What do the words "ceteris paribus" add to a causal hypothesis, that is, to a generalization that is intended to articulate the consequences of a causal mechanism? One answer, which looks almost too good to be true, is that a ceteris paribus hedge restricts the scope of the hypothesis to those cases where nothing undermines, interferes with, or undoes the effect of the mechanism in question, even if the hypothesis's own formulator is otherwise unable to specify fully (...) what might constitute such undermining or interference. I will propose a semantics for causal generalizations according to which ceteris paribus hedges deliver on this promise, because the truth conditions for a causal generalization depend in part on the—perhaps unknown—nature of the mechanism whose consequences it is intended to describe. It follows that the truth conditions for causal hypotheses are typically opaque to the very scientists who formulate and test them. (shrink)

Minsky proposed classifying firms in three categories: hedge finance units which borrow no more than they are able to service in interest and principal out of operating cash flows, speculative finance units which are overleveraged to the point where they can service interest on their debt out of operating cash flows, but cannot repay the principal, and thus must continually roll over their existing debt, and Ponzi finance units, whose operating cash flows are inadequate even to service interest on their (...) debt. In Minsky’s financial instability hypothesis protracted prosperity leads endogenously to firms overleveraging themselves and transforming a market dominated by hedge finance into one dominated by speculative and Ponzi finance. Since Ponzi finance units are forced to sell off assets to service their existing interest payments, once the market is sufficiently dominated by Ponzi finance units, this creates an oversupply of assets offered for sale, and the resulting debt deflation causes a financial crisis and drastic shortage of liquidity. It appears this crisis state can be brought about by a deceptively low critical mass of Ponzi and speculative finance units. This paper uses a large 2002–2009 quarterly data set of all publicly traded North American firms and foreign firms traded on North American exchanges, a total of 8,905 stocks. Financial ratios are used to classify these firms in each quarter according to Minsky’s FIH categories. Market value is used to weight the categories, and average betas are computed as measures of volatility. Results provide dramatic support for the FIH. The FIH is then reinterpreted in terms of Austrian business cycle theory, which depends on inflationary credit expansion to drive the unsustainable prosperity. According to Minsky’s FIH, unsustainable prosperity emerges endogenously as long periods of economic expansion make borrowers and lenders alike more willing to engage in investment activities for which they fail to see the inherent risk. It becomes clear that this process is amplified and exacerbated by credit expansion. Minsky’s FIH helps flesh out some of the missing dynamics of the malinvestment liquidation phase of ABC theory, and the two views turn out to be surprisingly complementary. (shrink)

While the Value-Free Ideal of science has suffered compelling criticism, some advocates like Gregor Betz continue to argue that science policy advisors should avoid value judgments by hedging their hypotheses. This approach depends on a mistaken understanding of the relations between facts and values in regulatory science. My case study involves the morning-after pill Plan B and the “Drug Fact” that it “may” prevent implantation. I analyze the operative values, which I call zygote-centrism, responsible for this hedged drug label. (...) Then, I explain my twofold account of value-ladenness, involving the constitutive role of value judgments in science and the social function of facts as political tools. Because this drug fact is ineliminably value-laden in both senses, I conclude that hedged hypotheses are not necessarily value-free. (shrink)

The efficient markets hypothesis has been the central proposition in finance for nearly thirty years. It states that securities prices in financial markets must equal fundamental values, either because all investors are rational or because arbitrage eliminates pricing anomalies. This book describes an alternative approach to the study of financial markets: behavioral finance. This approach starts with an observation that the assumptions of investor rationality and perfect arbitrage are overwhelmingly contradicted by both psychological and institutional evidence. In actual financial (...) markets, less than fully rational investors trade against arbitrageurs whose resources are limited by risk aversion, short horizons, and agency problems. The book presents and empirically evaluates models of such inefficient markets. Behavioral finance models both explain the available financial data better than does the efficient markets hypothesis and generate new empirical predictions. These models can account for such anomalies as the superior performance of value stocks, the closed end fund puzzle, the high returns on stocks included in market indices, the persistence of stock price bubbles, and even the collapse of several well-known hedge funds in 1998. By summarizing and expanding the research in behavioral finance, the book builds a new theoretical and empirical foundation for the economic analysis of real-world markets. (shrink)

The efficient markets hypothesis has been the central proposition in finance for nearly thirty years. It states that securities prices in financial markets must equal fundamental values, either because all investors are rational or because arbitrage eliminates pricing anomalies. This book describes an alternative approach to the study of financial markets: behavioral finance. This approach starts with an observation that the assumptions of investor rationality and perfect arbitrage are overwhelmingly contradicted by both psychological and institutional evidence. In actual financial (...) markets, less than fully rational investors trade against arbitrageurs whose resources are limited by risk aversion, short horizons, and agency problems. The book presents and empirically evaluates models of such inefficient markets. Behavioral finance models both explain the available financial data better than does the efficient markets hypothesis and generate new empirical predictions. These models can account for such anomalies as the superior performance of value stocks, the closed end fund puzzle, the high returns on stocks included in market indices, the persistence of stock price bubbles, and even the collapse of several well-known hedge funds in 1998. By summarizing and expanding the research in behavioral finance, the book builds a new theoretical and empirical foundation for the economic analysis of real-world markets. (shrink)

Background: The vascular depression hypothesis emphasizes the significance of vascular lesions in late-life depression. At present, no meta-analytic model has investigated whether a difference in hyperintensity burden compared to controls between late-life and late-onset depression is evident. By including a substantial number of studies, focusing on a meaningful outcome measure, and considering several moderating and control variables, the present meta-analysis investigates the severity of hyperintensity burden in major depressive disorder (MDD) and bipolar disorder (BD). A major focus of the (...) present meta-analysis refers to the role of age at illness onset. It is analyzed whether late-onset rather than late-life depression characterizes vascular depression. Method: In total, 68 studies were included in the meta-analysis and a multilevel random effects model was calculated using Hedges’ g as the effect size measure. Results: The severity of hyperintensity burden was significantly greater in the patient group compared to the control group. This effect was evident regarding the whole patient group (g = 0.229) as well as both depression subgroups, with a significantly greater effect in BD (g = 0.374) compared to MDD (g = 0.189). Hyperintensity burden was more pronounced in late-onset depression than in early-onset depression or late-life depression. A considerable heterogeneity between the included studies was observed, which is reflected by the large variability in effects sizes. Conclusion: In conclusion, the present meta-analysis underscores the association of hyperintensities with MDD and BD. Especially late-onset depression is associated with an increased hyperintensity burden, which is in line with the vascular depression hypothesis. The results suggest that it might be more feasible to confine the concept of vascular depression specifically to late-onset depression as opposed to late-life depression. Further research is needed to understand the causal mechanisms that might underlie the relation between hyperintensity burden and depression. (shrink)

What do the words ceteris paribus add to a causal hypothesis, that is, to a generalization that is intended to articulate the consequences of a causal mechanism? One answer, that looks almost too good to be true, is that a ceteris paribus hedge restricts the scope of the hypothesis to those cases where nothing undermines, interferes with, or undoes the effect of the mechanism in question, even if the hypothesis’s own formulator is otherwise unable to specify fully (...) what might constitute such undermining or interference. This paper proposes a semantics for causal generalizations according to which ceteris paribus hedges deliver on this promise, because the truth conditions for a causal generalization depend in part on the -- perhaps unknown -- nature of the mechanism whose consequences it is intended to describe. It follows that the truth conditions for causal hypotheses are typically opaque to their own formulators. (shrink)

My dissertation asks how we affect conversational context and how it affects us when we participate in any conversation—including philosophical conversations. Chapter 1 argues that speakers make pragmatic presuppositions when they use proper names. I appeal to these presuppositions in giving a treatment of Frege’s puzzle that is consistent with the claim that coreferential proper names have the same semantic value. I outline an explanation of the way presupposition carrying expressions in general behave in belief ascriptions, and suggest that substitutivity (...) failure is a special case of this behavior. Chapter 2 develops a compositional probabilistic semantics for the language of subjective uncertainty, including epistemic adjectives scoped under quantifiers. I argue that we should distinguish sharply between the effects that epistemically hedged statements have on conversational context, and the effects that they have on belief states. I also suggest that epistemically hedged statements are a kind of doxastic advice, and explain how this hypothesis illuminates some otherwise puzzling phenomena. Chapter 3 argues that ordinary causal talk is deeply sensitive to conversational context. The principle that I formulate to characterize that context sensitivity explains at least some of the oddness of ‘systematic causal overdetermination,’ and explains why some putative overgenerated causes are never felicitously counted, in conversation, as causes. But the principle also makes metaphysical theorizing about causation rather indirectly constrained by ordinary language judgments. (shrink)

There is a growing appreciation of the extent of transcriptome variation across individual cells of the same cell type. While expression variation may be a byproduct of, for example, dynamic or homeostatic processes, here we consider whether single‐cell molecular variation per se might be crucial for population‐level function. Under this hypothesis, molecular variation indicates a diversity of hidden functional capacities within an ensemble of “identical” cells, and this functional diversity facilitates collective behavior that would be inaccessible to a homogenous (...) population. In reviewing this topic, we explore possible functions that might be carried by a heterogeneous ensemble of cells; however, this question has proven difficult to test, both because methods to manipulate molecular variation are limited and because it is complicated to define, and measure, population‐level function. We consider several possible methods to further pursue the hypothesis that “variation is function” through the use of comparative analysis and novel experimental techniques. (shrink)

This article argues that modern finance should be an important object of attention. Particularly worthy of study are three demarcations: the changing disciplinary boundary of economics, the distinction between private and public knowledge, and the legal and cultural demarcation between legitimate trading and gambling. The balance between what Barnes calls N-type and S-type terms in finance is different from, for example, that in physics, but that is no criticism of finance theory: the activities of those who disbelieve finance theory’s efficient (...) market hypothesis probably make the hypothesis more true. The case of Black-Scholes-Merton option pricing theory is drawn on to argue that the loops of self-reference intrinsic to S-terms seem predominantly performative: they increase the truth of finance theory’s typical assumptions. S-loops in the financial markets do not always promote stability, however, as is shown here by a case study of the fate of the hedge fund, Long-Term Capital Management. (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)

In many papers dealing with the stylistic features of legal texts, metaphor is highlighted as a stylistic figure often used in the language of law. On a daily basis we can witness the frequent use of metaphoric collocations like soft laws, hard laws, silent partner, hedge funds, etc. In this paper, the author analyses the use of denotations for colours as constituent parts of metaphoric collocations in the language of law. The analysis is conducted by using a comparative approach to (...) examples extracted by means of computer technology from international bills and conventions available online. In the main part of the paper, examples are classified by using a colour denotation as the main criterion for the classification. After that, the examples are compared with corresponding expressions used in German and Croatian. Taking into account the main principle of the Skopos translation theory that differences between cultures strongly influence the translation process, the hypothesis of this research is that in many cases there will be no lexical equivalence between collocations with colour denotation in three languages. Due to the fact that international bills and conventions build the corpus of the research, and that the English language has become the lingua franca of international communication, it can be expected that some metaphoric terms and collocations would be literally translated from English. Conclusions drawn from the comparative analysis of legal collocations containing denotations for colours can be interesting to lawyers and LSP teachers in the field of law. In this sense, results of the research can contribute to motivational aspects of teaching Legal English and Legal German. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Brian Boyd responds:In responding to my critical discussion, Lisa Zunshine restates the argument of Why We Read Fiction at some length but replies to none of my specific criticisms. These criticisms are all based on the evidence of the texts that she offers as case studies, especially Mrs Dalloway and Lolita. Although I—and the textual evidence—contradict her claims, she provides no answers to the criticisms.Let me respond to two (...) restatements. First: "Fictional narratives endlessly experiment with rather than automatically execute our evolved cognitive adaptations" (p. 190). This is often, but almost tautologically, true in the case of experimental fiction, as the work of Richardson, Woolf, and Nabokov (to cite Zunshine's key examples) was in their time. It is not necessarily true in the sense Zunshine especially means it—that authors give us a demanding cognitive workout of our capacity for Theory of Mind by incorporating multiple embedding, A's thoughts of B's thoughts of C's thoughts of D's thoughts of E—even in the case of fictional experimenters like Defoe, Tolstoy, or Joyce, and it is not true of the vast bulk of fiction, from folk tale or jokes to soap operas or pulp [End Page 196] novels, and it cannot therefore be an explanation for "why we read fiction," though it may explain why some of us read some fiction. And to identify overloaded embedding when it is not present, as Zunshine does in discussing Mrs Dalloway, constitutes a simple misreading.Second: "Our Theory of Mind makes literature as we know it possible" (p. 191). Granted, without Theory of Mind we would not have fiction. But nor would we have fiction without many other features of human nature: without sociality, episodic memory, language, childhood pretend play, empathy, the brain's inhibitory mechanisms, folk physics, our mental databases for individuals, and much, much more. An evolutionary and cognitive understanding of fiction needs to take into account many aspects of our capacity for understanding events and stories, not just one.Apart from one three-word phrase, Zunshine's sole quotation from my review is this: "To what extent has Zunshine benefited from the methodology, rather than results, of science?" (I refer to "the results of science" here because I note that although, for instance, she relies most heavily on Simon Baron-Cohen among Theory of Mind researchers, while ignoring major figures in the field like Janet Astington or Josef Perner, she does not even cite the book or any of the more than twenty papers of which Baron-Cohen has been primary author since his 1995 Mindblindness.) Her quotation from my review continues: "Alas, she appears to have learned less than one would have hoped.... Her formulations are often weak and indecisive, hedgings, rather than strong testable hypotheses. Rather than apply scientific stringency to her literary analysis, she seems more interested in exploiting than testing what she can find." She confesses herself puzzled by this charge. Let me explain one simple point.Science's core methodological principle is that claims should be subjected to the test of evidence, and accepted or rejected on the basis of their compatibility with the relevant evidence. Leo Spitzer long ago pointed out that good reading follows scientific method: we read, we make hypotheses about the text, and we either confirm or disconfirm the hypotheses according to what we find in the text, and search for ampler hypotheses when previous ones have been discredited.1 Literary scholarship has long been vitiated by a far flabbier methodology, by the naïve assumption that evidence for a proposition suffices: "I see a and b in the text, therefore my claim C is a valid interpretation." But if reading or interpretation C is incompatible with counter-evidence d and e in the text, it is a falsified hypothesis and needs to yield to a better [End Page 197] reading, an interpretation that can incorporate this counter-evidence. I showed that Zunshine's claims about her prime examples were not compatible with evidence in the texts. She does not challenge the textual counter-evidence I provide, but just ignores it. That is where literary criticism most urgently needs to learn from scientific... (shrink)

Care is a feature of all of our lives, all of the time. An analysis of Scotland's Curriculum for Excellence reveals that care and caring permeate complex dimensions of life in and after school and we ask here, if, on some accounts, care can do the work required of it. Acknowledging the significance of her contribution to care, we focus on the work of Nel Noddings suggesting that she pays insufficient attention to other emotions implicated in the work of morally (...) appropriate care. We argue here that Noddings' version of care would benefit from the support of an ethical theory of the emotions, including a moralized form of compassion, if care in schools is to be both better understood and more likely realised. (shrink)

In this paper, we draw on Alfred Schutz’s theoretical framework to better understand how oppression is enacted through discriminatory acts. By closely examining the role of typifications and relevances in our experience of others, and by supplementing this analysis with contemporary social scientific resources, we argue that a Schutzian perspective on oppression yields important phenomenological insights. We do this in three key steps. Firstly, we contextualise Equality and the Meaning Structure of the Social World within Schutz’s broader body of work, (...) elucidating his central conditions of discrimination. Secondly, we highlight the limitations of Schutz’s account, in how it fails to capture more peripheral, subtle, and implicit oppressive practices. Finally, we introduce two underexplored insights derived from Schutz’s framework: the role of relevances in understanding the motivational underpinnings of implicit biases, and the connection between self-typification and stereotype threat. With this multidimensional approach, we hope to enhance our understanding of oppression whilst bridging gaps in Schutz’s original conceptualization. (shrink)

In this paper, my aim is to develop a phenomenological understanding of discrimination from the perspective of the discriminator. Since early existential phenomenology, the phenomenon of discrimination has received a great deal of attention. While much of this work has focused on the experience of the discriminatee, recent scholarship has begun to reflect on the intentional structures on the side of the discriminator. In a contribution to this trend, I argue that our sense of what is (ab)normal plays a constitutively (...) significant role in the reiteration and reinforcement of harmful discriminatory practices. More specifically, I argue that Husserl's distinction between two forms of normality, namely, concordance-normality [Einstimmigkeit] and optimal-normality [Optimalität], is an important tool for illuminating otherwise overlooked aspects of the discriminator's experience. I achieve this by demonstrating how these two notions of normality play distinct constitutive roles when comparing deliberate acts of discrimination committed with malintent, compared with more primordial, habitual, and prereflective expectations which are already discriminatory in nucleo. I argue that at the heart of discriminatory practices there is a naïve, normalizing attempt to stabilize concordance at the expense of critical self-reflection, normative revisions, and enriched horizons of expectation. In doing so, this paper provides a novel and important contribution to philosophical discussions surrounding discrimination. (shrink)

In recent years, misogyny has become a central concept in philosophy as well as an established concept in public discourse and political policy. But where is misogyny’s supposed counterpart, namely, misandry? In this paper I argue for an ameliorative analysis of "misandry", arguing that it can be reformulated in an effort to reclaim it from its misogynistic weaponisation. The term "misandry" is used almost exclusively as a misogynistic rhetorical device for attributing unjust anger, hatred, or other similar emotions to a (...) speaker, thereby undermining their epistemic authority. Rather than dismissing the term as conceptually flawed and politically problematic, I argue that we ought to ameliorate misandry to instead refer to a felt anger, hostility, or fear toward the patriarchal social order and its valorisation and/or expression in misogynistic and machismo behaviour. To support these claims, I begin with a discussion of Kate Manne's analysis of misogyny before reflecting on how this can inform our understanding of misandry. I then demonstrate the various ways in which misandry is rhetorically deployed as a means of silencing speakers that express dissent against the patriarchy. Following this, I argue that we should ameliorate the term, not only to undermine these misogynistic practices, but also to articulate a legitimate affective and reactive attitude against the patriarchal imposition of a hierarchical gender binary. (shrink)

Over the years, phenomenology has provided illuminating descriptions of discrimination, with its mechanisms and effects being thematised at the most basic levels of embodiment, (dis)orientation, selfhood, and belonging. What remains somewhat understudied is the lived experience of the discriminator. In this paper I draw on Husserl's phenomenological account of normality to reflect on the ways in which we discriminate at the prereflective levels of perceptual experience and bodily being. By critically reflecting on the intentional structures undergirding discriminatory practices, I argue (...) that discrimination is characteristic of a naïve normalising attitude which is habitually interested in securing a familiar experience of a static normality. I first demonstrate how this attitude problematically tends to reproduce, enforce, and further sediment discriminatory and exclusionary norms. Further, I provide an internal critique which problematises discrimination—without recourse to external normative standards—on three fronts: as epistemically unproductive, experientially obscuring, and normatively non-instantiating. In discriminatory acts we see an abnormal refusal to enrich, revise, and genetically establish new normative commitments, new ways of seeing, and a new normality. (shrink)

Fans of arthouse cinema may lament that über-indie idol Greta Gerwig sold out to mainstream cinema with her foray into Barbie. Yet for every film snob who refuses to watch Barbie, innumerable other...

Phenomenological discussions of sociality have long been concerned with the relations between the I, the You, and the We. Recently, dialogue between phenomenology and analytic philosophical work on collective intentionality has given rise to a corpus of literature oriented around the first-person plural 'we'. In this paper, I demonstrate how these dominant accounts of the 'we' are not exhaustive of first-person plural experiences as such. I achieve these aims by arguing for a phenomenological distinction between an experience of being part (...) of a 'we' compared to an experience of being part of an 'us'. To have a 'we-experience' there must be a plurality of (unified) subjects sharing in an experience together such that the experience has the phenomenal character of being ours. An 'us-experience', on the other hand, requires the experiential salience of an external 'Third' in a way which is constitutively significant. Drawing on Sartrean social ontology, I argue that the 'us' is distinct from the 'we' on three levels, all of which pertain to the constitutive and unifying role of the Third. I then outline two forms of us-experiences: (1) the experience of being grouped and (2) the experience of apprehending one's seriality. (shrink)

Cinema has long played a crucial role in the way that societies remember and represent themselves. In the last quarter century, film has been an important medium in the public debate around the memory of the Holocaust and of Hiroshima; of the Algerian war for independence and of the Spanish Civil War; of the Allende legacy in Chile, the utopian dreams of 1968, and the aborted project of the German Democratic Republic; in identity formation in Palestine and in the African (...) diaspora. Hedges discusses the role of cinema within a global perspective that spans five continents, and proposes an original typology of cultural memory. In the process, she re-evaluates the contributions of major directors and uncovers hitherto neglected yet important works. The author develops her arguments in an approachable style that will encourage readers to rethink their own memories of films and to reflect on the way that cinema contributes to collective and cultural memory. The book's innovative approach should transform the way that we think of film and its social effects. (shrink)

Human allografts for life-threatening organ failure have been demonstrated to be lifesaving and are now considered to be standard of care for many conditions. Transplantation of non-vital anatomic body parts has also been accomplished. Hand transplantation after limb loss in adults has been shown to offer some promising benefits in both functional and psychological measures in preliminary studies. It has been suggested to expand eligibility criteria to include minors, with one such operation having already been performed. With this in mind, (...) we examine the current state of hand transplantation research in the context of available alternatives. We examine the ethics of carrying out these operations in minors, including under the protections of clinical research. We argue that children should not be considered for this surgery due to the substantial risks of immunosuppressive medication, the likelihood that the graft will need to be replaced during the patient’s lifetime and the lack of significant compensatory advantages over modern prosthetics. (shrink)

Fans of arthouse cinema may lament that über-indie idol Greta Gerwig sold out to mainstream cinema with her foray into Barbie. Yet for every film snob who refuses to watch Barbie, innumerable other...

The August 2011 riots in England occasioned widespread condemnation from government and the media. Here, we apply the concepts of hypocrisy and affiliation to explore reactions to these riots. Initially acknowledging that politics necessitates a degree of hypocrisy, we note that some forms of hypocrisy are indefensible: they compromise integrity. With rioters condemned as thugs and members of a feral underclass, some reactions exemplified forms of corrosive hypocrisy that deflected attention away from economic, social and cultural problems. Moreover, such reactions (...) omitted to attend to the concept of [dis]affiliation amongst young rioters. Accordingly, we look to the role that education might play in re-affiliating those who do not feel they belong to, or have a sufficient stake in, society. Whilst our focus is on the riots in England, the exploration of hypocrisy and affiliation, and discussion of education for re-affiliation, transcends that national context. (shrink)

Often regarded simply as a nuisance in clinical drug trials in which the aim is to separate drug response from placebo response in a statistically significant manner, the placebo response has important implications. These implications relate to the nature of illness, the study of non-specific factors in the treatment setting that are related to clinical improvement, methods of enhancing these non-specific sources of benefit, and the neurobiology that is associated with the placebo response. Specific sources of clinical improvement in medical (...) and psychological treatment generally consist of drugs or clear interventions that appear to directly contribute to the desired treatment. Non-specific factors, on the other hand, include the clinician–patient relationship, installation of hope, relationship with authority, and other such factors that are more implicit to treatment and may contribute to the placebo response. Our understanding of how these non-specific aspects of treatment relate to clinical improvement and ways of enhancing these non-pharmacological elements of therapy may form important aspects of treatment. Furthermore, an important, albeit potentially overlooked element of the placebo response are clinical-trial designs and methodologies, themselves. Specific neurobiological changes also appear to be associated with the placebo response in at least some cases. Finally, it is suggested that the placebo response may in some instances represent a type of brain plasticity in which expectation and desire — agency — can result in specific changes in brain function that either may mirror or differ from the effects of certain drugs. (shrink)