This paper will present an alternative to the mainstream Western approach to human development. The mainstream Western approach to human development does not countenance contemplative interiority as a means of cognitive inquiry and a domain of cognitive value. Hence, its conception of human development is narrowly confined to the domain of formal-operational thinking and its application to material exteriority. The alternative I will present is the work of the twentieth Indian philosopher Aurobindo (1872–1950) whose (...) integral theory of human of development inclusively countenances as realms of cognitive inquiry and value both contemplative interiority and formal-operational thinking and its application to material exteriority. The structure of Aurobindo’s integral theory of humandevelopment will be clarified and some of its implications for educational practice will be explored. (shrink)

Fifty years after the death of Edmund Husserl, the main founder of the phenomenological current of thought, we present to the public a four book collection showing in an unprecedented way how Husserl's aspiration to inspire the entire universe of knowledge and scholarship has now been realized. These volumes display for the first time the astounding expansion of phenomenological philosophy throughout the world and the enormous wealth and variety of ideas, insights, and approaches it has inspired. The basic commitment to (...) phenomenological concerns found in all this variety makes this collection a most signifi cant historical document. This second volume of the collection bears witness to a deliberate shift of attention from the earlier to the later phase of Husserl's reflections. We see how his issues - intersubjectivity, ethics, human encounter, the societal world, empathy, the sphere of the self, and the surpassing of dichotomies (bodylpsyche, etc.) - are now at the center of attention in the human sciences. Among the authors are H. Tellenbach, A. Rigobello, C. Balzer, C. Bjurvill, V. Molchanov, E. Syristova, O. Balaban, R. Boehm, M. Sancipriano, O. M. Anwar, Y. Okamoto, B. Holyst, T. Sodeika, and M. De Negri. The studies were gathered at the programs held by The World Institute for Advanced Phenomenological Research and Learning in the commemorative year 1988/1989, chiefly at the First World Congress of Phenomenology at Santiago de Compos tela, Spain, with the aim of assessing the current state of phenomenology. A-T. T. (shrink)

In her introduction to this collection, Tymieniecka presents her phenomenology of life - the leitmotif of the three-volume anniversary publication of Analecta Husserliana - as something that stands out from preceding historical attempts to investigate life in an 'integral' or 'scientific' way. After an incubation lasting throughout the 2000 years of Occidental philosophy, this scientific phenomenology/philosophy of life at last uncovers the entire area of the 'inner workings of Nature', exposing the way in which the 'sufficient reason' and the 'ground' (...) of beingness as such crystallise out of the 'onto poietic' process. This onto-poietic process, continuing as it does in the human creative condition, also reveals the authentic genius of the works of the human spirit. This new and original philosophy, free of fallacious simplifications, speculations and reductionism, opens up a basic starting point for all philosophy. Life, 'the theme of our times', at last receives a profound philosophical treatment. (shrink)

Pharmaceutical firms seek to fulfill their responsibilities to stakeholders by developing drugs that treat diseases. We evaluate the social and financial costs of developing new drugs relative to the realized benefits and find the industry falls short of its potential. This is primarily due to legislation-mandated reliance on animal test results in early stages of the drug development process, leading to a mere 10 percent success rate for new drugs entering human clinical trials. We cite hundreds of biomedical (...) studies from journals including Nature, Science, and the Journal of the American Medical Association to show animal modeling is ineffective, misleading to scientists, unable to prevent the development of dangerous drugs, and prone to prevent the development of useful drugs. Legislation still requires animal testing prior to human testing even though the pharmaceutical sector has better options that were unavailable when animal modeling was first mandated. We propose that the U.S. Food and Drug Administration and Congress should work together to abolish regulations and policies that require animal use. Doing so will benefit pharmaceutical industry stakeholders, including patients whose health depends on drugs and the many people who rely on the financial well-being of pharmaceutical firms. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 14.1 (2004) 47-54 [Access article in PDF] Ethical Guidelines for Human Embryonic Stem Cell Research*(A Recommended Manuscript) Adopted on 16 October 2001Revised on 20 August 2002 Ethics Committee of the Chinese National Human Genome Center at Shanghai, Shanghai 201203 Human embryonic stem cell (ES) research is a great project in the frontier of biomedical science for the twenty-first century. Be- cause (...) the research involves the use of human embryos, it triggers serious debate on ethical issues. Opponents consider the embryo to be an early form of human life that should be respected and not destroyed. However, the majority of scientists support embryonic stem cell research, believing that it offers good prospects for the treatment of diseases that have remained incurable until now and so will benefit humankind. The Ethics Committee of the Department of Ethical, Legal, and Social Implications of the Chinese National Human Genome Center at Shanghai seriously discussed the ethical debate initiated by embryonic stem cell research. We concluded that we should support the scientists of our country in actively carrying out human embryonic stem cell research for the noble cause of "medicine being a beneficent art." For the healthy and orderly development of human embryonic stem cell research in our country, we put forward the following recommended Ethical Guidelines for Human Embryonic Stem Cell Research as a reference for leaders, administrative departments, and related scientists. Preface Article 1. Human embryonic stem cells are the primitive cells that play the main role in the growth and development of a human body. These [End Page 47] primitive cells have the potential for infinite proliferation, self-renewal, and multi-directional differentiation. If scientists can discover the mechanism of differentiation of human embryonic stem cells, it will be possible to induce differentiation of human embryonic stem cells to form various types of human cells for clinical cell therapy. If human embryonic stem cell research can be integrated with modern biomedical engineering techniques, it also will be possible to make repair and replacement of human tissues and organs a reality. Article 2. There are two ways to classify human embryonic stem cells. One way is to classify them according to their potential for differentiation. There could be three kinds of stem cells: totipotent stem cells, pluripotent stem cells, and unipotent stem cells.A totipotent stem cell has the potential to develop into a whole individual. It can differentiate into the more than 200 cell types in the whole body, construct any tissue or organ of the body, and finally develop into a whole individual. The fertilized egg and the cleavage cells at the very early stage of embryonic development are totipotent stem cells.A pluripotent stem cell has the potential to differentiate into many cell types derived from the three embryonic layers. However, it has lost the capacity to develop into a complete organism.A unipotent stem cell is derived from the further differentiation of the pluripotent stem cell. It can differentiate only into one cell type such as a hematopoietic stem cell, neural stem cell, and others.The other way is to classify human stem cells according to their source. There could be two kinds of human stem cells: embryonic stem cells and tissue stem cells (also called adult stem cells). The former involves experimentation with embryos, which has serious ethical implications. Ethical issues associated with the latter are mainly expressed in the various opinions regarding the allocation of health resources. Article 3. Human embryonic stem cells are the group of cells called the blastocyst inner cell mass during the early stage of embryonic development. They are the main source of totipotent stem cells, and hence the focal and hot point in stem cell research. Studies on the clinical application of embryonic stem cells probably will involve use of the somatic cell nucleus transfer (SCNT) technique, which destroys the early human embryo. At present, the ethical and moral debate is very serious in human embryonic stem cell research regarding whether the research will develop... (shrink)

orbit and far beyond it. Indeed, the immense, painstaking, indefatigable and ever-improving effort of Husserl to find ever-deeper and more reliable foundations for the philosophical enterprise (as well as his constant critical re-thinking and perfecting of the approach and so called "method" in order to perform this task and thus cover in this source-excavation an ever more far-reaching groundwork) stands out and maintains itself as an inepuisable reservoir for philosophical reflec tion in which all the above-mentioned work has either its (...) core or its source. In fact, in his undertaking to re-think the entire philosophical enterprise as such and to recreate philosophy upon what he sought to be at least a satisfactorily legitimated basis, Husserl, through his already systematised and "authorized" work, and his courses, and later on in his spontaneous reflection (which did not find its way into a definitive corpus but was nevertheless sufficiently coherent with his previously established body of thought to be considered a continuation of it), uncovers perspectives upon the universe of man and projects their new philosophical thematisation that brings together all the attempts by philosophers (e. g., Merleau-Ponty, who drew upon this material and found there his own inspiration) who succeeded him with foundational intentions; it also gives a core of philosophical ideas and insights for the youngergenerationofphilosophers today. (shrink)

Background: The Multidimensional Inventory for Religious/Spiritual Well-Being was developed in order to address a religious/spiritual dimension as being an important part of psychological well-being. In the meantime, the instrument has been successfully applied in numerous studies. Subsequently, a short version, the MI-RSWB 12 was constructed, especially for the use in clinical assessment. Here it is intended to contribute to the further development of the MI-RSWB 12 by investigating its structural validity through structural equation modeling.Materials and Methods: A total sample (...) of 1,097 German-speaking adults from the normal population filled in the MI-RSWB 12 via an online-survey. In line with theoretical assumptions 5 different factor structure models for the MI-RSWB 12 were tested: a single-factor model, a model with four correlated RSWB dimensions, a single higher-order model with four lower order factors, a two higher-order model with four lower order factors, a bifactor model, which includes four specific RSWB dimensions.Results: The single-factor model provided the poorest model fit, with no indices falling within the acceptable range. The four-factor, two higher-order factors and the bifactor models showed overall acceptable fit indices. With regard to the Akaike information criterion, the four-factor model demonstrated superiority compared to both the two higher-order factor model and the bifactor model, which in turn showed did not differ from each other.Conclusion: Four different MI-RSWB 12 sub-scales should be calculated in future studies, while a general factor and two higher order factors are statistically valid as well. Further applications of the MI-RSWB 12, especially in the clinical patient groups, are encouraged. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:At the Vortex of Controversy:Developing Guidelines for Human Embryo ResearchRonald M. Green (bio)Because of the unavoidable time delay between the submission and publication of this article, its readers will have a significant advantage over its writer: You will know whether the recommendations of the Report of the Human Embryo Research Panel, on which I have served as a member since its inception in January of this year, (...) are progressing smoothly as the basis for evaluating future, federally-funded embryo research—or whether any of the recommendations has become stalled in controversy and political dispute. Staid journals like Science already are predicting that the Panel's Report is likely to create a stormy autumn for the National Institutes of Health.The Panel formally presented its Report to NIH Director Harold Varmus on September 27. The Panel's recommendations will be reviewed by the Advisory Committee to the Director (ACD) until the ACD's next meeting in early December. At that time, the ACD will make formal recommendations to Dr. Varmus, who then will initiate the process of drafting federal regulations that could go into effect by Spring 1995.Historical BackgroundControversy is not new to the area of human embryo research. In the United States, federal regulations enacted in the mid-1970s required any research on the human embryo to be approved by a federally mandated Ethics Advisory Board (EAB). The EAB drafted a significant report that provided ethical guidelines for research on the early, ex utero, human embryo. However, before the report could be acted upon, a new administration, which was opposed to abortion and anything remotely viewed as threatening to prenatal life, came to office, and when the EAB's charter expired in 1980, it was not renewed. In this manner, the Reagan and Bush administrations forestalled any federal support for embryo research in the United States. The next 13 years saw a significant expansion of infertility services in this country, but in the absence of federal funding and [End Page 345] review, there was very little systematic research on either infertility procedures or the human embryo.In January 1993, the U.S. political environment changed again when the Clinton administration fulfilled a campaign promise to remove a nearly five-year-old ban on fetal tissue transplantation research. Although fetal tissue research, which uses the remains of an aborted fetus, significantly differs from embryo research, which involves the developing conceptus ex utero before its transfer to and implantation in a womb, the changed political environment stimulated public discussion of embryo research as well. As a result, in June 1993, Congress nullified the federal regulations requiring EAB review for embryo research. Although this presumably left NIH free to fund embryo research without restrictions, NIH officials felt that guidelines were needed to ensure that such research was conducted in an ethically and socially responsible manner. Accordingly, in January 1994, NIH formed the Human Embryo Research Panel to propose such guidelines.The Panel Begins its WorkChaired by Steven Muller, President emeritus of the Johns Hopkins University, the Panel's 19 members included 7 basic and clinical scientists, 4 ethicists, 2 lawyers, and 6 individuals representing various backgrounds relevant to the making of public policy. Patricia King of the Georgetown University Law Center and Brigid Hogan, a cell biologist at Vanderbilt University, were appointed policy and science co-chairs respectively. Meeting for the first time in early February, the Panel was told by its chair and co-chairs that NIH's need for guidance in the face of pending proposals meant that it had approximately six months—including five one- to two-day meetings each month in Washington—in which to complete its work.In his charge, Dr. Varmus asked the Panel to place the possible areas of research into three categories: (1) acceptable for federal funding; (2) warranting additional review; and (3) unacceptable for federal support. In addition, he asked the Panel to draft guidelines for the review and conduct of the research deemed acceptable.Looking back after months of work, I vividly recall a sense of the enormity of the task facing us. We were being asked, in a short period of time, not only to master... (shrink)

Background: Although the term “mental pain” is often the subject of expert opinions regarding claims for damages, there is still no standardized questionnaire in the German-speaking area to operationalize this concept. Therefore, the aim of this work is the development and validation of a self-assessment measurement for psychological pain after traumatic events.Methods:A first version of the questionnaire was applied on a sample of the German speaking general population. After performing an item analysis and exploratory factor analysis, the questionnaire was (...) shortened and tested on a second German speaking general population sample. Finally, the newly developed questionnaire was related to the extent of traumatization and already established instruments for the assessment of psychiatric symptom burden, which included the Brief Symptom Inventory-18 and the Post-traumatic-Stress-Scale.Results: The final version of the FESSTE consists of a total of 30 items and covers the subscales “Somatization,” “Depression,” “Intrusive Memories,” “Dissociation” and “Anxiety,” and a total scale “Mental Pain.” Based on the confirmatory factor analysis, it is assumed that the latent factor structure of the FESSTE can be best described as a bifactor-model. The final version shows a satisfactory model fit, high internal consistencies, and strong positive correlations with the BSI-18 and PTSS-10, as well as the extent of traumatic experiences.Discussion: The FESSTE enables an operationalization of mental pain comprising five subscales and one total scale. What is more, the trauma checklist attached to the FESSTE allows for the standardized assessment of potentially traumatic experiences and the corresponding extent of these experiences. The results indicate that the FESSTE is a reliable and valid self-assessment procedure for mental pain, which is suitable for use in research and in expert practice. (shrink)

BackgroundIn recent years, there have been many studies using the Affective Neuroscience Personality Scales (ANPS) to investigate individual differences in primary emotion traits. However, in contrast to other primary emotion traits proposed by Jaak Panksepp and colleagues, there is a considerable lack of research on the LUST (L) dimension – defined as an individual’s capacity to attain sexual desire and satisfaction – a circumstance mainly caused by its exclusion from the ANPS. Therefore, this study aims to take a first step (...) toward the development of a standardized self-rate measurement for the L-disposition. For this purpose, two versions of the L-scales (L-12 and L-5) were developed and evaluated regarding reliability and aspects of validity.Materials and MethodsAfter a pilot study (N= 204; female: 81%) with an initial 20-item pool item reductions were conducted. This led to the construction of a 12-item (L-12) version and a 5-item version (L-5), which were assessed in a second sample consisting of 371 German-speaking healthy adults (58.50% female) aged 18–69 years (M= 28;SD= 9.75). Aspects of external validity were assessed by investigation of correlations with the ANPS, psychiatric symptoms (Brief Symptom Inventory-18), attachment security (Adult Attachment Scales) and personality functioning (Operationalized Psychodynamic Diagnostics Structure Questionnaire). To evaluate structural validity, both L-scales were investigated via confirmatory factor analysis (CFA).ResultsCronbach’s α indicated excellent internal consistency regarding L-12 (α = 0.90), while L-5 showed acceptable reliability (α = 0.82). CFA of a bifactor model of the L-12 indicated excellent model fit. Moreover, an excellent model fit was observed regarding a single factor model of L-5. For both scales small to moderate positive correlations were observed with SEEKING, PLAY, and secure attachment, while they exhibited small to moderate negative correlations with SADNESS, insecure attachment, lower personality functioning, and increased psychiatric symptom load.ConclusionBoth newly developed scales exhibit satisfying psychometric properties, indicating high reliability, good structural validity and plausible correlations with external criteria. Hence, this study poses an important step toward the operationalization of the LUST concept. However, more research is needed in particular with respect to the scale’s external validity and its applicability in clinical populations. (shrink)

Until recently, ethics was a highlyabstruse activity, with little reference to everydayaffairs. It dealt largely with what is calledmetaethics, and was in danger of becoming moribund asan intellectual activity. But for some years,ethics has been undergoing a process of rejuvenationand development. We now seem to be experiencing thebirth of this new discipline (or at least in the EU –the US has been engaged in it somewhat longer). The EurSafeCongress held at Wageningen University, March 4–6,1999 exemplifies this rejuvenation, and itstrongly (...) suggests that a new discipline is emerging, that is not only exciting from an intellectualperspective, but also addresses issues of fundamentalsocial and political concern. It can beargued that, in this context, ethicists are in the position of guides.It is not their job to pronounce on what is right andwrong, but having trodden many of the theoreticalpaths through the forest, they are in a position toadvise and facilitate sound ethical decision-making byothers. The need for ethical insight in this field islikely to progressively increase over the comingyears. Ethicists have a duty to respond to this need. (shrink)

The dynamic development of science and technology in the last decades has led to new challenges in jurisprudence. This holds for individual fields of doctrinal law as well as the concerned fields of jurisprudence. It is especially significant for the structure of justice, the efficiency of law as a steering instrument of society, and the empirical conditions of legal responsibility. In a jurisprudential perspective, the philosophy of law is rather engaged with the adaptiveness of its traditional principles and categories (...) or the capacity to come to terms with the new developments and less concerned with concrete matters of law. (shrink)

During the last congress of the International Association of Bioethics in Beijing, there was a special session on human enhancement. John Harris, pioneer in the discussions on the ethics of enhancement,1 summarised this session, describing the focus of different panelists.2 This session included: Biopsychological enhancements The possibility of regulating emotions through pharmacological means Biases that may affect our judgments against human enhancement Health care inequalities that will follow from the adoption of genetic technology Social impact and costs of (...) adopting the new technology A discussion on women enhancing their physical strength as men through genetic modification .The Beijing panel did not address women’s involvement in the enhancement scenario. Of course, not every aspect of a topic can be covered in one session of a congress and some aspects may remain unaddressed; mainly, because these sessions draw from the research interests of the presenters. However, neither John Harris nor Julian Savulescu has yet addressed women’s crucial involvement in the enhancement scenario. It is the aim of this paper to draw attention to the invisibility of the ‘vessel’ in these discussions. Enhancement may be justified; but clearly, it will also affect women. In this scenario, will women be worse off?LATE ONSET DISEASES AND ENHANCEMENTFirstly, I would like to point out that I believe that enhancement may be a necessary step in the future of human evolution. As I have explained elsewhere,3 health care systems in the developed world are near to collapse under the pressure of late onset chronic diseases. Largely successful in preventing early deaths in the last century, health care systems have prompted a new plague, recognised lately by the World Health Organization as a new pandemic …. (shrink)

The human is a microcosm, a child of Natura naturans; and so the human is primordially not only a creature but also a creative being: Homo creans. The predestination of philosophy consists in co-clarifying and co-creating the essence (logos) of being. One of the main purposes of philosophical education is to affirm and develop an original thinking of a personality. -/- .

In 2022, the Research Center for Islamic Legislation & Ethics (CILE) and the World Innovation Summit for Health (WISH) submitted a proposal to host the 17th edition of the World Congress of Bioethics. After announcing that the CILE‐WISH proposal was the winning bid, concerns were raised by bioethicists based in Europe and the USA. To address these concerns, the International Association of Bioethics (IAB) developed a dedicated FAQ section, in coordination with the host institutions, for the first time in IAB (...) history. One‐to‐one communication ensued and individual responses were shared with these colleagues. As a continuation of this conversation, we (CILE Acting Director, WISH Research Fellow and Head of Content, and WISH CEO) address the concerns raised in the Letter‐to‐the‐Editor of Bioethics by Graaf et al. As we support the call to revisit some contentious issues within the global community of bioethicists, we maintain that this should be based on meticulously discussed, informed, consistent and equitable criteria. We also argue that mutual learning from diverse cultures and moral traditions is the optimal way for our scholarly community to be truly global and to eschew the flaws ensuing from ethnocentric discourses. (shrink)

In this critique, Martha Nussbaum argues that our dominant theories of development have given us policies that ignore our most basic human needs for dignity and self-respect.

In lieu of an abstract, here is a brief excerpt of the content:The Human Genome ProjectSharon J. Durfy (bio) and Amy E. Grotevant (bio)In recent years, scientists throughout the world have embarked upon a long-term biological investigation that promises to revolutionize the decisions people make about their lives and lifestyles, the way doctors practice medicine, how scientists study biology, and the way we think of ourselves as individuals and as a species. It is called the Human Genome Project, (...) and its ultimate goal is to map and determine the chemical sequence of the three billion nucleotide base pairs that comprise the human genome. The feat is expected to take about fifteen years (see General Surveys).These three billion base pairs include an estimated 50,000 to 100,000 genes. The rest of the genome—perhaps 95 percent of it—is nongenic sequences with unknown function, sometimes called "junk." Determining the order and organization of all this material has been likened to tearing six volumes of the Encyclopaedia Brittanica into pieces, then trying to put it all back together to read the information (Surveys: Hall 1990). The effort could be well worth it, many scientists say, because it is expected to yield major insights into many common and complex diseases, including cancer, cardiovascular disease, and Alzheimer's disease (Debate: Dulbecco 1986; Koshland 1989).The Human Genome Project is not without controversy, however (Debate: Davis 1990; Leder 1990; Rechsteiner 1990). Many scientists fear that funding for it will be diverted from other areas of research, rather than obtained from new funding sources. This has enlivened the debate about the relative value of "big" versus "small" science. Also, the value of undertaking a complete sequencing of the genome has been questioned, especially given the high proportion of non-genic sequences.Advocates of the effort converted many critics by making two alterations in the original plan. Plans were included to simultaneously determine the nucleotide sequence of the genomes of other organisms; this provides comparisons and points of reference for the human sequence (U.S.: NIH/DOE 1990). Second, in response to concerns about the high cost of developing technology to sequence the whole [End Page 347] genome, the focus moved from large-scale sequencing to mapping the genome, which would hasten the search for disease genes (U.S.: NIH/DOE 1990).The ideal map would be both genetic, locating DNA markers, or signposts, at closely spaced intervals along the chromosomes, and physical, indicating the exact distance between these markers (Map: McKusick 1991). Since 1973, Human Gene Mapping workshops (HGM) have been held at least every two years to locate, compare, and compile genetic markers. This information is published and is accessible through Genome Database at Johns Hopkins University (McKusick 1991). The most recent Human Genome Mapping workshop was held in August 1991, at which the Human Genome Organization (HUGO) began to assume increased responsibility for coordination of the international mapping effort (Surveys: Maddox 1991).Historical Background of the United States EffortThe first serious discussions about sequencing the entire human genome occurred at a workshop at the University of California at Santa Cruz in 1985 (U.S.: Sinsheimer 1989). A second workshop, organized by the U.S. Department of Energy (DOE) and held in March 1986, addressed the feasibility of an organized program (U.S.: DOE 1986). Shortly thereafter, DOE instituted its own genome project (U.S.: DOE 1987). Reports in early 1988 from both the National Research Council (NRC) of the National Academy of Sciences (NAS) and Congress' Office of Technology Assessment (OTA) (U.S.: NRC 1988; OTA 1988) served as catalysts, and in fiscal year 1988, the U.S. Congress officially launched the Human Genome Project by appropriating funds to both the Department of Energy and the National Institutes of Health (NIH).To avoid potential congressional "meddling" (U.S.: Roberts 1988), NIH and DOE drafted a memorandum of understanding for interagency coordination in October 1988 (U.S.: NIH/DOE 1990). The agencies then created both separate and joint committees, and working groups to administer the project. NIH established the Office of Human Genome Research in 1988 (directed by James D. Watson) to plan and coordinate NIH genome activities. That office has evolved into the National Center for Human Genome Research (NCHGR... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.2 (2002) 215-224 [Access article in PDF] Bioethics Inside the Beltway Expanding Human Research Oversight Ellen Holt [Table]Overwhelmed by all the changes and proposed changes in the system to ensure human subject protection? It is an important subject and one in which everyone is interested. Being for human subject protection is like being for Mom. However, we all know that Mom (...) sometimes can be a handful! So I shall quickly review how we got to where we are, what is being done, and who is doing it. The table at the end of this article provides an additional summary of the current state of human subject protections. How We Got Here The current system of human subject protection was built 30 years ago with Institutional Review Boards (IRBs) as the cornerstone. Some well-publicized system failures in the last decade prompted evaluations that identified increasing volume and research complexity as primary threats to the system's effectiveness. In response, the Department of Health and Human Services (DHHS) Office of Inspector General (OIG 1998), and the National Bioethics Advisory Commission (NBAC 2001) issued recommendations calling for education and reform. Since then, initiatives in pursuit of these objectives have been rolling out non-stop. What Is Being Done The Office of Human Research Protections (OHRP) is leading the effort for DHHS, holding noncompliant research organizations accountable, while expanding the government's capacity for oversight, monitoring, and educating the research community. OHRP already has leveraged resources by: (1) implementing a unified federal registration system for all IRBs that identifies where IRBs are, how they are constituted, what kinds of research they are reviewing, and what volume of work they handle; (2) implementing a streamlined assurance process allowing all federal agencies to recognize a single, common assurance and avoid redundancy. The assurance is a commitment from any entity that receives federal funds for research to follow federal rules for protection of research subjects; and (3) redeploying resources from the process of negotiating assurances to supporting [End Page 215] quality improvement, including increasing the number site visits and providing IRBs with tools for self assessment and guidance for improvement.The goal is to prevent problems before they occur, and positive reinforcement and supportive training are the preferred themes. OHRP does wield a big stick and can shut down clinical studies in response to lax oversight, but it also has developed a big carrot by creating a national awards program to recognize excellence in protection of human research subjects—e.g., best practices, innovations in protecting research volunteers, and lifetime achievement for outstanding protection activities.Dr. Greg Koski, Director of OHRP, also is working with other government agencies to consolidate and build a comprehensive program. OHRP has four goals for a new oversight framework: Simplicity, Uniformity, Efficiency and Effectiveness. Selecting representatives from throughout the federal government, Dr. Koski has created the "SUEE" task force to identify and eliminate inefficiencies between the various agencies' human testing regulatory approaches. In addition, the SUEE task force will suggest improvements to current OHRP practices that can be achieved relatively quickly and easily.OHRP is working in concert with the Food and Drug Administration (FDA), which in October 2001, established the Office of Good Clinical Practice (OGCP) to improve the conduct and oversight of clinical research and to promote the protection of participants in FDA-regulated clinical research. Congressional Developments Although Dr. Koski is leading an aggressive charge to consolidate oversight across the federal government, many feel that reform will require legislation to succeed.Action on Capitol Hill is encouraging Bush administration efforts to reform oversight of clinical research. The House International Relations Committee has approved a measure that protects individuals in clinical trials overseas. A six-part Washington Post series (17-22 December 2000), "The Body Hunters," prompted an amendment to the Export Administration Act that, if finalized, will require drug companies to show that a U.S. ethics committee has approved the clinical trial as part of the application for authorization to export the investigational product.Members of Congress also are considering legislation to expand federal oversight of... (shrink)

This book is a collection of the selected proceedings of the 4th International Conference "Human Being in Contemporary Philosophical Conceptions," which was held under the patronage of UNESCO at Volgograd State University (Russia) on May 28-31, 2007. In the letter to the organizers, Mr. Koïchiro Matsuura wrote: "I should like to congratulate you on this important initiative to promote philosophical reflection, which is one of the central objectives of UNESCO's Intersectoral Strategy on Philosophy." There is an interesting fact: the (...) 19th World Congress of Philosophy in Moscow (1993) had no session on philosophical anthropology, the next Congress in Boston (1998) had one such session, the 21st Congress of Philosophy in Istanbul (2003) had already four sessions, and the 22nd World Congress of Philosophy in Seoul (2008) had six sessions on philosophical anthropology. Obviously, we may observe a new anthropological renaissance in contemporary thought. This book serves the philosophical anthropology becoming as well. Perhaps an idea of integral studies is the most attractive trend in the contemporary philosophy and science. The book presents an experience in integral philosophy of human being. Also, the development of philosophical anthropology is closely connected with practical tasks. Our political activities, welfare projects and educational programs can become really useful only when we are guided by knowledge of what human being is, what we are able to do, what are own needs, and what we must become. Philosophical anthropology could correctly define the research purposes of all human sciences. This volume includes various reflexions and styles of thinking. By this, all the papers demonstrate metaphysics of respect for human being. The contributors, scholars from the different countries, are open for free discussions and fresh ideas. (shrink)

"The Bush administration and Congress are in concert on the goal of developing a fleet of unmanned aircraft that can reduce both defense costs and aircrew losses in combat by taking on at least the most dangerous combat missions. Unmanned combat aerial vehicles (UCAVs) will be neither inexpensive enough to be readily expendable nor-- at least in early development-- capable of performing every combat mission alongside or in lieu of manned sorties. Yet the tremendous potential of such systems is (...) widely recognized, and allies as well as potential adversaries are moving quickly to mount their own research and development programs. The United States is committed to fielding UCAV capabilities by 2010, principally for the missions of suppression of enemy air defense and deep strike, which are among the highest risk tasks for the Air Force and naval aviation."--Overview. (shrink)

The paper develops a theory of human rights under three main headings: that ways of acting or of being treated require effective normative justification, that they must have authoritative political endorsement or acknowledgement, and that they must be maintained by conforming conduct and, where need be, by governmental enforcement. The paper, then, applies this notion of human rights to two main cases: as constitutional rights within individual states , and as international human rights maintained by confederations of (...) states or by looser international coalitions. (shrink)

The key issue of traditional theories of human nature in China is De or virtue, Yu or desire and their correlation. It leads to two developing currents: one is the old tradition since Xia, Shang and Zhou, the Three Dynasties which take desire as nature, another is the new tradition later Confucius initiated which take virtue as nature. So the understanding of human nature in early China experienced a process from desire to virtue, or from the instinct of (...) human to the essence of human. Prior to Confucius, nature is desire and instinct. In that time, the theories of human nature has two themes, namely to manage nature by virtue and to explain nature by Qi. Since Lao Zi, virtue was taken as the inner essence of human. Later Confucius further to take virtue as nature directly, so completes the fundamental transformation of traditional theory of human nature. This is the source of the idea nature of reason and the origin of the theory nature is good. Zisi advocated “what Heaven has conferred is called the nature” to promote the new tradition, and named desire as “the inner”. The new excavated bamboo book Xing Zi Ming Chu not only developed the idea of “the inner” of Zisi, but also further to restore desire as nature, and constructed a unique system of outer moral apriorism for it. Shortly afterward, Mencius turns this trend and advocates none but the four beginnings is nature, desire only is impartment, therefore he develops the new tradition to extremes. Even though, before the period between Tang and Song dynasties, the mainstream of the theory of human nature in China was the oldtradition, and that the new tradition merely like a flash in the pan. In fact, the dualism of human nature in Song and Ming dynasties carried on the old tradition, and at the same time, succeeded the new tradition, and put them into a unified thought system. (shrink)

The paper covers the origins, development, perspectives and solutions of the civilizational catastrophe of humanity. Humanity is defined as the restricted number of ideal, material, and temporal qualities of human beings. Its civilizational catastrophe is the contingent evolution of the specific element of human consciousness implementing rationality and technique, knowing no limits and no purposes, progressing outside ideal, material, and temporal boundaries of humanity, overcoming on its way limitations of human savagery and transcendental elements. Due to (...) the particular quality of civilizational development, the law of humanity catastrophe could be stated, as the stage of civilization is inversely proportional to the level of humanity in human beings. Civilization catastrophe couldfinalize into other-being or non-being of humanity. Its evolution canalizes into different fields of activity, which are named categories of humanity civilization catastrophe, because each of them leads towards cardinal qualitative changes of humanity or its annihilation. The basic categories are elimination – civilized ability of humans to kill one another, speedization – permanent acceleration of the overhuman speed of civilizational processes; babylonization – the cobeingof different collective qualitative realizations; supermanization – scientific production of over-human being; transsexualization – the negation of sexual immobility of humanity; ballastization – the overproduction of information; ritualizatin – the murder of simple love activity in Jesus manner into ecclesiastic discourse. The onlysalvation of humanity is the total negation of civilization and selftransformation of humankind on the basis of its transcendental element which is love knowing no exceptions. (shrink)

The paper develops a theory of human rights under three main headings: that ways of acting or of being treated require effective normative justification, that they must have authoritative political endorsement or acknowledgement, and that they must be maintained by conforming conduct and, where need be, by governmental enforcement. The paper, then, applies this notion of human rights to two main cases: as constitutional rights within individual states (the case primarily contemplated within the UN's Universal Declaration), and as (...) international human rights maintained by confederations of states or by looser international coalitions. (shrink)

The paper develops a theory of human rights under three main headings: that ways of acting or of being treated require effective normative justification, that they must have authoritative political endorsement or acknowledgement, and that they must be maintained by conforming conduct and, where need be, by governmental enforcement. The paper, then, applies this notion of human rights to two main cases: as constitutional rights within individual states, and as international human rights maintained by confederations of states (...) or by looser international coalitions. (shrink)

The so-called Brundtland-Report defines Sustainable Development as a conception of intra- and intergenerational justice, which is to be realized by a globally just distribution of possibilities for satisfying human basic needs as well as assuring such possibilities for future generations. Hence, any political and/or societal decision is addressed by the ethical demands of Sustainable Development insofar it affects possibilities for satisfying human basic needs. In particular, this concerns – contrary to the widespread opinion that Sustainable (...) class='Hi'>Development only has to deal with problems of environmental ethics – the legitimization of biomedical applications. After all, especially such decisions often face the problem of measuring and trading-off potential advantages and disadvantages regarding possibilities for satisfying human basic needs. Based on the example of decisions about establishing biobanks, my talk firstly will show that Sustainable Development actually demands much more from political and societal decisions than just being concerned about environmental ethics. Secondly, it will clarify these demands in detail. Thirdly, it will address the issues of how these demands can be implemented adequately. My talk therefore will show which conditions political and/or societal decision processes have to meet in order to comply with Sustainable Development. (shrink)

The so-called Brundtland-Report defines Sustainable Development as a conception of intra- and intergenerational justice, which is to be realized by a globally just distribution of possibilities for satisfying human basic needs as well as assuring such possibilities for future generations. Hence, any political and/or societal decision is addressed by the ethical demands of Sustainable Development insofar it affects possibilities for satisfying human basic needs. In particular, this concerns – contrary to the widespread opinion that Sustainable (...) class='Hi'>Development only has to deal with problems of environmental ethics – the legitimization of biomedical applications. After all, especially such decisions often face the problem of measuring and trading-off potential advantages and disadvantages regarding possibilities for satisfying human basic needs. Based on the example of decisions about establishing biobanks, my talk firstly will show that Sustainable Development actually demands much more from political and societal decisions than just being concerned about environmental ethics. Secondly, it will clarify these demands in detail. Thirdly, it will address the issues of how these demands can be implemented adequately. My talk therefore will show which conditions political and/or societal decision processes have to meet in order to comply with Sustainable Development. (shrink)

The so-called Brundtland-Report defines Sustainable Development as a conception of intra- and intergenerational justice, which is to be realized by a globally just distribution of possibilities for satisfying human basic needs as well as assuring such possibilities for future generations. Hence, any political and/orsocietal decision is addressed by the ethical demands of Sustainable Development insofar it affects possibilities for satisfying human basic needs. In particular, this concerns – contrary to the widespread opinion that Sustainable Development (...) only has to deal with problems of environmental ethics – the legitimization of biomedical applications. After all, especially such decisions often face the problem of measuring and trading‐off potential advantages and disadvantages regarding possibilities for satisfying human basic needs. Based on the example of decisions about establishing biobanks, my talk firstly will show that Sustainable Development actually demands much more from political and societal decisions than just being concerned about environmental ethics. Secondly, it will clarify these demands in detail. Thirdly, it will address the issues of how these demands can be implemented adequately. My talk therefore will show which conditions political and/or societal decision processes have to meet in order to comply with Sustainable Development. (shrink)

The so-called Brundtland-Report defines Sustainable Development as a conception of intra- and intergenerational justice, which is to be realized by a globally just distribution of possibilities for satisfying basic human needs as well as by assuring such possibilities for future generations. Hence, any political and/orsocietal decision is addressed by the ethical demands of Sustainable Development insofar it affects possibilities for satisfying basic human needs. In particular, this concerns – contrary to the widespread opinion that Sustainable (...) class='Hi'>Development only has to deal with problems of environmental ethics – the legitimization ofbiomedical applications. After all, especially such decisions often face the problem of measuring and trading-off potential advantages and disadvantages regarding possibilities for satisfying human basic needs. Based on the example of decisions about establishing biobanks, the paper firstly will show that Sustainable Development actually demands much more from political and societal decisions than just being concerned with environmental ethics. Secondly, itwill clarify these demands in detail. Thirdly, it will address the issues of how these demands can be implemented adequately. The paper therefore will show which conditions political and/or societal decision processes have to meet in order to comply with Sustainable Development. (shrink)

The so-called Brundtland-Report defines Sustainable Development as a conception of intra- and intergenerational justice, which is to be realized by a globally just distribution of possibilities for satisfying human basic needs as well as assuring such possibilities for future generations. Hence, any political and/or societal decision is addressed by the ethical demands of Sustainable Development insofar it affects possibilities for satisfying human basic needs. In particular, this concerns – contrary to the widespread opinion that Sustainable (...) class='Hi'>Development only has to deal with problems of environmental ethics – the legitimization of biomedical applications. After all, especially such decisions often face the problem of measuring and trading-off potential advantages and disadvantages regarding possibilities for satisfying human basic needs. Based on the example of decisions about establishing biobanks, my talk firstly will show that Sustainable Development actually demands much more from political and societal decisions than just being concerned about environmental ethics. Secondly, it will clarify these demands in detail. Thirdly, it will address the issues of how these demands can be implemented adequately. My talk therefore will show which conditions political and/or societal decision processes have to meet in order to comply with Sustainable Development. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Religion after September 11th World CongressMontreal, Quebec, September 11–15, 2006Frances S. AdeneyThis global conference, organized by Professor Arvind Sharma and a team of international scholars, began on the fifth anniversary of the terrorist attacks on the World Trade Center in New York City and the Pentagon in 2001. Conference themes stressed the commonalities among religions seeking peace, the unity all religions share in our common humanity, the necessity for (...) religions to formulate cogent views of human rights, and the importance of nonviolent socially engaged religion.Those themes were carried through the congress in individual paper presentations, panel discussions, and plenary sessions. The participants represented many nations and religions with Buddhist, Hindu, Jain, Muslim, Jewish, and Christian scholars, religious leaders and lay persons participating at every level of the conference.A central feature of many of the presentations was the connection between the political realm and religion. How religions could formulate their sources for human rights and press for human rights implementation, what forms of just war theory could be developed for the current age of terrorist warfare, and how religious groups could be protected from indiscriminate or dishonest proselytizing were among the topics addressed.The Religion after September 11th World Congress brought together people of different religions, political persuasions, and cultures around issues crucial to us all. [End Page 141]Frances S. AdeneyLouisville Presbyterian Theological SeminaryCopyright © 2007 The University of Hawai'i Press... (shrink)

I discuss the nature and genesis of international development ethics as well as its current areas of consensus, controversies, challenges, and agenda. A relatively new field of applied ethics, international development ethics is ethical reflection on the ends and means of socioeconomic change in poor countries and regions. It has several sources: criticism of colonialism and post-World War II developmental strategies; Denis Goulet's writings; Anglo-American philosophical debates about the ethics of famine relief; and Paul Streeten's and Amartya Sen's (...) approaches to development. Development ethicists agree that the moral dimension of development theory and practice is just as important as the scientific and policy components. What is often called "development" may be bad for people, communities, and the environment. Hence, the process of development should be reconceived as beneficial change, usually specified as alleviating human misery and environmental degradation in poor countries. (shrink)

My aim is to defend the concept of sustainable development both against economists' interpretations that make it involve perpetual gains to human well-being, and against sceptical accounts that make its meaning vary from speaker to speaker, serving as a cloak for the status quo and the suggestion that it be discarded. The assumptions of the economists' interpretation are questioned, and the centrality among early advocates of sustainable development of sustainable practices and of sustainability being social and ecological (...) as well as economic is used to support a different interpretation. On this interpretation, sustainable development involves the satisfaction of basic needs and comprises the precondition of economically, socially and ecologically sustainable practices. What is to be sustained is overtly practices and more basically intrinsic value. This account is shown to assist with solving conflicts between nature preservation and alleviation of poverty, solutions to which are argued to embody sustainable development even in the absence of prospects of ever-increasing quality of life for humanity. While this interpretation already counts against sceptical accounts, these are also shown to arise from the adoption of the radical concept of sustainable development by governments, international agencies and multinational business at the Rio Summit of 1992, and consequent re-interpretations. But the rational response is not discarding the concept but rediscovering the radical core and potential to which these various bodies are in theory committed. (shrink)

My aim is to defend the concept of sustainable development both against economists' interpretations that make it involve perpetual gains to human well-being, and against sceptical accounts that make its meaning vary from speaker to speaker, serving as a cloak for the status quo and the suggestion that it be discarded. The assumptions of the economists' interpretation are questioned, and the centrality among early advocates of sustainable development of sustainable practices and of sustainability being social and ecological (...) as well as economic is used to support a different interpretation. On this interpretation, sustainable development involves the satisfaction of basic needs and comprises the precondition of economically, socially and ecologically sustainable practices. What is to be sustained is overtly practices and more basically intrinsic value. This account is shown to assist with solving conflicts between nature preservation and alleviation of poverty, solutions to which are argued to embody sustainable development even in the absence of prospects of ever-increasing quality of life for humanity. While this interpretation already counts against sceptical accounts, these are also shown to arise from the adoption of the radical concept of sustainable development by governments, international agencies and multinational business at the Rio Summit of 1992, and consequent re-interpretations. But the rational response is not discarding the concept but rediscovering the radical core and potential to which these various bodies are in theory committed. (shrink)

According to author, value of human dignity has its place in his ethics of social consequences which is a form of non-utilitarian consequentialism. This is so because it is compatible with the value of positive consequences that creates one of the crucial criteria in ethics of social consequences. There exist two aspects of human dignity in this ethical theory. The first is related to the value of life that is worthy of esteem and respect, which brings positive consequences (...) (moral biocentrism), second aspect is related to the fact that human dignity is a function of the positive consequences of our action and behavior prevailing over the negative consequences of our action and behavior. This creates a basis for assigning moral agents with an additional, qualitative value of human dignity. In caseof human beings without developed consciousness and who are only potential moral agents, the first aspect of human dignity is dominant in our judgments about them. In the judgments concerning moral agents the second aspect of human dignity dominates. (shrink)

The main aim of the paper is to reflect the problem of the concept of human rights as well as to make analysis from the perspective of human security. The principal attention is paid to the fundamentals of human rights, first of all, to the human security. Only the world that ensures personal and national security and creative development for its entire people can be world of the real embodiment of human rights. Author considers (...) the education as one of the backbones of human security due to the fact that education fulfils its true purpose by allowing individuals to make their own decisions and take control of their own lives; and creates persons identity. The possibility to develop a human and social identity means a real implementation of human rights. Human rights, based on human security and development, is a permanent process that takes its point of departure in human and social needs within cultural characteristics. So it means that human rights can not be defined once and for all. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 171-174 [Access article in PDF] Bioethics Inside the Beltway The Oversight of Human Gene Transfer Research LeRoy Walters Jesse Gelsinger's death last September in a gene transfer study being conducted at the University of Pennsylvania has helped to spark a national debate. In part, this debate parallels the broader discussion of how human subjects research should be reviewed and regulated (...) in the United States. However, human gene transfer research is one of a handful of biomedical technologies that seem to deserve special attention, at least in the early years of their development.The major participants in the national debate on human gene transfer include the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Bioethics Advisory Commission, members of Congress, biotechnology and pharmaceutical companies, disease-oriented advocacy groups, reporters, and academics. At the December 1999 meeting of the NIH Recombinant DNA Advisory Committee (RAC), the protocol that involved Jesse Gelsinger was a central focus of discussion, but other topics emerged as well. One ad hoc panel reviewed adverse events that had occurred in other research protocols using adenovirus vectors, while a second proposed changes in the general system for reporting adverse events to NIH and the RAC.During the first several months of the year 2000, the United States Congress also became involved in the human gene transfer debate. In February, Senator Bill Frist (R-TN) convened a hearing to which Jesse Gelsinger's father, representatives of NIH and FDA, and several other witnesses were invited. At approximately the same time, the House Commerce Committee and its Subcommittee on Oversight and Investigations initiated their own inquiries, asking the Office of Inspector General at the Department of Health and Human Services to review the oversight roles of NIH and FDA. In March and April, the House committee also wrote directly to the NIH Director, the FDA Commissioner, and the President of the University of Pennsylvania, requesting extensive documentation on gene transfer, in general, and the trial in which Jesse Gelsinger was involved, in particular. Congressman Henry Waxman (D-CA) and Senator Edward Kennedy (D-MA) have also raised questions and proposed solutions in multiple letters to the NIH Director and the Secretary of Health and Human Services. [End Page 171]The major general questions that have emerged from this discussion are the following:(1) What kinds of information about adverse events should be reported by researchers or sponsors during the course of human gene transfer trials?(2) To what group or groups should adverse-event information be reported? How often and in what ways should the information be analyzed?(3) Should the information about adverse events remain confidential, or should it be discussed publicly?(4) How can the disclosure and consent process in gene transfer trials be improved?(5) Which federal agency should have primary responsibility for overseeing human gene transfer research, and how can it best fulfill its oversight role?How these questions are answered will have immediate relevance to the field of human gene transfer research as it enters into its next phase. At the same time, the models that are created for this important cutting-edge field also may be useful in other complex or controversial arenas of biomedical research, for example, xenotransplantation or human embryonic stem-cell research. In addition, the lessons learned from this one important area of human subjects research may suggest ways to improve protections for all the volunteers who make clinical research--and medical progress--possible.In the remainder of this article, I will turn from reporting, in as objective a way as possible, on the status of the public policy debate about human gene transfer research to suggesting measures for improving the current oversight system for such research. My initial general recommendation is that we should not expect a single regulatory agency to be solely responsible for a field as large and dynamic as human gene transfer research. Rather, there should be some helpful redundancy or, to change the metaphor, checks and balances in the public oversight of this field. Thus, an... (shrink)

In what follows, I focus on the partiality and fallibility of each of us as individuals, and explore what that means for us as epistemic agents. When we examine the tradition of Western European thought, we note that most epistemological theories assume individuals can know the answer, and are able to critique what is passed down to others as socially constructed knowledge. Many have made the argument that while humanity can be deceived, one individual can know, and therefore teach the (...) others about their deceptions and false beliefs. I argue that because we are embedded and embodied social beings who do not have transcendental, objective, "God's eye views" of the world in which we live, we need each other to help us be potential knowers able to make knowledge claims. Others help us become aware of our own situatedness and help us develop enlarged views. Rather than thinking that individual philosophers, credentialed experts in their field of study, know more and therefore have knowledge they can teach humanity, I argue that all of us, as members of humanity, have much that we can teach each other. My position is that it is only with the help of others that we are able to know anything. (shrink)

Marx's theory of alienation is of great importance to contemporary political developments, due both to the re-emergence of anti-capitalist struggle in Zapatismo, 21st Century Socialism, and the New Democracy Movement, and to the fact that the most important theorists of these movements single out Marx's theory of alienation as critical to their concerns. Despite this renewed practical and theoretical interest, however, these and other writers have been sparing in their accounts of the normative components which the theory of alienation incorporates. (...) Along with many recent commentators, I argue that the normative components of the theory of alienation are to be found in a notion of human development, and that a conception of the particular importance of the human species-essence plays a critical role in this respect. However, I take a different, and somewhat more detailed, tack than these previous authors in presenting a more detailed conception of human development and flourishing on the basis of Marx's c... (shrink)

Integral human development is a human-centered development perspective that originated from Catholic social teaching. The perspective holds that authentic development is development that makes every person “more human.” Although it is seldom named in the literature, integral human development has had considerable influence on notions of authentic development, and in turn, development ethics. In this short chapter, I provide a brief explanation of the origins and implications of the conceptual (...) foundations of integral human development both within and beyond the Catholic Church. I argue that integral human development offers a truly radical participatory approach to human development. I briefly raise and respond to some concerns about agency, civic liberty, and integral human development’s connection to the Catholic Church. I conclude with a short explanation of integral human development in practice. (shrink)

Drawing on and integrating unorthodox thought from a broad range of disciplines including clinical psychology, linguistics, philosophy, natural science and psychoanalysis, this book offers a provocative, original analysis of the global threats to our survival, and proposes a remedy.

A series of features of the contemporary globalization of human society, especially its dual positive arid negative effects, shows that contemporary globalization has great significance for the survival and development of mankind as a whole. From the point of view of its deep axiological significance, globalization has resulted in the formation of common human interests that manifest themselves negatively as the emergence of various global problems. The formation of common human interests and the emergence of global (...) problems in turn have objectively introduced a specific norm of value to contemporary global society. This norm of value requires people in the contemporary global society to take common human interests as their value orientation when dealing with the relationship between the human being and the world, if they are to solve various contemporary global problems and make possible the continued survival of mankind and the sustainable development of human society. (shrink)

This paper concerns broadly with the works of such ethical postmodern theorists as Jacques Derrida, Emmanuel Levinas, Giles Deleuze, focusing on how we can contribute to the development of their ideas by discussing Laozi and Zhuanzi’s Taoism, Buddhism, and modern Korean Neo-Confucianism of Toe-gae Lee. I claim that for criticism and art, literature, film and culture as well as philosophy itself, we are now facing this new need of another notion of subjectivity that not only accepts difference but takes (...) the position of whole positivity toward the Other. This different view of subjectivity that can be called "the sublime subjectivity" or the sublime totality of a human being or a society is essentially an aesthetic one, rather than one that depends upon logic, and it is vital to take advantage of Oriental ideas. From the perspective of the ethics of Levinas, I first place the sublime, jouissance, or pure enjoyment, at the heart of literary criticism. The pure sensibility of the sublime, or jouissance, unlike the raw feelings of pleasure, is an aesthetic sensibility beyond the ontological unity of feelings of pleasures and pains. Then with the Oriental thought, I make an attempt to contribute to the development of the ideas on the ethics of the relation of the reader and the literary text’s language. Laozi’s Taote Ching, Chuanzi, Diamond Sutra, and Toe-gae Lee’s notion of Taeguk are briefly explored in view of the aesthetic transphenomenal dimension and the sublime totality. (shrink)

In Avicenna's allegorical treatises humans are envoys of two worlds; on one hand, as products of natural evolution they are representatives of the earthly, physical world; on the other, as products of divine emanation they represent the cosmic principle. But in the process of spiritual contemplation they overcome theduality and split nature of their being and restore the fractured harmony between themselves and the cosmic world. Thus, having attained the highest form of cognition and moral beauty, the individual 'self becomes (...) the universal essence identified in the language of Sufism as 'the perfect human'. Avicenna tries in hisallegorical treatises to makes his of becoming a perfect individual is not a sudden act of illumination, but a pyramid-like development, arranged, like the heavenly spheres, hierarchically, and calling for an incredible exertion of followers recognize that each person is able to rise to the level of the 'perfect individual', the road to which lies through moral purification and mastery of learning and the sciences, primarily philosophy. But the process strength, self-limitation and effort of will to pass through the stages of perfection and achieve the aim. (shrink)

Marx's theory of alienation is of great importance to contemporary political developments, due both to the re-emergence of anti-capitalist struggle in Zapatismo, 21st Century Socialism, and the New Democracy Movement, and to the fact that the most important theorists of these movements single out Marx's theory of alienation as critical to their concerns. Despite this renewed practical and theoretical interest, however, these and other writers have been sparing in their accounts of the normative components which the theory of alienation incorporates. (...) Along with many recent commentators, I argue that the normative components of the theory of alienation are to be found in a notion of human development, and that a conception of the particular importance of the human species-essence plays a critical role in this respect. However, I take a different, and somewhat more detailed, tack than these previous authors in presenting a more detailed conception of human development and flourishing on the basis of Marx's conceptions of powers and needs and comparing it to the most prominent non-Marxist theory of human development: the capabilities approach. I then show that this understanding of powers and needs, along with a notion of the particularly important human power of conscious self-directed activity, underpins the critique of capitalism Marx presents in his theory of alienation. This will allow us a better understanding of the normative components of Marx's theory of alienation and its potential relevance and plausibility to the theorists and movements it is influencing. (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)