Suchergebnisse

Cover -- Inhalt -- Menschenrechte und Vulnerabilität in der Medizin -- I. GRUNDLAGEN: VERLETZLICHKEIT UND AUTONOMIE IN PHILOSOPHIE, MENSCHENRECHT UND MEDIZINETHIK -- Vulnerabilität als Menschenrechtsthema -- Empowerment, soziale Bewegungen und das Recht auf Gesundheit -- Ethische Probleme im Gesundheitswesen und Konzepte von Vulnerabilität -- II. VULNERABILITÄT UND SELBSTBESTIMMUNG: PROBLEME IN DER KLINISCHEN PRAXIS -- Autonomie und Lebendnierenspende -- Gute Behandlung bei medikamentenresistenter Tuberkulose -- Zur Vulnerabilität von Menschen mit Demenz und ihren Angehörigen -- III. AUTONOMIE, VULNERABILITÄT UND RECHT AUF GESUNDHEIT: DAS BEISPIEL MIGRATION -- Migrantinnen und Migranten ohne Papiere im Gesundheitssystem -- Das Menschenrecht auf Gesundheit und die medizinische Versorgung irregulärer Migrant_innen -- Weibliche Geflüchtete und das Recht auf Gesundheit -- Autorinnen und Autoren mit Adressen

The printed version of this title will be available on Unigrafia online store: https://shop.unigrafia.fi/?lang=en ; The paradigm of personalized medicine is an emerging topic, triggering some specific legal and ethical challenges as regards data collection, sharing and use, informed consent, privacy and public trust, and the changing status of patients and social equality. These legislative developments and challenges have been discussed in light of the Finnish and the common-European experiences. During recent years, the Finnish legislative processes aiming at generating 'innovation-friendly' legislation for scientific research purposes as well as integrating genomic research results into the clinical setting have been heavily challenged by rapid developments in technology and medicine. In particular, there is a need to pursue the right balance between scientific and commercial interests, public health, and individual rights. We aim at providing insights into the legislative processes surrounding personalized medicine with a special focus on how the freedom of science, equitable access to healthcare, public health, and commercial issues that must be balanced with individual rights as expressed in the EU Charter and the Council of Europe's Oviedo Convention on Human Rights and Biomedicine. A wide spectrum of different types of challenges arises; among other things, there is a need to discuss the Finnish and international legislation of genome testing in terms of consent on behalf of a young child. Also the legal and ethical aspects of disruptive gene-editing technologies need to be analysed: How should we interpret the concept of human dignity in the bioethical discussion surrounding germline editing? Furthermore, an overview of ongoing initiatives to accelerate the market-entry of advanced therapy medicinal products will be provided. The European regulators are now taking measures to create a facilitative regulatory environment that encourages innovation, protects public health, and enables timely patient access to innovative, new therapies whilst ensuring patient safety. The role of risk-proportionate adaptations to clinical trials and GMP manufacture along with the European Medicines Agency's early-access incentives and initiatives are presented as potential facilitators of market entry. Furthermore, in this context, the role of conditional reimbursement schemes and risk sharing-agreements is also discussed in light of the newest Finnish experiences. Furthermore, in terms of patent law, some specific challenges arise; in this anthology, attention is paid to the recent transatlantic legal dispute over a patent concerning the use of the CRISPR/Cas9 system in eukaryotic cells. Finally, some considerations beyond legal or ethical aspects of personalised medicine are presented. How can machine learning be used to support personalized care that addresses the patient's needs?

AbstractBecause of the necessity for morality and virtue in the practice of medicine, ethical leadership becomes a fundamental obligation of the profession in its relations with the society it serves. Ethical leadership entails leading others in setting standards of, and therefore defining, moral or acceptable behaviour. Leaders must act in conformity with these accepted standards as they carry out the activities mandated by society. This paper examines the primary sources of ethical leadership in the medical profession. Historically, professional associations and medical licensing bodies have been allocated the most important responsibility for providing this leadership. When the public felt that such leadership was being exerted, trust in the profession remained high and when this leadership has been seen to falter, trust has fallen. There have traditionally been additional sources of ethical leadership with editorials in medical journals having a powerful role. Medical schools also can be a source of leadership as can the academic community outside of medicine—particularly bioethics and sociology. Finally, individuals of great stature, no matter what their role in society, are capable of offering guidance and support for the value base of medicine.RésuméEn raison du besoin de moralité et de vertu dans l'exer‐cice de la médecine, le leadership moral devient une obligation fondamentale de la profession dans les rapports qu'elle entretient avec la société qu'elle serf. Le leadership moral consiste à montrer aux autres la façon d'établir des normes en matière de comportement moral ou acceptable et par conséquent à définir ce terme. Les dirigeants doivent agir dans le respect de ces normes reconnues tandis qu'ils accomplissent les activités que la société leur confie. Historiquement, les associations professionnelles et les organes de délivrance de permis d'exercer la médecine se sont vues confier la respon‐sabilité de ce leadership. Lorsque le public estime que ce leadership s'exerce, la confiance dans la profession reste élevée alors que si ce leadership est perçu comme défaillant, la confiance a tendance à chuter. Il y a toujours eu d'autres sources de leadership moral, dont les éditoriaux des revues de médecine ont été les plus puissants. Les écoles de médecine peuvent également être une source de leadership, au même titre que des disciplines universitaires en dehors de la médecine, en particulier la bioéthique et la sociologie. Enfin, les person‐nes d'envergure, quel que soil leur rôle dans la société, sont en mesure d'offrir des directives et une aide pour garantir le respect des valeurs fondamentales de la médecine.

"Informed consent is a central topic in contemporary biomedical ethics. Yet attempts to set defensible and feasible standards for consenting have led to persistent difficulties. In Rethinking Informed Consent in Bioethics, Neil Manson and Onora O'Neill set debates about informed consent in medicine and research in a fresh light. They show why informed consent cannot be fully specific or fully explicit, and why more specific consent is not always ethically better. They argue that consent needs distinctive communicative transactions, by which other obligations, prohibitions and rights can be waived or set aside in controlled and specific ways

This book addresses the ethical problems in maternal-fetal medicine which impact directly on clinical practice. It is divided into parts by the stages of pregnancy and looks at issues of power, new technology, 'designer babies', and cultural, religious difference. It unites analytic philosophy and actual practice for clinicians

National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and Sweden. Both ethical values and conditions for registry-based research are similar in the Nordic countries. While Denmark, Finland, Iceland, Norway, and Sweden have chosen different legal frameworks, these differences can be resolved through mutual recognition of ethical applications and by harmonizing the different systems, likely leading to increased collaboration and enlarged studies.

Abstract
Big data techniques, data-driven science and their technological applications raise many serious ethical questions, notably about privacy protection. In this paper, we highlight an entanglement between epistemology and ethics of big data. Discussing the mobilisation of big data in the fields of biomedical research and health care, we show how an overestimation of big data epistemic power – of their objectivity or rationality understood through the lens of neutrality – can become ethically threatening. Highlighting the irreducible non-neutrality at play in big data tools, we insist upon the ethical importance of a critical epistemological approach in which big data are understood as possibly valuable only when coupled with human intelligence and evaluative rationality.

Jonas F Ludvigsson,1,2 Siri E Håberg,3 Gun Peggy Knudsen,3 Pierre Lafolie,4,5 Helga Zoega,6 Catharina Sarkkola,7 Stephanie von Kraemer,7 Elisabete Weiderpass,1,7–10 Mette Nørgaard11 1Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, 2Department of Pediatrics, Örebro University Hospital, Örebro, Sweden; 3Norwegian Institute of Public Health, Oslo, Norway; 4Department of Medicine, Clinical Pharmacology Unit, 5The Stockholm Regional Ethical Review Board, Karolinska Institutet, Stockholm, Sweden; 6Center of Public Health Sciences, Faculty of Medicine, University of Iceland, Reykjavík, Iceland; 7Genetic Epidemiology Group, Folkhälsan Research Center, Helsinki, Finland; 8Department of Community Medicine, Faculty of Health Sciences, University of Tromsø, 9The Arctic University of Norway, Tromsø, 10Department of Research, Cancer Registry of Norway, Oslo, Norway; 11Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark Abstract: National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and Sweden. Both ethical values and conditions for registry-based research are similar in the Nordic countries. While Denmark, Finland, Iceland, Norway, and Sweden have chosen different legal frameworks, these differences can be resolved through mutual recognition of ethical applications and by harmonizing the different systems, likely leading to increased collaboration and enlarged studies. Keywords: ethical review, ethics, institutional review board, Nordic countries, registry-based research, informed consent

AbstractPersonalized medicine is an emerging term for a medical philosophy that uses a person's individual clinical, genetic, genomic, and environmental information to tailor a treatment plan that will maximize efficacy and safety for that individual. While the technology offers much promise, it also is also challenged by some ethical and social questions in both its clinical application and in its research enterprise. Questions about privacy, safety, phenotypical expression, drug interactions, and genetic vs. social group identities will challenge clinical pharmacogenetics. Research studies raise some similar issues, as well as fairness in subject selection. Finally, personalized medicine will change the economics of drug production and distribution. Issues such as these and other complications of the coming focus on personalized medicine are discussed.

The ethical problems of the Med profession stem from the extraordinarily high value placed on life, wellbeing, & freedom from pain in our culture; from the necessarily intimate relation of MD & patient; from the strains of private practice, a small entrepreneur role, in a society of big gov, big business, big labor, & big cities; & from contradictory soc values in matters of religion, sex, & right of privacy in the individual's own body; from failures of medicine & the limits of sci; & from the conflict over change in the org of Med service. The profession has fought its battles with notable success on most fronts, but without a fully satisfactory answer to the tough problem of maintaining quality. Med society discipline & malpractice suits have not provided effective enforcement. Isolated individual practice is diminishing. Group practice, certification of advanced training, widened hosp-staff membership, & improved hos certification provide new disci- ; plines to enforce quality. The language of medicine's codes &,of the politico-econ debate have contributed to a public image of guild restrictionism & self-protection. Though impossible to measure, change appears to have been, in fact, to marked improvement in quality & protection of the patient against negligent, incompetent, or exploitative Med service. The introduction of compulsory sickness insurance & soc'ized medicine raises the new ehical issue of the MD's strike. HA.

National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and Sweden. Both ethical values and conditions for registry-based research are similar in the Nordic countries. While Denmark, Finland, Iceland, Norway, and Sweden have chosen different legal frameworks, these differences can be resolved through mutual recognition of ethical applications and by harmonizing the different systems, likely leading to increased collaboration and enlarged studies.

Human activities associated with greenhouse gas emissions have unequivocally caused global warming. Widespread adverse impacts on people, living organisms, and the environment are already being observed, mostly affecting vulnerable communities who are least responsible for current climate change. Unless drastic mitigation and adaptation measures are taken, continued greenhouse gas emissions will further exacerbate dangerous climate change. This expert report maps and analyses the complex justice issues that arise in the context of climate change and evaluates policy responses to the impacts of climate change from a climate justice perspective.