Good Clinical Practice is an international quality standard for conducting trials that involve participation of human subjects. Currently, the most widely accepted international document forming the base for GCP is the ICH Harmonised Tripartite Guideline for GCP, which defines in detail the responsibilities and obligations of parties engaged in clinical research. The purpose of this paper is to analyse how compliance with GCP provides protection of the trial subjects and assures quality and credibility of the data obtained.

On February 13, 2020, the Toronto Police Services (TPS) issued a statement admitting that its members had used Clearview AI’s controversial facial recognition technology (FRT). The controversy sparked widespread outcry by the media, civil society, and community groups, and put pressure on policy-makers to address FRTs. Public consultations presented a key tool to contain the scandal in Toronto and across Canada. Drawing on media reports, policy documents, and expert interviews, we investigate four consultations held by the Toronto Police Services Board (...) (TPSB), the Office of the Privacy Commissioner (OPC), and the parliamentary Standing Committee on Access to Information, Privacy and Ethics (ETHI) to understand how public opinion and outrage translate into policy. We find that public consultations became a powerful closure mechanism in the policy-making toolbox, inhibiting rather than furthering democratic debate. Our findings show that consultations do not advance public literacy; that opportunities for public input are narrow; that timeframes are short; and that mechanisms for inclusion are limited. Even in the best-case circumstances, consultations are merely one of many factors in AI governance and seldom impact concrete policy outcomes in the cases studied here. (shrink)

The increasing incidence of ethical dilemmas in long-term care settings, in concert with recommendations from the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, has prompted long-term care institutions to develop mechanisms to address these concerns. Some facilities have chosen to set up an ethics committee, although estimates obtained in the past few years indicate that only between 2 and 27% of institutional long-term care settings have such committees. Ethics committees are responsible (...) for assisting staff, residents, and families with the resolution of ethi- cal concerns, and typically engage in policy review and development, case review, and education. Such committees usually count among their membership representatives from a variety of disciplines, with family members, patients, and representatives from patient advocacy groups supplementing the professional component of the committee. (shrink)

This book approaches the problems and circumstances confronting blacks in the context of black values, the black community, and the role of government. ^BContents:: The Black Community's Values as a Basis for Action; The Community as Agent of Change; and The Government's Role in Meeting New Challenges.

One enduring legacy of the twentieth century will be the slow, certain transformation of the world from insular civilizations to interactive societies enmeshed in global systems of electronic communication, economics, and politics. Financial news from Thailand or Brazil is often more important globally than political events in the old centers of power. Some bemoan the uncertainty and flux of all this. However, the mutual definition of the world’s societies presents an extraordinary opportunity to humanize a situation that all too quickly (...) could degenerate into a Weberian ‘iron cage’ of truly global proportions. What contribution can the world’s great philosophical traditions make toward humanity’s common task of civilizing the rise of globalization? Here the ancient concept of paideia walks upon the stage of the twenty-first century. (shrink)

One enduring legacy of the twentieth century will be the slow, certain transformation of the world from insular civilizations to interactive societies enmeshed in global systems of electronic communication, economics, and politics. Financial news from Thailand or Brazil is often more important globally than political events in the old centers of power. Some bemoan the uncertainty and flux of all this. However, the mutual definition of the world’s societies presents an extraordinary opportunity to humanize a situation that all too quickly (...) could degenerate into a Weberian ‘iron cage’ of truly global proportions. What contribution can the world’s great philosophical traditions make toward humanity’s common task of civilizing the rise of globalization? Here the ancient concept of paideia walks upon the stage of the twenty-first century. (shrink)

One enduring legacy of the twentieth century will be the slow, certain transformation of the world from insular civilizations to interactive societies enmeshed in global systems of electronic communication, economics, and politics. Financial news from Thailand or Brazil is often more important globally than political events in the old centers of power. Some bemoan the uncertainty and flux of all this. However, the mutual definition of the world’s societies presents an extraordinary opportunity to humanize a situation that all too quickly (...) could degenerate into a Weberian ‘iron cage’ of truly global proportions. What contribution can the world’s great philosophical traditions make toward humanity’s common task of civilizing the rise of globalization? Here the ancient concept of paideia walks upon the stage of the twenty-first century. (shrink)

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

In lieu of an abstract, here is a brief excerpt of the content:Martin Heidegger and OntologyEmmanuel Levinas (bio)The prestige of Martin Heidegger 1 and the influence of his thought on German philosophy marks both a new phase and one of the high points of the phenomenological movement. Caught unawares, the traditional establishment is obliged to clarify its position on this new teaching which casts a spell over youth and which, overstepping the bounds of permissibility, is already in vogue. For once, (...) Fame has picked one who deserves it and, for that matter, one who is still living. Anyone who has studied philosophy cannot, when confronted by Heidegger’s work, fail to recognize how the originality and force of his achievements, stemming from genius, are combined with an attentive, painstaking, and close working-out of the argument—with that craftsmanship of the patient artisan in which phenomenologists take such pride. In this study, it is important for us to understand, above all, the true intentions of our author, to illuminate what he thinks really needs to be said, and to surmise what is most critical for him.To get to the heart of Heidegger’s system, it seems fitting to begin with a problem that is generally familiar. We choose the problem of knowledge, a deeper understanding of which takes us to the very threshold of Heidegger’s thought. For this problem, central to modern philosophy, is one of the main obstacles of modern philosophy that Heidegger wishes to surmount. Neo-Kantianism, which takes knowledge as the philosophical problem of the first rank, is the movement against which Heidegger rebels with all his strength. We have, thus, every chance of gaining access to his thought by the main door, so to speak. Once inside the system we will try to trace its outlines, 2 reserving, for a second part of our work, the determination of Heidegger’s place in the history of ideas, especially in the phenomenological movement, as well as of his relations with the philosopher to whom he owes so much—Edmund Husserl. 31In its most general form, the problem of the theory of knowledge has a critical significance. It consists in delineating a domain where knowledge can be certain and in determining the criteria for the legitimate scope of knowledge. But this problem, as normal and as simple as it may appear, has deeper roots. That knowledge should need a criterion at all presupposes that truth is not identical to all that is known and that the course [End Page 11] of things can fail to correspond with the course of thought. “How does knowledge correspond to being?” is a more profound formulation of the problem of knowledge.But we are not going to touch anymore on the primordial phenomenon that generates the problem. The problem of correspondence between thing and thought presupposes a free activity of thought and its isolation in relation to the object. It is precisely this presupposition which renders their harmony and even their contact problematic. “How does the subject take leave of itself to attain the object?” is what the problem of knowledge, in the last analysis, boils down to. Its true source is thus the concept of “subject” as elaborated by modern philosophy. The cogito presided over the subject’s birth. The cogito was the affirmation of the privileged nature of the subject’s immanent sphere, of its unique place in existence; hence, the cogito was the specificity of the subject’s connection to the rest of reality, the sui generis nature which opens up the passage from immanence to transcendence, the passage from ideas contained in the thinking substance to 4 their “formal existence.”The concept of the subject, understood as a substance having a specific position in the entire domain of being, presents us with difficulties of two kinds. First, how do we understand this leave-taking from the self which the thinking substance brings about and which displays an entirely original aspect? Indeed, we could say that thought, in reaching out toward objects, does not actually take leave of itself, since its objects—considered as ideas and contents of thought—are, in a certain sense, already within it. In order to make sense of this paradox, Descartes... (shrink)

“Poland 2050” Report is a publication of a distinctive sort. While the idea of producingthis report has a long history, it began to take shape about two years ago. It isbased on the two tenets. The first, raised at numerous conferences held in the past underthe auspices of the “Poland 2000 Plus” Committee, is the conviction that economicgrowth does not transpose automatically into societal (or more broadly “civilizational”)advancement. Indeed, the preliminary analysis has indicated that the two processes are,in fact, (...) divergent. While there have been convergent processes evident in Poland’s andthe EU’s economic domains, no such convergence is significantly evident in the case ofsocietal progress. This gave rise to the vision set forth in this Report, formulated as“minimizing Poland’s developmental gap with respect to the more advanced EU states.”The second tenet upon which this Report is based is even more important. Numerousanalyses carried out by the Committee indicate that quantitative changes cannot bepredicted four decades in advance with great likelihood. And so, we did not base ourReport on existing quantitative trends, but rather on analysis of the pathways that willmake it possible to minimize Poland’s developmental gap with respect to the advancedEU states. The Report also strives to highlight threats that exist in the social and “civilizational”sphere.The Report was based on the materials published in the three volumes of the publicationWizja przyszłości Polski – Studia i Analizy [A Vision of Poland’s Future—Studies and Analyses], vol. 1: Społeczeństwo i państwo [Society and State], vol. 2: Gospodarkai środowisko [Economy and Environment], and vol. 3: Ekspertyzy [ExpertStudies]. (shrink)

Research question and aim Clinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020, a CEC was established in an Oncology Research Hospital in the North of Italy. This paper describes the development process and the activities performed 20 months from the CEC’s implementation, to increase knowledge about CEC’s implementation strategy. Research design We collected quantitative data related to number and characteristics of CEC activities carried out (...) from October 2020 to June 2022 using the CEC internal database. Data were reported descriptively and compared with data from the literature to provide a complete overview of the CEC’s development and implementation process. Participants and research context The study has been conducted at the local health authority (LHA) of Reggio Emilia. It is a report of the activities provided by the CEC, where no HPs or patients were involved. Ethical Considerations The report is part of a larger study named EVAluating a Clinical Ethics Committee implementation process (EvaCEC), which has been approved by the Local Ethics Committee (AUSLRE Protocollo n° 2022/0026554 of 24/02/2022). EvaCEC is also the first author's PhD project. Findings In total, the CEC performed 7 ethics consultations (EC), published three policies related to particular ethical questions of clinical and organizational practice, provided one educational online course on ethics consultation targeting employed HPs, and promoted a specific dissemination process among the different departments of the LHA. According to our results, the CEC widely fulfilled the standard threefold set of clinical ethics support services tasks (namely, ethics consultation, ethics education, and policy development), but further investigations are needed to evaluate the CEC’s impact on clinical practice. Conclusion Our findings may increase knowledge regarding the composition, role, and tasks of a CEC in an Italian setting, informing future strategies and efforts to regulate these institutions officially. (shrink)

Originally published in 1961. Michael Polanyi was a polymath who influenced economics and the sciences as well as philosophy. His wide-ranging research in physical science is as well-known as his work on freedom and knowledge and his arguments against positivism and reductionism. This collection of essays written for him touches on all aspects of his influence but rotates around his published lectures Personal Knowledge: Towards a Post-Critical Philosophy. The contributors address four areas – The Scientist as Knower, Historical Perspectives, The (...) Knowledge of Society and the Knowledge of Living Things. (shrink)

Name der Zeitschrift: Jahrbuch für Wissenschaft und Ethik Jahrgang: 20 Heft: 1 Seiten: 355-366.

Compilation of the most important documents and speeches by Pierre de Coubertin on Olympism and the Olympic Games.

Doctoral programs at U.S. universities play a critical role in the development of human resources both in the United States and abroad. This volume reports the results of an extensive study of U.S. research-doctorate programs in five broad fields: physical sciences and mathematics, engineering, social and behavioral sciences, biological sciences, and the humanities. Research-Doctorate Programs in the United States documents changes that have taken place in the size, structure, and quality of doctoral education since the widely used 1982 editions. This (...) update provides selected information on nearly 4,000 doctoral programs in 41 subdisciplines at 274 doctorate-granting institutions. This volume also reports the results of the National Survey of Graduate Faculty, which polled a sample of faculty for their views on the scholarly quality of program faculty and the effectiveness of doctoral programs in preparing research scholars/scientists. This much-anticipated update of such an essential reference will be useful to education administrators, university faculty, and students seeking authoritative information on doctoral programs. (shrink)

Despite a decade of federal regulation and debate over the appropriateness of financial ties in research and their management, little is known about the actual decision-making processes of university conflict of interest (COI) committees. This paper analyzes in detail the discussions and decisions of three COI committees at three public universities in California. University committee members struggle to understand complex financial relationships and reconcile institutional, state, and federal policies and at the same time work to protect the integrity of (...) the scientific process, the autonomy and intellectual freedom of their faculty colleagues and students, and the financial interests of the university. (shrink)

Traditionally the domain of scientists, the history of science became an independent field of inquiry only in the twentieth century and mostly after the Second World War. This process of emancipation was accompanied by a historiographical departure from previous, ‘scientistic’ practices, a transformation often attributed to influences from sociology, philosophy and history. Similarly, the liberal humanists who controlled the Cambridge History of Science Committee after 1945 emphasized that their contribution lay in the special expertise they, as trained historians, brought (...) to the venture. However, the scientists who had founded the Committee in the 1930s had already advocated a sophisticated contextual approach: innovation in the history of science thus clearly came also from within the ranks of scientists who practised in the field. Moreover, unlike their scientist predecessors on the Cambridge Committee, the liberal humanists supported a positivistic protocol that has since been criticized for its failure to properly contextualize early modern science. Lastly, while celebrating the rise of modern science as an international achievement, the liberal humanists also emphasized the peculiar Englishness of the phenomenon. In this respect, too, their outlook had much in common with the practices from which they attempted to distance their project. (shrink)

Simonet, Emanuel Nicolas Cortes; Herbert, Dilinie The Caroline Chisholm Centre for Health Ethics1 was established through the collaboration of private catholic hospitals in Victoria, namely: Cabrini Health, Calvary Health Care Bethlehem, Caritas Christi Hospice, Mercy Hospital for Women, Mercy Werribee Hospital, Mercy Palliative Care, St John of God Health Care, St Vincent's Hospital Melbourne, and St Vincent's Private Hospital Melbourne. Our role is to develop, review and respond to policies and procedures affecting Catholic Health Care; provide educational resources and formation (...) in ethics and offer ethics consultation and advisement. The Chisholm Health Ethics Bulletin is our quarterly publication that reports on ethical issues arising in health care as well as literature reviews of pertinent research topics that effect national and international interests. (shrink)

In its recent statement 'Sex Selection and Preimplantation Genetic Diagnosis', the Ethics Committee of the American Society of Reproductive Medicine concluded that preimplantation genetic diagnosis for sex selection for non-medical reasons should be discouraged because it poses a risk of unwarranted gender bias, social harm, and results in the diversion of medical resources from genuine medical need. We critically examine the arguments presented against sex selection using preimplantation genetic diagnosis. We argue that sex selection should be available, at least (...) within privately funded health care. (shrink)

Definition of the problemFrom an ethical point of view we analyse the ruling of the German Federal Joint Committee (Gemeinsamer Bundesausschuss, G‑BA) of September 2019 to revise the guidelines about the coverage of noninvasive prenatal tests (NIPT) by mandatory health insurance, in order to include them under specified conditions. The decision contains four essential elements: a definition of the aim of NIPT testing (to avoid invasive testing), a criterion of access (test must be “necessary” for the pregnant woman to (...) tackle her individual situation), statements about the process of decision-making (after counselling by a physician and case by case) and a normative contextualization (termination of pregnancy under § 218 a German penal law) which is to be found in its explanations. There are tensions in the proposed model that oscillate about two axes: (1) The suffering that results from a possible birth of a child with trisomy or from not knowing about the genetic condition of the fetus can ultimately only be evaluated subjectively, from the perspective of the pregnant woman. (2) The meaning of an individual decision in the case-by-case model remains unclear because when judging about individual cases general points of view also need to be considered. However, we argue that the model of the G‑BA could be a sociopolitically and ultimately also ethically defensible pragmatic solution, exactly because of its paradoxes and its inherent flexibility. (shrink)