In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:The Varieties of Vernacular Mysticism (1350–1550) by Bernard McGinnDennis J. Billy C.Ss.R.The Varieties of Vernacular Mysticism (1350–1550). By Bernard McGinn. New York: Crossroad, 2012. Pp. xiv + 721. $70.00 (cloth). ISBN: 978-0-8245-9901-0.This fifth volume of McGinn’s Presence of God: A History of Western Christian Mysticism covers the Dutch, Italian, and English vernacular mystics of the late Middle Ages. In previous volumes, the author treated the Foundations (vol. (...) 1), Growth (vol. 2), Flowering (vol. 3), and Harvest (vol. 4) of Western Christian mysticism from its roots in the Jewish matrix and the Greek ideal to its fruition in the German vernacular writings of Meister Eckhart and his students. In this latest volume, he continues his history of Western Christian mysticism by focusing on varieties of vernacular mysticism in the Low Countries, Italy, and England from 1350 to 1550.Conscious of the dangers of historical periodization and regional classification, as well as the relationship of mysticism to the greater ecclesiastical world, McGinn takes pains to show the distinctive character of each mystic under consideration, while at the same time pointing out appropriate parallels with Western and Eastern Christian mystics from past historical epochs and those contemporary voices from both within and [End Page 476] without each mystic’s linguistic region. In his preface, he apologizes to his readers for the long gestation of the present volume and offers a brief account of how his original plan of writing a three-volume history of Western Christian mysticism evolved into a series of seven, due in large part to the sheer wealth of sources and his desire to give them a thorough treatment. Rather than following his original intention of including other vernacular traditions in his previous volume on German mysticism, he wisely chose to devote an entire volume to these other important strands (ix–x).Instead of writing a general introduction to the volume, McGinn decides to give a brief introduction to each of the three major parts. He divides his work into thirteen chapters constructed along the following lines: (1) “Late Medieval Mysticism in the Low Countries” (chaps. 1–5), (2) “Mysticism in Late Medieval Italy” (chaps. 6–9), and (3) “Mysticism in Late Medieval England” (chaps. 10–13). The volume closes with a brief conclusion (491–94), extended annotations (495–661), an extensive bibliography (662–704), and indices for Scripture references (705–6), names (707–12), and subjects (713–21). The book’s organization reflects the theme of diversity highlighted in its title. Although each part has its own internal structure and stands on its own as a survey of the material at hand, it also fits well into the volume’s overall plan of pointing out the distinctiveness and great variety of the vernacular mysticisms produced during this period. Taken individually, each part can be considered a probing monograph on the vernacular mysticism in each region. Taken together, the parts offer a unique glimpse into the mystic and literary creativity that sets this period apart as one of the most fertile periods in the history of Christian mysticism.In part 1, “Late Medieval Mysticism in the Low Countries,” McGinn notes that “the period ca. 1350 to ca. 1550 is the central era for Dutch mysticism” and “witnessed a florescence of mystical authors writing in the Dutch-Flemish language” (1). Although he hesitates to refer to a Dutch “school” of mysticism and thinks that “Ruusbroec should not be made the yardstick by which all later Dutch mystics are measured,” he has no reservations about considering him “a gravitational center in the history of Dutch mysticism” (2). This section of the book begins with an in-depth look at the mystical writings of Jan van Ruusbroec (1293–1381) (chap. 1) and continues with a study of Goenendaal mysticism after Ruusbroec (chap. 2). It then turns to a treatment of the mystical aspects of the Devotio Moderna, with a special emphasis on The Imitation of Christ and some vernacular mystics numbered among the Devout, such as Hendrik Mande (ca. 1360–1431, Gerlach Peters (ca. 1375–1411), and Alijt Bake (1415–55), and adds a brief note on the nominalistic... (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)

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

We present a comprehensive study of the axiom schemas IΣ - n , BΣ - n (induction and collection schemas for parameter free Σ n formulas) and some closely related schemas.

This article shows how there is a great kinship between Polanyi's thought and that of Bernard Haring, "the father of modern moral theology" in the Roman Catholic Church. Haring advocated an ethics of personal responsibility that calls for an epistemology such as Polanyi developed for history and social sciences in The Study of Man.

There have undoubtedly been ample reasons to discourage a translator from approaching this commentary on the Metaphysics. The reasons stem mainly from the lack of a critical text. As is well enough known, such a text is at present in preparation by the Dominicans. Until it appears, attempts even at discussing the many disconcerting problems about the commentary run the risk of proving futile. In consequence, discussions have fallen off in recent years. As Rowan is careful to point out in (...) his introduction, there is sufficient evidence not only that errors have been made through simple negligence in the editions of the commentary, but also that "all sorts of liberties" may have been taken with the text. What we have at present, moreover, might possibly be a running text based on redactions dating from different years in St. Thomas' teaching career. If one may judge from the way Rowan presents the different views, he personally prefers hypotheses that simplify the situation and allow the text now available to be considered as a single continuous writing left in its present form by Aquinas himself. (shrink)

We present a new modeling framework for recognition memory and repetition priming based on signal detection theory. We use this framework to specify and test the predictions of 4 models: (a) a single-system (SS) model, in which one continuous memory signal drives recognition and priming; (b) a multiple-systems-1 (MS1) model, in which completely independent memory signals (such as explicit and implicit memory) drive recognition and priming; (c) a multiple-systems-2 (MS2) model, in which there are also 2 memory signals, but some (...) degree of dependence is allowed between these 2 signals (and this model subsumes the SS and MS1 models as special cases); and (d) a dual-process signal detection (DPSD1) model, 1 possible extension of a dual-process theory of recognition (Yonelinas, 1994) to priming, in which a signal detection model is augmented by an independent recollection process. The predictions of the models are tested in a continuous-identification-with-recognition paradigm in both normal adults (Experiments 1–3) and amnesic individuals (using data from Conroy, Hopkins, & Squire,2005). The SS model predicted numerous results in advance. These were not predicted by the MS1 model, though could be accommodated by the more flexible MS2 model. Importantly, measures of overall model fit favored the SS model over the others. These results illustrate a new, formal approach to testing theories of explicit and implicit memory. (shrink)

The human immune system can directly lyse invading micro‐organisms and aberrant host cells by generating pores in the cell envelope, called membrane attack complexes (MACs). Recent studies using single‐particle cryoelectron microscopy have revealed that the MAC is an asymmetric, flexible pore and have provided a structural basis on how the MAC ruptures single lipid membranes. Despite these insights, it remains unclear how the MAC ruptures the composite cell envelope of Gram‐negative bacteria. Recent functional studies on Gram‐negative bacteria elucidate that local (...) assembly of MAC pores by surface‐bound C5 convertase enzymes is essential to stably insert these pores into the bacterial outer membrane (OM). These convertase‐generated MAC pores can subsequently efficiently damage the bacterial inner membrane (IM), which is essential for bacterial killing. This review summarizes these recent insights of MAC assembly and discusses how MAC pores kill Gram‐negative bacteria. Furthermore, this review elaborates on how MAC‐dependent OM damage could lead to IM destabilization, which is currently not well understood. A better understanding on how MAC pores kill bacteria could facilitate the future development of novel strategies to treat infections with Gram‐negative bacteria. (shrink)

The Oxford Handbook of Positive Psychology is the seminal reference in the field of positive psychology, which in recent years has transcended academia to capture the imagination of the general public. The handbook provides a roadmap for the psychology needed by the majority of the population -- those who don't need treatment but want to achieve the lives to which they aspire. These 65 chapters summarize all of the relevant literature in the field. The content's breadth and depth provide an (...) unparalleled cross-disciplinary look at positive psychology from diverse fields and all branches of psychology, including social, clinical, personality, counseling, school, and developmental psychology. Topics include not only happiness but also hope, strengths, positive emotions, life longings, creativity, emotional creativity, courage, and more, plus guidelines for applying what has worked for people across time and cultures. (shrink)

The present volume is, we believe, the first-ever edited volume devoted to the emotion of disgust. In this chapter we address the following issues: 1. Why was disgust almost completely ignored until about 1990, 2. Why has there been a great increase in attention to disgust since about 1990?, 3. The outline of an integrative, body-to-soul preadaptation theory of disgust, 4. Some specific features of disgust that make it particularly susceptible to laboratory research and particularly appropriate to address some fundamental (...) issues in psychology. In the final section, we outline some new questions that arise from the recent increased interest in disgust in the areas of brain mechanisms, psychopathology, the psychometric approach to the structure of disgust, and disgust and morality. We then indicate some important aspects of disgust that have yet to receive systematic investigation. (shrink)

In this volume twenty-three major scholars comment on and critically evaluate In Search of a Universal Ethic, the 2009 document written by the International Theological Commission (ITC) of the Catholic Church. That historic document represents an official Church contribution both to a more adequate understanding of a universal ethic and to Catholicism s own tradition of reflection on natural law. The essays in this book reflect the ITC document s complementary emphases of dialogue across traditions (universal ethic) and reflection on (...) broadly applicable ethical guidance within the Christian tradition (natural law). Among other things, the document situates the natural law ethical tradition within the larger search for a universal ethic. Along with its insightful essays, Searching for a Universal Ethic offers — for the first time in published form — the Vatican s official English translation of In Search of a Universal Ethic. Contributors: John Berkman Serge-Thomas Bonino, O.P. David Burrell, C.S.C. Lisa Sowle Cahill Joseph E. Capizzi David Cloutier Anver M. Emon Robert P. George Sherif Girgis Jennifer A. Herdt Russell Hittinger M. Cathleen Kaveny Anthony J. Kelly, C.Ss.R. Fergus Kerr, O.P. Steven A. Long William C. Mattison III Gilbert Meilaender Livio Melina Michael S. Northcott David Novak Jean Porter Martin Rhonheimer Tracey Rowland. (shrink)

The internet is widely used for health information and support, often by vulnerable people. Internet-based research raises both familiar and new ethical problems for researchers and ethics committees. While guidelines for internet-based research are available, it is unclear to what extent ethics committees use these. Experience of gaining research ethics approval for a UK study (SharpTalk), involving internet-based discussion groups with young people who self-harm and health professionals is described. During ethical review, unsurprisingly, concerns were raised about the vulnerability of (...) potential participants. These were dominated by the issue of anonymity, which also affected participant safety and consent. These ethical problems are discussed, and our solutions, which included: participant usernames specific to the study, a closed website, private messaging facilities, a direct contact email to researchers, information about forum rules displayed on the website, a ‘report’ button for participants, links to online support, and a discussion room for forum moderators. This experience with SharpTalk suggests that an approach to ethics, which recognises the relational aspects of research with vulnerable people, is particularly useful for internet-based health research. The solutions presented here can act as guidance for researchers developing proposals and for ethics committees reviewing them. (shrink)

The Oxford Handbook of Positive Psychology, Second Edition is the seminal reference in the burgeoning field of positive psychology, which, in recent years, has transcended academia to capture the imagination of the general public. The handbook provides a roadmap for the psychology needed by the majority of the population--those who don't need treatment, but want to achieve the lives to which they aspire. The 65 chapters summarize all of the relevant literature in the field, and each of the international slate (...) of contributors is essentially defining a lifetime of research. The content's breadth and depth provide an unparalleled cross-disciplinary look at positive psychology from diverse fields and all branches of psychology, including social, clinical, personality, counseling, school, and developmental psychology. Topics include not only happiness--which has been perhaps misrepresented in the popular media as the entirety of the field--but also hope, strengths, positive emotions, life longings, creativity, emotional creativity, courage, and more, plus guidelines for applying what has worked for people across time and cultures. (shrink)

Many studies have addressed the justice of public land acquisition, but few studies have addressed the question of what landowners perceive as just. Individual perceptions drive an important part of the social and scientific debates on legitimate and just land acquisition. This article addresses this gap by studying landowners’ and land purchasers’ perceptions of just land acquisition. We did this by uncovering the prevailing discourse on just land acquisition and studying the values that shaped people’s perceptions of just land acquisition. (...) The results showed that perceptions of justice are based on the values of lawfulness, decentness and equality. These values were translated into different norms that resulted in expectations pertaining to just land acquisition. Insight into the different perceptions and the prevailing discourse of just land acquisition and their underlying values increases the understanding of land acquisition processes and land policy strategies. First, it becomes apparent that land acquisition has an essential element of injustice that cannot be avoided by a good process or a just compensation fee. Second, insight in different discourses provides valuable input for debates on just land acquisition. Third, such insight shows that money is not always a sufficient means of indemnification. The combination of sufficient financial compensation, the opportunity of a new location, attractive selling conditions and accurate and open process are all important requisites to ensure that public land acquisition is perceived by the majority of landowners as just. (shrink)

Many studies have addressed the justice of public land acquisition, but few studies have addressed the question of what landowners perceive as just. Individual perceptions drive an important part of the social and scientific debates on legitimate and just land acquisition. This article addresses this gap by studying landowners’ and land purchasers’ perceptions of just land acquisition. We did this by uncovering the prevailing discourse on just land acquisition and studying the values that shaped people’s perceptions of just land acquisition. (...) The results showed that perceptions of justice are based on the values of lawfulness, decentness and equality. These values were translated into different norms that resulted in expectations pertaining to just land acquisition. Insight into the different perceptions and the prevailing discourse of just land acquisition and their underlying values increases the understanding of land acquisition processes and land policy strategies. First, it becomes apparent that land acquisition has an essential element of injustice that cannot be avoided by a good process or a just compensation fee. Second, insight in different discourses provides valuable input for debates on just land acquisition. Third, such insight shows that money is not always a sufficient means of indemnification. The combination of sufficient financial compensation, the opportunity of a new location, attractive selling conditions and accurate and open process are all important requisites to ensure that public land acquisition is perceived by the majority of landowners as just. (shrink)

This paper addresses the definition and the operational use of intuitions in philosophical methods in the form of a research study encompassing several regions of the globe, involving 282 philosophers from a wide array of academic backgrounds and areas of specialisation. The authors tested whether philosophers agree on the conceptual definition and the operational use of intuitions, and investigated whether specific demographic variables and philosophical specialisation influence how philosophers define and use intuitions. The results obtained point to a number of (...) significant findings, including that philosophers distinguish between intuitions used to formulate (discovery) and to test (justification) philosophical theory. The survey results suggest that strategies implemented to characterise philosophical intuition are not well motivated since, even though philosophers do not agree on a single account of intuition, they fail to capture a preferred usage of intuitions as aspects of discovery. The quantitative summary of survey findings informs the debate on this topic, and advances more defined routes for subsequent approaches to the study of intuitions. (shrink)

Are there common mechanisms that apply across different therapies that might explain their effectiveness? Many psychologists, psychotherapists and counsellors, whether clinicians or researchers, now recognize that one such key mechanism involves the transformation of meaning in the process of therapy. The purpose of this book is to show how the transformation of meaning is related to therapeutic change. Change in therapy can and should occur at a number of levels for improvement to be maintained, whether in behavior therapy, cognitive therapy (...) or psychoanalytic therapy. The leading scientists and practitioners who have contributed to this book approach therapy from very different perspectives, but they together help to fashion a common framework for understanding the role of meaning in therapeutic change. (shrink)

Psychiatry is rapidly changing. The authors review the history of psychiatry in the United States, its gradual integration into medicine and society, and the dialectic between its “biologic” and “mentalist” outlooks. After describing the current state of the profession and its knowledge base, they discuss the likely future of the field: psychiatry's projected mode of practice and economics; its future as a science for understanding human behavior; its expected boundaries with other treatment disciplines; its anticipated relationship with academia and with (...) the community at large; and internal issues for the profession. Unprecedented internal and external pressures on the field are likely to require important reconceptualizations of psychiatry both by its members and by the rest of the American public. (shrink)

For a variety of reasons, including the common use of deception in psychology experiments, participants often disbelieve experimenters' assertions about important task parameters. This can lead researchers to conclude incorrectly that participants are behaving non- normatively. The problem can be overcome by deriving and testing normative models that do not assume full belief in key task parameters. A real experimental example is discussed.

'A fascinating book. It contains a sweeping survey of approaches to causation and explanation from the Presocratic philosophers to the Neo-platonist philosophers. Hankinson pays a visit to every major figure and movement in between: the sophists, Plato, Aristotle, the Stoics, the Sceptics, the Epicureans and a variety of medical writers, early and late... impressive... Hankinson's observations are regularly intriguing, at times refreshingly trenchant, and in some cases straightforwardly arresting... the history itself is excellent: clear, intelligently conceived and executed, and broadly (...) accessible. Those in search of a philosophically astute history of clasical philosophy given in terms of one of its own central unifying obsessions will delight in reading R. J. Hankinson's work.' -Christopher Sheilds, Times Literary SupplementR. J. Hankinson traces the history of ancient Greek thinking about causation and explanation. He examines how the Greeks dealt with questions about how and why things happen as and when they do, about the basic constitution and structure of things, about function and purpose, laws of nature, chance, coincidence, and responsibility. Such diverse questions are unified by the fact that they are all demands for explanation, for an account of the world that will render it amenable to prediction and control. (shrink)

Many theories of complex cognitive-motor skill learning are built on the notion that basic cognitive processes group actions into easy-to-perform sequences. The present work examines predictions derived from laboratory-based studies of motor chunking and motor preparation using data collected from the real-time strategy video game StarCraft 2. We examined 996,163 action sequences in the telemetry data of 3,317 players across seven levels of skill. As predicted, the latency to the first action is delayed relative to the other actions in the (...) group. Other predictions, inspired by the memory drum theory of Henry and Rogers, received only weak support. (shrink)