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...

In 1967, the superior general of the Society of Jesus, Pedro Arrupe, sent a memorandum on the American “racial crisis” to the Jesuit priests, brothers, and social institutions of the United States. Through appeals to the American legal and Catholic moral traditions, On the Interracial Apostolate articulated why Jesuits should strive to achieve racial equality, initiating a historic period of expansion in Jesuit civil rights programs. Given scholars’ limited engagement with On the Interracial Apostolate’s distinctive rhetorical features, this article explains (...) why the document was framed within the discursive framework of prophetic indictment by uncovering the influence of William J. Kenealy, a Jesuit legal scholar, on the document’s drafting. In light of this drafting history, this article concludes by suggesting that the emergence of twentieth-century “Jesuit anti-racism” can, in part, be explained by how questions about racial equality came to be understood as discrete expressions of broader debates about the American legal tradition’s moral foundations. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:The Varieties of Vernacular Mysticism (1350–1550) by Bernard McGinnDennis J. Billy C.Ss.R.The Varieties of Vernacular Mysticism (1350–1550). By Bernard McGinn. New York: Crossroad, 2012. Pp. xiv + 721. $70.00 (cloth). ISBN: 978-0-8245-9901-0.This fifth volume of McGinn’s Presence of God: A History of Western Christian Mysticism covers the Dutch, Italian, and English vernacular mystics of the late Middle Ages. In previous volumes, the author treated the Foundations (vol. 1), (...) Growth (vol. 2), Flowering (vol. 3), and Harvest (vol. 4) of Western Christian mysticism from its roots in the Jewish matrix and the Greek ideal to its fruition in the German vernacular writings of Meister Eckhart and his students. In this latest volume, he continues his history of Western Christian mysticism by focusing on varieties of vernacular mysticism in the Low Countries, Italy, and England from 1350 to 1550.Conscious of the dangers of historical periodization and regional classification, as well as the relationship of mysticism to the greater ecclesiastical world, McGinn takes pains to show the distinctive character of each mystic under consideration, while at the same time pointing out appropriate parallels with Western and Eastern Christian mystics from past historical epochs and those contemporary voices from both within and [End Page 476] without each mystic’s linguistic region. In his preface, he apologizes to his readers for the long gestation of the present volume and offers a brief account of how his original plan of writing a three-volume history of Western Christian mysticism evolved into a series of seven, due in large part to the sheer wealth of sources and his desire to give them a thorough treatment. Rather than following his original intention of including other vernacular traditions in his previous volume on German mysticism, he wisely chose to devote an entire volume to these other important strands (ix–x).Instead of writing a general introduction to the volume, McGinn decides to give a brief introduction to each of the three major parts. He divides his work into thirteen chapters constructed along the following lines: (1) “Late Medieval Mysticism in the Low Countries” (chaps. 1–5), (2) “Mysticism in Late Medieval Italy” (chaps. 6–9), and (3) “Mysticism in Late Medieval England” (chaps. 10–13). The volume closes with a brief conclusion (491–94), extended annotations (495–661), an extensive bibliography (662–704), and indices for Scripture references (705–6), names (707–12), and subjects (713–21). The book’s organization reflects the theme of diversity highlighted in its title. Although each part has its own internal structure and stands on its own as a survey of the material at hand, it also fits well into the volume’s overall plan of pointing out the distinctiveness and great variety of the vernacular mysticisms produced during this period. Taken individually, each part can be considered a probing monograph on the vernacular mysticism in each region. Taken together, the parts offer a unique glimpse into the mystic and literary creativity that sets this period apart as one of the most fertile periods in the history of Christian mysticism.In part 1, “Late Medieval Mysticism in the Low Countries,” McGinn notes that “the period ca. 1350 to ca. 1550 is the central era for Dutch mysticism” and “witnessed a florescence of mystical authors writing in the Dutch-Flemish language” (1). Although he hesitates to refer to a Dutch “school” of mysticism and thinks that “Ruusbroec should not be made the yardstick by which all later Dutch mystics are measured,” he has no reservations about considering him “a gravitational center in the history of Dutch mysticism” (2). This section of the book begins with an in-depth look at the mystical writings of Jan van Ruusbroec (1293–1381) (chap. 1) and continues with a study of Goenendaal mysticism after Ruusbroec (chap. 2). It then turns to a treatment of the mystical aspects of the Devotio Moderna, with a special emphasis on The Imitation of Christ and some vernacular mystics numbered among the Devout, such as Hendrik Mande (ca. 1360–1431, Gerlach Peters (ca. 1375–1411), and Alijt Bake (1415–55), and adds a brief note on the nominalistic... (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.

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)

Ecological psychologists and enactivists agree that the best explanation for a large share of cognition is nonrepresentational in kind. In both ecological psychology and enactivist philosophy, then, the task is to offer an explanans that does not rely on representations. Different theorists within these camps have contrasting notions of what the best kind of nonrepresentational explanation will look like, yet they agree on one central point: instead of focusing solely on factors interior to an agent, an important aspect of cognition (...) is found in the link or coupling between an agent and the external world. This link is fluid, dynamic, and active in a variety of ways, and we do not need to add any internal extra something in the perception-action-cognition process. At the same time, even devout defenders of ecological psychology and enactivism recognize that plenty happens inside an agent during cognition. In particular, no one denies that the brain plays an important role. What, then, is the role of the brain if it’s not in the game of representing the environment? One possible option is to describe the brain as a resonant organ instead of a representational organ. In this paper we consider the history of resonance in more detail. Particular focus will be placed on two different sets of approaches that have developed the concept of resonance: a representational reading of resonance and a nonrepresentational, dynamic account of resonance. We then apply these accounts to a case study on music performance, specifically in the context of standard tonal jazz. From this application, we propose that a nonrepresentational resonance account consistent with both enactivism and ecological psychology is a viable way of explaining jazz performance. We conclude with future considerations on research regarding the brain as a resonant organ. (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)

Any determination of Hans‐Georg Gadamer's place in Continental philosophy needs to begin by noting that his contribution to that tradition is associated with the style of philosophizing designated as “hermeneutics.” But while a presentation of Gadamer's thought is well‐advised to begin with a discussion of his conception of hermeneutics, it must not end with that theme. In fact, what is perhaps most notable about Gadamer's work is both its historical and disciplinary breadth as well as the wide range of issues (...) that it addresses. That engagement with the history of philosophy and such a diverse collection of issues is itself a reflection of the project of hermeneutics as Gadamer has developed it: not a “method,” Gadamer's hermeneutics is more aptly described as the effort to solicit the experience of limits harbored by all experience, and to demonstrate that this experience of finitude is not restricted only to some forms of experience. So one turns to his body of work and finds significant texts on ancient Greek philosophy and literature, all forms of art, translation, questions of contemporary culture and politics, theology, as well as issues in medicine and health. Just as one finds a remarkable pluralization of the fields in which Gadamer's hermeneutics can take root, so too one finds a similar situation with respect to the formative influences upon Gadamer's thought: while he is most frequently associated with the name of his teacher, heidegger (Article 18), it is clear that Plato, Aristotle, Augustine, Holderlin, kant (Article 2), hegel (Article 6), dilthey (Article 37), husserl (Article 15), Rilke, and Celan need to be understood as providing many of the decisive impulses for Gadamer's own original philosophic contributions. (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)

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.

Whitehead’s widely cited and accepted remark that the history of philosophy is but a series of footnotes to Plato has implications for how both Plato and the history of philosophy is to be understood. Such an understanding does an injustice to both Plato and the history of philosophy. A recent book by John Sallis, Platonic Legacies, presents us with a counterview, one that offers a more exciting view of both Plato and the meaning of his legacy for the history of (...) philosophy. The chief purpose of this article is to unpack some of Sallis’s contributions in this regard. (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)

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)

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)

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)

Transcranial magnetic stimulation (TMS) is a method capable of transiently modulating neural excitability. Depending on the stimulation parameters information processing in the brain can be either enhanced or disrupted. This way the contribution of different brain areas involved in mental processes can be studied, allowing a functional decomposition of cognitive behavior both in the temporal and spatial domain, hence providing a functional resolution of brain/mind processes. The aim of the present paper is to argue that TMS with its ability to (...) draw causal inferences on function and its neural representations is a valuable neurophysiological tool for investigating the causal basis of neuronal functions and can provide substantive insight into the modern interdisciplinary and (anti)reductionist neurophilosophical debates concerning the relationships between brain functions and mental abilities. Thus, TMS can serve as a heuristic method for resolving causal issues in an arena where only correlative tools have traditionally been available. (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)

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)

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 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)

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