Volume 20, Issue 7, July 2020, Page 150-152.

Tom Andersen’s reflecting team process, which allowed families to witness and respond to the talk of professionals during therapy sessions, has been described as revolutionary in the field of family therapy. Reflecting teams are prominent in a number of family therapy approaches, more recently in narrative and dialogical therapies. This way of working is considered more a philosophy than a technique, and has been received positively by both therapists and service users. This paper describes how dialogical therapists conceptualise the reflective (...) process, how they work to engage families in reflective dialogues and how this supports change. We conducted semi-structured, reflective interviews with 12 dialogical therapists with between 2 and 20 years of experience. Interpretative Phenomenological analysis of transcribed interviews identified varying conceptualisations of the reflecting process and descriptions of therapist actions that support reflective talk among network members. We adopted a dialogical approach to interpretation of this data. In this sense, we did not aim to condense accounts into consensus but instead to describe variations and new ways of understanding dialogical reflecting team practices. Four themes were identified: Lived experience as expertise; Listening to the self and hearing others; Relational responsiveness and fostering connection; and Opening space for something new. We applied these themes to psychotherapy process literature both within family therapy literature and more broadly to understand more about how reflecting teams promote helpful and healing conversations in practice. (shrink)

For a computable structure A\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${\mathcal{A}}$$\end{document}, there may not be a computable infinitary Scott sentence. When there is a computable infinitary Scott sentence φ\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${\varphi}$$\end{document}, then the complexity of the index set I\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${I}$$\end{document} is bounded by that of φ\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${\varphi}$$\end{document}. There are results giving “optimal” Scott sentences for (...) structures of various familiar kinds. These results have been driven by the thesis that the complexity of the index set should match that of an optimal Scott sentence. In this note, it is shown that the thesis does not always hold. For a certain subgroup of Q\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${\mathbb{Q}}$$\end{document}, there is no computable d-Σ2\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${\Sigma_2}$$\end{document} Scott sentence, even though the index set is d-Σ20\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${\Sigma^0_2}$$\end{document}. (shrink)

The importance of non-codifying DNA polymorphism for the administration of justice is now well known. In Spain, however, this type of test has given rise to questions in recent years: Should consent be obtained before biological samples are taken from an individual for DNA analysis? Does society perceive these techniques and methods of analysis as being reliable? There appears to be lack of knowledge concerning the basic norms that regulate databases containing private or personal information and the protection that information (...) of this type must be given. This opinion survey and the subsequent analysis of the results in ethical terms may serve to reveal the criteria and the degree of information that society has with regard to DNA databases. In the study, 73.20% of the population surveyed was in favour of specific legislation for computer files in which DNA analysis results for forensic purposes are stored. (shrink)

Recent years have witnessed tremendous growth in the epidermal growth factor (EGF) family of peptide growth factors and the ErbB family of tyrosine kinases, the receptors for these factors. Accompanying this growth has been an increased appreciation for the roles these molecules play in tumorigenesis and in regulating cell proliferation and differentiation during development. Consequently, a significant question has been how diverse biological responses are specified by these hormones and receptors. Here we discuss several characteristics of hormone-receptor interactions and receptor (...) coupling that contribute to specificity: 1) a single EGF family hormone can bind multiple receptors; 2) a single ErbB family receptor can bind multiple hormones; 3) there are three distinct functional groups of EGF family hormones; 4) EGF family hormones can activate receptors in trans, and this heterodimerization diversifies biological responses; 5) ErbB3 requires a receptor partner for signaling; and 6) ErbB family receptors differentially couple to signaling pathways and biological responses. BioEssays 20:41–48, 1998. © 1998 John Wiley & Sons, Inc. (shrink)

No. 20 in the Marquette series "Mediaecal [[sic]] Philosophical Texts in Translation," this translation is based on J. R. O’Donnell’s edition of the only extant manuscript of the Universal Treatise, and is preceded by a helpful introduction of 28 pp. plus a selected bibliography. An English version of this work should be welcomed by scholars not versed in Latin who are nonetheless interested in Nicholas’ thought, whether because of his highly critical reactions to Aristotle and Averroes or because of certain (...) similarities between his philosophical views and those of Hume. If the latter are primarily to be found in his two extant letters to Bernard of Arezzo, the former constitute the very heart of this work. It should also be noted that the Universal Treatise was originally intended to recall university professors, especially at Paris, to the study of Christianity and ethics. Written c. 1340, its attacks on Aristotle and Averroes were intended to contribute to this purpose. Nevertheless, some of the positions expressed therein were to bring Nicholas himself into conflict with ecclesiastical authority. Not least among these troublesome views from the standpoint of religious orthodoxy was the suggestion that all things are eternal. The situation was further complicated by Nicholas’ contention that not all the views found in the Treatise represent his own convictions. Many are to be taken as probable or more probable. In his attacks on Aristotle and Averroes he does not claim to disprove demonstratively what they held, but only to show that their opinions are less probable than those he advances. Granted that the chief unifying factor in this work is negative, its anti-Aristotelian and anti-Averroistic thrust, yet, as is suggested in the introduction, some kind of positive unifying theme is also at work, Nicholas’ view of the good. Since the universe must always contain the same amount of goodness, everything in it must remain in existence. Therefore the universe consists of unchangeable atoms. From this atomism follows the view that space consists of points and time of instants. Since change in quantity and place cannot produce or destroy real being, Nicholas must therefore hold that quantity is really identical with material substance and that movement is nothing but change in the position of atoms. Moreover, if things are eternal, it is probable that the same holds for the actions of the soul. As eternal such acts remain unchanged and hence do not vary in degree of intensity. They simply pass from person to person. Consequently, the same object cannot be seen clearly and obscurely. Nicholas also suggests that all things are as they appear, granted that such must be accepted not because it has been proved but because this conviction gives pleasure to the mind. Again, he argues that since a cause can produce only one kind of effect, not all things have been produced by God whether as their total or as their partial cause. He then suggests that because God’s power is infinite, no effect can be produced by him naturally. As finite such an effect would not be proportioned to his infinite power. His arguments against any kind of Averroistic theory of one separate intellect for all mankind are both interesting and unusual. In fact he appears to go to the opposite extreme, not only defending individual intellects for individual men but also suggesting that in one and the same soul there are as many intellects as concepts. That Nicholas himself saw some difficulties with this position may be inferred from his admonition that further thought be given to this matter. If the same might be said of other unusual theories advanced in the Treatise, its translators are to be commended for having made it available to English language readers.—J. F. W. (shrink)

DNA gyrase, an enzyme unique to prokaryotes, has been implicated in almost all processes that involve DNA. Although efficient inhibitors of this protein have been known for more than 20 years, none of them have enjoyed prolonged pharmaceutical success. It is only recently that the mechanisms of inhibition for some of these classes of drugs have been established unequivocally by X‐ray crystallography. It is hoped that this detailed structural information will assist the design of novel, effective inhibitors of DNA gyrase.

To characterize human emotions, researchers have increasingly utilized Automatic Facial Expression Analysis (AFEA), which automates the Facial Action Coding System (FACS) and translates the facial muscular positioning into the basic universal emotions. There is broad interest in the application of FACS for assessing consumer expressions as an indication of emotions to consumer product-stimuli. However, the translation of FACS to characterization of emotions is elusive in the literature. The aim of this systematic review is to give an overview of how FACS (...) has been used to investigate human emotional behavior to consumer product-based stimuli. The search was limited to studies published in English after 1978, conducted on humans, using FACS or its action units to investigate affect, where emotional response is elicited by consumer product-based stimuli evoking at least one of the five senses. The search resulted in an initial total of 1,935 records, of which 55 studies were extracted and categorized based on the outcomes of interest including (i) method of FACS implementation; (ii) purpose of study; (iii) consumer product-based stimuli used; and (iv) measures of affect validation. Most studies implemented FACS manually (73%) to develop products and/or software (20%) and used consumer product-based stimuli that had known and/or defined capacity to evoke a particular affective response, such as films and/or movie clips (20%); minimal attention was paid to consumer products with low levels of emotional competence or with unknown affective impact. The vast majority of studies (53%) did not validate FACS-determined affect and, of the validation measures that were used, most tended to be discontinuous in nature and only captured affect as it holistically related to an experience. This review illuminated some inconsistencies in how FACS is carried out as well as how emotional response is inferred from facial muscle activation. This may prompt researchers to consider measuring the total consumer experience by employing a variety of methodologies in addition to FACS and its emotion-based interpretation guide. Such strategies may better conceptualize consumers' experience with products of low, unknown, and/or undefined capacity to evoke an affective response such as product prototypes, line extensions, etc. (shrink)

The European Clinical Trials Directive (EU 2001; 2001/20/EC) was introduced to improve the efficiency of commercial and academic clinical trials. Concerns have been raised by interested organizations and institutions regarding the potential for negative impact of the Directive on non-commercial European clinical research. Interested researchers within the European Group for Blood and Marrow Transplantation (EBMT) were surveyed to determine whether researcher experiences confirmed this view. Following a pilot study, an internet-based questionnaire was distributed to individuals in key research positions in (...) the European haemopoietic SCT community. Seventy-one usable questionnaires were returned from participants in different EU member states. The results indicate that the perceived impact of the European Clinical Trials Directive has been negative, at least in the research areas of interest to the EBMT. (shrink)

Die metaphysische Spekulation über die Natur der Ideen gilt als eines der wichtigsten philosophischen Themen bis weit ins 20. Jahrhundert hinein. Im Nachdenken über die Ideen hat die Metaphysik versucht, die unveränderlichen Prinzipien zu entdecken, die die Wirklichkeit ordnen und ihren intelligiblen Charakter erklären und begründen. Die Frage nach den Ideen liegt somit an der Basis des metaphysischen Denkens überhaupt, das nach der klassischen Bestimmung des Aristoteles als Wissenschaft von den Prinzipien und Ursachen des Seienden als solchen verstanden werden kann.

Continuous recordings of brain electrical activity were obtained from a group of 176 patients throughout surgical procedures using general anesthesia. Artifact-free data from the 19 electrodes of the International 10/20 System were subjected to quantitative analysis of the electroencephalogram (QEEG). Induction was variously accomplished with etomidate, propofol or thiopental. Anesthesia was maintained throughout the procedures by isoflurane, desflurane or sevoflurane (N = 68), total intravenous anesthesia using propofol (N = 49), or nitrous oxide plus narcotics (N = 59). A set (...) of QEEG measures were found which reversibly displayed high heterogeneity of variance between four states as follows: (1) during induction; (2) just after loss of consciousness (LOC); (3) just before return of consciousness (ROC); (4) just after ROC. Homogeneity of variance across all agents within states was found. Topographic statistical probability images were compared between states. At LOC, power increased in all frequency bands in the power spectrum with the exception of a decrease in gamma activity, and there was a marked anteriorization of power. Additionally, a significant change occurred in hemispheric relationships, with prefrontal and frontal regions of each hemisphere becoming more closely coupled, and anterior and posterior regions on each hemisphere, as well as homologous regions between the two hemispheres, uncoupling. All of these changes reversed upon ROC. Variable resolution electromagnetic tomography (VARETA) was performed to localize salient features of power anteriorization in three dimensions. A common set of neuroanatomical regions appeared to be the locus of the most probable generators of the observed EEG changes. (shrink)

Joint attention (JA) is hypothesized to have a close relationship with developing theory of mind (ToM) capabilities. We tested the co-occurrence of ToM and JA in social interactions between adults with no reported history of psychiatric illness or neurodevelopmental disorders. Participants engaged in an experimental task that encouraged nonverbal communication, including JA, and also ToM activity. We adapted an in-lab variant of experience sampling methods (Bryant, Coffey, Povinelli, & Pruett, 2013) to measure ToM during JA based on participants’ subjective reports (...) of their thoughts while performing the task. This experiment successfully elicited instances of JA in 17/20 dyads. We compared participants’ thought contents during episodes of JA and non-JA. Our results suggest that, in adults, JA and ToM may occur independently. (shrink)

Synaesthesia is a condition in which one type of stimulation evokes the sensation of another, as when the hearing of a sound produces photisms, i.e. mental percepts of colours. R is a 20 year old colour blind subject who, in addition to the relatively common grapheme-colour synaesthesia, presents a rarely reported cross modal perception in which a variety of visual stimuli elicit aura-like percepts of colour. In R, photisms seem to be closely related to the affective valence of stimuli and (...) typically bring out a consistent pattern of emotional responses. The present case study suggests that colours might be an intrinsic category of the human brain. We developed an empirical methodology that allowed us to study the subject's otherwise inaccessible phenomenological experience. First, we found that R shows a Stroop effect elicited by photisms despite the fact that he does not show a regular Stroop with real colours. Secondly, by manipulating the colour context we confirmed that colours can alter R's emotional evaluation of the stimuli. Furthermore, we demonstrated that R's auras may actually lead to a partially inverted emotional spectrum where certain stimuli bring out emotional reactions opposite to the normal ones. These findings can only be accounted for by considering R's subjective colour experience or qualia. Therefore the present paper defends the view that qualia are a useful scientific concept that can be approached and studied by experimental methods. (shrink)

Adolescence methamphetamine use is an issue of considerable concern due to its correlation with later delinquency, divorce, unemployment and health problems. Understanding how adolescents initiate methamphetamine abuse is important in developing effective prevention programs. We formulate a mathematical model for the spread of methamphetamine abuse using nonlinear ordinary differential equations. It is assumed that susceptibles are recruited into methamphetamine use through imitation. An epidemic threshold value, Ra\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${\mathcal {R}}_a$$\end{document}, termed the abuse reproduction (...) number, is proposed and defined herein in the drug-using context. The model is shown to exhibit the phenomenon of backward bifurcation. This means that methamphetamine problems may persist in the population even if Ra\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${\mathcal {R}}_a$$\end{document} is less than one. Sensitivity analysis of Ra\documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$${\mathcal {R}}_a$$\end{document} was performed to determine the relative importance of different parameters in methamphetamine abuse initiation. The model is then fitted to data on methamphetamine users less than 20 years old reporting methamphetamine as their primary substance of abuse in the treatment centres of Cape Town and parameter values that give the best fit are chosen. Results show that the proportion of methamphetamine users less than 20 years old reporting methamphetamine as their primary substance of abuse will continue to decrease in Cape Town of South Africa. The results suggest that intervention programs targeted at reducing adolescence methamphetamine abuse, are positively impacting methamphetamine abuse. (shrink)

Synaesthesia is a condition in which one type of stimulation evokes the sensation of another, as when the hearing of a sound produces photisms, i.e. mental percepts of colours. R is a 20 year old colour blind subject who, in addition to the relatively common grapheme-colour synaesthesia, presents a rarely reported cross modal perception in which a variety of visual stimuli elicit aura-like percepts of colour. In R, photisms seem to be closely related to the affective valence of stimuli and (...) typically bring out a consistent pattern of emotional responses. The present case study suggests that colours might be an intrinsic category of the human brain. We developed an empirical methodology that allowed us to study the subject's otherwise inaccessible phenomenological experience. First, we found that R shows a Stroop effect (delayed response due to interference) elicited by photisms despite the fact that he does not show a regular Stroop with real colours. Secondly, by manipulating the colour context we confirmed that colours can alter R's emotional evaluation of the stimuli. Furthermore, we demonstrated that R's auras may actually lead to a partially inverted emotional spectrum where certain stimuli bring out emotional reactions opposite to the normal ones. These findings can only be accounted for by considering R's subjective colour experience or qualia. Therefore the present paper defends the view that qualia are a useful scientific concept that can be approached and studied by experimental methods. (shrink)

We report the identification of a recurrent, 520-kb 16p12.1 microdeletion associated with childhood developmental delay. The microdeletion was detected in 20 of 11,873 cases compared with 2 of 8,540 controls and replicated in a second series of 22 of 9,254 cases compared with 6 of 6,299 controls. Most deletions were inherited, with carrier parents likely to manifest neuropsychiatric phenotypes compared to non-carrier parents. Probands were more likely to carry an additional large copy-number variant when compared to matched controls. The clinical (...) features of individuals with two mutations were distinct from and/or more severe than those of individuals carrying only the co-occurring mutation. Our data support a two-hit model in which the 16p12.1 microdeletion both predisposes to neuropsychiatric phenotypes as a single event and exacerbates neurodevelopmental phenotypes in association with other large deletions or duplications. Analysis of other microdeletions with variable expressivity indicates that this two-hit model might be more generally applicable to neuropsychiatric disease. © 2010 Nature America, Inc. All rights reserved. (shrink)

We report specific heat and μSR measurements on Th and/or B substituted UBe13. The specific heat data show that either Th or B substitution reduces the Kondo temperature TK and increases the entropy at the superconducting transition by almost 20%, indicating an enhanced density of states. However, whereas μSR shows clear evidence for magnetic correlations for Th substitutions, no magnetism is observed for B substitutions. The enhanced specific heat jump in the B-substituted material is associated with a change in the (...) superconducting properties as TK is reduced. (shrink)

This panel considered the uses of and prospects for the stakeholder theory/approach. After 20 years of popularity, the stakeholder concept has still notemerged as a true theory. However, it offers some unique perspectives on business organizations and there is plenty of room to develop stakeholder theory and research. These session notes are offered to further the scholarly discussion.

During the 1980's and the early 1990's South Africa experienced disturbing political violence of an unprecedented scope, intensity and nature. It was disturbing because it entailed acts of horrifying brutality, notably the ‘necklace' and the massacre, all of this against the background of ‘civilized' and measured com promise and negotiation. It stubbornly continued despite the unbanning of the liberation political organisations, and the holding of ‘free and fair' elections in April 1994. And it was unprecedented in a whole range of (...) ways, but mainly because of the fact that it was intracommunal, or black- on- black, violence. It was the first time that Black political organisations had turned on each other rather than their white oppressors. For our purposes, what is interesting is the range of responses emanating from South African social scientists in explaining this new phenomenon. Historically, explaining Black political violence in South Africa has had a difficult time of it. Starting with Pierre van den Berghe in 1962, predictions of imminent revolution against the apartheid regime have been so regularly and frequently proved wrong, that a whole industry has arisen in explaining quiescence rather than violence (P. van den Berghe, 1965). The first cluster of theories spawned by the 1976 schools uprising, as Frank Molteno noted in his 1979 review, were analytically disappointing, if not crudely racist. Subsequent overviews by Manganyi & du Toit in 1990, and Beinart in 1992 have born evidence of considerably greater sophistication (Molteno, F (1979).; Manganyi, N & A du Toit, (1990); Beinart, W (1992)). Nevertheless, as I shall show, most have remained within quite conventional theoretical and structuralist parameters. Many have their roots in the earlier dominant Marxism of the 1970's. In this sense they tend towards structural and class determinism, towards absolutist notions of power, and absolutist moral judgement of both apartheid and the individuals associated, however indirectly, with it. In consequence, Black incumbents of apartheid structures were inevitably depicted as willess and powerless puppets dancing to the tune of omnipotent White masters. In this context, it was wrong to talk of black- on- black violence, since one side of this equation, in reality, represented white interests. Much of this analysis also started from quite easy notions of the origins of violence. In this view it was sufficient to show (objective) conflicts of interest, or contra diction, in order to conclude that violence had been adequately explained. Against this background the more hermeneutic contribution by André du Toit to the debate stands out as theoretically innovative, nuanced and bold. This is not to say that it is with out problems. But I do wish to present a picture of a social theorist of considerable imagination and subtletly. Looking back over these theories, it would be tempting to say that the first category of structuralist accounts, should be supplemented with the second category of hermeneutic, accounts. But simply adding theoretically discrepant accounts together is too easy. It is only when the whole notion of structure, employed in the first category, is rethought in post-structuralist form, that an integration of the two elements becomes feasible. This paper follows a Giddensian line in pursuing this reconceptualization. S. Afr. J. Philos. Vol.20(1) 2001: 102-123. (shrink)

In his note [5] Hausner states a simple combinatorial principle, namely: $$(H)\left\{ {\begin{array}{*{20}c} {if f is a function a non - empty finite set \sigma into itself, p a} \\ {prime, f^p = i_\sigma and \sigma _0 the set of fixed points of f, then } \\ {\left| \sigma \right| \equiv \left| {\sigma _0 } \right|(mod p).} \\\end{array}} \right.$$ .He then shows how this principle can be used to prove:Fermat's little theorem,Cauchy's theorem for finite groups,Lucas' theorem for binomial numbers.Letε=(0,1, ...),ℱ (...) 1−1 the family of all one-to-one functions from a subset ofε intoε andℳ 1−1 the family of all p.r. (i.e., partial recursive) one-to-one functions from a subset ofε intoε. A subsetα of ε is finite, ifα is not equivalent to a proper subset under a function inℱ 1−1. The setα is calledisolated, if it is not equivalent to a proper subset under a function inℳ 1−1. An isolated set can also be defined as a subset ofε which has no infinite r.e. (i.e., recursively enumerable) subset. While every finite set is isolated, there are $c = 2^{\aleph _0 }$ infinite sets which are isolated; these sets are calledimmune. It is the purpose of this paper to generalize (H) to a principle (H*) for isolated sets and to show how (H*) can be used to prove generalizations of Fermat's little theorem and Cauchy's theorem for finite groups. We have been unable to generalize Lucas' theorem in a similar manner. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Buddhist-Christian Studies 20 (2000) 311-315 [Access article in PDF] Book Review Fire and Water: Basic Issues in Asian Buddhism and Christianity Fire and Water: Basic Issues in Asian Buddhism and Christianity. By Aloysius Pieris, S. J. Maryknoll: Orbis Books, 1996. Aloysius Pieris, Jesuit priest and Buddhist scholar, is well known in theological and interreligious dialogue circles in Asia, and this is the third collection of essays of his to (...) be published in the Faith Meets Faith Series of Orbis Books. The eighteen essays which make up this book, all previously published elsewhere, are conveniently put together in three sections, under the following headings: 1) Women and Religion: Buddhist and Christian Appropriation of Feminist Criticism; 2) issues in Theology, Religion and Society; and 3) questions of Spirituality and Human Liberation. To merely summarize the content of the essays and offer a third-party critique would do injustice to the book, and could even mislead one who peruses such a summary into thinking one thereby "knows" what the book or Pieris is about. Such a hasty conclusion would deprive a would-be reader of the powerful experience that awaits in wrestling with Pieris through each essay of this volume. Judith Berling puts it well in her blurb at the back, pointing out that the author "uses poetry, evocative symbolism, and humor to offer a theological call to action in a voice that is liberationist, Asian, and feminist." Indeed, this volume invites one to a way of seeing that can also transform one's way of being in this world marked by increasing violence, poverty, and a systemic kind of oppression dehumanizing to both the perpetrators as well as the victims.The title of the present volume, Fire and Water, alludes to a dynamic dipolarity, masterfully sketched for the reader by Paul Knitter in his foreword, which underlies the author's vision of reality and vivifies much of his writing. The masculine and the feminine, the (Buddhist) gnostic and the (Christian) agapeic, the metacosmic (transcendent) [End Page 311] and the cosmic (immanent), the prophetic and the mystical, are different ways of naming this dipolarity. The way to ultimate liberation is in the effective embrace of both poles in complementarity and mutual interplay, whereas taking one pole in preference over the other results in a warped vision or mode of being, in imbalance, or even in abuse.In this review I would like to simply echo some key themes that will jump at one perusing the essays, reiterating that the very act of reading them can of itself be a transformative experience for an open-minded, open-hearted, and open-handed reader.The thrust of the six essays comprising the first section can perhaps be summed up in the thesis as formulated by the author himself: "Religion cannot survive in the future without appropriating the feminist critique, just as feminism cannot achieve its liberative goal without the aid of a religion so critiqued" (p. 62). Behind this statement is Pieris' emphatically critical stance, on the one hand, against all forms of patriarchal religion, whether Christian, Buddhist, Hindu, or other, which has justified, lent a hand in, or continued to perpetrate the physical, psychological, and especially religious abuse of women, and on the other hand, against secularist (or anti-religious) kinds of feminist theory that take off on what he enumerates as "five false starts" (pp. 50-51), which only result in unnecessary dichotomies that truncate the understanding of the goal of liberation, and consequently of the human as such.Pieris offers a vision of liberation centered on what he terms the humanum. This refers to the point of ultimate perfection to which the human, that is, "whatever pertains to men and women as self-conscious, other-oriented, and dreaming components of the cosmos," has the capacity to carry the cosmos. In this context, the human is no other than "this self-transcendent capacity immanent in the cosmos, this power to unfold within itself the Other, which is ever present from the first moment of evolution." To be human is inherently to be endowed... (shrink)

This is the second of a planned 5-volume translation of the most significant entries in Kierkegaard’s Papirer, which in the Danish edition consumes 20 volumes. The translation is done by Howard and Edna Hong, translators of the Philosophical Fragments and other works of Kierkegaard, and the winners of the National Book Award for Translation in 1967 for their translation of Volume I of the Journals. Volumes I through IV are arranged according to topics in alphabetical order, and within each topic (...) the entries appear in chronological order. Volume V will be devoted to autobiographical material. Some of the more significant themes covered in Volume II include faith, freedom, God, grace, Hegel, history, humor and irony, the individual, and knowledge. Each entry is numbered consecutively and then its source in the Danish edition and date are given. There is a collation of entries in the English edition with the Danish Papirer, and over 60 pages of notes by the translators. The journals of any philosopher are an important aid in understanding his thought, but in the case of Kierkegaard they are especially significant because of the indirect, pseudonymous and ironical character of Kierkegaard’s writings. We are fortunate to have this highly professional translation of these important texts at our disposal to assist us in the difficult work of interpreting Kierkegaard.—J.D.C. (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)