The critical issues facing the human community population growth, sustained development, threats to the environment, the arms race, the ethical/philosophical challenges in light of advances in science and technology, and our very survival as a species require a multidisciplinary approach grounded in a clear understanding of human behavior. Fifty-one scholars from 11 countries representing 19 disciplines met at Delphi, Greece, to discuss and debate why we do what we do to ourselves and our world. Out of this vigorous exchange emerged (...) the Delphi Society for long-term study of patterns of human behavior. This book offers a unique international perspective on global human problems. (shrink)

The historical background of the discovery of adverse health effects of medicines, food additives, pesticides, and other chemicals is reviewed, and the development of national and international regulations and testing procedures to protect the public against the toxic effects of these drugs and chemicals is outlined. Ethical considerations of the safety evaluation of drugs and chemicals by human experimentation and animal toxicity studies, ethical problems associated with clinical trials, with the falsification of clinical and toxicological data, and with inadequate experimental (...) methodology, are reviewed, and the ethics of the marketing of drugs and their post-marketing surveillance, are similarly considered. These ethical problems are illustrated with many specific examples, including the drugs neoarsphenamine, chloramphenicol, thalidomide, diethyl stilboestrol and benoxaprofen. (shrink)

The historical background of the discovery of adverse health effects of medicines, food additives, pesticides, and other chemicals is reviewed, and the development of national and international regulations and testing procedures to protect the public against the toxic effects of these drugs and chemicals is outlined. Ethical considerations of the safety evaluation of drugs and chemicals by human experimentation and animal toxicity studies, ethical problems associated with clinical trials, with the falsification of clinical and toxicological data, and with inadequate experimental (...) methodology, are reviewed, and the ethics of the marketing of drugs and their post-marketing surveillance, are similarly considered. These ethical problems are illustrated with many specific examples, including the drugs neoarsphenamine, chloramphenicol, thalidomide, diethyl stilboestrol and benoxaprofen. (shrink)

An extensive literature overlapping economics, statistical decision theory and finance, contrasts expected utility [EU] with the more recent framework of mean–variance (MV). A basic proposition is that MV follows from EU under the assumption of quadratic utility. A less recognized proposition, first raised by Markowitz, is that MV is fully justified under EU, if and only if utility is quadratic. The existing proof of this proposition relies on an assumption from EU, described here as “Buridan’s axiom” after the French philosopher’s (...) fable of the ass that starved out of indifference between two bales of hay. To satisfy this axiom, MV must represent not only “pure” strategies, but also their probability mixtures, as points in the (σ, μ) plane. Markowitz and others have argued that probability mixtures are represented sufficiently by (σ, μ) only under quadratic utility, and hence that MV, interpreted as a mathematical re-expression of EU, implies quadratic utility. We prove a stronger form of this theorem, not involving or contradicting Buridan’s axiom, nor any more fundamental axiom of utility theory. (shrink)

Private sector engagement (PSE) is increasingly acknowledged in both literature and practice as a necessary mechanism to sustainably address development challenges. Despite increased practitioner and academic interest in these partnerships, there have been negligible attempts to systematically investigate cross-sector partnerships to distill best practices from the multiple environments in which they are employed. This manuscript presents a robust review of the social science and business literatures on cross-sector partnerships, yielding an interdisciplinary, evidence-based framework detailing archetypes of three prominent partnership characteristics (...) of purpose, context, and relationship enablers. This work integrates a wide range of best practices and values pertinent to businesses and society, enabling researchers, practitioners, and partnership managers to characterize and evaluate partnerships systematically. The introduced framework also enables partners to situate and evaluate their partnership activities to optimize outcomes for each partner and impact on the challenge at hand. (shrink)

Identity, Morality, and Threat offers a critical examination of the social psychological processes that generate outgroup devaluation and ingroup glorification as the source of conflict. Daniel Rothbart and Karyna Korostelina bring together essays analyzing the causal relationship between escalating violence and opposing images of the Self and Other.

The paper looks at the establishment of religion clause in the First Amendment to the US Constitution, and cases, e.g. Brown v. Gilmore, followed by Croft v. Perry and Sherman v. Koch, cases that relate to the concept of the “moment of silence” in educational institutions in which it was claimed that such events constitute a breach of the establishment clause. Courts have been inconsistent in their decision-making, which may indicate a lack of transparency not only in the interpretation of (...) the relevant phrase in the Constitution but also in the judicial interpretation of the “three-pronged test” with regard to “excessive entanglement” as laid out in Lemon v. Kurtzman of 1971. The paper discusses the “moment of silence” within the framework of a model of silence in which this type of silence would be labeled as either textual or situational silence. (shrink)

Dennis H. Wrong postulates sociological theory’s origins in the asking of general questions about man and society. Th e answers lose their meaning if they are elaborated without reference to the questions, as has been the case in much contemporary theory. An example is the Hobbesian question of how men become tractable to social controls. Th e two-fold answer of contemporary theory is that man „internalizes“ social norms and seeks a favorable self-image by conforming to the „expectations“ of others. (...) Such a model of man denies the very possibility of his being anything but a thoroughly socialized being and thus denies the reality of the Hobbesian question. Th e Freudian view of man, on the other hand, which sociologists have misrepresented, sees man as a social though never a fully socialized creature. Wrong claims that sociologists need to develop a more complex, dialectical conception of human nature instead of relying on an implicit conception that is tailor-made for special sociological problems. (shrink)

I very much enjoyed reading and thinking about Krister Bykvist's interesting and carefully written paper. My comments will not be criticisms. I will not challenge the conclusions the paper draws about the complicated examples of conflicts between preferences that it discusses. For example, I will not attempt to defend any of the views criticized in section IV of the paper. And I agree with the positive solution presented in section V, when that solution is characterized in the broadest possible way. (...) In cases where a choice that I must make now will create one or the other of two possible future ‘selves’ whose preferences would conflict over the question of which choice I should make, prudence tells me to create the self that will experience a higher level of well-being or welfare. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Lord Nottingham and the Conscience of EquityDennis R. KlinckI. Introduction"There is nothing more in our Mouths than Conscience," wrote John Sharp in the 1680s, echoing a sentiment that had been expressed before in the seventeenth century.1 Indeed, one modern writer has observed, uncontroversially, that that century "can justly be called the Age of Conscience."2 Among the foci of this preoccupation one can identify such topics as moral and religious (...) casuistry and "liberty of conscience." My focus in this paper is somewhat different: conscience as a criterion of judgment in the Court of Chancery—the court of equity—and particularly its meaning for Heneage Finch, Lord Nottingham, successively Lord Keeper and Lord Chancellor from 1673 to 1682, a seminal figure in the history of English equity.The intimate connection of conscience with the equitable jurisdiction [End Page 123] is a commonplace,3 and certain aspects of it have been quite thoroughly studied.4 A central problem that has been identified with resort to conscience as a criterion of legal judgment is its subjective and hence ostensibly arbitrary nature. This concern goes back a long way. Thomas Audley, in 1526, argued that conscience was an uncertain ground of law because "it depended upon the 'arbitrament' of one man, the chancellor alone."5 The author of The Replication of a Serjeant at the Laws of England similarly raised the complaint of "divers men, divers conscience."6 No doubt the most remembered comment of this sort is John Selden's that the spaciousness of chancellors' consciences might vary as much as the length of their respective feet, so that equitable adjudication on the basis of conscience was "a roguish thing."7 Nottingham himself balked at the idea that justice might be dispensed according to the kind of conscience that amounted only to "the pleasure of a Court which took upon itself to be purely arbitrary."8Indeed, as the father of systematic equity,9 Nottingham apparently devoted himself to the project, undertaken in some measure by certain of his predecessors,10 of making the jurisdiction regular. He repeatedly makes this [End Page 124] point. In the case just cited, he observes that "equity itself would cease to be Justice if the rules and measures of it were not certain and known" and that "conscience" has to be "dispensed by the rules of science" (639). "Rules," "measures," and "science" are by-words of his preoccupation. Elsewhere, he asserts that "if equity be tied to no rule... everything becomes arbitrary."11At the same time, he did not abandon conscience as a kind of touchstone of equity. He refers to it repeatedly, and often speaks of Chancery as a "court of conscience,"12 as if this was a perfectly natural way of describing it. So the question becomes: how did he reconcile the tendency towards arbitrariness thought to be implicit in "conscience" with the ruled, measured, scientific system that he sought to develop? Or putting the question slightly differently: how did he understand or limit the notion of "conscience" so as to make it compatible with the "regular equity" to which he aspired?What appears to have been a crucial distinction for Nottingham in this regard was that between private conscience and public, or perhaps civic, conscience. In the Prolegomena, he says that "there is a twofold conscience, viz. conscientia politica et civilis, et conscientia naturalis et interna" and that "[m]any things are against inward and natural conscience, which cannot be reformed by the regular and political administration of equity" (194). He makes the point again in "the great case" of Cook v. Fountain: "With such a conscience which is only naturalis et interna this Court hath nothing to do; the conscience by which I am to proceed is merely civilis et politica, and tied to certain measures...."13 As Yale points out, this distinction was not new with Nottingham. The distinction between the forum internum and the forum externum was venerable;14 an anonymous Elizabethan case distinguishes between matters of conscience in which equity will intervene and those that must be left to the party's own moral judgment;15 Francis Bacon recognized, at least as alternatives, a party... (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)

The article deals, on the one hand, with a legal conflict between a musical performer/arranger, Mike Batt, and the estate of a composer of avant-garde music, John Cage, over copyright. It is also concerned with the field of intertextuality – how meaning is created in a text or in a work of art, whether it is visual, musical or verbal, through allusions and quotations to previous texts or works of art. The controversy, which did not reach the courts because of (...) a pre-trial settlement, was over an author’s rights to silence, or, as in this case, a silent piece of music. The central issue discussed is the way in which silence may be considered – if at all, to be protectable. (shrink)

I begin, in Parts I-III, by presenting the details of the Baker and Hacker/community consensus debate over the nature of rule-following in the later Wittgenstein. In Part IV this philosophical debate is related to the law through the argument that there is both an internal and an external element to rule-following in law. I here assert one of the principal claims of my position: viz., that legal argument is directed at constructing the point of law. Part V introduces the distinction (...) between the formal and the material elements of a concept. As I shall show in detail, form is a heuristic for illuminating conceptual understanding. In Part VI, I move on to provide several examples in support of the form/matter distinction. Part VI also provides arguments in support of the proposition that understanding is internal to a practice and thus not necessarily coextensive with regularity in behavior. Parts VII-IX examine relevant claims made by Wittgenstein and their application to law. Finally, Parts X-XI sketch and illustrate my ultimate claim, a narrative approach to law. (shrink)

The purpose of the article is to reveal philosophical ideas in the mythology and folklore of the indigenous peoples of North America. An important question: "Can we assume that the spiritual culture of the American Indians contained philosophical knowledge?" remains relevant today. For example, European philosophy is defined by appeals to philosophers of the past, their texts. The philosophical tradition is characterized by rational argumentation and formulation of philosophical questions that differ from the questions of ordinary language. However, the problem (...) lies in the term "philosophy", which belongs to the so-called "philosophical untranslatability" and has many definitions. The question of whether philosophy is exclusively a phenomenon of European culture is still controversial. In the article, the concept of philosophy is used in a broad sense, which allows the analysis of the intellectual heritage of the culture of the indigenous people of North America for philosophical ideas. Theoretical basis of the study consists of primary sources, which are limited due to the "documentary horizon". It contains myths about the Twins, ritual rhetoric, examples of dream interpretation practices and the practical wisdom of tribal chiefs. The Chronicle of "Vallamolum", or "the Red List", testifies to the special idea of the Indians about history and their own historicity. Analysis of cosmogonical and cosmological ideas reveals the special features of the anthropological ideas of the North American Indians. Combined with the philosophical ideas of the Puritan philosophy of the settlers of New England, this analysis allows us to explore in more detail the processes of acculturation. The study uses critical literature from scholars and leading researchers of the wisdom and philosophy of Native Americans, such as Michael Yellow Bird, J. Baird Callicott, Henry Wadsworth Longfellow, Dennis H. McPherson, Lewis Henri Morgan, Thomas M. Norton-Smith, J. Douglas Rabb, Paul Radin, Jon Ewbank Manchip White. The views of early American philosophers: R. Williams, W. Penn, R. W. Emerson, on the problem of the relationship between the culture of settlers and the indigenous people of North America are noteworthy. Originality lies in the application of historical and philosophical methodology, identifying the features of philosophizing in the spiritual culture and worldview of the indigenous people of North America. Conclusions. In the conclusions, the obtained results complement the history of the origin and development of philosophical thought of the early American philosophy. (shrink)

What is intellectual humility? In this essay, we aim to answer this question by assessing several contemporary accounts of intellectual humility, developing our own account, offering two reasons for our account, and meeting two objections and solving one puzzle.

The nature of the product to be discovered guides the reasoning to discover it. Biologists and medical researchers often search for mechanisms. The "new mechanistic philosophy of science" provides resources about the nature of biological mechanisms that aid the discovery of mechanisms. Here, we apply these resources to the discovery of mechanisms in medicine. A new diagrammatic representation of a disease mechanism chain indicates both what is known and, most significantly, what is not known at a given time, thereby guiding (...) the researcher and collaborators in discovery. Mechanisms of genetic diseases provide the examples. (shrink)

This innovative book focuses on the development of the gene theory as a case study in scientific creativity.

The compatibility of evolution with Aristotelian-Thomistic metaphysics is defended in response to Fr. Michal Chaberek’s thesis of incompatibility. The motivation and structure of Darwin’s theory are reviewed, including the roles of secondary causality, randomness and necessity. “Randomness” is an analogous term whose evolutionary use, while challenging, is fully compatible with theism. Evolution’s necessity derives from the laws of nature, which are intentional realities, the vehicle of divine providence. Methodological analysis shows that metaphysics lacks the evidentiary basis to judge biological theories. (...) Species are entia rationis whose immutability does not conflict with the evolutionary succession of biological populations. While Darwin’s theory was unknown to Aquinas, he endorses the possibility of new species immanent in the initial state of the universe, nor does his understanding of exemplar ideas offer ground for objection. Finally, five arguments given by Fr. Chaberek are answered. (shrink)

This paper extends several themes from recent work on norms of assertion. It does as much by applying those themes to the speech act of asking. In particular, it argues for the view that there is a species of asking which is governed by a certain norm, a norm to the effect that one should ask a question only if one doesn’t know its answer.

Reasoning in Biological Discoveries brings together a series of essays, which focus on one of the most heavily debated topics of scientific discovery. Collected together and richly illustrated, Darden's essays represent a groundbreaking foray into one of the major problems facing scientists and philosophers of science. Divided into three sections, the essays focus on broad themes, notably historical and philosophical issues at play in discussions of biological mechanism; and the problem of developing and refining reasoning strategies, including interfield relations and (...) anomaly resolution. Darden summarizes the philosophy of discovery and elaborates on the role that mechanisms play in biological discovery. Throughout the book, she uses historical case studies to extract advisory reasoning strategies for discovery. Examples in genetics, molecular biology, biochemistry, immunology, neuroscience and evolutionary biology reveal the process of discovery in action. (shrink)

Philosophers have proposed various kinds of relations between Mendelian genetics and molecular biology: reduction, replacement, explanatory extension. This paper argues that the two fields are best characterized as investigating different, serially integrated, hereditary mechanisms. The mechanisms operate at different times and contain different working entities. The working entities of the mechanisms of Mendelian heredity are chromosomes, whose movements serve to segregate alleles and independently assort genes in different linkage groups. The working entities of numerous mechanisms of molecular biology are larger (...) and smaller segments of DNA plus related molecules. Discovery of molecular DNA mechanisms filled black boxes that were noted, but unilluminated, by Mendelian genetics. (shrink)

This paper analyzes the generation and function of hitherto ignored or misrepresented interfield theories , theories which bridge two fields of science. Interfield theories are likely to be generated when two fields share an interest in explaining different aspects of the same phenomenon and when background knowledge already exists relating the two fields. The interfield theory functions to provide a solution to a characteristic type of theoretical problem: how are the relations between fields to be explained? In solving this problem (...) the interfield theory may provide answers to questions which arise in one field but cannot be answered within it alone, may focus attention on domain items not previously considered important, and may predict new domain items for one or both fields. Implications of this analysis for the problems of reduction and the unity and progress of science are mentioned. (shrink)

The concept of mechanism is analyzed in terms of entities and activities, organized such that they are productive of regular changes. Examples show how mechanisms work in neurobiology and molecular biology. Thinking in terms of mechanisms provides a new framework for addressing many traditional philosophical issues: causality, laws, explanation, reduction, and scientific change.

The central task of this dissertation is to develop a new interpretation of Leibniz's famous claim that there are no purely extrinsic denominations . Though Leibniz regarded NPE as one of his most important doctrines, he nowhere offers an explicit statement as to what he meant by it. One interpretation of NPE, which enjoys a modest consensus among interpreters, is that all extrinsic denominations reduce to intrinsic denominations. According to the reductionist view, things only have intrinsic denominations as properties; extrinsic (...) denominations are not genuine properties of things. Critics of reductionism have argued that the textual case for it is inconclusive at best, and I share this assessment with them. However, in my opinion, a satisfactory non-reductionist understanding of NPE has not been offered. The goal of my dissertation is to provide such a non-reductionist account. I contend that NPE, far from being a claim of the reducibility of extrinsic denominations, is actually an assertion that extrinsic denominations are genuine properties of the things they denominate. ;To establish my reading of NPE, I examine a line of textual evidence to which interpreters have paid little attention: the way Leibniz argues for NPE. In some passages Leibniz derives NPE from his predicate-in-subject principle of truth. In others, he employs his doctrine of the interconnection of all things to reach NPE. Elsewhere, he bases NPE on the principle of the identity of indiscernibles. Though, as mentioned, Leibniz never explicitly defines NPE, he does have much to say by way of explicit definition of each of these three principles. A consideration of what version of NPE could plausibly be drawn from them is thus a revealing way to proceed. In the case of each argument, I show that my interpretation of NPE is the conclusion naturally suggested by the given principle, while the reductionist version of NPE forms only an awkward, textually implausible fit with it. The result of the examination is an original and serious critique of the reductionist reading of NPE, as well as the development of a far more plausible understanding of that claim. (shrink)

Philosophers of science typically associate the causal‐mechanical view of scientific explanation with the work of Railton and Salmon. In this paper I shall argue that the defects of this view arise from an inadequate analysis of the concept of mechanism. I contrast Salmon’s account of mechanisms in terms of the causal nexus with my own account of mechanisms, in which mechanisms are viewed as complex systems. After describing these two concepts of mechanism, I show how the complex‐systems approach avoids certain (...) objections to Salmon’s account of causal‐mechanical explanation. I conclude by discussing how mechanistic explanations can provide understanding by unification. (shrink)