The kingship has been integrated into the fundamental relationship between Yahweh and the people and that relationship reaffirmed. A crisis has been described and resolved in narrative and theological terms, and a new era can begin.

What are the assumptions and tasks hidden in contemporary calls to "overcome" the metaphysical tradition? Reflecting upon the internal contradictions of the notions of "tradition" and "finiteness," Dennis J. Schmidt offers novel insights into how philosophy must relate to its traditions if it is to retain a vital sense of the plurality of "edges" that constitute its finiteness. He does this through a close examination of issues found in the work of Hegel and Heidegger, two philosophers who made the (...) ideas of both tradition and finiteness the center of their concern.Schmidt begins by asking how Heidegger can claim to have destroyed metaphysics despite Hegel's claim to have perfected its possibilities. Systematically following the development of Heidegger's critique of Hegel, Schmidt generates a dialogue between them. The topic of that dialogue is the nature of finiteness as it is articulated in time, nothing, the dialectical and hermeneutical circles, and in the notions of experience, work, technology, history, and preSocratic thought.Beginning with Heidegger's critique of Hegel in Being and Time, Schmidt's strategy is to disclose the complexities of philosophical discourse about the finite by drawing out the proximities between Hegel and Heidegger. The dialogue that results presents novel portraits of both philosophers. It also reveals that Heidegger's early, unacknowledged failure to separate himself from the Hegelian dialectic is the motive behind many of the turns and decisions of his later career.In concluding, Schmidt offers an interpretation of the wider significance of the results of that dialogue, and connects his study to other contemporary discussions of postmodernism. He expands upon the idea of the plurality of edges opened by finiteness, arguing that philosophy only understands its own past and future once it recognizes the meaning of its own finiteness.Dennis J. Schmidt is Associate Professor of Philosophy at the State University of New York at Binghamton. The Ubiquity of the Finite is included in the series Studies in Contemporary German Social Thought, edited by Thomas McCarthy. (shrink)

Ernst Bloch, one of the most original and influential of contemporary European thinkers and a founder of the Frankfurt School, has left his mark on a range of fields from philosophy and social theory to aesthetics and theology. Natural Law and Human Dignity, the first of his major works to appear in English is unique in its attempt to get beyond the usual oppositions between the natural law and social utopian traditions, providing basic insights on the question of human rights (...) in a socialist society. Natural Law and Human Dignity is a sweeping yet synthetic work that critically reviews the great legal philosophies, from Plato to the present, in order to uncover and clarify the normative features of true socialism. Along the way it offers thoughtful reflections on topics as diverse as the abolition of poverty and degradation, the nature of the state, and the installation of freedom and dignity.Taking the idea of natural law as his guiding thread, Bloch argues that revolution and right, rather than being antagonistic, are fundamentally interconnected. With their emphasis on human dignity, the traditions of natural law have an irreplaceable contribution to make to the socialist vision of a more humane society. In his effort to wed the demands of law and right to the agenda of social revolution, Bloch offers a radical restructuring of our understanding of the social world. This rethinking of the fundamental principles of political philosophy is the product of a long personal and philosophical odyssey. Bloch lived as a writer in Munich, Bern, and Berlin until he was forced to emigrate to Czechoslovakia and then to the United States during World War 11. After the war he returned to East Germany, where he held a chair in philosophy at the University of Leipzig. He emigrated to the west as the Berlin Wall was being built, and he taught at the University of Tübingen until his death. Natural Law and Human Dignity is included in the series Studies in Contemporary German Social Thought, edited by Thomas McCarthy. (shrink)

In this illuminating work, Dennis J. Schmidt examines tragedy as one of the highest forms of human expression for both the ancients and the moderns.

Role modeling is widely thought to be a principal vehicle for acquiring the virtues. Yet, little is known about role modeling as a process. This paper surveys the behavioral sciences for insights about how one person can find the actions of another person so inspirational that the person attempts to reproduce the behavior in question. In general, such inspiration occurs when an observer sees a model similar to herself, wrestling with a problem she is having, such that the model’s accomplishments (...) are seen as attainable. When the behavior modeled is moral, additional complications arise, not the least of which is the contemporary skepticism about anyone held up as a hero. The paper concludes with some suggestions about how organizations can facilitate the development of the virtues through role modeling. (shrink)

A natural heme deficiency that exists in cells outside of the circulation broadly compromises the heme contents and functions of heme proteins in cells and tissues. Recently, we found that the signaling molecule, nitric oxide (NO), can trigger or repress the deployment of intracellular heme in a concentration‐dependent hormetic manner. This uncovers a new role for NO and sets the stage for it to shape numerous biological processes by controlling heme deployment and consequent heme protein functions in biology.

Ethical scandals in business are all too common. Due to the increased public awareness of the transgressions of business executives and the potential costs associated with these transgressions, ethical leadership is among the top qualities sought by organizations as they hire and promote managers. This search for ethical leaders intersects with a labor force that is becoming more racially diverse than ever before. In this paper, we propose that the ethical leadership qualities of business leaders may be perceived differently depending (...) upon the race of the leader. Using two experimental studies in the USA, we examine the difference in ethical leadership perceptions between a Black hypocritical CEO and an ethical CEO. Next, we consider a Black ethically ambiguous CEO and an ethical CEO. The findings indicate that a Black leader faces larger negative impact in hypocritical and ambiguous conditions than a similar White leader. There were no significant race effects in the ethical conditions in which a leader demonstrated a personal commitment to ethics through words or actions. We discuss the implications of these findings. (shrink)

ABSTRACT:Practical wisdom has received scant attention in business ethics. Defined as a disposition toward cleverness in crafting morally excellent responses to, or in anticipation of, challenging particularities, practical wisdom has four psychological components: knowledge, emotion, thinking, and motivation. People's experience, reflection, and inspiration are theorized to determine their capacity for practical wisdom-related performance. Enhanced by their abilities to engage in moral imagination, systems thinking, and ethical reframing, this capacity is realized in the form of wisdom-related performance. This can be manifested (...) either in wise business decisions or through their performance as mentors, advice givers, or dispute handlers. (shrink)

Ethical leadership is an important construct in the literature on behavioral ethics in organizations, given its link with employee attitudes and behaviors. What remains unclear, however, is what leader characteristics are associated directly with ethical leader perceptions and indirectly with employee unethical behavior. In this paper, we use a socio-cognitive lens to integrate goal orientation theory with the literature on ethical behavior in organizations. Specifically, we propose that certain patterns of managers’ goal-oriented behavior provide signals and cues to employees about (...) their managers’ ethical leadership, which then relates to employee displays of more unethical behavior. Using a sample of 265 manager–employee dyads, our findings largely support our claims. We found that leader performance-avoid goal orientation was negatively related to perceptions of ethical leadership and positively related to employee unethical behavior. Moderated mediation tests indicated that the positive indirect effect of leader performance-avoid goal orientation on employee unethical behavior through perceptions of ethical leadership was attenuated by higher levels of leader learning goal orientation. Taken together, these findings suggest that when leaders emphasize avoiding failure while downplaying the importance of personal learning and development, employees perceive them as less ethical and are more willing to engage in ethical misconduct. We discuss implications of our findings for both theory and practice. (shrink)

Using practical formalism a deontological ethical analysis of peer relations in organizations is developed. This analysis is composed of two types of duties derived from Kant's Categorical Imperative: negative duties to refrain from the use of peers and positive duties to provide help and assistance. The conditions under which these duties pertain are specified through the development of examples and conceptual distinctions. A number of implications are then discussed.

In the target article, Cramer et al. suggest that diagnostic classification is improved by modeling the relationship between manifest variables (i.e., symptoms) rather than modeling unobservable latent variables (i.e., diagnostic categories such as Generalized Anxiety Disorder). This commentary discusses whether symptoms represent manifest or latent variables and the implications of this distinction for diagnosis and treatment.

“Big Data” in health and medicine in the 21st century differs from “Big Data” used in health and medicine in the 1700s and 1800s. However, the old data sets share one key component: large numbers. The term “Big Data” is not synonymous with large numbers. Large numbers are a key component of Big Data in health and medicine, both for understanding the full range of how a disease presents in a human for diagnosis, and for understanding if one treatment of (...) a disease is better than another treatment or better than just leaving the patient on his or her own without therapy. In this paper, we examine the first considerations of Big Data in medicine in Paris in the early 1800s when urologic surgeon Jean Civiale collected the first large numbers. Civiale collected the large numbers to defend the efficacy of his urologic instrument, the lithotrite, and the surgical procedure he developed, lithotrity, for the removal of bladder stones compared with earlier, more invasive surgical approaches. We examine how large numbers were adjudicated in social decision-making in the Académie des sciences, Paris, when a dispute arose among French urologic surgeons about the importance of large numbers in surgical science. After Civiale’s successful defense of his instrument and procedure in Paris, we examine how his approach to Big Data impacted data collection by George Buchanan in his use of the procedure at the Royal Hospital Infirmary in Glasgow. (shrink)

Abstract:Recent developments in personality research point to an alchemy of character composed of five elements: extroversion, agreeableness, conscientiousness, neuroticism, and openness to experience. This paper surveys this research for its implications to the study of the virtues in organizational ethics. After subjecting each of these five character traits to several tests as to what constitutes a virtue, the empirical evidence supports an organizational virtue of agreeableness and an organizational virtue of conscientiousness. Although the empirical evidence falls short, an argument is (...) mobilized on behalf of an additional organizational virtue of openness to experience. (shrink)

The purpose of this essay is to take up the question of how an ethical con­sciousness emerges, that is where ethics might begin, and to ask about some of the consequences one might draw from this beginning. The essay argues that one site for thinking through such a beginning is the consciousness of mortality. To unpack such a claim, the essay takes up Heidegger’s discussion of this point in Being and Time as well as Derrida’s discussion of this consciousness in (...) his seminar on Beast and Sovereign and his essay “Béliers.” The final stage of the argument concerns the sameness of birth and death for an understanding of ethical sense: both speak to the vulnerability and the absoluteness that expose the questions of ethical life, and both intensify a sense of what is at stake in such a life. (shrink)

Kant's purpose in the Critique of Pure Reason was to describe the nature and set the boundaries of human knowledge. At the heart of this ambitious enterprise is his doctrine of apperceptive self-identity. He insists that in order for us to know anything, there must be a unitary self capable of being aware of its own identity over time. Unfortunately, Kant's descriptions of this unitary 'I think' are extremely obscure, and his accounts of how it functions in the first Critique's (...) overall theory of knowledge are extremely problematical. ;I believe that much of the diversity of opinion about Kant's theory of self-identity has arisen owing to a lack of consensus about what really constitutes an adequate account of self-identity in the first Critique. I contend that an adequate account must satisfy four basic requirements. First, the theory must be compatible with his solutions to certain philosophical problems that emerge in the analysis of ordinary human cognition. Second, the theory must be consistent with the principles underlying his general account of human knowledge. Third, the theory must explain the cognitive relation between the momentary phenomenal self and the transtemporal, a priori unity of apperception. And fourth, it must explain the ontological status of this unitary 'I think'. ;I contend that the key to Kant's theory of apperceptive self-identity is found in his notion of synthesis. I look closely at what synthesis means for Kant, what he does with it in his account of human knowledge, and how his detailed account of objective synthesis may be used to shed light upon his more obscure accounts of the unitary synthesizing agent. I suggest that Kant's theory of apperceptive self-identity may be understood as a more generalized version of his theory of schematism. Both involve the synthetic unification of something pure and actively formal with some empirical and passively given content; and both are intimately connected with the nature of time. I show how these two facts may be used to elucidate the nature of the apperceptive subject, and how Kant's theory is able to satisfy the four requirements. (shrink)

One of the characteristics of Big Data is that it often involves “imperfect” information. This paper examines the work of John Graunt in the tabulation of diseases in London and the development of a life table using the “imperfect data” contained in London’s Bills of Mortality in the 1600s. London’s Bills of Mortality were Big Data for the 1600s, as they included information collected over time, the depth and accuracy of which improved gradually. The main shortcoming of the data available (...) at the time was its nonuniform upkeep and the lack of depth of variables included at its outset. Due to these characteristics, it provides a perfect model for the examination of imperfect Big Data, as it has been analyzed, criticized, and interpreted repeatedly since the 1600s. (shrink)

Ethical analyses of the relations between managers and subordinates have traditionally focused on the employment contract. The inequality and requisite mutual trust between managers and subordinates makes the sub-disciplines of professional ethics and feminist ethics more applicable than the contractarian perspective. When professional ethics is applied to hierarchic relationships, specific obligations emerge for managers and subordinates alike. The application of feminist ethics results in the identification of an entirely different, though not contradictory, set of obligations. In toto, the analysis improves (...) on the conventional wisdom governing hierarchic relationships while at the same time remaining consistent with our moral intuitions. (shrink)

This chapter argues that as the tradition of hermeneutic reflection develops, it should come to show more clearly this very real and original concern with ethical life. It is also the most promising way of thinking the questions of ethics in our times. The chapter remarks on this topic to Gadamer's work on the ethical sensibility of hermeneutics. There are four rather obvious links between hermeneutic theory and ethics that can help illuminate this claim. First, hermeneutics is formulated with reference (...) to the question of ethical judgment as it is developed by Kant in his Third Critique; second, it is modeled on Aristotle's notion of ϕρóνησíς in his Nicomachean Ethics; third, it is concerned with conversation and listening, and with the need to engage others genuinely; and fourth, it is animated by a deep respect for alterity and a sensitivity to the complexities of historical realities. (shrink)

The purpose of this essay is to look at the ethical concerns and sensibilities that emerge out of Hegel and Heidegger’s respective interpretations of Antigone. Curiously, both of them turn to this ancient Greek tragedy in order to lay out the foundations of ethical life and the complexities of such a life in the present historical moment. The argument here in the end is that both Hegel and Heidegger find the lesson of the radical singularity defining ethical life to be (...) a key to what one sees in Antigone. Both see this above all in the role of death in the tragedy. Both focus upon questions of mourning, burial, and of the dead body. My suggestion is that birth too needs to be understood as confronting us with the problem of our being in the singular, our being an idiom among other idioms. (shrink)

Discussions of the relationship between perception and cognition often proceed without a definition of these terms. The sensory-modality specific nature of low-level perceptual processes provides a means of distinguishing them from cognitive processes. A more explicit definition of terms provides insight into the nature of the evidence that can resolve questions about the relationship between perception and cognition.

The intention of this article is investigate ways in which the image and metaphor of the garden open productive avenues for thinking the being of nature. The primary focus of this investigation is found in two instances in which gardens play significant roles in presenting, even if only tacitly, an image of nature: Homer’s Odyssey and Plato’s reference to the “Gardens of Adonis” in Phaedrus.

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)