Family carers of individual’s living with Huntington’s Disease (HD) manage a distinct and unique series of difficulties arising from the complex nature of HD. This paper presents the validation of the definitive measure of quality of life for this group. The Huntington’s Disease Quality of Life Battery for carers (HDQoL-C) was expanded and then administered to an international sample of 1716 partners and family carers from 13 countries. In terms of the psychometric properties of the tool, exploratory analysis of half (...) of the sample, demonstrated good internal consistency and reliability. Some items on the full version did not meet psychometric thresholds and a short version (HDQoL-Cs) was developed based on more stringent criteria. Confirmatory Factor Analysis of the model structure showed a good fit for all Factors and, indicated that the HDQoL-C and HDQoL-Cs are psychometrically robust measures of quality of life. We found that carers who lived with and looked after their spouse/partner had reduced sense of coping, hope for the future and overall quality of life. Carers with children who were at risk, carried the gene or were symptomatic also had poorer quality of life outcomes. Findings indicated the HDQoL-C and HDQoL-Cs are valid in multiple languages and across varied cultures as measures of self-reported quality of life in family carers of individual’s living with HD. These psychometrically validated tools can aid and guide the implementation of therapeutic interventions to improve life quality in this population. (shrink)

Part I of this two-part paper provided a broad overview of clinical and experimental findings bearing on the neural correlates of conscious processes. It was argued that several neurocognitive models related to: orienting to the outer world, dream sleep, and the integration of sensory-motor representations, converge upon a core ‘conscious system’, dubbed the extended reticular-thalamic activating system . The functions of the ERTAS, which shares extensive projections with the cerebral cortex, are mostly ‘implicit’, in contrast to the explicit representation of (...) conscious content within the neocortex. Part II expands this ERTAS model to encompass: the generation of coherent patterns of EEG activation, the integration of distributed cortical processes into a stream of unified percepts , and selective attention, as well as links between the ERTAS and systems providing the neural substrates for episodic memory and volition. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:69 WILLIAM ROBERTSON AND DAVID HUME: THREE LETTERS The relationship between David Hume and his fellow Scottish historian William Robertson has always seemed one-sided. Despite the existence of fifteen letters to Robertson in the standard volumes of Hume's correspondence,1 Hume scholars have long had reason to regret the lack of a single extant letter from Robertson to Hume. None are to be found, for example, where one would most (...) expect them to be — in the Royal Society of Edinburgh, alongside the letters to Hume from various other Moderate clergymen and literati in Robertson's circle, such as Hugh Blair and Adam Ferguson. Fortunately, however, two of Robertson's letters to Hume (numbered II and III below) have now turned up where one would not expect them to be — among Robertson's own correspondence in the Robertson2 Macdonald Papers, National Library of Scotland. They are not mere drafts, such as one is accustomed to find among an author's private papers; rather, they are autograph signed letters that appear to have actually been posted. How and when they found their way back to Robertson's personal papers, and what became of the rest of Robertson's letters to Hume, are questions open to speculation. For the moment we are grateful for the letters we now have, neither of which is known to have been published before in whole or in part. Nor has Hume been identified before as the recipient of either of these letters, though internal evidence makes it clear that he was. Both letters date from the late 1760s, when Hume was living in London and Robertson was at the peak of his multi-faceted career in Edinburgh as university principal, parish minister, ecclesiastical leader, and man of letters. The first of them, dated 27 March 1767, was sent to Hume in his capacity as under- 70 secretary of state in the Northern Department (an office he held from February 1767 to January 1768). It is plainly a reply to a letter of 19 March, in which Hume had discussed three topics to which Robertson was 5 responding: Robertson's efforts to secure a military chaplaincy for a certain Scottish minister (evidently named Brodie); Conway's role in the famous dispute between Hume and Rousseau; and the public response to Adam Ferguson's newly published Essay on the History of Civil Society. In addition Robertson addresses a matter that Hume had apparently broached with him at some earlier time: the attempt to find a suitable Scottish church to which Hume might obtain a crown presentation for his nephews' tutor, the Rev. Christopher Tait. The letter concludes on a note of admiration that is characteristic not only of Robertson but of most of Hume's other "Protestant Pastors" in Scotland. The second letter to Hume, dated 31 January 1769, is chiefly concerned with the forthcoming publication of Robertson's History of Charles V and the French translation of it by J.-B.-A. Suard — subjects that had been treated in two letters from Hume to 7 Robertson of autumn 1768. It also contains a strong recommendation for a bright young Scottish writer (in both the legal and literary senses of that term) who would one day become Robertson's most vitriolic critic: Gilbert Stuart. On the personal side, there is encouragement for the now unemployed Hume to return to Edinburgh, as he was then threatening to do, after his "great glut of society" at Paris and London, and there are allusions in the closing paragraph to Hume's part in introducing his friend to polite society when Robertson had visited London to arrange the publication of Charles V in the spring of 1768. 71 To these two letters from Robertson we have prefixed a third from earlier in the same decade, one Q not actually addressed to Hume but largely about him. Robertson wrote it to their common friend Gilbert Elliot (later Sir Gilbert Elliot) on 8 March 1762, two days before the Town Council elected Robertson principal of Edinburgh University. The first paragraph deals with the principalship and relates to Hume only indirectly, as we point out in a footnote. The second paragraph, however, contains interesting... (shrink)

This volume continues the grouping of natural philosophers with cosmological interests and moral philosophers. With the natural philosophers, the contrast is between those who deny that true being can be found in the sensible world and those atomists who react to this monism in favour of the multiplicity of the sensible world. Since the exactly opposite conclusion has been recently maintained, Guthrie's assertion that Parmenides distinguished the concept of eternity from the concept of everlastingness is of particular interest. Of course, (...) Guthrie's acumen and erudition are so well established as to make his projected five volume history of Greek philosophy indispensable for any student—D. J. B. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and informed (...) consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This guide accompanies the following article(s): ‘Full Disclosure of the “Raw Data” of Research on Humans: Citizens’ Rights, Product Manufacturer’s Obligations and the Quality of the Scientific Database.’Philosophy Compass 6/2 (2011): 90–99. doi: 10.1111/j.1747‐9991.2010.00376.x Author’s Introduction Securing consent (and informed consent) from patients and research study participants is a key concern in patient care and research on humans. Yet, the legal doctrines of consent and informed consent differ in their applications. In patient care, the judicial doctrines of consent and informed (...) consent are disclosure doctrines based on the obligation of physicians to inform their patients of the following types of information: the nature of the procedure the physician is recommending in the patent’s care (P), the alternatives to the physician‐recommendation (A), and the risks of procedure and its alternatives (R). In addition, the physician must provide truthful answers to the patient’s questions (Q) to the best of the physician’s abilities. In research on humans, the onus of disclosure by study sponsors and principal investigators is much greater than in patient care precisely because the purpose of research is not patient care. The purpose of research is the identification and development of new generalizable knowledge. Thus, participation in a research study or trial may not benefit the study volunteer at all. In addition, the participant may carry a heavy risk burden in relationship to any testing of a newly designed drug or device as part of their experiences in the research study. Presently, despite the risks borne by the research study participant, the raw data collected from volunteers in research trials are treated by courts as if they were the private property of the study sponsor rather than generally owed to the public as would be expected by an effort like research participation aimed at contributing to the development of generalizable knowledge. This paper reviews the obligations that study sponsors owe to their study participants based on the very definition of research as a systematic activity whose purpose is to develop generalizable knowledge to help all humans. Author Recommends Court cases Canterbury v. Spence, United States Court of Appeals, District of Columbia Circuit 464 F.2d 772 (1972). (Federal appellate decision heard in the District of Columbia, USA) Reibl v. Hughes, 2 S.C.R. 880 (1980). (Supreme Court of Canada) Rogers v. Whitaker, 175 C.L. R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Canterbury v. Spence is the landmark Federal informed consent case in the United States heard in the District of Columbia. In this case, Judge Spottswood Robinson articulated the reasonable person standard of informed consent. This standard was subsequently adopted by the Supreme Court of Canada (Reibl v. Hughes, 2 S.C.R. 880 (1980)) and the High Court of Australia (Rogers v. Whitaker, 175 C.L. R. 479 (1992)). The House of Lords rejected the reasonable person standard in England in Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985). Book Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. This book is a detailed guide for the review of scientific and ethical aspects of research on humans contained in the research study protocols and research informed consent forms which need to be submitted by study sponsors and principal investigators to institutional review boards (IRBs) for IRB review before a research study can receive approval to be conducted within a human study population in those institutions over which the IRB has authority. It also presents basic definitions in the area of research on humans and basic approaches to help conduct a deep review of the underlying scientific and ethical issues that are present within a research study protocol and its accompanying research informed consent form. Report National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). This U.S. National Commission in the Belmont Report argued for the necessity of a reasonable volunteer standard in research on humans in the United States. Arguing that the professional standard and the reasonable person standard of consent and informed consent were insufficient to base a disclosure standard in research on humans, this National Commission developed the reasonable volunteer standard where a study participant is to be approached in research informed consent with that information that a reasonable volunteer would want to know. Online Materials Belmont Report: Syllabus Topics for Lecture and Discussion Week I: Introduction and Overview Readings: Rogers v. Whitaker, 175 C.L.R. 479 (1992). (High Court of Australia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week II: The Different Standards of Consent and Informed Consent Readings: Canterbury v. Spence, 464 F.2d 772 (1972). (Federal appellate opinion heard in the District of Columbia) Sidaway v. Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others. 1 A.C. 871 (1985) (House of Lords) Week III: Definition of Research Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 2 and 3) Week IV: How to Review a Research Study Protocol and Research Informed Consent Form Reading: Mazur, Dennis J. The Science and Ethics of Research on Humans. Baltimore, MD: Johns Hopkins University Press, 2007. (Especially Chapters 4–6, 10, and 12–14) Week V: Obligations in Research of Humans Versus Patient Care Reading: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: Ethical Guidelines for the Protection of Human Subjects of Research. Washington, DC: DHEW Publications, 1978 (78‐0012). Focus Questions • How do the judicial doctrines of consent in England and Australia compare to the judicial doctrines of informed consent in the United States and Canada? • How does a professional standard of disclosure differ from a reasonable person standard of disclosure? • What is the definition of research? • How is a research study (study proposal and research informed consent form) reviewed from scientific and ethical bases for considerations of approval by an IRB? • How do the obligations of a study sponsor, a principal investigator, and a research team conducting a research trial on human study participants differ from the obligations of a physician caring for a patient? • Should all raw data of research derived from humans be made available to the public for use in developing generalizable knowledge to help others, or should raw data be considered the private property of the study sponsors (for example, prescription drug manufacturers), who fund the research trials? Seminar/project Idea Draw a timeline of the development of the basic concepts of consent and informed consent in patient care and in patient research. On this timeline, first place the dates of the key court cases in England, the United States, Canada, and Australia on consent and informed consent. Then place the date of the development of the Belmont Report. Why do differences exist between these four countries in terms of the legal requirements of informedness of a patient (in medical care) and a study participant (in medical research)? What roles if any do the concepts of self‐determination and self‐decision have in consent and informed consent in patient care and in informed consent in research on humans among the four countries of interest? What are the realities of research on human participants that require a new standard of informed consent, the reasonable volunteer standard, to be developed beyond the two standards in patient care, the professional standard, and the reasonable person standard? Counterpoint Arguments The following are counterpoint arguments that need to be appreciated to more fully understand the concepts that impact the thesis that ‘raw data’ should be open to the public to allow the opportunity of checking of the results of its associated scientific paper and for further analysis. De‐Identified (Anonymized) Raw Data A current approach to identifying (anonymizinig) raw data is based on the Health Insurance Portability and Accountability Act (HIPAA) of 1996 (P.L.104‐191). HIPAA was enacted by the U.S. Congress in 1996 to keep a person’s medical information private. In a research study, a person’s private medical information can become research data. HIPAA’s Privacy Rule allows a covered entity to de‐identify data by removing all 18 elements that could be used to identify the individual or the individual’s relatives, employers, or household members; these elements are enumerated in the Privacy Rule. The covered entity must also have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information. Under this method, the identifiers that must be removed are the following: 1 Names. 2 All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: 2a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. 2b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000. 3 All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death, and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. 4 Telephone numbers. 5 Facsimile numbers. 6 Electronic mail addresses. 7 Social security numbers. 8 Medical record numbers. 9 Health plan beneficiary numbers. 10 Account numbers. 11 Certificate/license numbers. 12 Vehicle identifiers and serial numbers, including license plate numbers. 13 Device identifiers and serial numbers. 14 Web universal resource locators (URLs). 15 Internet protocol (IP) address numbers. 16 Biometric identifiers, including fingerprints and voiceprints. 17 Full‐face photographic images and any comparable images. 18 Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re‐identification. Even though ‘raw data’ can be de‐identified (anonymized) so that there is no way to trace back the data to the study participant from which it was drawn, there are still questions whether the ‘de‐identified raw data’ can be given to other researchers or made public without the original study participant’s approval. It may be the case that this approval could be done at the start of any research study where the individual considering study participation would be counseled on what the process of de‐identification consists of and would be asked whether the participant would allow use of the data by other researchers or made available to the public in a de‐identified state. However, there may be questions of the study participants as to whether the data are truly de‐identified and untraceable back to the study participant since the participant would not be able to see the process actually being carried out in detail in all relevant circumstances. Using Raw Data in Context Simply being in possession of raw data is never enough to build on that data from a research perspective. Researchers need to understand the context of the scientific research study in which the data were collected. This research context includes (but is not limited to): (i) the scientific hypothesis of the research study, (ii) the inclusion and exclusion criteria selected by the research designers of the study to determine which study participants were included and which were excluded from the study, (iii) the methods used to collect the data and possibilities of errors in the data collection processes, and (iv) answers to questions regarding whether any data were excluded from the study data and why these data were excluded. Ownership Rights Over Data There are ownership rights over data. Ownership rights include court decision making related to the question which parties are to be considered as the owners of the data. Possible owners here include (but are not limited to) (i) the study sponsor whose only role was to fund that study, (ii) the principal investigator(s) who developed the scientific hypothesis, and (iii) individual study participants through special contracts made by individual participants who negotiate such contracts with study sponsors and principal investigators to share in the ownership of data. Examples of such data are participant sources of unique gene lines or unique cell lines to be used in future research. Objections to Data Sharing Finally, individual researchers may simply object to sharing data. A researcher’s arguments here may be simply stating that he or she has a right to fully analyze the data since the collection of the data was the researchers’ idea in the first place. These researchers may argue that they have the right to mine the data as fully as they can before deciding to make the data open to the public for others to analyze. Works Cited 1 Kaiser, J. ‘Making Clinical Data Widely Available.’Science 322.5899 (10 Oct. 2008): 217–8. 2 de Lusignan, S., J.F. Metsemakers, P. Houwink, V. Gunnarsdottir, and J. van der Lei. ‘Routinely Collected General Practice Data: Goldmines for Research? A Report of the European Federation for Medical Informatics Primary Care Informatics Working Group (EFMI PCIWG) from MIE2006, Maastricht, The Netherlands.’Informatics in Primary Care 14.3 (2006): 203–9. 3 Sim, I. ‘Human Studies Database Project’, CTSA Data Repositories Symposium (17 Oct. 2008). 23 Nov. 2010. 4 Sim, I., C.G. Chute, H. Lehmann, R. Nagarajan, M. Nahm, and R.H. Scheuermann. ‘Keeping Raw Data in Context.’Science 323.5915 (6 Feb. 2009): 713. 5 U.S. Department of Health and Human Services, National Institutes of Health, HIPAA Privacy Rule, Information for Researchers. 13 Nov. 2010. 6 Wilczynski, N.L., R.B. Haynes, and Hedges Team. ‘EMBASE Search Strategies for Identifying Methodologically Sound Diagnostic Studies for Use by Clinicians and Researchers.’BMC Medicine 29.3 (March 2005): 7. (shrink)

This paperback consists of a reprint of Feigl's now famous paper published originally in Volume II of the Minnesota Studies in the Philosophy of Science and a short postscript written ten years after. When Feigl first published his article, his main concern was to show that linguistic philosophy had not succeeded in showing that the problems involved in understanding mind and body were linguistic pseudo-problems. And he developed in great detail the outlines of a proposed solution to the problems. The (...) vast literature of the last ten years certainly has vindicated Feigl's claim about the liveness and importance of the issues. While Feigl ended his original article with a budget of problems still to be confronted, he did think that his double-knowledge or double-designation view was essentially correct. As a result of ten years of criticisms, Feigl is far more tentative about many of his specific claims and recognizes that there are many unresolved difficulties in the three main issues of the cluster of mind-body problems: sentience, sapience, and selfhood.--R. J. B. (shrink)

The sixteen essays contained in this book were all written independently of each other and date back over a considerable period of time to 1956. Most of the essays have been previously published and are reprinted here with little or no change or additions. Only two were specially written for this volume. All but two deal with the theoretical as distinct from the practical dimensions of science. The two exceptions are a set of reflections on the morality of the atomic (...) bombing of Japan in World War II and an essay which sketches a framework for the consideration of issues in nursing as a practical discipline. (shrink)

This paper explores a remarkable convergence of ideas and evidence, previously presented in separate places by its authors. That convergence has now become so persuasive that we believe we are working within substantially the same broad framework. Taylor's mathematical papers on neuronal systems involved in consciousness dovetail well with work by Newman and Baars on the thalamocortical system, suggesting a brain mechanism much like the global workspace architecture developed by Baars (see references below). This architecture is relational, in the sense (...) that it continuously mediates the interaction of input with memory. While our approaches overlap in a number of ways, each of us tends to focus on different areas of detail. What is most striking, and we believe significant, is the extent of consensus, which we believe to be consistent with other contemporary approaches by Weiskrantz, Gray, Crick and Koch, Edelman, Gazzaniga, Newell and colleagues, Posner, Baddeley, and a number of others. We suggest that cognitive neuroscience is moving toward a shared understanding of consciousness in the brain. (shrink)

Aim: Patients with advanced cancer need information about end-of-life treatment options in order to make informed decisions. Clinicians vary in the frequency with which they initiate these discussions.Patients and methods: As part of a long-term longitudinal study, patients with an expected 2-year survival of less than 50% who had advanced gastrointestinal or lung cancer or amyotrophic lateral sclerosis were interviewed. Each patient’s medical record was reviewed at enrollment and at 3 months for evidence of the discussion of patient wishes concerning (...) ventilator support, artificial nutrition and hydration , resuscitation and hospice care. A Kaplan–Meier analysis was also performed and 2-year survival calculated.Results: 60 cancer and 32 ALS patients were enrolled. ALS patients were more likely than cancer patients to have evidence of discussion about their wishes for ventilator support , ANH , DNR and hospice care . At 6 months, 91% of ALS patients were alive compared with 62% of cancer patients; at 2 years, 63% of ALS patients were alive compared with 23% of cancer patients .Conclusions: Cancer patients were less likely than ALS patients to have had documented advanced care planning discussions despite worse survival. This may reflect perceptions that ALS has a more predictable course, that advanced cancer has a greater number of treatment options, or differing views about hope. Nevertheless, cancer patients may be less adequately prepared for end-of-life decision-making. (shrink)

Conditionals are central to inference. Before people can draw inferences about a natural language conditional, they must interpret its meaning. We investigated interpretation of uncertain conditionals using a probabilistic truth table task, focussing on (i) conditional event, (ii) material conditional, and (iii) conjunction interpretations. The order of object (shape) and feature (color) in each conditional's antecedent and consequent was varied between participants. The conditional event was the dominant interpretation, followed by conjunction, and took longer to process than conjunction (mean di (...) erence 500 ms). Material conditional responses were rare. The proportion of conditional event responses increased from around 40% at the beginning of the task to nearly 80% at the end, with 55% of participants showing a qualitative shift of interpretation. Shifts to the conditional event occurred later in the feature-object order than in the object-feature order. We discuss the results in terms of insight and suggest implications for theories of interpretation. (shrink)

Everywhere the 1990s have been characterized by an odd mixture of ideological triumphalism-Fukuyama's "end of history" being only the crassest example-and of ideological uncertainty-can there be, should there be, a "third way"? For all its pretensions to universality, the "New World Order" has never lost a fragility in appearance. Students of historiography can scarcely be surprised to learn that an uneasiness over the present and future has in turn frequently entailed uncertainty about the past and particularly about those parts of (...) the past which had seemed most able to give clear and significant "lessons."One evident example is the history of what in my Explaining Auschwitz and Hiroshima I called the "long" Second World War, that is, that crisis in confidence in the relationship between political and economic liberalism and the nation-state which, by the end of 1938, had left only Britain, France, the Low Countries, and Scandinavia as in any sense preserving those "liberal" freedoms which had spread across Europe since 1789. In this article, I briefly review the most recent difficulties World War II combatant societies have had in locating a usable past in the history of those times. However, my major focus is on the specific case of Italy, very much a border state in the Cold War system, and today the political home of an "Olive Tree" and a "Liberty Pole" whose historical antecedents and whose philosophical base for the future are less than limpid. 1990s Italian historians thus give very mixed messages about the Fascist past; these are the messages I describe and decode. (shrink)

Psychological determinants of contraceptive use were investigated in Great Britain and Germany, using national data obtained in 1992. It was hypothesised that current contraceptive use among sexually active, fertile women aged 15-45 was related to their attitude towards the various contraceptive methods, social influences, perceptions of being able to use a method correctly and consistently, a correct estimation of fertility, and communication with their partner. Effects of age and country were also taken into account.The attitude of respondents towards the various (...) contraceptive methods was ambivalent and no method was seen as ideal. On medical methods many respondents expressed doubts as to their safety for health. Social influences most frequently concerned the use of OCs. Respondents considered themselves able to use oral contraceptives correctly, but expressed general fear about intrauterine devices and sterilisation, and many women believed they were not able to use condoms and periodic abstinence consistently.Multifactorial analyses revealed that current contraceptive use was principally determined by social influences, attitude and self-efficacy with respect to medical methods. Age and country, and, for use of unreliable methods, fertility awareness also played a role. Communication with the partner was less relevant.Contraceptive choice depended greatly on encouragement to use and being in favour of medical methods. A lack of social support for use of medical methods and a negative attitude towards them was related to higher use rates of condoms, periodic abstinence, withdrawal and reliance on ‘luck’. In the case of withdrawal and/or no method, underestimation of fertility played an additional role.Contraceptive choice appears to be determined more by a general like or dislike of medical methods rather than on a weighing of the merits of individual available methods. (shrink)

Sandia National Laboratories, located in Albuquerque, New Mexico, was originally a part of Los Alamos Laboratory. In 1949, AT&T agreed to manage Sandia, which they did for the next 44 years. During those Cold War years, Sandia was the prime weapons engineering laboratory for Los Alamos and Lawrence Livermore. As such, it bore prime responsibility for designing and adapting nuclear weapons for the military services' delivery systems, and ensuring the safety and reliability of the stockpile. The Labs' history has been (...) unevenly documented, hindered by the secret nature of its work and the desire of management to maintain a low public profile. There have been three history programs at Sandia: a restricted history published internally in 1963; another history program in the early 1980s that resulted in a history of the Labs' first decade; and the current history program dating from the mid-1990s, which has published a general history and several monographs. This article discusses the challenges and problems inherent in documenting the history of a national weapons laboratory during the last 50 years. (shrink)

Focusing on a discussion by Ruddich and Stassen of the ?Remarks on Frazer's Golden Bough?, this paper shows that some of the usual criticisms made by sociologists of Wittgenstein are misplaced. He does not reject causal explanations of beliefs and actions and replace them with some other form of explanation, but dismisses the idea that any explanation is called for here. His argument that the origin of the desire to explain beliefs is to be found in a misconceived parallel between (...) science and magic is explained and discussed. (shrink)