578 resultados para biomedical ethics
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Understanding ethics and law in health care is an essential part of nurses’ and midwives’ professional standards. Ethics, Law and Health Care focuses on teaching applied ethics and law in a manner that illustrates the real world applications of these core components of the nursing and midwifery curriculum and practice. It equips readers with the ability to recognise and address legal and ethical issues that will arise in their professional practice. The book uses the four principles of biomedical ethics (autonomy, non-maleficence, beneficence and justice) together with the use of both the Nursing and Midwifery Codes of Ethics and Codes of Professional Conduct, issued by the Nursing and Midwifery Board of Australia, as a central means through which to analyse and approach ethical and legal issues. Ethics, Law and Health Care is scaffolded to assist readers in understanding legal and ethical principles, to integrate them in the context of a particular issue within professional practice, and provide them with a decision-making framework to take action in a professional context by utilising the Codes as well as state and federal law. Aided by pedagogical features such as case studies, review questions, further reading and a glossary of common terms, this book is an essential resource for students, academics and practitioners.
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Who is the patient? A social-ethical study of the Finnish practice of prenatal screening. The aim of this study is to examine the Finnish practice of prenatal screening from a social-ethical perspective. Analyzing ethical problems in medicine and medical practice only on a general scale may conceal relevant ethical dilemmas. Previous studies have suggested that many pregnant women view the prenatal screening practices customary in the Finnish maternal care system as intimidating and oppressive. This study analyzes the ethical questions of prenatal screening by focusing on the experiences and decision-making of a pregnant woman. Finnish women s experiences of and decision-making on the most common prenatal screening methods are reflected in the basic principles of biomedical ethics described by Tom L. Beauchamp and James F. Childress in Principles of Biomedical Ethics. To concretize women s experiences I refer to studies of Finnish women s experiences of prenatal screenings. This study shows that the principles of autonomy, non-maleficence and beneficence seem to materialize rather poorly in the Finnish practice of prenatal screening. The main ethical problem with prenatal screening is that the likelihood of a foetal cure is very limited and, upon detection of an affected foetus, the choice is usually whether to continue with the pregnancy or to undergo an abortion. Although informed consent should be required, women s participation in prenatal testing is, in many cases at least, not based on their active decision. Many women experience severe anxiety when they receive a positive screening result and must wait for the final results. Medical studies indicate that long- term anxiety may negatively influence the foetus and the mother-child relationship. This study shows that the practice of prenatal screening as such may cause more harm than benefit to many pregnant women and their foetuses. This study examines the decision-making process of a pregnant woman by using the theory of medical casuistry described in Jonsen, Siegler and Winslade s Clinical Ethics. This study focuses on each of the four points of view recommended by the theory. The main problem seems to be the question of whom the patient of prenatal screening is and whom the practice is intended to benefit: the mother, the foetus, the family or society? This study shows that the concepts of health in Finnish maternal care in general, and of the prenatal screening system in particular, differ considerably. It also demonstrates that the purpose and the aims of prenatal screening, aside from the woman s right to choose, has been expressed neither in Finnish public health programmes nor in the public recommendations of prenatal screening. This study suggests that the practice of prenatal screening is a statement, though unexpressed, of public health policy and as such comprises part of the policy of disability. This study further demonstrates that through a single explicit aim (the woman s right to choose) society actually evades its obligation to women by saddling pregnant women with the entire moral responsibility as well as the possible negative consequences of her choice, such as sorrow, regrets and moral balancing. The study reveals several ethical problems in the Finnish practice of prenatal screening. Such problems should be dealt with as the Finnish practice of prenatal screening advances.
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A tese analisa decisões judiciais prolatadas em casos da bioética clínica, especificamente: requerimento de autorização para interrupção de gestação de feto anencéfalo, liberdade de recusa à imposição de procedimento de transfusão de sangue em razão de crença religiosa em paciente Testemunha de Jeová e a mudança de nome e sexo de transexual com ou sem realização de cirurgia de transgenitalismo. A escolha dos três tipos de casos levados a julgamento ao Poder Judiciário se deu em virtude de serem questões características ao direito existencial, de repercussão no Ser do indivíduo, em seus direitos personalíssimos. Para isso foram analisadas 84 decisões judiciais, mediante a aplicação da teoria Principiológica de Beauchamp & Childress e análise de cada decisão quanto à aplicação dos quatro Princípios que desenvolve: do respeito à autonomia, da não maleficência, da beneficência e da justiça. O resultado da análise demonstrou que ao utilizar os quatro Princípios, com especificação e ponderação dos mesmos, o julgador profere decisões de cunho liberal. Quando não utiliza os Princípios ou extrapola os limites de sua aplicação, o julgador profere decisões de cunho conservador. As decisões judiciais de caráter liberal são despidas de preconceitos e moralismos e permitem o respeito aos direitos individuais sem descuidar dos direitos dos demais membros da sociedade. As decisões conservadoras se baseiam na literalidade da lei e violam direitos individuais, sem acrescentar segurança à sociedade. A apropriação desta teoria da ética biomédica pelo biodireito, se apresenta como método seguro e eficaz na prolação de decisão judicial em casos da bioética clínica e conduz o julgador a decisões mais justas por serem apoiadas em boas razões.
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La littérature abordant les enjeux socio-éthiques et réglementaires associés aux médicaments est relativement abondante, ce qui n’est pas le cas des dispositifs médicaux (DM). Ce dernier secteur couvre une très large diversité de produits qui servent à de multiples applications: diagnostic, traitement, gestion des symptômes de certaines conditions physiques ou psychiatriques, restauration d’une fonction débilitante, chirurgie, etc. À tort, on a tendance à croire que les DM sont réglementés de la même manière que les médicaments, que ce soit pour les exigences concernant leur mise en marché ou des pratiques de surveillance après mise en marché. Or, au cours des dernières années, leur usage élargi, leur impact sur les coûts des soins de santé, et les rappels majeurs dont certains ont fait l’objet ont commencé à inquiéter la communauté médicale et de nombreux chercheurs. Ils interpellent les autorités réglementaires à exercer une plus grande vigilance tant au niveau de l’évaluation des nouveaux DM à risque élevé avant leur mise en marché, que dans les pratiques de surveillance après mise en marché. Une stratégie plus rigoureuse d’évaluation des nouveaux DM permettrait d’assurer un meilleur suivi des risques associés à leur utilisation, de saisir la portée des divers enjeux socio-éthiques découlant de l’utilisation de certains DM, et de préserver la confiance du public. D’emblée, il faut savoir que les autorités nationales n’ont pas pour mandat d’évaluer la portée des enjeux socio-éthiques, ou encore les coûts des DM qui font l’objet d’une demande de mise en marché. Cette évaluation est essentiellement basée sur une analyse des rapports risques-bénéfices générés par l’usage du DM pour une indication donnée. L’évaluation des impacts socio-éthiques et l’analyse coûts-bénéfices relèvent des agences d’Évaluation des technologies de santé (ÉTS). Notre recherche montre que les DM sont non seulement peu fréquemment évalués par les agences d’ÉTS, mais l’examen des enjeux socio-éthiques est trop souvent encore incomplet. En fait, les recommandations des rapports d’ÉTS sont surtout fondées sur une analyse coûts-bénéfices. Or, le secteur des DM à risque élevé est particulièrement problématique. Plusieurs sont non seulement porteurs de risques pour les patients, mais leur utilisation élargie comporte des impacts importants pour les systèmes de santé. Nous croyons que le Principisme, au cœur de l’éthique biomédicale, que ce soit au plan de l’éthique de la recherche que de l’éthique clinique, constitue un outil pour faciliter la reconnaissance et l’examen, particulièrement par les agences d’ÉTS, des enjeux socio-éthiques en jeu au niveau des DM à risque élevé. Également, le Principe de Précaution pourrait aussi servir d’outil, particulièrement au sein des agences nationales de réglementation, pour mieux cerner, reconnaître, analyser et gérer les risques associés à l’évaluation et l’utilisation de ce type de DM. Le Principisme et le Principe de Précaution pourraient servir de repères 1) pour définir les mesures nécessaires pour éliminer les lacunes observées dans pratiques associées aux processus de réglementation, et 2) pour mieux cerner et documenter les enjeux socio-éthiques spécifiques aux DM à risque élevé.
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El consentimiento informado (CI) en medicina corre el riesgo de quedar reducido a un formalismo legal sin valor moral; esto puede suceder por dos cosas: 1) como consecuencia de que el paciente no comprenda con suficiencia el concepto de autonomía y 2) debido a la disminución de la autonomía práctica del paciente por efecto de la autoridad del personal médico o de las instituciones de salud. Este artículo tiene como fin mostrar bajo qué condiciones se puede evitar la reducción del CI a un formalismo legal desprovisto de valor moral. Para servir a este propósito, se considera el concepto de autonomía relacional como eje articulador que pone en relación al paciente con su comunidad moral y con el médico, lo que impulsa al personal de la salud a proporcionar las condiciones para tal fin. Así, se afirma que la valía moral del CI puede conservarse, primero, a partir de una concepción relacional de la autonomía y, segundo, mediante la aplicación, por parte del médico y de la institución, de un protocolo que disminuya la posibilidad de choque entre la autonomía y la autoridad.
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Este texto presenta un estudio científico y jurídico sobre la genética y el derecho penal, con el objeto de realizar un pequeño aporte para la superación de la polarización política y moral de los debates sobre la genética y el derecho, que sólo ha conducido a una desafortunada paralización de la regulación sobre el tema que aumenta los riesgos para la salud humana y el equilibrio de los ecosistemas. Ante una problemática tan compleja, el derecho moderno no plantea una solución unitaria, sino una metodología a través de la cual cada sociedad democráticamente pueda adoptar sus propias decisiones frente a la salvaguarda de su patrimonio genético.
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This paper presents an assessment with simulated activities with the aim of analyzing the perception of ease/difficulty of the use of faucets (taps) handles by 180 Brazilian adults. Five different handles faucets were activated for subsequent collection of perceptual data. The procedures were based on main recommendations for biomedical ethics and human research. The results indicate that handles with levers are significantly (p <= 0.05) easier to use. The most difficult are characterized by not having support points for the rotation (levers) or more points of pressure concentration in the hand.
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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
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Licensed under a Creative Commons Attribution 4.0 International License.
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The ethical governance of biomedical research is an area of intense international debate. Scholars argue about who should regulate and how, the appropriate role for ethics committees, what kind of research should be included, and who should be involved in monitoring compliance. A particular aspect of these debates concerns the inclusion of women as research participants and the efforts to ensure that researchers consistently investigate questions of sex and gender in health research. There is increasing evidence of the role of sex in the manifestation and course of some illnesses and their treatment. Moreover, evidence suggests that gendered expectations also affect health outcomes. This special issue investigates how researchers are addressing these issues and debates the appropriate roles of policy makers, ethicists, and lawyers in ensuring that sex and gender differences are taken into account in the development, conduct, and reporting of health research.
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One of the core values to be applied by a body reviewing the ethics of human research is justice. The inclusion of justice as a requirement in the ethical review of human research is relatively recent and its utility had been largely unexamined until debates arose about the conduct of international biomedical research in the late 1990s. The subsequent amendment of authoritative documents in ways that appeared to shift the meaning of conceptions of justice generated a deal of controversy. Another difficulty has been that both the theory and the substance of justice that are applied by researchers or reviewers can be frequently seen to be subjective. Both the concept of justice – whether distributive or commutative - and what counts as a just distribution or exchange – are given different weight and meanings by different people. In this paper, the origins and more recent debates about the requirement to consider justice as a criterion in the ethical review of human research are traced, relevant conceptions of justice are distinguished and the manner in which they can be applied meaningfully in the ethical review all human research is identified. The way that these concepts are articulated in, and the intent and function of, specific paragraphs of the National Statement on Ethical Conduct in Human Research (NHMRC, ARC, UA, 2007) (National Statement) is explained. The National Statement identifies a number of issues that should be considered when a human research ethics committee is reviewing the justice aspects of an application. It also provides guidance to researchers as to how they can show that there is a fair distribution of burdens and benefits in the participant experience and the research outcomes. It also provides practical guidance to researchers on how to think through issues of justice so that they can demonstrate that the design of their research projects meets this ethical requirement is also provided
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This chapter explores how the EU is a largely overlooked exporter of normative power through its facilitation and use of clinical trials data produced abroad for the marketing of safe pharmaceuticals at home; a move that helps to foster the growing resort to pharmaceuticals as a fix for public health problems. This is made possible by the EU’s (de)selection of international ethical frameworks in preference to the international technical standards it co-authors with other global regulators. Clinical trials abroad underscore how ethics are contingent and revisable in light of market needs, producing weak protections for the vulnerable subjects of EU law. I argue that these components and effects of the regime are ultimately about that which undergirds, shapes and directs regulatory design. That is, I point to the use, infiltration, perpetuation and extension of market-oriented ideas, values and rationalities into formally non-market domains like biomedical knowledge production and public health. I explain how these are central to efforts at producing and legitimating the EU, its related imagined socio-political order based on a more innovative, profitable and competitive pharmaceutical sector in order to foster economic growth, jobs and prosperity, and with them the project of European integration. ‘Bioethics as risk’ is highlighted as a way to reshape and redirect the regulatory regime in ways that are more consistent with the spirit and letter of the ethical standards (and through them the human rights) the EU claims to uphold.
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Compte-rendu / Review