BackgroundIn the Canadian Alliance for Healthy Hearts and Minds cohort, participants underwent magnetic resonance imaging of the brain, heart, and abdomen, that generated incidental findings. The approach to managing these unexpected results remain a complex issue. Our objectives were to describe the CAHHM policy for the management of IFs, to understand the impact of disclosing IFs to healthy research participants, and to reflect on the ethical obligations of researchers in future MRI studies.MethodsBetween 2013 and 2019, 8252 participants were recruited with (...) a follow-up questionnaire administered to 909 participants at 1-year. The CAHHM policy followed a restricted approach, whereby routine feedback on IFs was not provided. Only IFs of severe structural abnormalities were reported.ResultsSevere structural abnormalities occurred in 8.3% of participants, with the highest proportions found in the brain and abdomen. The majority of participants informed of an IF reported no change in quality of life, with 3% of participants reporting that the knowledge of an IF negatively impacted their quality of life. Furthermore, 50% reported increased stress in learning about an IF, and in 95%, the discovery of an IF did not adversely impact his/her life insurance policy. Most participants would enrol in the study again and perceived the MRI scan to be beneficial, regardless of whether they were informed of IFs. While the implications of a restricted approach to IF management was perceived to be mostly positive, a degree of diagnostic misconception was present amongst participants, indicating the importance of a more thorough consent process to support participant autonomy.ConclusionThe management of IFs from research MRI scans remain a challenging issue, as participants may experience stress and a reduced quality of life when IFs are disclosed. The restricted approach to IF management in CAHHM demonstrated a fair fulfillment of the overarching ethical principles of respect for autonomy, concern for wellbeing, and justice. The approach outlined in the CAHHM policy may serve as a framework for future research studies.Clinical trial registrationhttps://clinicaltrials.gov/ct2/show/nct02220582. (shrink)
Jakob Friedrich Fries (1773-1843): A Philosophy of the Exact Sciences -/- Shortened version of the article of the same name in: Tabula Rasa. Jenenser magazine for critical thinking. 6th of November 1994 edition -/- 1. Biography -/- Jakob Friedrich Fries was born on the 23rd of August, 1773 in Barby on the Elbe. Because Fries' father had little time, on account of his journeying, he gave up both his sons, of whom Jakob Friedrich was the elder, to (...) the Herrnhut Teaching Institution in Niesky in 1778. Fries attended the theological seminar in Niesky in autumn 1792, which lasted for three years. There he (secretly) began to study Kant. The reading of Kant's works led Fries, for the first time, to a deep philosophical satisfaction. His enthusiasm for Kant is to be understood against the background that a considerable measure of Kant's philosophy is based on a firm foundation of what happens in an analogous and similar manner in mathematics. -/- During this period he also read Heinrich Jacobi's novels, as well as works of the awakening classic German literature; in particular Friedrich Schiller's works. In 1795, Fries arrived at Leipzig University to study law. During his time in Leipzig he became acquainted with Fichte's philosophy. In autumn of the same year he moved to Jena to hear Fichte at first hand, but was soon disappointed. -/- During his first sojourn in Jenaer (1796), Fries got to know the chemist A. N. Scherer who was very influenced by the work of the chemist A. L. Lavoisier. Fries discovered, at Scherer's suggestion, the law of stoichiometric composition. Because he felt that his work still need some time before completion, he withdrew as a private tutor to Zofingen (in Switzerland). There Fries worked on his main critical work, and studied Newton's "Philosophiae naturalis principia mathematica". He remained a lifelong admirer of Newton, whom he praised as a perfectionist of astronomy. Fries saw the final aim of his mathematical natural philosophy in the union of Newton's Principia with Kant's philosophy. -/- With the aim of qualifying as a lecturer, he returned to Jena in 1800. Now Fries was known from his independent writings, such as "Reinhold, Fichte and Schelling" (1st edition in 1803), and "Systems of Philosophy as an Evident Science" (1804). The relationship between G. W. F. Hegel and Fries did not develop favourably. Hegel speaks of "the leader of the superficial army", and at other places he expresses: "he is an extremely narrow-minded bragger". On the other hand, Fries also has an unfavourable take on Hegel. He writes of the "Redundancy of the Hegelistic dialectic" (1828). In his History of Philosophy (1837/40) he writes of Hegel, amongst other things: "Your way of philosophising seems just to give expression to nonsense in the shortest possible way". In this work, Fries appears to argue with Hegel in an objective manner, and expresses a positive attitude to his work. -/- In 1805, Fries was appointed professor for philosophy in Heidelberg. In his time spent in Heidelberg, he married Caroline Erdmann. He also sealed his friendships with W. M. L. de Wette and F. H. Jacobi. Jacobi was amongst the contemporaries who most impressed Fries during this period. In Heidelberg, Fries wrote, amongst other things, his three-volume main work New Critique of Reason (1807). -/- In 1816 Fries returned to Jena. When in 1817 the Wartburg festival took place, Fries was among the guests, and made a small speech. 1819 was the so-called "Great Year" for Fries: His wife Caroline died, and Karl Sand, a member of a student fraternity, and one of Fries' former students stabbed the author August von Kotzebue to death. Fries was punished with a philosophy teaching ban but still received a professorship for physics and mathematics. Only after a period of years, and under restrictions, he was again allowed to read philosophy. From now on, Fries was excluded from political influence. The rest of his life he devoted himself once again to philosophical and natural studies. During this period, he wrote "Mathematical Natural Philosophy" (1822) and the "History of Philosophy" (1837/40). -/- Fries suffered from a stroke on New Year's Day 1843, and a second stroke, on the 10th of August 1843 ended his life. -/- 2. Fries' Work Fries left an extensive body of work. A look at the subject areas he worked on makes us aware of the universality of his thinking. Amongst these subjects are: Psychic anthropology, psychology, pure philosophy, logic, metaphysics, ethics, politics, religious philosophy, aesthetics, natural philosophy, mathematics, physics and medical subjects, to which, e.g., the text "Regarding the optical centre in the eye together with general remarks about the theory of seeing" (1839) bear witness. With popular philosophical writings like the novel "Julius and Evagoras" (1822), or the arabesque "Longing, and a Trip to the Middle of Nowhere" (1820), he tried to make his philosophy accessible to a broader public. Anthropological considerations are shown in the methodical basis of his philosophy, and to this end, he provides the following didactic instruction for the study of his work: "If somebody wishes to study philosophy on the basis of this guide, I would recommend that after studying natural philosophy, a strict study of logic should follow in order to peruse metaphysics and its applied teachings more rapidly, followed by a strict study of criticism, followed once again by a return to an even closer study of metaphysics and its applied teachings." -/- 3. Continuation of Fries' work through the Friesian School -/- Fries' ideas found general acceptance amongst scientists and mathematicians. A large part of the followers of the "Fries School of Thought" had a scientific or mathematical background. Amongst them were biologist Matthias Jakob Schleiden, mathematics and science specialist philosopher Ernst Friedrich Apelt, the zoologist Oscar Schmidt, and the mathematician Oscar Xavier Schlömilch. Between the years 1847 and 1849, the treatises of the "Fries School of Thought", with which the publishers aimed to pursue philosophy according to the model of the natural sciences appeared. In the Kant-Fries philosophy, they saw the realisation of this ideal. The history of the "New Fries School of Thought" began in 1903. It was in this year that the philosopher Leonard Nelson gathered together a small discussion circle in Goettingen. Amongst the founding members of this circle were: A. Rüstow, C. Brinkmann and H. Goesch. In 1904 L. Nelson, A. Rüstow, H. Goesch and the student W. Mecklenburg travelled to Thuringia to find the missing Fries writings. In the same year, G. Hessenberg, K. Kaiser and Nelson published the first pamphlet from their first volume of the "Treatises of the Fries School of Thought, New Edition". -/- The school set out with the aim of searching for the missing Fries' texts, and re-publishing them with a view to re-opening discussion of Fries' brand of philosophy. The members of the circle met regularly for discussions. Additionally, larger conferences took place, mostly during the holidays. Featuring as speakers were: Otto Apelt, Otto Berg, Paul Bernays, G. Fraenkel, K. Grelling, G. Hessenberg, A. Kronfeld, O. Meyerhof, L. Nelson and R. Otto. On the 1st of March 1913, the Jakob-Friedrich-Fries society was founded. Whilst the Fries' school of thought dealt in continuum with the advancement of the Kant-Fries philosophy, the members of the Jakob-Friedrich-Fries society's main task was the dissemination of the Fries' school publications. In May/June, 1914, the organisations took part in their last common conference before the gulf created by the outbreak of the First World War. Several members died during the war. Others returned disabled. The next conference took place in 1919. A second conference followed in 1921. Nevertheless, such intensive work as had been undertaken between 1903 and 1914 was no longer possible. -/- Leonard Nelson died in October 1927. In the 1930's, the 6th and final volume of "Treatises of the Fries School of Thought, New Edition" was published. Franz Oppenheimer, Otto Meyerhof, Minna Specht and Grete Hermann were involved in their publication. -/- 4. About Mathematical Natural Philosophy -/- In 1822, Fries' "Mathematical Natural Philosophy" appeared. Fries rejects the speculative natural philosophy of his time - above all Schelling's natural philosophy. A natural study, founded on speculative philosophy, ceases with its collection, arrangement and order of well-known facts. Only a mathematical natural philosophy can deliver the necessary explanatory reasoning. The basic dictum of his mathematical natural philosophy is: "All natural theories must be definable using purely mathematically determinable reasons of explanation." Fries is of the opinion that science can attain completeness only by the subordination of the empirical facts to the metaphysical categories and mathematical laws. -/- The crux of Fries' natural philosophy is the thought that mathematics must be made fertile for use by the natural sciences. However, pure mathematics displays solely empty abstraction. To be able to apply them to the sensory world, an intermediatory connection is required. Mathematics must be connected to metaphysics. The pure mechanics, consisting of three parts are these: a) A study of geometrical movement, which considers solely the direction of the movement, b) A study of kinematics, which considers velocity in Addition, c) A study of dynamic movement, which also incorporates mass and power, as well as direction and velocity. -/- Of great interest is Fries' natural philosophy in view of its methodology, particularly with regard to the doctrine "leading maxims". Fries calls these "leading maxims" "heuristic", "because they are principal rules for scientific invention". -/- Fries' philosophy found great recognition with Carl Friedrich Gauss, amongst others. Fries asked for Gauss's opinion on his work "An Attempt at a Criticism based on the Principles of the Probability Calculus" (1842). Gauss also provided his opinions on "Mathematical Natural Philosophy" (1822) and on Fries' "History of Philosophy". Gauss acknowledged Fries' philosophy and wrote in a letter to Fries: "I have always had a great predilection for philosophical speculation, and now I am all the more happy to have a reliable teacher in you in the study of the destinies of science, from the most ancient up to the latest times, as I have not always found the desired satisfaction in my own reading of the writings of some of the philosophers. In particular, the writings of several famous (maybe better, so-called famous) philosophers who have appeared since Kant have reminded me of the sieve of a goat-milker, or to use a modern image instead of an old-fashioned one, of Münchhausen's plait, with which he pulled himself from out of the water. These amateurs would not dare make such a confession before their Masters; it would not happen were they were to consider the case upon its merits. I have often regretted not living in your locality, so as to be able to glean much pleasurable entertainment from philosophical verbal discourse." -/- The starting point of the new adoption of Fries was Nelson's article "The critical method and the relation of psychology to philosophy" (1904). Nelson dedicates special attention to Fries' re-interpretation of Kant's deduction concept. Fries awards Kant's criticism the rationale of anthropological idiom, in that he is guided by the idea that one can examine in a psychological way which knowledge we have "a priori", and how this is created, so that we can therefore recognise our own knowledge "a priori" in an empirical way. Fries understands deduction to mean an "awareness residing darkly in us is, and only open to basic metaphysical principles through conscious reflection.". -/- Nelson has pointed to an analogy between Fries' deduction and modern metamathematics. In the same manner, as with the anthropological deduction of the content of the critical investigation into the metaphysical object show, the content of mathematics become, in David Hilbert's view, the object of metamathematics. -/-. (shrink)
Wir möchten der Charter on Medical Professionalism, die wir für vorbildlich halten, eine durchdachte Anreicherung hinzufügen. Wir beginnen mit einer skeptischen Note gegen das verbreitete theoretische Vorurteil, die wichtigsten Probleme im Gesundheitssystem seien Gerechtigkeitsprobleme und diese seien theoretisch gut beherrschbar. Unter Bezug auf Norman Daniels, der John Rawls’ Theorie der politischen Gerechtigkeit auf die Bewertung und Gestaltung von Gesundheitssystemen anwendet, sowie auf die biomedizinische Ethik, die von Beauchamp und Childress vertreten wird, analysieren wir das komplexe Verhältnis zwischen moralischer Integrität von (...) Strukturen und Organisationen einerseits und natürlichen Personen, die in ihnen arbeiten, andererseits. Anschließend interpretieren wir die Charta als eine Spezifizierung der ärztlichen professionsmoralischen Verantwortung auf mehreren Ebenen, die Tugend- und Organisationsethik verklammern. (shrink)
Der Band untersucht die besonderen ethischen Probleme, die die Entwicklung autonom „handelnder“ und „kommunizierender“ medialer Systeme aufwirft. Da sie Prozesse nicht nur eigenständig vollziehen, sondern zugleich steuern, stellt sich die Frage, inwieweit sie in diesem „Handeln“ und „Entscheiden“ normativ orientiert werden können. Über frühere Entwicklungen hinaus entsteht zudem eine computergesteuerte digitale Infrastruktur, die alle symbolischen Operationen integriert und an sich bindet. Ausgehend von der Mediatisierungstheorie werden die medienethischen Implikationen solcher Systeme diskutiert.
The volume deals with the normative challenges and the ethical questions imposed by, and through, the developments and changes in everyday life, culture and society in the context of media change. It is thus concerned with the questions of whether and how the central concept of ethics must evolve under these premises – or in other words: what form do ethics take in mediatized societies? In order to address this question and to stimulate and initiate a debate, the authors focus (...) on two concepts: responsibility and resistance. Their contributions try to shed light not only on the empirical shreds of evidence of change in mediatized societies, but also on the normative challenges and ethical possibilities of these developments. (shrink)
Between 1819 and 1832 Friedrich Schleiermacher was giving lectures on the life of Jesus at the University of Berlin. The following article includes two partial editions, which document the introductory parts of the lectures from 1819/20 and 1829/30. Both are based on manuscripts written by Schleiermacher’s listeners. Especially to explore the development of Schleiermacher’s conceptual considerations this two partial editions should be a useful addition to the new critical edition of Schleiermacher’s Vorlesungen über das Leben Jesu published in 2018 (...) by Walter Jaeschke. (shrink)
That certain paper bills have monetary value, that Vladimir Putin is the president of Russia, and that Prince Philip is the husband of Queen Elizabeth II: such facts are commonly called ‘institutional facts’. IFF are, by definition, facts that exist by virtue of collective recognition. The standard view or tacit belief is that such facts really exist. In this paper we argue, however, that they really do not—they really are just well-established illusions. We confront realism about IFF with six criteria (...) of existence, three established and three less so but highly intuitive. We argue that they all tell against the existence of IFF. An obvious objection to IFF non-realism is that since people’s behaviour clearly reflects the existence of IFF, denying their existence leaves an explanatory gap. We reject this argument by introducing a variant of the so-called ‘Thomas Theorem,’ which says that when people collectively recognize a fact as existing, they largely behave accordingly, regardless of whether that fact really exists or not. (shrink)
The court of King Arthur, the center of the Arthurian romances that were so popular in the Middle Ages, is illuminated anew in this book from an interdisciplinary perspective as an institution which is fictionally staged, stabilized and problematized. The book explores the forces, figures and positions that constitute or endanger the court as a picture of society in miniature or as a literary experiment. Finally, the contributions critically question the ideality of the court of King Arthur and investigate the (...) function and reception of the court even in contexts remote from courts. ". (shrink)
A general class of labeled sequent calculi is investigated, and necessary and sufficient conditions are given for when such a calculus is sound and complete for a finite -valued logic if the labels are interpreted as sets of truth values. Furthermore, it is shown that any finite -valued logic can be given an axiomatization by such a labeled calculus using arbitrary "systems of signs," i.e., of sets of truth values, as labels. The number of labels needed is logarithmic in the (...) number of truth values, and it is shown that this bound is tight. (shrink)
A uniform construction for sequent calculi for finite-valued first-order logics with distribution quantifiers is exhibited. Completeness, cut-elimination and midsequent theorems are established. As an application, an analog of Herbrand’s theorem for the four-valued knowledge-representation logic of Belnap and Ginsberg is presented. It is indicated how this theorem can be used for reasoning about knowledge bases with incomplete and inconsistent information.
The article compares the doctrine of election in the theology of Friedrich Schleiermacher, particularly his magisterial essay on the topic from 1819, and the theology of Karl Barth between 1920 and 1925. It argues that both positions are strikingly similar, in regard to both their critical evaluation of the tradition and their constructive proposals for a new foundation. Both theologians offer a theocentric reassessment that shuns the particularism of previous approaches and affirms the unity of the divine will. Schleiermacher (...) defends the Augustinian-Calvinist view of election as a bulwark against Manichaeism and Pelagianism. Still, he criticizes the idea of eternal damnation and argues that the concept of reprobation instead should be understood as a temporal ‘passing over’. The kingdom of God is realized gradually, not in one instant. Similarly, for Barth predestination is not a pre-temporal decree that divides human beings into two separate groups of persons but is actualized ever anew in history, when God’s address entails the miracle of faith through the work of the Holy Spirit. The twofold possibility of faith and unbelief is constitutive for the human encounter with God, and it concerns believers and unbelievers alike, since no person is forever exclusively elect or reprobate. Barth also insists that the relation between reprobation and election is non-dualistic and teleological: predestination is a movement from reprobation to election, and never the other way around. The ultimate goal is salvation. (shrink)
A construction principle for natural deduction systems for arbitrary, finitely-many-valued first order logics is exhibited. These systems are systematically obtained from sequent calculi, which in turn can be automatically extracted from the truth tables of the logics under consideration. Soundness and cut-free completeness of these sequent calculi translate into soundness, completeness, and normal-form theorems for natural deduction systems.
This is a reproduction of a book published before 1923. This book may have occasional imperfections such as missing or blurred pages, poor pictures, errant marks, etc. that were either part of the original artifact, or were introduced by the scanning process. We believe this work is culturally important, and despite the imperfections, have elected to bring it back into print as part of our continuing commitment to the preservation of printed works worldwide. We appreciate your understanding of the imperfections (...) in the preservation process, and hope you enjoy this valuable book. ++++ The below data was compiled from various identification fields in the bibliographic record of this title. This data is provided as an additional tool in helping to ensure edition identification: ++++ Friedrich Heinrich Jacobi's Werke: Bd. David Hume Uber Den Glauben Oder Idealismus Und Realismus: Ein GesprAch. Uber Die Unzertrennlichkeit Des Begriffes Der Freyheit Und Vorsehung Von Dem Begriffe Der Vernunft. Etwes, Das Lessing Gesagt Hat: Ein Commentar Zu Den Reisen Der PAbste. Anhang Zu Dem ...; Volume 2 Of Friedrich Heinrich Jacobi's Werke; Friedrich Von Roth Friedrich Heinrich Jacobi, Johann Georg Hamann, Friedrich von Roth, Friedrich KOppen G. Fleischer d. jUng, 1815. (shrink)
The aim of this paper is to emphasize the fact that for all finitely-many-valued logics there is a completely systematic relation between sequent calculi and tableau systems. More importantly, we show that for both of these systems there are al- ways two dual proof sytems (not just only two ways to interpret the calculi). This phenomenon may easily escape one’s attention since in the classical (two-valued) case the two systems coincide. (In two-valued logic the assignment of a truth value and (...) the exclusion of the opposite truth value describe the same situation.). (shrink)
ZusammenfassungWir möchten der Charter on Medical Professionalism, die wir für vorbildlich halten, eine durchdachte Anreicherung hinzufügen. Wir beginnen mit einer skeptischen Note gegen das verbreitete theoretische Vorurteil, die wichtigsten Probleme im Gesundheitssystem seien Gerechtigkeitsprobleme und diese seien theoretisch gut beherrschbar. Unter Bezug auf Norman Daniels, der John Rawls’ Theorie der politischen Gerechtigkeit auf die Bewertung und Gestaltung von Gesundheitssystemen anwendet, sowie auf die biomedizinische Ethik, die von Beauchamp und Childress vertreten wird, analysieren wir das komplexe Verhältnis zwischen moralischer Integrität von (...) Strukturen und Organisationen einerseits und natürlichen Personen, die in ihnen arbeiten, andererseits. Anschließend interpretieren wir die Charta als eine Spezifizierung der ärztlichen professionsmoralischen Verantwortung auf mehreren Ebenen, die Tugend- und Organisationsethik verklammern. (shrink)
In this paper, the notion of sustainability as a general regulative idea is distinguished from sustainable development as a more concrete concept leading to practical actions. After that, different economic meanings of sustainable development are discussed, and a concept of critical sustainability is proposed especially with respect to the problem of climate change. Maintaining critical crash barriers and bottlenecks presupposes, however, demanding, continuous improvements in energy efficiency. After discussing problems of decision theory in cases of uncertainty, which is constitutive for (...) climate change, the links between intragenerational and intergenerational justice are analyzed, and by using Barry's notion of justice and Goodin's concept of vulnerability, two possible positions of the general idea of fairness inherent in sustainable development are presented. We conclude by shortly sketching the notion of sufficiency as an additional supplementary sustainability strategy in cases where efficiency improvements based on innovation are less than sufficient for securing the (energetic) fundaments of economic activity and human life. (shrink)
Offering the only anthology of Hegel's religious thought, Vanderbilt University's Professor Peter C. Hodgson provides sympathetic and clear entree to the German philosopher's religious achievement through his major relevant texts starting with early theological writings and culminating with Hegel's1824 lectures on the philosophy of religion.
Der evangelische Theologe und Padagoge Friedrich Schleiermacher weist in der Debatte um die Judenemanzipation im ausgehenden 18. Jahrhundert den potentiellen Vorwurf, er sei ein Judenfeind, als missverstandlich zuruck. Dieses Ansinnen ist umso auffalliger, als Schleiermacher bereits dezidiert judenfeindliche Positionen vertreten hatte, bevor die Judenfrage um die Mitte des 19. Jahrhunderts zu einem feststehenden Begriff wurde. Hinsichtlich der theologischen Bedeutung des Judentums sowie der Emanzipation und Akkulturation der Juden konnen seine Positionen nur als Ausdruck eines theologischen und sozialen Antijudaismus verstanden (...) werden. Sie sind auch in die zentralen Uberlegungen seines Erziehungsdenkens eingegangen. In diesem Buch wird gezeigt, welche Rolle Antijudaismus und Antisemitismus in der Theoriebildung uber Erziehung und Bildung bereits vor dem Nationalsozialismus gespielt haben. (shrink)
The Gratitude Questionnaire-Six Item Form (GQ-6; McCullough et al., 2002) is a well-established instrument for measuring gratitude. Recently, the Multi-Component Gratitude Measure (MCGM) was developed as a more holistic approach (Morgan et al., 2017). While the GQ-6 mainly focuses on the emotional component of gratitude, the MCGM encompasses conceptual, attitudinal and behavioral aspects. As of today, there is no validated German measure for gratitude. In order to close that research gap, the present study focused on validating the German versions of (...) the GQ-6 (GQ-6-G) and of the MCGM (MCGM-G). In addition, multi-group comparisons were conducted to test for cultural measurement invariance. Construct validity was tested similar to original validation studies of the two scales focusing on affect, well-being, empathy, anxiety and depression. The online survey was completed in random order by 508 participants. The one-factor model of the GQ-6-G and the hierarchical structure of the MCGM-G could be replicated. However, model fit of the Gratitude Questionnaire was significantly better after eliminating one item (GQ-5-G). Multi-group comparisons revealed cultural measurement invariance was established for the GQ-5-G and partial measurement invariance for five of six factors of the MCGM-G, respectively. Reliability analyses revealed good internal consistency for both instruments and measures for criterion-related and discriminant validity have shown hypothesized relationships. Thus, the GQ-5-G and the MCGM-G are two instruments with good reliability and validity for measuring gratitude in Germany. (shrink)
Michael Dummett, Frege and other philosophers. Oxford:Clarendon Press, 1991. xii + 330pp. £35. ISBN W.Balzer and C.U.Moulines, Structuralist theory of science:focal issues, new results, Berlin; de Gruyter, 1996. xi + 295 pp.DM 210. ISBN 3-11-014075-6 Henry Prakken, Logical tools for modeling legal argument a study of defeasible reasoning in law.Dordrecht, The Netherlands:Kluwer Academic, 1997, xiii + 314pp.£75.00/$125.00 J.Srzednicki and Z.Stachniak Lesniewski’s Systems.Protothetic.Nijhoff International Philosophy Series, 54, Dordrecht, Boston and London:Kluwer, 1998. xiv + 310 pp, £99. ISBN 0-7923-4504-5.
Background Sharing anonymized/de-identified clinical trial data and publishing research outcomes in scientific journals, or presenting them at conferences, is key to data-driven scientific exchange. However, when data from scientific publications are linked to other publicly available personal information, the risk of reidentification of trial participants increases, raising privacy concerns. Therefore, we defined a set of criteria allowing us to determine and minimize the risk of data reidentification. We also implemented a review process at Takeda for clinical publications prior to submission (...) for publication in journals or presentation at medical conferences. Methods Abstracts, manuscripts, posters, and oral presentations containing study participant information were reviewed and the potential impact on study participant privacy was assessed. Our focus was on direct and indirect identifiers, such as sex, age or geographical indicators in rare disease studies or studies with small sample size treatment groups. Risk minimization was sought using a generalized presentation of identifier-relevant information and decision-making on data sharing for further research. Additional risk identification was performed based on study participant/personnel parameters present in materials destined for the public domain. The potential for participant/personnel identification was then calculated to facilitate presentation of meaningful but de-identified information. Results The potential for reidentification was calculated using a risk ratio of the exposed versus available individuals, with a value above the threshold of 0.09 deemed an unacceptable level of reidentification risk. We found that in 13% of Takeda clinical trial publications reviewed, either individuals could potentially be reidentified or inappropriate data sharing plans could pose a data privacy risk to study participants. In 1/110 abstracts, 58/275 manuscripts, 5/87 posters and 3/58 presentations, changes were necessary due to data privacy concerns/rules. Despite the implementation of risk-minimization measures prior to release, direct and indirect identifiers were found in 11% and 34% of the analysed documents, respectively. Conclusions Risk minimization using de-identification of clinical trial data presented in scientific publications and controlled data sharing conditions improved privacy protection for study participants. Our results also suggest that additional safeguards should be implemented to ensure that higher data privacy standards are met. (shrink)