64 results on '"Dominique Sprumont"'
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2. Including adolescents of childbearing potential in clinical trials with possible exposure to teratogenic medication: a challenge for paediatricians and researchers
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Pierre-André Michaud, Manuel Diezi, Linda Guihard, Martine Jacot-Guillarmod, Peter Kleist, Dominique Sprumont, and Pascale Wenger
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adolescent ,ethics ,competence ,female ,childbearing ,menarche ,Medicine - Abstract
The issue of contraception and pregnancy tests among minor adolescent women participating in clinical trials, whether healthy or suffering from a disease, represents a challenging issue for paediatricians and researchers, given the potential harmful effect of various therapeutic procedures being tested. First, they need to gauge at what age or developmental stage they need to impose pregnancy tests and contraception. Second, if the adolescent denies any sexual activity, it may be ethically questionable to impose such procedures. Third, these professionals must deal with the issue of confidentiality, taking into account the fact that some adolescents engage in penetrative sexual intercourse without their parents or caregivers knowing. Fourth, in such cases, they must assess the extent to which a minor adolescent can be considered as competent (capable of making autonomous decisions) and deserves privacy and confidentiality. There is indeed a legal obligation for the provider to check that sexual experiences and intercourse take place within a safe relationship. Fifth, if the prescription of contraception is warranted, they have to decide who should assist the adolescent in choosing the method. Finally, with the occurrence of a positive pregnancy test, they may face the rare instance of a competent minor adolescent who refuses to inform her parents. This article has been developed by a group of experts under the auspices of swissethics, the Swiss Association of Research Ethics Committees and SwissPedNet, the umbrella organisation that coordinates the paediatric research in Switzerland. The paper reviews how to address practical and ethical questions regarding minor adolescents of childbearing potential enrolled in a clinical trial that may involve teratogenic medication and offers a series of concrete advice and tools for dealing with problematic situations. Most paediatric protocols stipulate that adolescents included in clinical trials involving potentially teratogenic drugs should undergo pregnancy tests and use contraception. The circumstances in which such requirements are undertaken, however, has not been sufficiently addressed. The recommendations presented in this article will assist researchers in assessing which circumstances apply when considering minor adolescents as individuals with childbearing potentials. It also offers concrete suggestions for tackling such situations.
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- 2020
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3. Good collaborative practice: reforming capacity building governance of international health research partnerships
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Claire Leonie Ward, David Shaw, Dominique Sprumont, Osman Sankoh, Marcel Tanner, and Bernice Elger
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Global Health Research ,Governance ,Ethics ,Collaborative partnership ,Capacity building ,Social justice ,Public aspects of medicine ,RA1-1270 - Abstract
Abstract In line with the policy objectives of the United Nations Sustainable Development Goals, this commentary seeks to examine the extent to which provisions of international health research guidance promote capacity building and equitable partnerships in global health research. Our evaluation finds that governance of collaborative research partnerships, and in particular capacity building, in resource-constrained settings is limited but has improved with the implementation guidance of the International Ethical Guidelines for Health-related Research Involving Humans by The Council for International Organizations of Medical Sciences (CIOMS) (2016). However, more clarity is needed in national legislation, industry and ethics guidelines, and regulatory provisions to address the structural inequities and power imbalances inherent in international health research partnerships. Most notably, ethical partnership governance is not supported by the principal industry ethics guidelines – the International Conference on Harmonization Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) Good Clinical Practice (ICH-GCP). Given the strategic value of ICH-GCP guidelines in defining the role and responsibility of global health research partners, we conclude that such governance should stipulate the minimal requirements for creating an equitable environment of inclusion, mutual learning, transparency and accountability. Procedurally, this can be supported by i) shared research agenda setting with local leadership, ii) capacity assessments, and iii) construction of a memorandum of understanding (MoU). Moreover, the requirement of capacity building needs to be coordinated amongst partners to support good collaborative practice and deliver on the public health goals of the research enterprise; improving local conditions of health and reducing global health inequality. In this respect, and in order to develop consistency between sources of research governance, ICH-GCP should reference CIOMS ethical guidelines as the established standard for collaborative partnership. Moreover, greater commitment and support should be given to co-ordinate, strengthen and enforce local laws requiring equitable research partnerships and health system strengthening.
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- 2018
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4. Twelve tips to promote excellence in ethical review: translation and adaptation of e-learning in research ethics
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Pollyana Gontijo, Dirce Guilhem, Dominique Sprumont, and Dirceu Greco
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Translating ,Education, distance ,Ethics, research ,Ethics committees, research ,Special aspects of education ,LC8-6691 ,Medicine - Abstract
Usage of and investment in e-learning has also grown in the field of research ethics. There are currently several distance capacity building programs on this theme, although few are translated to the language and adapted to the legislation of countries with less resources to implement local training. Translating and adapting an already existing e-learning is a more accessible strategy, since it makes use of an already existing online platform and capacity building strategies that were previously tested and are recognized in the scientific community and society in general. This training needs to be adapted to local needs and there must be guidelines for the translation and adaptation stages of the distance education programs for ethics in research involving human beings. In this article, we put forward 12 steps for the translation and adaptation of e-learning on research ethics, based on our experience of implementing the Brazilian version of TRREE e-learning.
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- 2016
5. Informed consent: Do not be afraid
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Dominique Sprumont
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doctor-patient partnership ,doctor-patient relationship ,informed consent ,patient's rights ,professional obligation ,Medicine (General) ,R5-920 - Abstract
Informed consent is the cornerstone of the doctor–patient relationship. At least this is how it is presented in theory. In practice, doctors struggle with their obligation to inform their patient before obtaining their approval prior to a medical intervention. In Taiwan, the culture is often mentioned to justify the doctor's reluctance to speak openly with their patient. Invoking the importance of the family in the society, doctors tend to rely less on their patients and more on their relatives to make important decisions. Yet, the cultural argument for not seeking the patients' informed consent sounds more like a mere excuse than the real cause of the difficulties doctors face today in obtaining their patients' consent. This paper argues that today the doctors in Taiwan are mostly governed by the same fear that was the rule in the USA and Europe until the 1980s. It may be time for changing the paradigm, admitting that patients are able to handle even the most dramatic diagnosis. It seems also important to get away from the sterile opposition of doctor's paternalism versus patient's autonomy and to introduce a true partnership between doctors and patients.
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- 2017
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6. A Call for the Application of Patient Safety Culture in Medical Humanitarian Action: A Literature Review
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Dominique Sprumont, Jean-Marc Biquet, P. Michel, and Doris Schopper
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Safety Management ,Leadership and Management ,business.industry ,Public Health, Environmental and Occupational Health ,Public relations ,Variety (cybernetics) ,Intervention (law) ,Patient safety ,Systematic review ,Political science ,Health care ,Macro level ,Humans ,Health Facilities ,Patient Safety ,Humanitarian action ,business ,Delivery of Health Care ,Inclusion (education) ,health care economics and organizations - Abstract
OBJECTIVES The aims of the study were to assess lessons learned on patient safety in Organization for Economic Cooperation and Development (OECD) countries and to assess whether they are applied or can be applied to the humanitarian medicine. METHODS This is (a) a 2013-2018 rapid literature review of reviews and systematic reviews articles (PubMed database) on "patient safety" and "medical error" to look for lessons learned regarding patient safety in OECD countries and (b) a rapid literature review (PubMed and Embase databases) on "humanitarian medicine" and "patient safety," from their creation to 2018, to find any articles related to patient safety in humanitarian medicine. In both reviews were excluded articles specifically related to one device, disease, or medical act. These reviews were complemented by a Google search. RESULTS Of the 245 references retrieved, 104 met the inclusion criteria. Of 308 references, 39 respected the inclusion criteria. In OECD countries, patient safety comprises correlated measures taken at three levels. The micro level focuses on individual staff involved in healthcare provision or management; the meso level focuses on medical institutions; the macro level focuses on national healthcare systems. Only one reference mentioned the implementation of a medical error reporting and analysis system in medical humanitarian organization. CONCLUSIONS The adoption of strategies and a culture of safety will need to be adapted to address the variety of intervention contexts and to respond first to the fears and expectations of humanitarian staff. Medical humanitarian organizations, in the absence of an overarching authority for the sector, have a major responsibility in the development of a general patient safety policy applicable in all their operations.
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- 2021
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7. Research ethics: respecting the fundamental principles and cultural differences
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Dominique Sprumont
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Protocol (science) ,Research ethics ,Clinical research ethics ,Political science ,Cultural diversity ,Good clinical practice ,Multilingualism ,Engineering ethics ,General Medicine ,Human research - Abstract
The article describes the 10-year experience of distributing the TRREE project (Training and Resources in Research Ethics Evaluation). This is a free open e-learning program for specialists from the Clinical Research Ethics Committees on regulatory standards in this field. The survey of these specialists showed that there are similar needs for training in fundamental ethical principles related to human research, in accordance with the laws and regulations applicable in the respective countries, and in conducting an ethical assessment of the research protocol. TRREE operates in seven languages, providing access to national laws in ten languages related to research ethics and standards of GCP (Good Сlinical Рractice). The author asks whether the module should be created in Russian.
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- 2021
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8. Recherche avec des enfants et découvertes fortuites : quels devoirs des parents ?
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Alexandre Dosch and Dominique Sprumont
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General Medicine - Published
- 2022
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9. Santé personnalisée : définition, caractéristiques et perspectives pour le futur
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Géraldine Marks Sultan, Alexandre Dosch, and Dominique Sprumont
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General Medicine - Published
- 2021
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10. [Personalized health : definition, characters and prospects for the future]
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Géraldine, Marks Sultan, Alexandre, Dosch, and Dominique, Sprumont
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Humans ,Public Health ,Delivery of Health Care - Abstract
Personalization is at the center of medical practice. With the sequencing of the genome, the rise in technologies and big data processing capacities, it was then envisioned in an even more precise way, for more targeted treatments on patients' distinctive features. In the last few years, prospects for this personalization went in the direction of public health. Beyond patients, the aim is thus to pursue the entire population, to identify and adjust action on the social, environmental, and biomedical factors that make individuals vulnerable in a health perspective. This is referred as personalized health. Its objective is to better understand the interactions between these factors for a more efficient approach of healthcare and interventions on the social conditions for maintaining the good health of all.La personnalisation des soins est au centre de la pratique médicale. Avec le séquençage du génome, l’essor des technologies et du traitement de données massives, elle est maintenant envisagée de manière encore plus précise pour des soins toujours plus ciblés sur les caractéristiques des patients. Depuis quelques années, ces techniques déploient aussi leur potentiel en matière de santé publique. Au-delà des patients, il s’agit ici de viser toute la population, pour identifier et ajuster l’action sur les facteurs sociaux, environnementaux et biomédicaux qui rendent les individus vulnérables du point de vue de la santé. On parle de santé personnalisée. Son objectif est de mieux comprendre les interactions entre ces facteurs pour une approche plus efficace des soins et des interventions sur les conditions sociales du maintien de la bonne santé pour tous.
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- 2021
11. Bibliographie der jüngsten Publikationen im Gesundheitsrecht
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null Sabrina Burgat, Nathalie Brunner, Astrid Pilottin, Jérôme Saint-Phor, Dominique Sprumont, Vladislava Talanova, Félix Delerm, Alexandre Dosch, Olivier Guillod, Aude Guillot, Sandra Hotz, Mélanie Levy, and Géraldine Marks
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General Medicine - Published
- 2021
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12. Droits des patient·e·s
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Dominique Sprumont
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- 2020
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13. Patienten- und Patientinnenrechte
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Dominique Sprumont
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- 2020
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14. Knowledge, attitudes, and Expectations of Medical Staff Toward Medical Error Management Policies in Humanitarian Medicine: A Qualitative Study
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Jean-Marc Biquet, Doris Schopper, Dominique Sprumont, and Philippe Michel
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Medical education ,Health Knowledge, Attitudes, Practice ,Motivation ,Medical Errors ,Leadership and Management ,business.industry ,media_common.quotation_subject ,Public Health, Environmental and Occupational Health ,MEDLINE ,Blame ,Patient safety ,Policy ,Health care ,Medical Staff ,Humans ,Thematic analysis ,business ,Psychology ,Developed country ,health care economics and organizations ,Qualitative research ,media_common ,Diversity (politics) - Abstract
Background Patient safety, a major component of quality of care, is now an attribute of health care systems in developed countries at least. Although there is ever more research on this subject in developed countries, humanitarian medicine, mainly implemented in resource-poor countries, has yet to structure its own set of policies and strategies on patient safety and the management of medical errors. Objectives We assessed the knowledge, attitudes, and expectations of medical humanitarian staff regarding the development of policies and strategies related to patient safety and medical error management in medical humanitarian action. Methods We conducted 36 semistructured interviews with international medical and paramedical staff active in 6 medical humanitarian organizations after having interviewed the medical directors or the person in charge of quality of care and the legal advisors. Interviews were transcribed verbatim and subjected to a thematic analysis. Results The interviews confirmed the current absence of clear investments in dealing with safety risks in the selected medical humanitarian organizations. The difficulties experienced by medical staff in reporting medical errors such as blame culture, lack of training, and absence of leadership committed on patient safety are nonspecific. Other arguments are related to the specific conditions of humanitarian settings: coexistence of different medical culture, absence of international or local regulations or external pressures, and great diversity of activities and contexts. Conclusions Interviewed staff expressed high expectations of receiving guidance from their organizations and support to adopt clear patient safety and medical error management policies adapted to their complex operational and clinical realities.
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- 2020
15. Integrating public health programs and research after the malaria vaccine implementation program (MVIP): Recommendations for next steps
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Eugenijus Gefenas, David Haerry, Johannes J. M. van Delden, Dirceu Bartolomeu Greco, Anant Bhan, Rieke van der Graaf, Alex John London, Dominique Sprumont, Annette Rid, Ruth Macklin, Samia Hurst, and Rodolfo Saracci
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Value (ethics) ,medicine.medical_specialty ,Biomedical Research ,Process (engineering) ,education ,030231 tropical medicine ,Ethics, Research ,03 medical and health sciences ,0302 clinical medicine ,Informed consent ,Political science ,Malaria Vaccines ,medicine ,Humans ,030212 general & internal medicine ,Protocol (science) ,Research ethics ,Informed Consent ,General Veterinary ,General Immunology and Microbiology ,International ethics ,Public health ,Public Health, Environmental and Occupational Health ,Infectious Diseases ,Molecular Medicine ,Engineering ethics ,Public Health ,Case analysis ,Ethics Committees, Research - Abstract
Background In February 2020, international controversy arose about the ethical acceptability of the WHO Malaria Vaccine Implementation Program (MVIP). Whereas some have argued that this program must be seen as research that is not in line with international ethical standards, notably regarding informed consent and local ethical review, some WHO representatives consider the MVIP as a public health implementation program that need not adhere to these standards. Methods We performed a case analysis in light of the 2016 CIOMS International Ethical Guidelines for Health-related Research involving Humans. Findings We argue that the MVIP has a substantial research component, and that it is prudent to therefore apply ethical norms for research involving humans, such as the CIOMS guidelines. Accordingly, we agree that the ethical requirements of informed consent and independent ethical review have not been met. In addition, we are concerned that the study might not meet CIOMS’s social value requirement. Recommendations We urge WHO to release more details about the process that led to the MVIP program and make the MVIP protocol publicly available. The full protocol should be assessed by the relevant ethics committees, new and already enrolled parents should be informed about the uncertainties under investigation and given a real opportunity to consent or refuse (continued) participation, communities should be engaged, and aspects of MVIP that require alteration in light of ethical review should be altered, if possible. Furthermore, in order to improve good ethical practices, it is necessary to engage in international debate regarding the integration of research and public health programs. Procedurally, vaccine implementation programs that combine both prevention and research should involve the wider international ethics community and ensure participation of the target populations in setting the proper conditions for launching such programs.
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- 2020
16. A need to simplify informed consent documents in cancer clinical trials. A position paper of the ARCAD Group
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Cathy Eng, G. Decoster, H.-J. Schmoll, Al B. Benson, Annette K. Larsen, Alberto Sobrero, A. de Gramont, Charles S. Fuchs, Harry Bleiberg, Masashi Fujii, John Zalcberg, Jean-Yves Douillard, Dominique Sprumont, Roberto Labianca, Edith P. Mitchell, Ph. Rougier, and Benoist Chibaudel
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Health Knowledge, Attitudes, Practice ,medicine.medical_specialty ,good clinical practice ,media_common.quotation_subject ,education ,Legibility ,Institution Review Board ,Consent Forms ,03 medical and health sciences ,0302 clinical medicine ,Documentation ,Informed consent ,Neoplasms ,inform consent ,Humans ,Medicine ,030212 general & internal medicine ,Patient participation ,media_common ,Clinical Trials as Topic ,Medical education ,Informed Consent ,business.industry ,clinical trial ,Hematology ,ethics ,Cancérologie ,Clinical trial ,Editor's Choice ,Oncology ,030220 oncology & carcinogenesis ,Family medicine ,oncology ,Practice Guidelines as Topic ,Good clinical practice ,Special Articles ,Position paper ,Patient Participation ,business ,Autonomy ,Hématologie - Abstract
Background: In respect of the principle of autonomy and the right of self-determination, obtaining an informed consent of potential participants before their inclusion in a study is a fundamental ethical obligation. The variations in national laws, regulations, and cultures contribute to complex informed consent documents for patients participating in clinical trials. Currently, only few ethics committees seem willing to address the complexity and the length of these documents and to request investigators and sponsors to revise them in a way to make them understandable for potential participants. The purpose of this work is to focus on the written information in the informed consent documentation for drug development clinical trials and suggests (i) to distinguish between necessary and not essential information, (ii) to define the optimal format allowing the best legibility of those documents., SCOPUS: ar.j, info:eu-repo/semantics/published
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- 2017
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17. Country Reports
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Ma'n H. Zawati, Don Chalmers, Sueli G. Dallari, Marina de Neiva Borba, Miriam Pinkesz, Yann Joly, Haidan Chen, Mette Hartlev, Liis Leitsalu, Sirpa Soini, Emmanuelle Rial-Sebbag, Nils Hoppe, Tina Garani-Papadatos, Panagiotis Vidalis, Krishna Ravi Srinivas, Gil Siegal, Stefania Negri, Ryoko Hatanaka, Maysa Al-Hussaini, Amal Al-Tabba', Lourdes Motta-Murgía, Laura Estela Torres Moran, Aart Hendriks, Obiajulu Nnamuchi, Rosario Isasi, Dorota Krekora-Zajac, Eman Sadoun, Calvin Ho, Pamela Andanda, Won Bok Lee, Pilar Nicolás, Titti Mattsson, Vladislava Talanova, Alexandre Dosch, Dominique Sprumont, Chien-Te Fan, Tzu-Hsun Hung, Jane Kaye, Andelka Phillips, Heather Gowans, Nisha Shah, and James W. Hazel
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Research Report ,Economic growth ,Internet ,Biomedical Research ,Internationality ,Health Policy ,Genomic research ,Patient Selection ,General Medicine ,Genomics ,Hazardous Substances ,Research Personnel ,Issues, ethics and legal aspects ,Direct-To-Consumer Screening and Testing ,Surveys and Questionnaires ,Humans ,Genetic Testing ,Psychology ,Policy Making ,Confidentiality ,Biological Specimen Banks ,Ethics Committees, Research - Published
- 2020
18. Bibliografie der jüngsten Publikationen im Gesundheitsrecht
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Astrid Pilottin, Nathalie Brunner, Jérôme Saint-Phor, Alexandre Dosch, Dominique Sprumont, Géraldine Marks, Rachel Christinat, Sabrina Burgat, Vladislava Talanova, and Olivier Guillod
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General Medicine - Published
- 2020
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19. Bibliographie der jüngsten Publikationen im Gesundheitsrecht
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null Sabrina Burgat, Nathalie Brunner, Rachel Christinat, Alexandre Dosch, Olivier Guillod, Géraldine Marks, Astrid Pilottin, Jérôme Saint-Phor, Dominique Sprumont, and Vladislava Talanova
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General Medicine - Published
- 2020
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20. Zigaretten Marketing und Jugendschutz
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Valéry Bezençon, Joachim Marti, Dominique Sprumont, Milo Puhan, and Suzanne Suggs
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Microbiology (medical) ,Immunology ,Immunology and Allergy ,General Medicine - Published
- 2019
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21. The 'Nuremberg Code': Rules of Public International Law
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Pascal Arnold and Dominique Sprumont
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Tribunal ,Law ,Political science ,Nuremberg Code ,Character (symbol) ,Medical ethics ,Public international law ,Helsinki declaration - Abstract
This chapter discusses the International Military Tribunal (IMT) trial and the “Principles of Nuremberg”. It explores the influence of these principles on the doctor’s trial, as well as the trial’s international character. The chapter focuses on an evaluation of the legal valence of the “Nuremberg Code” in public international law. It assesses the relationship between the “Nuremberg Code” and codes of medical ethics, in particular the Helsinki Declaration. To understand the “Nuremberg Code’s” significance in public international law, it is necessary to analyze the post-World War II trials at Nuremberg. The practice of public international law in the post-IMT era has in large part confirmed the validity of the Principles of Nuremberg. The greatest contribution of the Nuremberg trial was that for the first time war criminals were condemned before an international tribunal under rules of public international law.
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- 2019
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22. Ethical Research : The Declaration of Helsinki, and the Past, Present, and Future of Human Experimentation
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Ulf Schmidt, Andreas Frewer, Dominique Sprumont, Ulf Schmidt, Andreas Frewer, and Dominique Sprumont
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- Research--Moral and ethical aspects, Human experimentation in medicine, Bioethics
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At the heart of research with human beings is the moral notion that the experimental subject is altruistic, and is primarily concerned for the welfare of others. Beneath the surface, however, lies a very different ethical picture. Individuals participating in potentially life-saving research sometimes take on considerable risks to their own well-being. Efforts to safeguard human participants in clinical trials have intensified ever since the first version of the World Medical Association's Declaration of Helsinki (1964) and are now codified in many national and international laws and regulations. However, a comprehensive understanding of how this cornerstone document originated, changed, and functions today does not yet exist in the sphere of human research. Ethical Research brings together the work of leading experts from the fields of bioethics, health and medical law, the medical humanities, biomedicine, the medical sciences, philosophy, and history. Together, they focus on the centrality of the Declaration of Helsinki to the protection of human subjects involved in experimentation in an increasingly complex industry and in the government-funded global research environment. The volume's historical and contemporary perspectives on human research address a series of fundamental questions: Is our current human protection regime adequately equipped to deal with new ethical challenges resulting from advances in high-tech biomedical science? How important has the Declaration been in non-Western regions, for example in Eastern Europe, Africa, China, and South America? Why has the bureaucratization of regulation led to calls to pay greater attention to professional responsibility? Ethical Research offers insight into the way in which philosophy, politics, economics, law, science, culture, and society have shaped, and continue to shape, the ideas and practices of human research.
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- 2020
23. National public health law: a role for WHO in capacity-building and promoting transparency
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Scott Burris, Géraldine Marks-Sultan, Feng Jen Tsai, Florian Kastler, Dominique Sprumont, and Evan D. Anderson
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medicine.medical_specialty ,Capacity Building ,Public health law ,Disaster Planning ,Public administration ,Global Health ,World Health Organization ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Global health ,Humans ,030212 general & internal medicine ,Health policy ,030503 health policy & services ,Public health ,Health Policy ,Public Health, Environmental and Occupational Health ,Transparency (behavior) ,Health promotion ,Policy & Practice ,Preparedness ,Public Health Practice ,Health law ,Business ,Public Health ,0305 other medical science ,Delivery of Health Care - Abstract
A robust health infrastructure in every country is the most effective long-term preparedness strategy for global health emergencies. This includes not only health systems and their human resources, but also countries' legal infrastructure for health: the laws and policies that empower, obligate and sometimes limit government and private action. The law is also an important tool in health promotion and protection. Public health professionals play important roles in health law - from the development of policies, through their enforcement, to the scientific evaluation of the health impact of laws. Member States are already mandated to communicate their national health laws and regulations to the World Health Organization (WHO). In this paper we propose that WHO has the authority and credibility to support capacity-building in the area of health law within Member States, and to make national laws easier to access, understand, monitor and evaluate. We believe a strong case can be made to donors for the funding of a public health law centre or unit, that has adequate staffing, is robustly networked with its regional counterparts and is integrated into the main work of WHO. The mission of the unit or centre would be to define and integrate scientific and legal expertise in public health law, both technical and programmatic, across the work of WHO, and to conduct and facilitate global health policy surveillance.Avoir une infrastructure sanitaire solide dans chaque pays est la meilleure stratégie à long terme de préparation aux urgences sanitaires mondiales. Il s'agit non seulement des systèmes de santé et de leurs ressources humaines, mais aussi de l'infrastructure juridique des pays en matière de santé: les lois et les politiques qui permettent, obligent et parfois limitent l'action du gouvernement et du secteur privé. La législation est également un outil important pour la promotion et la protection de la santé. Les professionnels de la santé publique jouent un rôle important vis-à-vis de la législation sanitaire - de l'élaboration des politiques à leur application, en passant par l'évaluation scientifique de l'impact des lois sur la santé. Les États membres sont déjà chargés de faire part de leurs lois et règlements nationaux en matière de santé à l'Organisation mondiale de la Santé (OMS). Le présent article suggère que l'OMS, qui dispose de l'autorité et de la crédibilité pour le faire, participe au renforcement des capacités dans le domaine de la législation sanitaire des États membres et facilite l'accès, la compréhension, le contrôle et l'évaluation des lois nationales. Des arguments convaincants peuvent être présentés aux bailleurs de fonds pour le financement d'un centre ou d'une unité de législation de la santé publique qui disposerait du personnel nécessaire, entretiendrait de solides relations avec ses homologues régionaux et serait intégré aux principaux travaux de l'OMS. La mission de cette unité ou de ce centre consisterait à définir et intégrer l'expertise scientifique et juridique dans la législation de la santé publique, sur le plan technique et programmatique, dans le cadre des travaux de l'OMS, et à réaliser et faciliter la surveillance des politiques sanitaires mondiales.Una infraestructura sanitaria firme en todos los países es la estrategia de preparación más eficaz a largo plazo para tratar las emergencias sanitarias en todo el mundo. Esto no solo incluye los sistemas sanitarios y sus recursos humanos, sino también la infraestructura legal para la salud de cada país: las leyes y políticas que facultan, obligan y, en ocasiones, limitan la acción privada y del gobierno. La legislación también es una herramienta importante para el fomento y la protección de la salud. Los profesionales de la salud pública tienen funciones fundamentales en la legislación sanitaria: desde el desarrollo de políticas a través de su puesta en vigor, hasta la evaluación científica del impacto sanitario de las leyes. Ya se ha encomendado a los Estados Miembros que comuniquen sus leyes y normativas de salud nacionales a la Organización Mundial de la Salud (OMS). Este artículo propone que la OMS tenga la autoridad y credibilidad para dar apoyo a la creación de capacidad de las leyes sanitarias de los Estados Miembros, y para facilitar el acceso, la comprensión, la supervisión y la evaluación de las leyes nacionales. Creemos que hay argumentos firmes a favor de las contribuciones para la financiación de un centro o unidad de derecho de salud pública que cuente con el personal adecuado, tenga un sistema de redes sólido con sus contrapartes regionales y esté integrado con el trabajo principal de la OMS. La misión de la unidad o centro sería definir e integrar la experiencia científica y legal en la ley de salud pública, tanto en el aspecto técnico como programático, a través del trabajo de la OMS, así como dirigir y facilitar el control de las políticas sanitarias globales.إن إنشاء بنية تحتية قوية للصحة في كل بلد يمثل استراتيجية التأهب الأكثر فعالية على المدى الطويل لحالات الطوارئ الصحية العالمية. وهذا الأمر لا يشمل فقط أنظمة الصحة والموارد البشرية الخاصة بها، وإنما يمتد أيضًا ليشمل البنية التحتية القانونية للصحة في البلدان، بما يشمل: القوانين والسياسات التي تعمل على تمكين وفرض الإجراءات الحكومية والخاصة وأحيانًا الحد من تأثيرها. ويمثل القانون أيضًا أداةً مهمة في مجال حماية الصحة وتشجيع الحفاظ عليها. ويؤدي المتخصصون في مجال الصحة العامة أدوارًا هامة في قانون الصحة – بداية ًمن وضع السياسات، حتى إنفاذها، ونهايةً بإجراء التقييم العلمي عن التأثير الصحي للقوانين. تم إلزام الدول الأعضاء بالفعل بإعلام منظمة الصحة العالمية بقوانينها الصحية الوطنية ولوائحها التنظيمية. نقترح في هذه الدراسة منح منظمة الصحة العالمية الصلاحية والمصداقية لدعم بناء القدرات في مجال القوانين الصحية داخل نطاق الدول الأعضاء، وتسهيل الاطلاع على القوانين الوطنية وفهمها ومتابعتها وتقييمها بشكلٍ أكبر. ونحن نعتقد أنه يمكن تقديم عرض مُقنِع للجهات المانحة لتمويل مركز أو وحدة قانون الصحة العامة، التي يتواجد فيها عدد كافٍ من الموظفين، والتي يتم توصيلها بشبكة قوية بنظيراتها الإقليمية، مع دمجها في نطاق العمل الرئيسي لمنظمة الصحة العالمية. وعلى أن تتمثل مهمة الوحدة أو المركز في تحديد ودمج الخبرات العلمية والقانونية في قانون الصحة العامة، لكل من الخبرات التقنية والبرمجية، وذلك عبر نطاق الأعمال التي تؤديها منظمة الصحة العالمية، والعمل على إجراء أعمال مراقبة السياسة الصحية العالمية وتسهيلها.在每个国家建立稳健的卫生基础设施是应对全球性卫生突发事件最有效的长期准备战略。 这不仅包括卫生系统及其人力资源,而且还包括各国有关卫生的法律基础设施: 赋予权力、义务并且有时限制政府和民间活动的法律和政策。 法律也是促进卫生和卫生防护的重要工具。 从政策的制定、执行,到科学评估法律对卫生的影响——公共卫生专业人员在卫生法律中发挥重要的作用。 成员国必须将其国家卫生法律和法规传达给世界卫生组织。 在本文中,我们建议世界卫生组织凭借其权威性和公信力在成员国中支持卫生法律领域的能力建设,并且使国家法律更加便于查阅、了解、监控和评估。 我们认为应强力主张捐助方为公共卫生法律中心或部门提供经费,使这些中心或部门配备足够的工作人员,与区域内的同行稳健地联网并且融入世界卫生组织的主要工作中。 这些部门或中心的任务将是在世界卫生组织的整个工作范围内确定与整合公共卫生法律中的科学与法律专业知识(包括技术和程序知识),并且开展和促进全球卫生政策监督。.Поддержание сильной инфраструктуры системы здравоохранения в каждой стране является наиболее эффективной долгосрочной стратегией обеспечения готовности к чрезвычайным ситуациям в области мирового здравоохранения. В данном случае под инфраструктурой понимаются не только системы здравоохранения и их людские ресурсы, но и правовая инфраструктура стран в области здравоохранения, а именно законы и положения, которые расширяют возможности, налагают обязательства и иногда вводят ограничения для деятельности правительств и частных лиц. Законодательство также является важным инструментом укрепления и охраны здоровья. Профессиональные работники сферы общественного здравоохранения играют важные роли в сфере здравоохранительного права, от разработки стратегий, их реализации до научной оценки воздействия законов на здоровье. Государства-участники уже приняли на себя обязательство сообщать Всемирной организации здравоохранения (ВОЗ) о своих национальных законах и правилах, относящихся к области здравоохранения. В данной статье высказывается предположение, что ВОЗ обладает достаточным авторитетом и репутацией для поддержки наращивания потенциала в сфере здравоохранительного права государств-участников и для облегчения доступа к внутренним законам, их понимания, отслеживания и оценки. Авторы уверены, что существуют веские доводы, которые можно привести донорам, в пользу финансирования ориентированного на сферу общественного здравоохранения юридического центра или группы, которые располагали бы кадровым составом соответствующего уровня подготовки, прочными связями со своими региональными партнерами и были бы вовлечены в основную деятельность ВОЗ. Миссия этой группы или центра заключалась бы в определении научных и юридических знаний (как технических, так и программных), их внедрении в законодательство, относящееся к общественному здравоохранению, во всех областях деятельности ВОЗ, а также в осуществлении надзора за политикой в сфере мирового здравоохранения и содействии ему.
- Published
- 2016
24. State of the fight against informal market of medicines in Togo: approaches and limitations
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Dominique Sprumont, Antoine Geissbuhler, A Awesso, Antoine Flahault, and Afeignindou Gnassingbe
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Economic growth ,education.field_of_study ,medicine.medical_specialty ,Informal sector ,Poverty ,Drug Industry ,Corruption ,Public health ,media_common.quotation_subject ,Population ,Public Health, Environmental and Occupational Health ,Self Medication ,Infectious Diseases ,Informal Sector ,Order (exchange) ,Political science ,Togo ,medicine ,Humans ,education ,Enforcement ,Health policy ,ddc:613 ,media_common - Abstract
The extent of medicines sales and consumption in the informal market in Togo raises many ethical and public health issues. In order to report on the situation of public action in the fight against this practice, we conducted a qualitative survey from 15 to 25 February 2016 in the commune of Lomé and in the Maritime Region among the actors of control system and resource people in the general population. This was supplemented by an analysis of Togo's pharmaceutical and health policy documents and a literature review on the illicit drug market issues relating to public health, political science, the social sciences applied to health. In spite of the existence of national and international tools, household poverty, cultural self-medication, ignorance of the population concerning the health risks of informal market medicines, weak political commitment, weakness regulation and enforcement, corruption, constitute obstacles to the success of actions to combat this practice.
- Published
- 2018
25. Pour un véritable contrôle des produits du tabac
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Luca Crivelli, Dominique Sprumont, Sandra Nocera, and Nino Künzli
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Microbiology (medical) ,Immunology ,Immunology and Allergy - Published
- 2018
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26. Bitte keine Täuschungsmanöver! Die Wissenschaft fordert Kontrolle von Tabakprodukten
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Dominique Sprumont, Nino Künzli, Sandra Nocera, and Luca Crivelli
- Subjects
General Medicine - Published
- 2018
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27. Does the Swiss School of Public Health exist?
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Luca Crivelli, Dominique Sprumont, Sandra Nocera, and Nino Künzli
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medicine.medical_specialty ,Health (social science) ,Career Choice ,Schools, Public Health ,business.industry ,Public health ,Public Health, Environmental and Occupational Health ,International health ,Public administration ,language.human_language ,German ,Strategic goal ,Politics ,Health promotion ,Environmental health ,Political science ,language ,medicine ,Health education ,Education, Graduate ,business ,Switzerland ,Health policy ,Forecasting - Abstract
‘‘Switzerland does not exist’’ or ‘‘La Suisse n’existe pas’’ was the statement the French artist Ben Vautier featured in the Swiss Pavilion at the World Exposition 1992 in Seville. It provoked an outcry in Switzerland, in particular in the political arenas of parliaments and the media. The Swiss School of Public Health (SSPH ?)—proud owner of the International Journal of Public Health—celebrated the 10th anniversary in 2015. Why would the SSPH? Directorate refer to Ben Vautier’s provocation to ask whether SSPH? does exist? As SSPH? moves into the second decade it will face the challenges of puberty and the years as a teenager. These are times of transitions, changes and reflections too. Table 1 summarizes the major achievements and highlights of the first 10 years of SSPH?. These successes, achieved under the leadership of the past Directors were also the result of the solid funding structure. SSPH?, initiated in July 2005 through funds from the Swiss University Conference (SUC), was transformed into a Foundation as of 2008. At that time, SSPH? expanded its network from six to eight Swiss universities, including all universities with major academic institutions of public health, namely Basel, Bern, Geneva, Lausanne, Lucerne, Lugano, Neuchâtel and Zurich. The SUC support for SSPH? was reserved for the first 12 years to then adopt a new financing model. Indeed, as of 2017, the SUC funds—in the past some 1–3 Mio CHF per year—will be replaced by a model where all the universities that carry SSPH? would become its direct funding bodies. This visionary model for a School of Public Health being a network of all academic public health constituencies rather than a classic central ‘‘school’’ is intriguing for a small country like Switzerland. The model gives a promising structure to strengthen public health in a country where excessively federalistic structures resulted so far in rather weak public health systems and infrastructures— comparable to the situation in Germany where an expert panel properly identified the need for strengthening the field (German National Academy of Sciences Leopoldina et al. 2015). Whether we will accomplish this goal in the next decade will depend on the future willingness to collaborate, which in turn will also depend on sustainable funds. At this stage, the foundation has neither been set on balanced nor stable grounds for its upcoming time as a teenager. As the budget will be lower than in the past and commitments of the eight university partners unequal (contributions of each university range between 5 and 60 % of the future budget) one primary strategic goal of the Directorate will be to strengthen the financial pillars of SSPH?. This Editorial was published on occasion of the 10th anniversary of the Swiss School of Public Health.
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- 2015
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28. Die Rolle der Sozialwissenschaften in den Gesundheitsberufen
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Settimio Monteverde, Marie-Noëlle Kerspern, Theresa Scherer, Dominique Sprumont, and University of Zurich
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10222 Institute of Biomedical Ethics and History of Medicine ,610 Medicine & health ,General Medicine - Published
- 2017
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29. Le droit à la santé en Suisse – théories et réalités de la situation des requérants d’asile et «sans-papiers»
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Géraldine Marks-Sultan and Dominique Sprumont
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Economics and Econometrics ,Materials Chemistry ,Media Technology ,Forestry - Published
- 2017
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30. Twelve tips to promote excellence in ethical review: translation and adaptation of e-learning in research ethics
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Dominique Sprumont, Dirceu Bartolomeu Greco, Pollyana Gontijo, and Dirce Guilhem
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Research ethics ,lcsh:LC8-6691 ,lcsh:Special aspects of education ,E-learning (theory) ,media_common.quotation_subject ,Ethics, research ,05 social sciences ,lcsh:R ,050301 education ,lcsh:Medicine ,Ethical review ,Translating ,Management ,Excellence ,Education, distance ,Ethics committees, research ,0501 psychology and cognitive sciences ,Engineering ethics ,Adaptation (computer science) ,Psychology ,0503 education ,050104 developmental & child psychology ,media_common - Abstract
This article was migrated. The article was marked as recommended. Usage of and investment in e-learning has also grown in the field of research ethics. There are currently several distance capacity building programs on this theme, although few are translated to the language and adapted to the legislation of countries with less resources to implement local training. Translating and adapting an already existing e-learning is a more accessible strategy, since it makes use of an already existing online platform and capacity building strategies that were previously tested and are recognized in the scientific community and society in general. This training needs to be adapted to local needs and there must be guidelines for the translation and adaptation stages of the distance education programs for ethics in research involving human beings. In this article, we put forward 12 steps for the translation and adaptation of e-learning on research ethics, based on our experience of implementing the Brazilian version of TRREE e-learning.
- Published
- 2016
31. Biobanques: il est urgent d'investir dans une loi fédérale
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Charles Joye, Astrid Pilottin, and Dominique Sprumont
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Microbiology (medical) ,Immunology ,Immunology and Allergy - Published
- 2016
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32. The legal and ethical aspects of the right to health of migrants in Switzerland
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Didier Leyvraz, Stefanie Kurt, Géraldine Marks-Sultan, and Dominique Sprumont
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medicine.medical_specialty ,Asylum seekers ,media_common.quotation_subject ,Refugee ,Fundamental rights ,Review ,Migrants ,03 medical and health sciences ,0302 clinical medicine ,Promotion (rank) ,Political science ,Right to health ,medicine ,030212 general & internal medicine ,Foreign national ,Constitutional rights ,media_common ,Community and Home Care ,Human rights ,030503 health policy & services ,Public health ,Foreign nationals ,Public Health, Environmental and Occupational Health ,Swiss legal framework ,Law ,Spite ,0305 other medical science - Abstract
The right to health of migrant populations, whether they are foreign nationals, foreign workers, tourists, asylum seekers or refugees, is enshrined in international human rights treaties. The effectiveness of the implementation of this fundamental right thus lies in national legal frameworks. In spite of its long humanitarian tradition, Switzerland has a strict migration policy, and while it has established a non-discriminatory legal framework for the protection and promotion of the right to health, its laws and regulations sometimes codify differences in treatment between foreign nationals and Swiss residents based on distinct situations. On the basis of shared responsibilities between the Federal State and the 26 cantons, this article describes the Swiss legal and regulatory approach to the right to health, the ways it is currently implemented and the possible vectors for an improved integration of migrants into the health system.
- Published
- 2016
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33. [Not Available]
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Nino, Künzli, Luca, Crivelli, Dominique, Sprumont, and Sandra, Nocera
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Biomedical Research ,Databases, Factual ,Schools, Public Health ,Humans ,Organizational Objectives ,Health Services Research ,Public Health ,Switzerland - Published
- 2016
34. Eine Klärung aus rechtlicher Sicht
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Olivier Guillod, Regina E. Aebi-Müller, Marco Borghi, and Dominique Sprumont
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General Medicine - Abstract
Die Schweizerische Akademie der Medizinischen Wissenschaften hat kurzlich ihre medizinisch-ethischen Richtlinien zu medizinischen Zwangsmassnahmen aktualisiert. Die Revision will die Richtlinien den Anforderungen des am 1. Januar 2013 in Kraft getretenen Kindes- und Erwachsenenschutzrechts anpassen.
- Published
- 2016
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35. Proteomics of blood plasma/serum samples stored in biobanks: insights for clinical application
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Jean-Daniel Tissot, Christine Currat, and Dominique Sprumont
- Subjects
Proteomics ,0301 basic medicine ,Proteome ,business.industry ,Sample (material) ,Blood Proteins ,Serum samples ,Bioinformatics ,Biochemistry ,Biobank ,03 medical and health sciences ,030104 developmental biology ,Blood plasma ,Blood Banks ,Humans ,Medicine ,business ,Molecular Biology ,Omics technologies - Abstract
The evolution of ‘omics technologies implies consideration of at least five dimensions: (1) the value and relevance of the scientific question; (2) the origin of the biological sample; (3) sample q...
- Published
- 2017
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36. Cigarettes, marketing et protection de la jeunesse
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Dominique Sprumont, Joachim Marti, Valéry Bezençon, and Suzanne Suggs
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General Medicine - Published
- 2019
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37. Das Arztgeheimnis im Gefängnis: eine falsche Polemik
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Philippe Ducor and Dominique Sprumont
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General Medicine - Abstract
Unter dem Titel «Mythen und Realitaten» hatten Steffen Lau und Josef Sachs in der SAZ das Arztgeheimnis bei der Behandlung gefahrlicher Haftlinge thematisiert. Die Rechtsprofessoren Sprumont und Ducor nehmen hierzu kritisch Stellung. Sie betonen die Unterschiede zwischen der arztlichen Rolle als Therapeut und der als Experte. Fur Therapeuten sei das Arztgeheimnis Eckpfeiler des Vertrauensverhaltnisses von Arzt und Patient.
- Published
- 2015
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38. [Evaluation of the role of social sciences in the training and practice of health professionals]
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Dominique, Sprumont
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Health Personnel ,Social Sciences - Published
- 2015
39. The Importance of National Laws in the Implementation of European Legislation of Biomedical Research
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Andrulionis Gytis and Dominique Sprumont
- Subjects
Research ethics ,Biomedical Research ,Drug Industry ,business.industry ,International Cooperation ,Health Policy ,Liability ,Liability, Legal ,Legislation ,Liability insurance ,Europe ,Internationalization ,Informed consent ,Political science ,Law ,Health law ,business ,Pharmaceutical industry - Abstract
The industrialization and internationalization of biomedical research is not without consequences on the regulation of research or, at least, on the interpretation of that regulation. As more research is done at the international level, the pharmaceutical industry and the research community are calling for a harmonized regulation to limit the administrative burden of controlling clinical trials and to fasten the R&D process. The purpose of this paper is to analyse briefly the role of the national laws in that process. Part I will outline the structure and the nature of the international regulation of research in a European perspective. Using the examples of research ethics committees (RECs), informed consent and the question of liability and liability insurance, Part II will analyze the importance of the national laws in the implementation of this international regulation.
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- 2005
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40. Le secret médical en prison: une fausse polémique
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Dominique Sprumont and Philippe Ducor
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Microbiology (medical) ,ddc:346.07 ,état de nécessité ,Immunology ,Immunology and Allergy ,Secret médical ,médecine pénitentiaire - Abstract
Sous le titre Mythen und Realitaten, Steffen Lau et Josef Sachs ont recemment revisite la question du secret medical dans la prise en charge de detenus dangereux. Leur intention etait de recentrer le debat sur la realite de la psychiatrie forensique en reponse au discours «emotionnel» qui, selon eux, predomine en Suisse romande. Malheureusement, loin de combattre les mythes, l’article ne fait que les accentuer tout en prenant quelques libertes avec le cadre legal de la pratique medicale en prison.
- Published
- 2015
41. Biobanks: Investigating in Regnlation
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Caroline Trouet and Dominique Sprumont
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Law ,Political science ,General Medicine ,International law ,Biobank ,Public international law - Published
- 2002
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42. Muerte súbita cardiovascular en el deporte. Año 2004
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Lukas Kappenberger, Folkert J. Meijboom, Domenico Corrado, Dominique Sprumont, Patricia Sangenis, Jan Hoogsten, Gaetano Thiene, Denis Oswald, Karin Bille, Mario Zorzoli, David Figueiras, Joel I. Brenner, Jon Dvorak, E. J. Meijboom, Susan Greinig, Laurent Rivier, and William J. McKenna
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Physical Therapy, Sports Therapy and Rehabilitation ,Orthopedics and Sports Medicine - Published
- 2008
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43. Legal Protection of Human Research Subjects in Europe
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Dominique Sprumont
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Consensus ,Internationality ,Human Rights ,Research Subjects ,International Cooperation ,Decision Making ,Guidelines as Topic ,Vulnerable Populations ,Political science ,Humans ,European Union ,Ethics Committees ,Informed Consent ,Health Policy ,Nontherapeutic Human Experimentation ,Persons ,Social Control, Formal ,Europe ,Human Experimentation ,Legal protection ,Pharmaceutical Preparations ,Law ,Government Regulation ,Health law ,Human research ,Ethics Committees, Research - Abstract
No Abstract
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- 1999
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44. Consensus standards for introductory e-learning courses in human participants research ethics
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Bocar Kouyaté, Antoine Geissbuhler, Marek Czarkowski, Alexander S. Pym, Mariana Kruger, Henry J. Silverman, Chien Te Fan, Dominique Sprumont, Keymanthri Moodley, Jean-Pierre Kraehenbhul, Francine Ntoumi, John R. Williams, Caroline Perrin Franck, Susan Bull, Marie Hirtle, Eugenjius Gefenas, Sara Tenorio, Thomas Nyirenda, Clement Adebamowo, Christian Burri, Paul G. Braunschweiger, and Ingrid Klingmann
- Subjects
Final version ,Research ethics ,Medical education ,Health (social science) ,Knowledge management ,business.industry ,Process (engineering) ,Health Policy ,E-learning (theory) ,Consensus Development Conferences as Topic ,Online Systems ,ddc:616.0757 ,Article ,Ethics, Research ,Issues, ethics and legal aspects ,Human Experimentation ,Arts and Humanities (miscellaneous) ,Humans ,business ,Psychology ,Standards-based assessment - Abstract
This paper reports the results of a workshop held in January 2013 to begin the process of establishing standards for e-learning programmes in the ethics of research involving human participants that could serve as the basis of their evaluation by individuals and groups who want to use, recommend or accredit such programmes. The standards that were drafted at the workshop cover the following topics: designer/provider qualifications, learning goals, learning objectives, content, methods, assessment of participants and assessment of the course. The authors invite comments on the draft standards and eventual endorsement of a final version by all stakeholders.
- Published
- 2014
45. [Public health research projects by third year medical students]
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Anne, Prévot and Dominique, Sprumont
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Students, Medical ,Research ,Humans ,Public Health - Published
- 2013
46. Ethique dans les pays en développement, éthique en développement
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Jérome Ateudjieu and Dominique Sprumont
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Economics and Econometrics ,Materials Chemistry ,Media Technology ,Forestry - Published
- 2013
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47. Legislation on direct-to-consumer genetic testing in seven European countries
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Camilla Fittipaldi Duarte Jales, Heidi Carmen Howard, Pascal Borry, Liam Curren, Jane Kaye, Tade Matthias Spranger, Rachèl E. van Hellemondt, Emmanuelle Rial-Sebbag, Dominique Sprumont, Herman Nys, Human genetics, Ethics, Law & Medical humanities, and EMGO - Quality of care
- Subjects
Genetic counseling ,Legislation ,Genetic Counseling ,03 medical and health sciences ,Informed consent ,Advertising ,Risk Factors ,Genetics ,medicine ,Humans ,Genetic Predisposition to Disease ,Genetic Testing ,License ,Genetics (clinical) ,Health policy ,030304 developmental biology ,Genetic testing ,0303 health sciences ,Informed Consent ,medicine.diagnostic_test ,Public economics ,Health Policy ,030305 genetics & heredity ,Community Participation ,3. Good health ,Test (assessment) ,Europe ,Policy ,Business ,Medical ethics - Abstract
An increasing number of private companies are now offering direct-to-consumer (DTC) genetic testing services. Although a lot of attention has been devoted to the regulatory framework of DTC genetic testing services in the USA, only limited information about the regulatory framework in Europe is available. We will report on the situation with regard to the national legislation on DTC genetic testing in seven European countries (Belgium, the Netherlands, Switzerland, Portugal, France, Germany, the United Kingdom). The paper will address whether these countries have legislation that specifically address the issue of DTC genetic testing or have relevant laws that is pertinent to the regulatory control of these services in their countries. The findings show that France, Germany, Portugal and Switzerland have specific legislation that defines that genetic tests can only be carried out by a medical doctor after the provision of sufficient information concerning the nature, meaning and consequences of the genetic test and after the consent of the person concerned. In the Netherlands, some DTC genetic tests could fall under legislation that provides the Minister the right to refuse to provide a license to operate if a test is scientifically unsound, not in accordance with the professional medical practice standards or if the expected benefit is not in balance with the (potential) health risks. Belgium and the United Kingdom allow the provision of DTC genetic tests.European Journal of Human Genetics advance online publication, 25 January 2012; doi:10.1038/ejhg.2011.278.
- Published
- 2012
- Full Text
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48. Training needs assessment in research ethics evaluation among research ethics committee members in three African countries: Cameroon, Mali and Tanzania
- Author
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Jérôme, Ateudjieu, John, Williams, Marie, Hirtle, Cédric, Baume, Joyce, Ikingura, Alassane, Niaré, and Dominique, Sprumont
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Cross-Sectional Studies ,Evaluation Studies as Topic ,Surveys and Questionnaires ,Committee Membership ,Humans ,Cameroon ,Mali ,Tanzania ,Needs Assessment ,Research Personnel ,Ethics Committees, Research ,Ethics, Research - Abstract
As actors with the key responsibility for the protection of human research participants, Research Ethics Committees (RECs) need to be competent and well-resourced in order to fulfil their roles. Despite recent programs designed to strengthen RECs in Africa, much more needs to be accomplished before these committees can function optimally.To assess training needs for biomedical research ethics evaluation among targeted countries.Members of RECs operating in three targeted African countries were surveyed between August and November 2007. Before implementing the survey, ethical approvals were obtained from RECs in Switzerland, Cameroon, Mali and Tanzania. Data were collected using a semi-structured questionnaire in English and in French.A total of 74 respondents participated in the study. The participation rate was 68%. Seventy one percent of respondents reported having received some training in research ethics evaluation. This training was given by national institutions (31%) and international institutions (69%). Researchers and REC members were ranked as the top target audiences to be trained. Of 32 topics, the top five training priorities were: basic ethical principles, coverage of applicable laws and regulations, how to conduct ethics review, evaluating informed consent processes and the role of the REC.Although the majority of REC members in the targeted African countries had received training in ethics, they expressed a need for additional training. The results of this survey have been used to design a training program in research ethics evaluation that meets this need.
- Published
- 2009
49. Formation de base en éthique de la recherche: retour aux sources avec le projet TRREE
- Author
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Dominique Sprumont
- Subjects
Economics and Econometrics ,Materials Chemistry ,Media Technology ,Forestry - Published
- 2009
- Full Text
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50. The International Olympic Committee (IOC) Consensus Statement on periodic health evaluation of elite athletes March 2009
- Author
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Martin Schwellnus, Robert Maloley, Howard Stupp, Antonio Pelliccia, Gordon O. Matheson, Roald Bahr, Patrick Schamasch, Erik J. Meijboom, Lars Engebretsen, Anthony F Clough, Guido de Bondt, Dominique Sprumont, Margo Mountjoy, Jiri Dvorak, Peter Jenoure, Arne Ljungqvist, Willem H. Meeuwisse, Christophe Dubi, Juan-Manuel Alonso, Christian Thill, and Jean-Benoìt Gauthier
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Gerontology ,medicine.medical_specialty ,data collection ,Sports medicine ,Physical Therapy, Sports Therapy and Rehabilitation ,forecasting ,health status ,athletic injuries ,prevention ,medicine ,Humans ,Orthopedics and Sports Medicine ,Reference group ,acute disease ,biology ,sports medicine ,Athletes ,business.industry ,Incidence (epidemiology) ,General Medicine ,Evidence-based medicine ,data mining ,medicine.disease ,biology.organism_classification ,Obesity ,cardiovascular diseases ,preventive health services ,Physical therapy ,Life expectancy ,Health education ,business ,evidence-based medicine ,human activities ,control ,chronic disease ,Sports - Abstract
The Olympic Games is the largest sport event in the world. In Beijing, 10 500 athletes competed, selected from a large group of elite athletes in 204 countries. Sports participation on the elite level, aside from winning medals, fame and other rewards, is also important from a health perspective. There is no longer any doubt that regular physical activity reduces the risk of premature mortality in general, and of coronary heart disease, hypertension, colon cancer, obesity and diabetes mellitus in particular. The question is whether the health benefits of sports participation outweigh the risk of injury and long-term disability, especially in high-level athletes. Sarna et al 1 have studied the incidence of chronic disease and life expectancy of former male world-class athletes from Finland in endurance sports, power sports and team sports. The overall life expectancy was longer in the high-level athlete compared with a reference group (75.6 vs 69.9 years). The same group also showed that the rate of hospitalisation later in life was lower for endurance sports and power sports compared with the reference group.2 This resulted from a lower rate of hospital care for heart disease, respiratory disease and cancer. However, the athletes were more likely to have been hospitalised for musculoskeletal disorders. Thus, the evidence suggests that although there is a general health benefit from sports participation, injuries represent a significant side effect. One priority of the International Olympic Committee (IOC) is to protect the health of the athlete. During recent years, prevention of injuries and illnesses has been high on the IOC agenda. During the Athens Games, an injury surveillance system was applied for all team sports.3 During the Beijing Games, the IOC ran, for the first time, an injury surveillance system covering all the athletes, showing a 10% incidence of injuries.4 In …
- Published
- 2009
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