Introduction. What are the arts and how do we respond to and evaluate them? -- Pictures : drawing, painting, printmaking, and photography -- Sculpture -- Architecture -- Music -- Literature -- Theatre -- Cinema -- Dance.

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)

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)

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)

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)

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.

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)

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 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)

Abstract:Vice is a neglected concept in business ethics. This paper attempts to bring vice back into the contemporary dialogue by exploring one vice that is destructive to employee and organization alike. Interestingly, this vice was first described by Aristotle asakolastos. Drawing extensively on the criminology literature, the findings challenge both common sense and popular images of white-collar crime and criminals. While not all instances of employee betrayal are attributable to vice, some most certainly are, and the paper offers a description (...) of those violations of trust in which vice may play a role. (shrink)

Abstract:Mentoring is an age-old process that continues to be practiced in most contemporary organizations. Although mentors are often heralded as virtuous agents of essential continuity, mentoring commonly results in serious dysfunctions. Not only do mentors too often exclude people different from themselves, but also the people they mentor are frequently abused in the process. Based on the conception of mentor as a quasi-professional, this paper lays out the ethical responsibilities of both parties in the mentoring process.

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.

This is a work of constitutional theory that explores the nature of American constitutional interpretation through a reconsideration of the long-standing debate between the interpretive theories of originalism and nonoriginalism. The book presents the novel argument that a critique of the underlying premises of originalism dissolves not just originalism but nonoriginalism as well, which leads to the recognition that constitutional interpretation is already and always structured. By their fidelity to the Constitution, Americans are a textual people in that they live (...) in and through the terms of a fundamental text. On the basis of this central idea, the book presents a new understanding of constitutional interpretation and an innovative account of the democratic legitimacy and binding capacity of the Constitution. (shrink)

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

The Belmont Report’s distinction between research and the practice of accepted therapy has led various authors to suggest that these purportedly distinct activities should be governed by different ethical principles. We consider some of the ethical consequences of attempts to separate the two and conclude that separation fails along ontological, ethical, and epistemological dimensions. Clinical practice and clinical research, as with yin and yang, can be thought of as complementary forces interacting to form a dynamic system in which the whole (...) exceeds the sum of its parts. Just as effective clinical practice cannot exist without clinical research, meaningful clinical research requires the context of clinical practice. We defend this thesis by triangulation, that is, by outlining how multiple investigators have reached this conclusion on the basis of varied theoretical and applied approaches. More confidence can be placed in a result if different methods/viewpoints have led to that result. (shrink)

There is a lack of research explicitly demonstrating the potential of applying critical realism in qualitative empirical Management and Organization Studies. If scholars are to obtain the exp...

Abstract:Employee-employee conflicts are common occasions for managerial intervention. In judging such disputes, managers bring to encounters a frame that is not conducive to employee due process. Making managers aware of their legal responsibilities in resolving employee disputes is a poor substitute for managers’ understanding and implementation of their ethical due process obligations. Moreover, moral imagination is necessary in order to counter the effects of the managerial frame that employees are either not worthy of due process protections or that such protections (...) are not a priority. (shrink)

Abstract:Employee-employee conflicts are common occasions for managerial intervention. In judging such disputes, managers bring to encounters a frame that is not conducive to employee due process. Making managers aware of their legal responsibilities in resolving employee disputes is a poor substitute for managers’ understanding and implementation of their ethical due process obligations. Moreover, moral imagination is necessary in order to counter the effects of the managerial frame that employees are either not worthy of due process protections or that such protections (...) are not a priority. (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)

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)

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.

Focusing on Heidegger and the work of Paul Klee, Schmidt pursues larger issues in the relationship between word, image, and truth.

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)

A wide-ranging attempt to develop a theory of ethical life from a hermeneutic understanding of language.

“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)

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)

Abstract The purpose of this paper is to argue that the connection between hermeneutics and practical philosophy is so strong that one needs to consider hermeneutics as the outline of an ethical sensibility, one that takes up the challenges that are outlined by Heidegger's call for an “original ethics.“ Part of this argument entails demonstrating how understanding, the real task of every hermeneutic project, is ultimately a form of self-understanding.

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)

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.