High quality images sell products. Here's how you do it. From cereal boxes to billboards to photos on Amazon, product photos have a strong impact on viewers. Now you can master the secrets of effective product photography with this essential guide. Author J. Dennis Thomas guides you through the basics, from selecting the right equipment and practicing different lighting techniques to controlling exposure, using backgrounds and props, and much more. Whether it's jewelry, food, fashion, or other products, learn how (...) to photograph for effective selling, while building the skills and tools you need for a career. Explains how to produce quality photos for product or commercial photography, including fashion, food, jewelry, technology, and more The author is a professional photographer whose work has been published in major U.S. magazines including Rolling Stone, Elle, W Magazine, and US Weekly Covers choosing the right equipment, practicing different lighting techniques, controlling exposure, using backgrounds and props, and more Gives new and even experienced photographers the tools they need to build careers in product photography Take photographs that impress, intrigue, dazzle, and sell with The Art and Style of Product Photography. (shrink)

The Nikon COOLPIX Digital Field Guide is filled with everything you need to know in order to take amazing photographs using any Nikon COOLPIX camera. This full-color portable guide walks you through the essential controls, features, and functions of the Nikon COOLPIX point-and shoot camera line using step-by-step instructions and full-color images of each menu screen. This robust guide not only shows you how to adjust a variety of settings on your Nikon COOLPIX, it also teaches you when and why (...) you should adjust them. The Nikon COOLPIX Digital Field Guide goes beyond camera settings to offer you a friendly guide to the principles of digital photography, covering the essentials of lighting and composition. Filled with amazing examples, this book also presents a variety of techniques for getting great photos, including specific tips and tricks for capturing portraits, candids, sports and action shots, travel pictures, macro photography, and much more. (shrink)

What you need to know to take amazing photos—or shoot movies!—with your Nikon D300s camera This portable, full-color guide explains all essential controls, features, and functions of the Nikon D300s camera, including the exciting new D-Movie with auto-focus feature, 3-inch LCD screen, quiet shutter release, and external microphone for movie recording. You’ll find step-by-step instructions and invaluable tips and tricks to help you take your best stills or live action, whether you’re capturing portraits, candid shots, sports or travel images, or (...) macro photography. Shows you how to get the very most out of your new Nikon D300s digital camera Discusses in detail all the essential controls, features, and functions of the Nikon D300s, including the new D-Movie feature Provides step-by-step instructions and full-color images of each menu screen Explains not only how to adjust white balance, autofocus, exposure, and other settings, it explains when and why you should adjust these settings Gives you a thorough digital photography refresher on lighting and composition Shares valuable tips and tricks to help you capture amazing shots Shows you topic-specific secrets to capturing portraits, candid shots, sports or travel photos, macro photography, and others Now that you have a Nikon D300s, make sure you have a copy of the Nikon D300s Digital Field Guide! (shrink)

Presents tips and techniques on creating professional lighting effects using the Canon Speedlite system.

A full-color, go-anywhere guide to Nikon's entire array of creative lighting possibilities Nikon's Creative Lighting System is like having a low-cost, wireless, studio lighting system that's portable enough to fit into a camera bag. Although the possibilities are endless and exciting, setting up, synchronizing the equipment, and determining lighting ratios can be a bit overwhelming. Luckily, this Digital Field Guide has been completely updated to shed some light on the situation! Beginning with the basic functions of the Nikon SB-900, the (...) SB-800, and the SB-600, the author then goes on to demystify the complexities of using multiple speedlights, adjusting flash outputs, and setting up a wireless studio. Clearly explains how to get the best results when using multiple speedlights Includes examples and unique advice on how to light specific subjects, such as weddings, wildlife, portraits, product shots, and corporate locations Covers other Creative Lighting System components, such as Nikon's wireless commander and macro speedlights With this handy, on-the-go guide, you'll no longer be in the dark on Nikon's Creative Lighting System. (shrink)

The proposed changes to the Common Rule, described in the recent Advanced Notice of Proposed Rulemaking, come more than 20 years after the U.S. Department of Health and Human Services adopted the Rule in 1991. Since that time, human subjects research has changed in significant ways. Not only has the volume of clinical research grown dramatically, this research is now regularly conducted at multiple collaborative sites that are often outside of the United States. Research takes place not only in academic (...) medical centers, but also at outpatient clinics, community hospitals, and other nontraditional venues. In addition, technological advances, such as sophisticated computer software programs, the Internet, social media, new research methods, and mobile applications have exponentially increased the volume of data available and the possibilities for accessing, analyzing, and sharing that data. (shrink)

The aim of the present research was to develop a difficulty model for logical reasoning problems involving complex ordered arrays used in the Graduate Record Examination. The approach used involved breaking down the problems into their basic cognitive elements such as the complexity of the rules used, the number of mental models required to represent the problem, and question type. Weightings for these different elements were derived from two experimental studies and from the reasoning literature. Based on these weights, difficulty (...) models were developed which were then tested against new data. The models had excellent predictive validity and showed the relative influence of rule based factors and factors relating to the number of underlying models. Different difficulty models were needed for different question types, suggesting that people used a variety of approaches and, at a wider level, that both mental models and mental rules may be used in reasoning. (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.

Lawrence J. Dennis’s intellectual biography of John L. Childs, a leading figure in twentieth-century American educational philosophy between 1930 and 1960, traces Childs’s influence not only on education but also on midcentury politics, economics, and social issues. A disciple of John Dewey and an associate of William Heard Kilpatrick, George S. Counts, Boyd Bode, and other key figures in modern American education, Childs laid the philosophic basis for social reconstruction and became an important contributor to and interpreter of pragmatism (...) as a philosophy of education. Dennis describes how the Christian beliefs so central to Childs as a youth led him as a young man into a decade of YMCA missionary work in China. When he returned to the United States, Childs studied with John Dewey, later coauthoring two chapters of a book with him. Though Childs became a recognized expert on Dewey’s educational theory, he eventually became more of a reconstructionist than his mentor. Dennis carefully recounts Childs’s long association with Dewey as well as his political activities in the American Labor Party, the Liberal Party, and the American Federation of Teachers. He likewise traces the debate about metaphysics, democracy, and indoctrination that ensued among the foremost pragmatists of the day. (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: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)

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)

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

If one takes a course in philosophy to-day at a British university, a discreet silence is usually observed about existentialism. Often the professors understand little of its methods or its doctrine. If their excuse in part is the inaccessibility in English of standard existentialist texts, it is true also that philosophers trained in the “critical philosophy” now in vogue feel a certain aversion to existentialism or, at all events, to the notion they have formed of it. If Christianity was a (...) scandal to the Greeks and remains a scandal, as Dr. Brunner has recently told us, to contemporary humanists, existentialism is a scandal to the positivists. The latter are aware that the existentialists habitually trespass in the fields of religion, ethics, aesthetics and psychology, fields which, on the positivist view, should be reserved to other disciplines than philosophy, which has its own distinctive subject-matter and approach. They know that certain existentialists, notably Heidegger, provide a happy hunting ground for examples of “metaphysics.” They have heard that existentialism has sought to turn the tables on positivism by accusing it, if not of metaphysics, at all events of a barrenness of significant content, of a preoccupation with mere logistics which removes philosophy completely from men's business and bosoms. If the positivist accuses the existentialist of perpetrating “nonsense” in a technical sense, the latter retorts by accusing the positivist of reducing philosophy to nonsense in a pragmatic sense. (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)

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)

This paper uses the intuition from the game of chickento model client-auditor financial reporting and audit effort strategies. Within an ethical context, our model is concerned with the client misreporting and its detection by the auditor. The paper uses a welfare game(similar to the game of chicken) to more formally model client-auditor strategies. The welfare game is then extended to provide additional insight into ethical and audit effort issues.Such a welfare gameprovides equilibrium in mixed strategies. This mixed strategy solution makes (...) possible four outcomes from the game: 1) Financial Statements are fairly presented by client and the auditor performs a normal audit, 2) Financial Statements are fairly presented by client and the auditor performs an extended audit (over auditing), 3) Financial State-ments are misstated by client and detected by the auditor, and 4) Financial Statements are misstated by client and not detected by the auditor (audit failure despite no intended unethical action on the part of the auditor). (shrink)

“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)

Those who invoke the word self-deception to represent one phenomenon often argue that those who use it to represent another are misusing the construct. Better to recognize that self-deception is a fuzzy concept that may be used to represent a variety of mental processes and states, and to direct our energy toward distinguishing empirically among its forms and functions.

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)

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)

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.

In the past decades, reductionism has dominated both research directions and funding policies in clinical psychology and psychiatry. The intense search for the biological basis of mental disorders, however, has not resulted in conclusive reductionist explanations of psychopathology. Recently, network models have been proposed as an alternative framework for the analysis of mental disorders, in which mental disorders arise from the causal interplay between symptoms. In this target article, we show that this conceptualization can help explain why reductionist approaches in (...) psychiatry and clinical psychology are on the wrong track. First, symptom networks preclude the identification of a common cause of symptomatology with a neurobiological condition; in symptom networks, there is no such common cause. Second, symptom network relations depend on the content of mental states and, as such, feature intentionality. Third, the strength of network relations is highly likely to depend partially on cultural and historical contexts as well as external mechanisms in the environment. Taken together, these properties suggest that, if mental disorders are indeed networks of causally related symptoms, reductionist accounts cannot achieve the level of success associated with reductionist disease models in modern medicine. As an alternative strategy, we propose to interpret network structures in terms of D. C. Dennett's (1987) notion ofreal patterns, and suggest that, instead of being reducible to a biological basis, mental disorders feature biological and psychological factors that are deeply intertwined in feedback loops. This suggests that neither psychological nor biological levels can claim causal or explanatory priority, and that a holistic research strategy is necessary for progress in the study of mental disorders. (shrink)