Society for Aesthetics.Copyright © 2010 Board of Trustees of the University of Illinois... (shrink)

The BMA’s recent discussion paper A rational way forward for the NHS in England, while wishing to free the English NHS from day-to-day politics, merely shifts the locus of the political conflict.In May this year, the British Medical Association published a discussion paper entitled “A rational way forward for the NHS in England”, outlining the association’s suggestions for reform of the English NHS.1The paper is worth reading for its insightful dissection and analysis of the current problems of the English NHS, (...) as well as for its interesting but not totally unexpected conflation of professional and clinical with medical in most of the report. Many of the recommendations are eminently sensible, but some of the suggestions for reconfiguration of the highest-level structures of the English NHS are problematic and unrealistic. What the BMA wants is to free the English NHS from the influence of day-to-day politics by the establishment of a constitution and an independent board of governors, while keeping it free at the point of delivery and paid by general taxation. This is expressed in the first five of the total of 24 recommendations that outline the BMA proposals …. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Balancing Depth and Breadth in Our Conversations:Denver 2022 SBCS Annual MeetingSandra Costen KunzIn 2020 and 2021, due to the corona virus pandemic, the Society for Buddhist-Christian Studies (SBCS) held its annual board meeting, members meeting, and paper sessions online. This year, in 2022, we were delighted to meet face-to-face again on November 18–19 in conjunction with the annual meeting of the American Academy of Religion (AAR). Because we (...) are an AAR "related scholarly organization," all of our events were scheduled through, and publicized by, AAR's staff. President Mark Unno not only presided at the board's table but also graciously ran a video conference, primarily to accommodate board and committee members who were outside the United States or dealing with travel-prohibiting health issues.The 2020 and 2021 fully online governance meetings, led by then-president Leo Lefebure, had been well organized, well run, highly effective, and a lot of fun. But as I watched the attentive eyes around the table this year and listened to the laughter, empathetic sighs, and plans for follow-up conversations, it seemed to me that meeting in person, in some ways, more powerfully supports the society's aim to foster in-depth Buddhist-Christian dialogue and comparative studies. Mark, then vice president, had organized the 2020 and 2021 online paper sessions carefully for online audiences. We were thrilled that these beautifully crafted and moderated presentations drew audiences that were amazingly broad in terms of both size and diversity. Planned as emergency extensions of the society's efforts to create, through our blog and Facebook page, safe online spaces for Buddhist-Christian dialogue and comparative studies, these sessions drew an international audience whose breadth astounded us! Conversations that had begun in these sessions could not, however, be quickly continued over a meal or coffee. In some ways, they did not appear to me to spark the same depth of ongoing conversation that the SBCS has prompted in our four decades of face-to-face meetings.As the board continues to discuss how to balance our desires for both depth and breadth of conversation among our board, our members, and nonmembers who attend our events, we sincerely welcome the wisdom of members and other readers. You can submit suggestions to: https://www.society-buddhist-christian-studies.org/contact. [End Page 263]board of governors meetingPresident's Opening RemarksCalling this year's board meeting to order a little past 9 a.m., Mark Unno said that he sensed that his father, Taitetsu Unno, "is with us, encouraging and congratulating the society on how far we've come in the past forty years." He recalled his father's participation in the Cobb–Abe dialogues and the network that evolved into the SBCS, and that these initial conversations were often highly theological—and testy—and often involved a translator. Mark is convinced, however, that this early debate was a necessary foundation for developing a more robust mutual learning community. Describing two significant ways the society is modeling collaborative learning, he said:1. We're providing a model of interreligious engagement for other people in our various traditions.2. Although we do have impacts on scholars and general audiences through our AAR sessions, journal, and online resources, our greatest impacts as board members have been on each other! Furthermore, any impact of lasting value will come through our embodiment of deep dialogue and mutual learning.Mark explained that we'd begin with the online European Network report, move to the Japan Society's report, and then to the treasurer's and secretary's reports, both of which would be presented online.International Advisor Report from EuropeElizabeth Harris, representing the European Network of Buddhist Christian Studies, explained that since its formation in the 1990s, its main work has been to hold a conference every other year and publish the papers. EOS Verlag has now published the papers that she and Perry Schmidt-Leukel edited from the 2020 conference titled "A Visionary Approach: Lynn A. de Silva and the Prospects for Buddhist-Christian Encounter." The 2022 conference titled "Euro-Buddhism and the Role of Christianity," whose papers are now being edited... (shrink)

This book examines the labour standards provisions in a number of Regional and Bilateral Trade Agreements, and assesses the potential of using the relevant clauses in these trade agreements as a benchmark for a multilateral approach. Based on the lessons learned from the Regional model, the book proposes a Global Labour and Trade Framework Agreement (GLTFA) combined with a joint ILO/WTO enforcement mechanism to resolve the contentious issue of the link between the CLS and international trade. The history of the (...) linkage between the Core Labour Standards (CLS) and international trade dates back roughly 150 years, and has recently become one of the most vexing issues facing policy-makers. At the heart of the debate is the question whether or not trade sanctions should be imposed on countries that do not respect the CLS as embodied in multilateral conventions administered by the International Labour Organization (ILO). Concretely, this would entail inserting a social clause in the World Trade Organization (WTO) rules, and would trigger the imposition of sanctions on those countries that do not adhere to the CLS. Kofi Addo is a policy advisor to the Board of Governors of the International Baccalaureate Organisation. He holds a PhD in law from the University of Bern, Switzerland.. (shrink)

On June 11, 1963, in a dramatic gesture that caught the nation's attention, Governor George Wallace physically blocked the entrance to Foster Auditorium on the University of Alabama's campus. His intent was to defy Attorney General Nicholas Katzenbach, sent on behalf of the Kennedy administration to force Alabama to accept court-ordered desegregation. After a tense confrontation, President Kennedy federalized the Alabama National Guard and Wallace backed down, allowing Vivian Malone and James Hood to become the first African Americans to enroll (...) successfully at their state's flagship university. That night, John F. Kennedy went on television to declare civil rights a "moral issue" and to commit his administration to this cause. That same night, Medgar Evers was shot dead. In The Schoolhouse Door, E. Culpepper Clark provides a riveting account of the events that led to Wallace's historic stand, tracing a tangle of intrigue and resistance that stretched from the 1940s, when the university rejected black applicants outright, to the post-Brown v. Board of Education era. We are there in July 1955 when Thurgood Marshall and lawyers at the NAACP Legal Defense Fund win for Autherine Lucy and "all similarly situated" the right to enroll at the university. We are in the car with Lucy in February 1956 as university officials escort her to class, shielding her from a mob jeering "Lynch the nigger," "Keep 'Bama white," and "hit the nigger whore." Clark exposes the many means, including threats and intimidation, used by university and state officials to discourage black applicants following the Lucy episode. And he explains how University of Alabama president Frank Anthony Rose eventually cooperated with the Kennedy administration to ensure a smooth transition toward desegregation. We also witness Robert Kennedy's remarkable face-to-face plea for Wallace's cooperation and the governor's adamant refusal: "I will never submit voluntarily to any integration in a school system in Alabama." As Clark writes, Wallace's carefully orchestrated surrender would leave the forces of white supremacy free to fight another day. And the Kennedys' public embrace of the civil rights movement would set in motion a political transformation that changed the presidential base of the Democratic party for the next thirty years. In these pages, full of courageous black applicants, fist-shaking demonstrators, and powerful politicians, Clark captures the dramatic confrontations that transformed the University of Alabama into a proving ground for the civil rights movement and gave the nation unforgettable symbols for its struggle to achieve racial justice. (shrink)

It has been argued that strikes are morally objectionable in the university context. They injure third parties – the students – and for this reason ought to be rejected. More generally, the strike weapon has led to a reduction of the power of Boards of Governors to adjust universities to changing times. And furthermore, the use of the strike weapon and the ensuing conflicts can injure the collegial form of governance that is essential to higher education. It is here (...) argued that these arguments are hardly conclusive, and that there are virtues to having the strike as a means to resolve disputes. But keeping things on track requires both parties to adhere to the moral and social virtue of civility. (shrink)

This article brings to light discourses that constituted the education of Asian-American children in California in the second half of the nineteenth century. Guided by Foucaultian ideas and critical race theory, I analyze California public school laws, speeches of a governor-elect and a superintendent, and a report of the board of supervisors, from the 1860s to the 1880s. During this targeted period, the images and narratives of Asian-American children were inscribed with racism. Racializing politics rendered them to be disqualified (...) from attending public schools. Segregated schooling for them was legally ordered and therefore unquestioned. It was a discursive practice implemented on their bodies by dint of a mechanism of a spatial division. This article reveals the shifting dominancy of discourses regarding Asian-American children. Rather than accepting the given historical facts, I intend to reread historical texts in order to rethink the education of Asian-American children through a Foucaultian encounter with critical race theory. Acknowledging different interpretations of the past events is a way of rethinking them and interrogating the history through the revelation of different histories in the education for Asian-American children. (shrink)

The quality of doctoral-level biochemistry (N=139), botany (N=83), cellular/molecular biology (N=89), microbiology (N=134), physiology (N=101), and zoology (N=70) programs at United States universities was assessed, using 16 measures. These measures focused on variables related to: (1) program size; (2) characteristics of graduates; (3) reputational factors (scholarly quality of faculty, effectiveness of programs in educating research scholars/scientists, improvement in program quality during the last 5 years); (4) university library size; (5) research support; and (6) publication records. Chapter I discusses prior attempts (...) to assess quality in graduate education, development of the study plans, and the selection of disciplines and programs to be evaluated. Chapter II discusses the methodology used, focusing on each of the assessment measures. Chapters III to VIII present, respectively, findings from the analyses of the biochemistry, botany, cellular/molecular biology, microbiology, physiology, and zoology programs. Chapter IX includes a summary of results, correlations among measures, several additional analyses, and suggestions for future studies. Among the findings reported are those indicating that cellular/molecular biology programs had, on the average, the largest number of faculty and that students in cellular/molecular biology, biology, biochemistry, microbiology, and physiology received a relatively high fraction of financial support. (Survey instruments and supporting documentation are included in appendices.) (JN). (shrink)

The quality of doctoral-level chemistry (N=145), computer science (N=58), geoscience (N=91), mathematics (N=115), physics (N=123), and statistics/biostatistics (N=64) programs at United States universities was assessed, using 16 measures. These measures focused on variables related to: program size; characteristics of graduates; reputational factors (scholarly quality of faculty, effectiveness of programs in educating research scholars/scientists, improvement in program quality during the last 5 years); university library size; research support; and publication records. Chapter I discusses prior attempts to assess quality in graduate education, (...) development of the study plans, and the selection of disciplines and programs to be evaluated. Chapter II discusses the methodology used, focusing on each of the assessment measures. Chapters III to VIII present, respectively, findings from the analyses of the chemistry, computer science, geoscience, mathematics, physics, and statistics/biostatistics programs. Chapter IX includes a summary of results, correlations among measures, several additional analyses, and suggestions for future studies. Among the findings reported are those indicating that mathematics programs had, on the average, the largest number of faculty (N=33) in December 1980 followed closely by physics (N=28) and chemistry (N=23), and that 80 percent of computer science students had job commitments by graduation. (Survey instruments and supporting documentation are included in appendices.) (JN). (shrink)

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

In the summer of 2015 the governor of Wisconsin signed an omnibus budget bill that, among other things, removed tenure from state statute—forcing the Board of Regents to rewrite it into board policy documents—and attempted to undermine aspects of shared governance that had been part of life at the university since the founding of the system in the early 1970s. Two years later, the Wisconsin Assembly passed a bill that directed the university to "strive to remain neutral on (...) the public policy controversies of the day". These actions and others like them in Wisconsin are part of a wider trend for states, particularly in those dominated by conservative legislatures and governors, to... (shrink)

This study examined the relationship between the proportion of women serving on firms' boards of directors and the extent to which these same firms engaged in charitable giving activities. Using a sample of 185 Fortune 500 firms for the 1991-1994 time period, the results provide strong support for the notion that firms having a higher proportion of women serving on their boards do engage in charitable giving to a greater extent than firms having a lower proportion of women serving on (...) their boards. Further, the results suggest a link between the percentage of women on boards and firm philanthropy in the areas of community service and the arts, but found no link between women boardmembers and firm giving to support education or public policy issues. The implications of the findings and some areas for future research are discussed. (shrink)

Over the past 20 years or so, a small but growing literature has emerged with the aim of modeling agents who are unaware of certain things. In this paper we compare two different approaches to modeling unawareness: the object-based approach of Board and Chung (Object-based unawareness: theory and applications. University of Minnesota, Mimeo, 2008) and the subjective-state-space approach of Heifetz et al. (J Econ Theory 130: 78-94,2006). In particular, we show that subjectivestate-space models (henceforth HMS structures) can be embedded (...) within object-based models (henceforth OBU structures), demonstrating that the latter are at least as expressive. As long as certain restrictions are imposed on the form of the OBU structure, the embedding can also go the other way. A generalization of HMS structures (relaxing the partitional properties of knowledge) gives us a full converse. (shrink)

Based on a survey of 2,361 directors in 291 of the largest companies of the Southeast States, this study empirically examined boards of directors' stakeholder orientations. The results indicate that there exist distinct stakeholder groups perceived by directors, directors have high stakeholder orientations, directors view some stakeholders differently depending on their occupation and type.

In this study, I examine the role racial minorities in the boardroom can play in reducing social injustice by promoting more equal access to mortgage credit to minority households. I develop a simple theoretical model that posits directors who are racial minorities provide the credit unions they govern with a perspective that shapes lenders’ trust of minority applicants. This trust is shaped by homophily and the tendency of individuals to prefer interactions with similar individuals. Using mortgage loan data from a (...) cross-section of credit unions in the United States from 185,446 applications, I find that credit unions where the majority of board members are minorities are less likely to reject a similarly qualified minority applicant than their counterparts. Governance by minority directors significantly reduces the effects of discrimination faced by minority applicants. The board’s effect is strongest in minority neighborhoods and where the homophily is stronger between directors and applicants. (shrink)

In a seminal paper, Aumann (1987, Econometrica 55, 1–18) showed how the choices of rational players could be analyzed in a unified state space framework. His innovation was to include the choices of the players in the description of the states, thus abolishing Savage’s (1954, The Foundations of Statistics. Wiley, New York) distinction between acts and consequences. But this simplification comes at a price: Aumann’s notion of Bayes rationality does not allow players to evaluate what would happen were they to (...) deviate from their actual choices. We show how the addition of a causal structure to the framework enables us to analyze such counterfactual statements, and use it to introduce a notion of causal rationality. Under a plausible causal independence condition, the two notions are shown to be equivalent. If we are prepared to accept this condition we can dispense with the causal apparatus and retain Aumann’s original framework. (shrink)

As an important way for enterprises to fulfill social responsibility, corporate philanthropy has attracted much attention from the academic community. But there are still few well-targeted theoretical and empirical studies on what functions the board of directors should perform to better fulfill philanthropic responsibilities. Taking this deficiency as a breakthrough, this study focuses on Chinese state-owned and private enterprises to analyze and test the functions performed by the BOD in CP. Based on the sample of Chinese A-share listed companies (...) from 2008 to 2019, the empirical results show that the BOD of state-owned enterprises mainly performs a monitoring function in CP while that of private enterprises mainly performs a consulting function. The above findings remain valid when potential biases in the quantitative analysis are considered. Further research shows that environmental dynamism and board fault lines inhibit the performance of the above two functions. The contributions of the study include clarifying the functional characteristics of the BOD in CP and its influencing factors, revealing new theories to the formation mechanism of CP, which provide references for enterprises to optimize philanthropic decision-making. The limitation should also be emphasized that our findings are based only on Chinese contexts. (shrink)

The Brown vs. Board of Education decision of 1954 mandated school integration. The decision also to recognize that inequalities outside the schools, of both a class- and race-based nature, prevent equality in education. Today, the most prominent argument for integration is that disadvantaged students benefit from the financial, social, and cultural “capital” of middle class families when the children attend the same schools. This argument fails to recognize that disadvantaged students contribute to advantaged students’ educational growth, and sends demeaning (...) messages to the disadvantaged students and messages of unwarranted superiority to the advantaged. Parents, teachers, and schools can adopt a justice perspective that avoids these deleterious aspects of the capital argument, and helps create a community of equals inside the integrated school. Struggles for educational justice must remain closely linked with struggles of both a class- and race-based nature for other forms of justice in the wider society. (shrink)

South Carolina State College was founded in 1896. As one of the Black institutions taking advantage of the Second Morrill Act of 1890, a large portion of the college's limited financial resources, its energies, and its programs were devoted to training students in agriculture, home economics, vocational trades, and in the education of teachers. These curriculums were considered appropriate for young Black men and women in the late nineteenth and early twentieth centuries.When the civil rights movement began to challenge segregation (...) in education in South Carolina in the late 1940s and early 1950s, the state's white leaders responded quickly and effectively by creating graduate and law programs at State College. To preserve the racial status quo and segregation in education, Governor James F. Byrnes subsequently raised funds, including one-half million dollars from the Rockefeller sponsored General Education Board, to improve long neglected facilities at State College. A sizable portion of the funds were devoted to the agricultural program.While the defense of “separate but equal” education by Byrnes and others ultimately failed, the changes fostered at State College did dramatically improve the institution in the 1950s and 1960s and brought a shift in its mission away from its traditional focus on rural and agricultural education for Black youngsters. By 1966, the college was nominally integrated. Paradoxically, in 1971 with enrollments declining and fewer students interested in pursuing agriculture as away of life, the agriculture program was discontinued. (shrink)

In today's world, the corporate image of the largest companies is closely linked to their performance in the field of corporate social responsibility and the disclosure of information on that topic, specifically, on climate change. Since the Board of Directors is the body responsible for this process, the aim of this article is to show the role that companies' Boards of Directors play in the accountability process vis-à-vis stakeholders in relation to one specific aspect which has enormous significance in (...) environmental information: practices used to monitor greenhouse gas emissions. In order to achieve this, we shall verify certain business characteristics, in addition to the size and activity of the Board of Directors, and we shall take different dependence models into consideration. These models will include variables related to the level of independence and diversity of the Board of Directors, which interact with dummy variables representing the company's litigation risks regarding environmental behavior and the institutional macro-context of the organization's country of origin. The results make it clear that Boards of Directors are basically focused on the traditional responsibility of creating economic value, instead of dealing with today's broader business world concepts, which include social responsibility. This focus, therefore, does not favor the accountability process before other stakeholders, if this makes it more difficult to protect the interests of shareholders. (shrink)

This study examines the impact of board of director gender diversity on corporate tax aggressiveness. Based on a sample of 418 U.S. firms covering the 2006–2009 period, our ordinary least squares regression results show a negative and statistically significant association between female representation on the board and tax aggressiveness after controlling for endogeneity. Our results are consistent across several measures of tax aggressiveness and additional robustness checks.

Business ethics is one of the most significant demands made by institutional and individual investors, who usually require the participation of the board of directors in the planning and implementation of ethical behaviour in corporations. This is done by drawing up an ethics code and then monitoring its fulfilment. This study has a dual objective: first, to analyse the role played by the composition of the board of directors, and by that we mean its independence and the diversity (...) of its members, on the implementation and scope of an EC, and, second, to detect whether the corporate governance system moderates the level of involvement of the board in ethical issues. The findings obtained from a data panel sample made up of 760 listed companies from 12 countries for the years 2003–2009 show that the largest companies with large-sized and diverse boards implement the most developed ECs. Nevertheless, the extent of involvement of the independent directors is conditioned by the level of shareholder orientation characteristic of the system of CG in the corporation’s country of origin. (shrink)

The governance structures of state public health systems vary as much as the states themselves, including the existence and role of state boards of health. Understanding these differences is essential to a complete understanding of the governmental public health enterprise. State boards of health are obvious vehicles for public health policy development in some states, where they work closely with or oversee state health agencies. In other states they do not exist or serve only in a non-binding advisory capacity.In this (...) article, we distinguish and identify state boards of health and state public health advisory boards, examine state boards of health in practice, and discuss their role in advocacy and policy development in the context of state politics. We used a set of mixed qualitative methods, including a literature review, online research of state statutes establishing state board of health authorities, and key informant interviews. Informants were five current and former state board of health members, four current and former state health officers, and nine state health agency senior policy staff, spanning 13 states. (shrink)