In East Asia, there has been a long tradition of using graphs and diagrams to express abstract ideas. This paper is to give an account of the East Asian methodsfor representing body, mind and the universe. The fundamental ideas of East Asian graphic interpretation mostly originated from the Yijing (I Ching, Zhouyi), and were later developed by Confucian and Daoist thinkers to describe the universe, the mind, and the body as an organic totality. By comparing different approaches to portraying the (...) universe, this paper offers a critical analysis of East Asian semiotics. (shrink)

In East Asia, there has been a long tradition of using graphs and diagrams to express abstract ideas. This paper is to give an account of the East Asian methodsfor representing body, mind and the universe. The fundamental ideas of East Asian graphic interpretation mostly originated from the Yijing (I Ching, Zhouyi), and were later developed by Confucian and Daoist thinkers to describe the universe, the mind, and the body as an organic totality. By comparing different approaches to portraying the (...) universe, this paper offers a critical analysis of East Asian semiotics. (shrink)

Objectives: To study the attitudes of both medical and non-medical students towards the do-not-resuscitate decision in a university in Hong Kong, and the factors affecting their attitudes.Methods: A questionnaire-based survey conducted in the campus of a university in Hong Kong. Preferences and priorities of participants on cardiopulmonary resuscitation in various situations and case scenarios, experience of death and dying, prior knowledge of DNR and basic demographic data were evaluated.Results: A total of 766 students participated in the study. There were statistically (...) significant differences in their DNR decisions in various situations between medical and non-medical students, clinical and preclinical students, and between students who had previously experienced death and dying and those who had not. A prior knowledge of DNR significantly affected DNR decision, although 66.4% of non-medical students and 18.7% of medical students had never heard of DNR. 74% of participants from both medical and non-medical fields considered the patient’s own wish as the most important factor that the healthcare team should consider when making DNR decisions. Family wishes might not be decisive on the choice of DNR.Conclusions: Students in medical and non-medical fields held different views on DNR. A majority of participants considered the patient’s own wish as most important in DNR decisions. Family wishes were considered less important than the patient’s own wishes. (shrink)

The representational epistemic approach to the design of visual displays and notation systems advocates encoding the fundamental conceptual structure of a knowledge domain directly in the structure of a representational system. It is claimed that representations so designed will benefit from greater semantic transparency, which enhances comprehension and ease of learning, and plastic generativity, which makes the meaningful manipulation of the representation easier and less error prone. Epistemic principles for encoding fundamental conceptual structures directly in representational schemes are described. The (...) diagrammatic recodification of probability theory is undertaken to demonstrate how the fundamental conceptual structure of a knowledge domain can be analyzed, how the identified conceptual structure may be encoded in a representational system, and the cognitive benefits that follow. An experiment shows the new probability space diagrams are superior to the conventional approach for learning this conceptually challenging topic. (shrink)

Six characteristics of effective representational systems for conceptual learning in complex domains have been identified. Such representations should: (1) integrate levels of abstraction; (2) combine globally homogeneous with locally heterogeneous representation of concepts; (3) integrate alternative perspectives of the domain; (4) support malleable manipulation of expressions; (5) possess compact procedures; and (6) have uniform procedures. The characteristics were discovered by analysing and evaluating a novel diagrammatic representation that has been invented to support students' comprehension of electricity—AVOW diagrams (Amps, Volts, Ohms, (...) Watts). A task analysis is presented that demonstrates that problem solving using a conventional algebraic approach demands more effort than AVOW diagrams. In an experiment comparing two groups of learners using the alternative approaches, the group using AVOW diagrams learned more than the group using equations and were better able to solve complex transfer problems and questions involving multiple constraints. Analysis of verbal protocols and work scratchings showed that the AVOW diagram group, in contrast to the equations group, acquired a coherently organised network of concepts, learnt effective problem solving procedures, and experienced more positive learning events. The six principles of effective representations were proposed on the basis of these findings. AVOW diagrams are Law Encoding Diagrams, a general class of representations that have been shown to support learning in other scientific domains. (shrink)

We discuss the relation of the Theory of Event Coding (TEC) to a computational model of expert perception, CHREST, based on the chunking theory. TEC's status as a verbal theory leaves several questions unanswerable, such as the precise nature of internal representations used, or the degree of learning required to obtain a particular level of competence: CHREST may help answer such questions.

Truth diagrams are introduced as a novel graphical representation for propositional logic. To demonstrate their epistemic efficacy a set of 28 concepts are proposed that any comprehensive representation for PL should encompass. TDs address all the criteria whereas seven other existing representations for PL only provide partial coverage. These existing representations are: the linear formula notation, truth tables, a PL specific interpretation of Venn Diagrams, Frege’s conceptual notation, diagrams from Wittgenstein’s Tractatus, Pierce’s alpha graphs and Gardner’s shuttle diagrams. The comparison (...) of the representations succeeds in distinguishing ideas that are fundamental to PL from features of common PL representations that are somewhat arbitrary. (shrink)

Six characteristics of effective representational systems for conceptual learning in complex domains have been identified. Such representations should: (1) integrate levels of abstraction; (2) combine globally homogeneous with locally heterogeneous representation of concepts; (3) integrate alternative perspectives of the domain; (4) support malleable manipulation of expressions; (5) possess compact procedures; and (6) have uniform procedures. The characteristics were discovered by analysing and evaluating a novel diagrammatic representation that has been invented to support students' comprehension of electricity—AVOW diagrams (Amps, Volts, Ohms, (...) Watts). A task analysis is presented that demonstrates that problem solving using a conventional algebraic approach demands more effort than AVOW diagrams. In an experiment comparing two groups of learners using the alternative approaches, the group using AVOW diagrams learned more than the group using equations and were better able to solve complex transfer problems and questions involving multiple constraints. Analysis of verbal protocols and work scratchings showed that the AVOW diagram group, in contrast to the equations group, acquired a coherently organised network of concepts, learnt effective problem solving procedures, and experienced more positive learning events. The six principles of effective representations were proposed on the basis of these findings. AVOW diagrams are Law Encoding Diagrams, a general class of representations that have been shown to support learning in other scientific domains. (shrink)

The possibility of ideography is an empirical question. Prior examples of graphic codes do not provide compelling evidence for the infeasibility of ideography, because they fail to satisfy essential cognitive requirements that have only recently been revealed by studies of representational systems in cognitive science. Design criteria derived from cognitive principles suggest how effective graphic codes may be engineered.

Individual differences in the strategies that control sequential behavior were investigated in an experiment in which participants memorized sentences and then wrote them by hand, in a non‐cursive style. Thirty‐two participants each wrote eight sentences, which had hierarchical structures with five levels. The dataset included over 31,000 letters. Despite the deliberately constrained nature of the task and stimuli, 23 patterns of behavior were identified from the durations of pauses that occurred before the inscription of letters at four chunk levels, spanning (...) letters, words, phrases, and sentences. A critical path task analytic model, Graphical Production of Memorized Sentences (GPoMS), shows that the control of writing relies on cues that continuously switch between motor actions and chunk retrievals in a just‐in‐time fashion at the level of letter information. GPoMS explains the individual differences in terms of variants of a motor production mechanism and variants of a chunk retrieval mechanism, which involve varying degrees of parallelism between cognitive actions and motor actions. A graphical technique for constructing GPoMS models was developed that enabled the estimation of ongoing working memory demands during production. (shrink)

Pioneering work in the 1940s and 1950s suggested that the concept of chunking might be important in many processes of perception, learning and cognition in humans and animals. We summarize here the major sources of evidence for chunking mechanisms, and consider how such mechanisms have been implemented in computational models of the learning process. We distinguish two forms of chunking: the first deliberate, under strategic control, and goal-oriented; the second automatic, continuous, and linked to perceptual processes. Recent work with discrimination-network (...) computational models of long- and short-term memory (EPAM/CHREST) has produced a diverse range of applications of perceptual chunking. We focus on recent successes in verbal learning, expert memory, language acquisition and learning multiple representations, to illustrate the implementation and use of chunking mechanisms within contemporary models of human learning. (shrink)

Scholars are increasingly calling for the environmental issues of the industrial agricultural system to be addressed via eventual agroecological system-level transformation. It is critical to identify the barriers to this transition. Drawing from Henke’s theory of “repair,” we explore how farmers participate in the reproduction of the industrial system through “discursive repair,” or arguing for the continuation of the industrial agriculture system. Our empirical case relates to water pollution from nitrogen fertilizer and draws data from a sample of over 150 (...) interviews with row-crop farmers in the midwestern United States. We find that farmers defend this system by denying agriculture’s causal role and proposing the potential for within-system solutions. They perform these defenses by drawing on ideological positions and may be ultimately led to seek system maintenance because they are unable to envision an alternative to the industrial agriculture system. (shrink)

The Common Thread Of Induction JOHN H. HOLLAND, KEITH J. HOLYOAK, RICHARD E. NISBETT, and PAUL R. THAGARD [1986]: Induction: Processes of Inference, Learning, and Discovery, The MIT Press, Cambridge, Massachusetts: London, England, xii + 385 pp. ISBN 0-262-08160-1.

Computational models of learning provide an alternative technique for identifying the number and type of chunks used by a subject in a specific task. Results from applying CHREST to chess expertise support the theoretical framework of Cowan and a limit in visual short-term memory capacity of 3–4 looms. An application to learning from diagrams illustrates different identifiable forms of chunk.

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

The ectoplasmic specialization (ES) is a testis‐specific, actin‐based hybrid anchoring and tight junction. It is confined to the interface between Sertoli cells at the blood–testis barrier, known as the basal ES, as well as between Sertoli cells and developing spermatids designated the apical ES. The ES shares features of adherens junctions, tight junctions and focal contacts. By adopting the best features of each junction type, this hybrid nature of ES facilitates the extensive junction‐restructuring events in the seminiferous epithelium during spermatogenesis. (...) For instance, the α6β1‐integrin–laminin 333 complex, which is usually limited to the cell–matrix interface in other epithelia to facilitate cell movement, is a putative apical ES constituent. Furthermore, JAM‐C and CAR, two tight junction integral membrane proteins, are also components of apical ES involving in spermatid orientation. We discuss herein the mechanisms that maintain the cross‐talk between ES and blood–testis barrier to facilitate cell movement and orientation in the seminiferous epithelium. BioEssays 29: 36–48, 2007. © 2006 Wiley Periodicals, Inc. (shrink)

This paper investigates potential motivations for late adopting U.S. companies to begin disclosing environmental liability amounts in their financial statements. Based on a review of 10-K reports filed from 1998 through 2012, inclusive, we identified 55 firms initiating environmental liability disclosure over the period, with all but three doing so by 2006. Focusing on the disclosers up through 2006, we argue that the companies may have used the disclosure as a tool of impression management to avoid potential stakeholder mis-estimation of (...) previously undisclosed liability exposures. We first compute tests to identify firms that may have begun the disclosure due to (1) materiality and (2) concerns of having proprietary costs imposed upon them due to changes in their environmental media coverage and environmental performance, and we find very few cases where these explanations might hold. For the remaining companies, we compared their newly disclosed liability amount, on average, with the mean level of environmental liability being disclosed by other firms in the year prior to the sample companies’ initiation, and find that it is significantly smaller, thus supporting our impression management argument. Finally, we find that overall level of environmental liability amounts was consistently decreasing over the time frame examined, suggesting that earlier adoption would have made more sense. However, it may also explain why almost no new firms began disclosing after the mid-2000s. (shrink)

The fifth base in human DNA, 5‐methylcytosine, is inherently mutagenic. This has led to marked changes in the distribution of the CpG methyl acceptor site and an 80% depletion in its frequency of occurrence in vertebrate DNA. The coding regions of many genes contain CpGs which are methylated in sperm and serve as hot spots for mutation in human genetic diseases. Fully 30–40% of all human germline point mutations are thought to be methylation induced even though the CpG dinucleotide is (...) under‐represented and efficient cellular repair systems exist. Importantly, tumor suppressor genes such as p53 also contain methylated CpGs and these serve as hot spots for mutations in some, but not all, human cancers. Comparison of the spectrum of mutations present in this gene in different human cancers allows for predictions to be made on the molecular mechanisms of tumorigenesis. (shrink)

Dopamine is critically important in the neural manifestation of motivated behavior, and alterations in the human dopaminergic system have been implicated in the etiology of motivation-related psychiatric disorders, most prominently addiction. Patients with chronic addiction exhibit reduced dopamine D2 receptor (DRD2) availability in the striatum, and the DRD2 TaqIA (rs1800497) and C957T (rs6277) genetic polymorphisms have previously been linked to individual differences in striatal dopamine metabolism and clinical risk for alcohol and nicotine dependence. Here, we investigated the hypothesis that the (...) variants of these polymorphisms would show increased reward-related memory formation, which has previously been shown to jointly engage the mesolimbic dopaminergic system and the hippocampus, as a potential intermediate phenotype for addiction memory. To this end, we performed functional magnetic resonance imaging (fMRI) in 62 young, healthy individuals genotyped for DRD2 TaqIA and C957T variants. Participants performed an incentive delay task, followed by a recognition memory task 24 h later. We observed effects of both genotypes on the overall recognition performance with carriers of low-expressing variants, namely TaqIA A1 carriers and C957T C homozygotes, showing better performance than the other genotype groups. In addition to the better memory performance, C957T C homozygotes also exhibited a response bias for cues predicting monetary reward. At the neural level, the C957T polymorphism was associated with a genotype-related modulation of right hippocampal and striatal fMRI responses predictive of subsequent recognition confidence for reward-predicting items. Our results indicate that genetic variations associated with DRD2 expression affect explicit memory, specifically for rewarded stimuli. We suggest that the relatively better memory for rewarded stimuli in carriers of low-expressing DRD2 variants may reflect an intermediate phenotype of addiction memory. (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)

Both Carnap and Quine made significant contributions to the philosophy of mathematics despite their diversedviews. Carnap endorsed the dichotomy between analytic and synthetic knowledge and classified certainmathematical questions as internal questions appealing to logic and convention. On the contrary, Quine wasopposed to the analytic-synthetic distinction and promoted a holistic view of scientific inquiry. The purpose of thispaper is to argue that in light of the recent advancement of experimental mathematics such as Monte Carlosimulations, limiting mathematical inquiry to the domain of (...) logic is unjustified. Robustness studies implemented inMonte Carlo Studies demonstrate that mathematics is on par with other experimental-based sciences. (shrink)

The story of the greatest of all philosophical friendships—and how it influenced modern thought David Hume is widely regarded as the most important philosopher ever to write in English, but during his lifetime he was attacked as “the Great Infidel” for his skeptical religious views and deemed unfit to teach the young. In contrast, Adam Smith was a revered professor of moral philosophy, and is now often hailed as the founding father of capitalism. Remarkably, the two were best friends for (...) most of their adult lives, sharing what Dennis Rasmussen calls the greatest of all philosophical friendships. The Infidel and the Professor is the first book to tell the fascinating story of the friendship of these towering Enlightenment thinkers—and how it influenced their world-changing ideas. The book follows Hume and Smith’s relationship from their first meeting in 1749 until Hume’s death in 1776. It describes how they commented on each other’s writings, supported each other’s careers and literary ambitions, and advised each other on personal matters, most notably after Hume’s quarrel with Jean-Jacques Rousseau. Members of a vibrant intellectual scene in Enlightenment Scotland, Hume and Smith made many of the same friends, joined the same clubs, and were interested in many of the same subjects well beyond philosophy and economics—from psychology and history to politics and Britain’s conflict with the American colonies. The book reveals that Smith’s private religious views were considerably closer to Hume’s public ones than is usually believed. It also shows that Hume contributed more to economics—and Smith contributed more to philosophy—than is generally recognized. Vividly written, The Infidel and the Professor is a compelling account of a great friendship that had great consequences for modern thought. (shrink)

For most observers of economics from both inside and outside the science, the term ‘economics’ is synonymous with neoclassical economics. It is the methodology of neoclassical economics that defines the discipline of economics. ‘Mainstream economics’ is neoclassical economics and anyone entering the discipline today who wishes to obtain an appointment at one of the leading universities of the world is well advised to master its techniques. The fact that virtually every winner of a Nobel prize from Paul Samuelson up to (...) his student Joseph Stiglitz has been a practitioner of neoclassical economics is ample proof of the methodology’s triumph. Despite the dominance of this methodology, however, neoclassical economics has been subject to a steady stream of criticisms and proposals for alternative methodological approaches throughout its life. This article focuses on two relatively recent challenges to the neoclassical orthodoxy that seem to have taken hold of a non-negligible minority of the profession, some of whom can be found at leading universities. These two challenges come from behavioural economics and evolutionary economics. The article describes the strengths and weaknesses of both of these methodological approaches and contrasts them with that of neoclassical economics. It concludes that all three methodologies have something positive to contribute to the study of human behaviour. Key Words: neoclassical economics • behavioural economics • evolutionary economics. (shrink)

This is a study of the political theory of the Enlightenment, focusing on four leading eighteenth-century thinkers: David Hume, Adam Smith, Montesquieu and Voltaire. Dennis C. Rasmussen calls attention to the particular strand of the Enlightenment these thinkers represent, which he terms the 'pragmatic Enlightenment'. He defends this strand of Enlightenment thought against both the Enlightenment's critics and some of the more idealistic Enlightenment figures who tend to have more followers today, such as John Locke, Immanuel Kant and Jeremy (...) Bentham. Professor Rasmussen argues that Hume, Smith, Montesquieu and Voltaire exemplify an especially attractive type of liberalism, one that is more realistic, moderate, flexible, and contextually sensitive than most other branches of this tradition. (shrink)

ABSTRACT In its attempt to prove that voters, politicians, and bureaucrats are motivated by the public interest, Self-Interest and Public Interest in Western Politics overlooks a great deal of public-choice research, to which much has been added during the two decades since it was published. The importance of self-interest at both the micro and macro levels of politics becomes clear once one looks not simply at the ?inputs? of a democracy but at its ?outputs? as well. The prevalence of interest (...) groups, the dysfunction of the United States tax code, the lobbying by unions for their members? self-interest, the earmarks in the Patriot Act, the numerous cases of corruption in Western democracies, and the dissatisfaction of citizens with their governments? failings all point to the importance of self-interest in politics. (shrink)

In its attempt to prove that voters, politicians, and bureaucrats are motivated by the public interest, Self-Interest and Public Interest in Western Politics overlooks a great deal of public-choice research, to which much has been added during the two decades since it was published. The importance of self-interest at both the micro and macro levels of politics becomes clear once one looks not simply at the “inputs” of a democracy but at its “outputs” as well. The prevalence of interest groups, (...) the dysfunction of the United States tax code, the lobbying by unions for their members’ self-interest, the earmarks in the Patriot Act, the numerous cases of corruption in Western democracies, and the dissatisfaction of citizens with their governments’ failings all point to the importance of self-interest in politics. (shrink)

This book also emphasizes the difference between religion and science as means for understanding causal relationships, but it focuses much more heavily on the challenge religious extremism poses for liberal democratic institutions. The treatment contains a discussion of human psychology, describes the salient characteristics of all religions, and contrasts religion and science as systems of thought. Historical sketches are used to establish a link between modernity and the use of the human capacity for reasoning to advance human welfare. The book (...) describes the conditions under which democratic institutions can advance human welfare, and the nature of constitutional rights as protectors of individual freedoms. Extremist religions are shown to pose a threat to liberal democracy, a threat that has implications for immigration and education policies and the definition of citizenship. (shrink)

Public choice or rational politics differs from other approaches to the study of political behavior in that it builds on models in which rational individuals seek to advance their own interests. This five-part volume surveys the main ideas and contributions of the field. It contains twenty-five essays written by thirty scholars, both economists and political scientists, from North America and Europe. Part I discusses the nature and justification for the existence of government and various forms it can take, including mixed, (...) private, and public institutions, international organizations, federalisms, and constitutional governments. Part II examines the properties of different voting rules and preference aggregation procedures. Part III explores multiparty systems, interest groups, logrolling and political business cycles. The individual decisionmaker is the focus of Part IV, with surveys of the experimental literature on individual behavior, and why people vote as they do. The final section applies public-choice reasoning to bureaucracy, taxation, and the size of government. (shrink)

Is it possible that all of the social sciences could employ a common methodology? If so, what would it be? This article adresses these questions. It takes off from James Coleman’s recent book, The Foundations of Social Theory. Coleman’s social theory is built on the postulate that individuals are rational actors, the same postulate that most of modern economics is built upon. This article critiques the use of this postulate in economics, and thus questions whether it is a useful building (...) block for the methodological foundations of social science research. It proposes an adaptive view of human behavior as an alternative in which preferences are conditioned by past experience. The work of Joseph Schumpeter is discussed as an exemplar of the methodology advocated here. (shrink)

The concept of rectifying names [cheng-ming] is a familiar one in the Confucian Analects. It occupies an important, if not central, position in the political philosophy of Confucius. Since, according to Confucius, the rectification of names is the basis of the establishment of social harmony and political order, one might suspect that later political theories of Confucian-ists should be traced back to the Confucian doctrine of rectifying names. It need not be added that the theory of rectifying names, as (...) developed by Hsün Tzu in the third century B. C., served the double purpose of strengthening his political doctrine of government on the one hand and repudiating doctrines of names on the other. (shrink)

Concerns about exploiting the poor or economically disadvantaged in clinical research are widespread in the bioethics community. For some, any research that involves economically disadvantaged individuals is de facto ethically problematic. The economically disadvantaged are thought of as “venerable” to exploitation, impaired decision making, or both, thus requiring either special protections or complete exclusion from research. A closer examination of the worries about vulnerabilities among the economically disadvantaged reveals that some of these worries are empirically or logically untenable, while others (...) can be better resolved by improved study designs than by blanket exclusion of poorer individuals from research participation. The scientific objective to generate generalisable results and the ethical objective to fairly distribute both the risks and benefits of research oblige researchers not to unnecessarily bar economically disadvantaged subjects from clinical research participation. (shrink)