Background: There is little research into medical students’ or doctors’ attitudes to abortion, yet knowing this is important, as policy makers should be aware of the views held by professionals directly involved in abortion provision and changing views may have practical implications for the provision of abortion in the future. Methods: We surveyed 300 medical students about their views on abortion, their beliefs about the status of the fetus and the rights of the mother, their attitude towards UK law and (...) their willingness to be involved in abortion provision as qualified doctors. Results: 62% of medical students were pro-choice, 33% pro-life and 7% undecided. Students’ views correlated with gender, year of study and holding a religious belief. Their beliefs about abortion, the status of the fetus and the rights of women significantly correlated with their attitudes towards the UK law and their willingness to be involved in abortion provision. Students’ willingness to be involved in abortion provision was related to their views on abortion, the extent of participation required, the circumstances of the pregnancy and the stage of pregnancy. Conclusions: The percentage of pro-choice students was lower than that found in research on general practitioners’ attitudes to abortion. It is unclear whether this is because students become more pro-choice as they progress through their medical career or because there is genuinely a change in attitudes to abortion. (shrink)

American physicians are increasingly concerned that they are losing professional control. Other analysts of medical power argue that physicians have too much power. This essay argues that current analyses are grounded in a structuralist reading of power. Deploying Michel Foucault's "care of the self" and rhetorician Raymie McKerrow's "critical rhetoric," this essay claims that medical power is better understood as a way that medical actors take on power through rhetoric rather than a force that has power over medical actors. Through (...) a close reading of an essay by Senator Bill Frist, this paper argues that physicians experience a process of "subjection" wherein they are both agents of and objects of medical power as it is combined with state and corporate power in the American "war on terror." This alternative mode of analyzing medical power has implications for our collective understanding of its operations and the means by which we propose alternative enactments of medical power. (shrink)

This essay analyzes Senator Bill Frist's 2001 address to the American Society of Thoracic Surgeons. The author argues that the address represents an attempt to reframe physicians' political identity to authorize more active participation by them. Frist authorizes and demands such participation through the construction of a medical jeremiad. He argues that American physicians must have greater involvement to preserve the health of the body politic and to reassert physician control over the biomedical system. Although Frist's arguments are built on (...) an apparently democratic form of address, his jeremiad illustrates aristocratic possibilities in medico-political rhetoric. (shrink)

The Tuskegee Syphilis Experiment (TSE) has shaped African Americans’ views of the American health care system, contributing to a reluctance to participate in biomedical research and a suspicion of the medical system. This essay examines public discourses surrounding President Clinton’s attempt to restore African Americans’ trust by apologizing for the TSE. Through a narrative reading, we illustrate the failure of this text as an attempt to reconcile the United States Public Health Service and the African American public. We conclude by (...) noting the limitations of rhetoric when equal prominence is not given to policy proposals in national apologies. (shrink)

Today, health systems around the world are under pressure to create greater value for patients and society [81, p. 1, 119]; increasing access, improving client orientation and responsiveness, reducing medical errors and safety, restraining utilization via managed care, and implementing priority allocation of resources for high-burden health problems are examples of strategies towards this end. The quality paradigm by virtue of its strategic consumer focus and its methods for achieving operational excellence has proved an effective approach for creating higher value (...) in many sectors. If applied in a deliberate and holistic manner, the quality paradigm can bring about a more cost-effective organization of the health systems. In this article, we apply quality concepts to healthcare in a conceptual format; we characterize the health system’s customers and outputs with their quality dimensions. The product of this effort is a blueprint for a customer-driven health system which identifies six types of customers, nine types of outputs and the associated operations. As a preliminary step, a new analysis and definition of health and disease is provided. Rethinking the structure of health system in this manner and the related conceptual model can guide medical research, health sciences education, and health services policy, and help the practitioner to integrate all modern trends in healthcare delivery. (shrink)

How can the objectivity of an argument’s conclusion be determined? To propose an answer, this paper builds on Betz’s view of premises as hedged hypotheses. If an argument’s premises are hedged, its conclusion must be hedged as well. But how? The paper first introduces a two-dimensional critical grid. The grid’s vertical dimension is inductive, reflecting the argument’s downward flow from premises to conclusion. It specifies the inductive probability of the conclusion given the premises. The grid’s horizontal dimension is epistemic, focusing (...) on the premises without dropping down to the conclusion. It evaluates the epistemic probability of the premises when conjoined. This two-dimensional grid is then applied to three kinds of cases: vertical and horizontal evaluations rely on point-valued probabilities; vertical and horizontal evaluations rely on interval probabilities; vertical and horizontal evaluations rely on non-numeric plausibilities. The result is that, in each case, the argument’s conclusion can be assigned a credence tag, as it were, that reflects a critical appraisal of its objectivity. Reference Betz, Gregor. 2013. “In defence of the value free ideal.” European Journal for Philosophy of Science 3, 207–220. (shrink)

Wallace became a full-time naturalist in 1848, the year when he and Bates set out on their journey to South America. Wallace was twenty-five at the time and over half of his life had been spent in various parts of Wales, the land of his birth. Commentators have tended to gloss over or ignore any formative influences from this early period of his life or even to dismiss them as non-existent. This is surprising as it was during the eight (...) or so years in Wales leading up to 1848 that Wallace's interest in natural history emerged. ‘The importance of this early period in Wallace's life can scarcely be over-emphasized’ wrote Durant in his account of the development of the Wallace personality, but he omitted any specific reference to the significance of the early period in Wales. Those seeking a simple unitary cause for Wallace's conversion to natural history usually locate this in his visit to Leicester in 1844 and his meeting there with H. W. Bates. ‘The odyssey began … in 1844, in Leicester’ wrote Brooks, adding that ‘the more remote parts of … southern Wales had offered little reading material…’ This, and similar claims, are presumably founded primarily on Wallace's belief—expressed sixty years later—that it was at Leicester that he first familiarized himself with Malthus'Essay on the Principles of Populationand Humboldt'sPersonal Narrative of Travels in South America.There is, however, evidence that Wallace was probably familiar with at least one of these books some time before his visit to Leicester and that it was during his period in southern Wales that his interest in natural history emerged and developed. (shrink)

Zájem současné sociologie a dalších společenských věd o výzkumy spokojenosti a štěstí zatemňuje skutečnost, že původně právě sociologie chtěla „štěstí" poskytovat a nahrazovat tak náboženské přístupy ke světu. Tento implicitně nábo- ženský charakter je patrný i v rané české sociologii v dílech prvních propagátorů sociologie, jako byl především Emanuel Makovička, a později u některých následovníků a epigonů T. G. Masaryka, v meziválečném období zejména u Ladislava Kunteho, R. I. Malého, Alexandra Sommera-Batěka, Jindřicha Fleischnera a Jana Duška. Z hlediska vývoje české (...) sociologie šlo o zcela okrajové postavy, ačkoli mnohé z nich vynikly v jiných oblastech, jako celek jsou nicméně vyjádřením jednoho z aspektů dobových teoretických úvah o společnosti, jejím uspořádání a vývoji, na který by nemělo být zapomínáno. Zatímco T. G. Masaryka a pozdější akademické sociology „omezoval" vědecký charakter jejich práce, a i pokud směřovali k sociálnímu reformismu, oddělovali jej od teoretické sociologie, „sociologie vedoucí ke štěstí" nalezla plné uplatnění ve vizích a ambiciózních projek- tech těchto amatérských takésociologů - třebaže skončily faktickými nezdary nebo ani nedošly praktického naplnění, ostatně stejně jako v případě jejich pravzoru, Comtova pozitivistického apoštolátu. (shrink)

This paper discusses the notion of ecopoetics in relation to the work of Martin Heidegger and his concept of dwelling. Our aim, broadly stated, is to respond to the question: "What frame of mind could bring about sustainability - and how might we develop it?" In the first part of the paper, we comment on Jonathan Bate's notion of ecopoetics and his discussion of Heidegger. Crucial here is the question of whether we can ever approach Nature in an non-ideological way (...) or are all attempts to capture Nature, theoretically or poetically or narratively, nothing more than our own peculiar appropriation of it? Ecopoetics might be conceived as a response to this question, although we dispute Bate's view. In the second part of the paper, following Micheal Haar's perceptive reading, we elaborate the four senses that Heidegger gives to Nature, and in the third section, we make some concluding comments about the notion of sustainability that might be explicated in relation to Heidegger's four senses of Nature. (shrink)

The author is a Czech physiologist who has given many years of experimental study to the temporal sense in man. He reviews the psychological literature on the sense of time, then describes his own experiments and the theory which he thinks explains them. He believes there are biological rhythms which determine our physiological sense of time and in particular that the alpha rhythm of the brain provides the fundamental reference rhythm by which the organism measures time. This rhythm is autonomous, (...) unchanging in the course of time, present when not evident externally and thus very suitable for time measurement. Experimental evidence for this view reported in the book concerns laborious studies of temporally conditioned reflexes in man carried out by the author over a number of years. He hedges his conclusions and concedes that there is much more work to be done, but his work is both interesting and important. There is little philosophizing in the book, but there is much of philosophical importance.--R. H. K. (shrink)

Some arguments are good; others are not. How can we tell the difference? This article advances three proposals as a partial answer to this question. The proposals are keyed to arguments conditioned by different degrees of uncertainty: mild, where the argument’s premises are hedged with point-valued probabilities; moderate, where the premises are hedged with interval probabilities; and severe, where the premises are hedged with non-numeric plausibilities such as ‘very likely’ or ‘unconfirmed’. For mild uncertainty, the article proposes to apply a (...) principle referred to as ‘Jeffrey’s rule’, for the principle is a generalization of Jeffrey conditionalization. For moderate uncertainty, the proposal is to extend Jeffrey’s rule for use with probability intervals. For severe uncertainty, the article proposes that even when lack of probabilistic information prevents the application of Jeffrey’s rule, the rule can be adapted to these conditions with the aid of a suitable plausibility measure. Together, the three proposals introduce an approach to argument evaluation that complements established frameworks for evaluating arguments: deductive soundness, informal logic, argumentation schemes, pragma-dialectics, and Bayesian inference. Nevertheless, this approach can be looked at as a generalization of the truth and validity conditions of the classical criterion for sound argumentation. (shrink)

Linear mixed-effects models (LMMs) are increasingly being used for data analysis in cognitive neuroscience and experimental psychology, where within-participant designs are common. The current article provides an introductory review of the use of LMMs for within-participant data analysis and describes a free, simple, graphical user interface (LMMgui). LMMgui uses the package lme4 (Bates et al., 2014a, b ) in the statistical environment R (R Core Team).

Part I: The Life of Cognitive Science:. William Bechtel, Adele Abrahamsen, and George Graham. Part II: Areas of Study in Cognitive Science:. 1. Analogy: Dedre Gentner. 2. Animal Cognition: Herbert L. Roitblat. 3. Attention: A.H.C. Van Der Heijden. 4. Brain Mapping: Jennifer Mundale. 5. Cognitive Anthropology: Charles W. Nuckolls. 6. Cognitive and Linguistic Development: Adele Abrahamsen. 7. Conceptual Change: Nancy J. Nersessian. 8. Conceptual Organization: Douglas Medin and Sandra R. Waxman. 9. Consciousness: Owen Flanagan. 10. Decision Making: J. Frank Yates (...) and Paul A. Estin. 11. Emotions: Paul E. Griffiths. 12. Imagery and Spatial Representation: Rita E. Anderson. 13. Language Evolution and Neuromechanisms: Terrence W. Deacon. 14. Language Processing: Kathryn Bock and Susan M. Garnsey. 15. Linguistics Theory: D. Terence Langendoen. 16. Machine Learning: Paul Thagard. 17. Memory: Henry L. Roediger III and Lyn M. Goff. 18. Perception: Cees Van Leeuwen. 19. Perception: Color: Austen Clark. 20. Problem Solving: Kevin Dunbar. 21. Reasoning: Lance J. Rips. 22. Social Cognition: Alan J. Lambert and Alison L. Chasteen. 23. Unconscious Intelligence: Rhianon Allen and Arthur S. Reber. 24. Understanding Texts: Art Graesser and Pam Tipping. 25. Word Meaning: Barbara C. Malt. Part III: Methodologies of Cognitive Science:. 26. Artificial Intelligence: Ron Sun. 27. Behavioral Experimentation: Alexander Pollatsek and Keith Rayner. 28. Cognitive Ethology: Marc Bekoff. 29. Deficits and Pathologies: Christopher D. Frith. 30. Ethnomethodology: Barry Saferstein. 31. Functional Analysis: Brian Macwhinney. 32. Neuroimaging: Randy L. Buckner and Steven E. Petersen. 33. Protocal Analysis: K. Anders Ericsson. 34. Single Neuron Electrophysiology: B. E. Stein, M.T. Wallace, and T.R. Stanford. 35. Structural Analysis: Robert Frank. Part IV: Stances in Cognitive Science:. 36. Case-based Reasoning: David B. Leake. 37. Cognitive Linguistics: Michael Tomasello. 38. Connectionism, Artificial Life, and Dynamical Systems: Jeffrey L. Elman. 39. Embodied, Situated, and Distributed Cognition: Andy Clark. 40. Mediated Action: James V. Wertsch. 41. Neurobiological Modeling: P. Read Montague and Peter Dayan. 42. Production Systems: Christian D. Schunn and David Klahr. Part V: Controversies in Cognitive Science:. 43. The Binding Problem: Valerie Gray Hardcastle. 44. Heuristics and Satisficing: Robert C. Richardson. 45. Innate Knowledge: Barbara Landau. 46. Innateness and Emergentism: Elizabeth Bates, Jeffrey L. Elman, Mark H. Johnson, Annette Karmiloff-Smith, Domenico Parisi, and Kim Plunkett. 47. Intentionality: Gilbert Harman. 48. Levels of Explanation and Cognition Architectures: Robert N. McCauley. 49. Modularity: Irene Appelbaum. 50. Representation and Computation: Robert S. Stufflebeam. 51. Representations: Dorrit Billman. 52. Rules: Terence Horgan and John Tienson. 53. Stage Theories Refuted: Donald G. Mackay. Part VI: Cognitive Science in the Real World:. 54. Education: John T. Bruer. 55. Ethics: Mark L. Johnson. 56. Everyday Life Environments: Alex Kirlik. 57. Institutions and Economics: Douglass C. North. 58. Legal Reasoning: Edwina L. Rissland. 59. Mental Retardation: Norman W. Bray, Kevin D. Reilly, Lisa F. Huffman, Lisa A. Grupe, Mark F. Villa, Kathryn L. Fletcher, and Vivek Anumolu. 60. Science: William F. Brewer and Punyashloke Mishra. Selective Biographies of Major Contributors to Cognitive Science: William Bechtel and Tadeusz Zawidzki. (shrink)

"Williams's masterful translation satisfies (at last!) a long-standing need. There are lots of good translations of Augustine's great work, but until now we have been forced to choose between those that strive to replicate in English something of the majesty and beauty of Augustine's Latin style and those that opt instead to convey the careful precision of his philosophical terminology and argumentation. Finally, Williams has succeeded in capturing both sides of Augustine's mind in a richly evocative, impeccably reliable, elegantly readable (...) presentation of one of the most impressive achievements in Western thought--Augustine's Confessions." --Scott MacDonald, Professor of Philosophy and Norma K. Regan Professor in Christian Studies, Cornell University. (shrink)

Trope theory is a leading metaphysical theory in analytic ontology. One of its classic statements is found in the work of Donald C. Williams who argued that tropes qua abstract particulars are the very alphabet of being. The concept of an abstract particular has been repeatedly attacked in the literature. Opponents and proponents of trope theory alike have levelled their criticisms at the abstractness of tropes and the associated act of abstraction. In this paper I defend the concept of a (...) trope qua abstract particular by rejecting arguments that purport to show that tropes should not be understood as abstract and by arguing that the abstractness of tropes plays an indispensable role in one of our more promising trope-theoretic analyses of universals and of concrete objects. (shrink)

The concept of instantiation is realized differently across a variety of metaphysical theories. A certain realization of the concept in a given theory depends on what roles are specified and associated with the concept and its corresponding term as well as what entities are suited to fill those roles. In this paper, the classic realization of the concept of instantiation in a one-category ontology of abstract particulars or tropes is articulated in a novel way and defended against unaddressed objections.

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)

Models of cognitive vulnerability claim that depressive symptoms arise as a result of an interaction between negative affect and cognitive reactions, in the form of dysfunctional attitudes and negative inferential style. We present a model that complements this approach by focusing on the appraisal processes that elicit and differentiate everyday episodes of emotional experience, arguing that individual differences in appraisal patterns can foster negative emotional experiences related to depression (e.g., sadness and despair). In particular, dispositional appraisal biases facilitating the elicitation (...) of these emotions more frequently and more intensely. This, in turn, is likely to have a negative influence on cognitive processing and emotion regulation in general. (shrink)

Since the publication of Edmund Gettier's challenge to the traditional epistemological doctrine of knowledge as justified true belief, Roberts and Wood claim that epistemologists lapsed into despondency and are currently open to novel approaches. One such approach is virtue epistemology, which can be divided into virtues as proper functions or epistemic character traits. The authors propose a notion of regulative epistemology, as opposed to a strict analytic epistemology, based on intellectual virtues that function not as rules or even as skills (...) but as habits of the heart. To that end, they divide the task of clarifying and expounding their notion in the book's two parts.In the first part, Roberts and Wood examine various components that constitute their notion of regulative epistemology. The first are the epistemic goods or goals that drive the epistemic process. What is needed, claim Roberts and Wood, is an enriched notion of these goods rather than the restricted notion of justified true belief. Epistemic agents are more than calculating devices in that …. (shrink)