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1.
Bull World Health Organ ; 99(2): 138-147, 2021 Feb 01.
Artículo en Inglés | MEDLINE | ID: mdl-33551507

RESUMEN

Objective: To assess the current state of national ethics committees and the challenges they face. Methods: We surveyed national ethics committees between 30 January and 21 February 2018. Findings: In total, representatives of 87 of 146 national ethics committees (59.6%) participated. The 84 countries covered were in all World Bank income categories and all World Health Organization regions. Many national ethics committees lack resources and face challenges in several domains, like independence, funding or efficacy. Only 40.2% (35/87) of committees expressed no concerns about independence. Almost a quarter (21/87) of committees did not make any ethics recommendations to their governments in 2017, and the median number of reports, opinions or recommendations issued was only two per committee Seventy-two (82.7%) national ethics committees included a philosopher or a bioethicist. Conclusion: National ethics (or bioethics) committees provide recommendations and guidance to governments and the public, thereby ensuring that public policies are informed by ethical concerns. Although the task is seemingly straightforward, implementation reveals numerous difficulties. Particularly in times of great uncertainty, such as during the current coronavirus disease 2019 pandemic, governments would be well advised to base their actions not only on technical considerations but also on the ethical guidance provided by a national ethics committee. We found that, if the advice of national ethics committees is to matter, they must be legally mandated, independent, diverse in membership, transparent and sufficiently funded to be effective and visible.


Asunto(s)
Bioética , Comités de Ética/organización & administración , Encuestas y Cuestionarios , Estudios Transversales , Gobierno , Humanos , Internacionalidad
3.
Cuad Bioet ; 31(102): 167-182, 2020.
Artículo en Español | MEDLINE | ID: mdl-32910670

RESUMEN

In this paper present, from a bioethical perspective, a reflection on how to reconcile efforts to combat the COVID-19 pandemic with the safeguard of human rights. To do this, I develop three points. First, the regulatory framework that justifies the restriction or suspension of rights in the face of serious threats to public health. Second, the declarations of the international bioethics committees on the way in which human rights should be protected during public health crisis. And third, a review of the main rights threatened both by the public health crisis and by the means adopted to combat it. Before going into each of these points, I offer a preliminary note to clarify certain legal concepts and underline the need to overcome disjunctive approaches in considering human rights.


Asunto(s)
Betacoronavirus , Control de Enfermedades Transmisibles/legislación & jurisprudencia , Derechos Humanos/ética , Pandemias/prevención & control , Salud Pública/ética , Control de Enfermedades Transmisibles/métodos , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/prevención & control , Comités de Ética , Unión Europea , Libertad , Recursos en Salud/ética , Recursos en Salud/provisión & distribución , Accesibilidad a los Servicios de Salud/ética , Derechos Humanos/legislación & jurisprudencia , Humanos , Pandemias/ética , Pandemias/legislación & jurisprudencia , Derechos del Paciente/ética , Derechos del Paciente/legislación & jurisprudencia , Autonomía Personal , Neumonía Viral/epidemiología , Neumonía Viral/prevención & control , Guías de Práctica Clínica como Asunto , Salud Pública/legislación & jurisprudencia , Cuarentena/ética , Cuarentena/legislación & jurisprudencia , Sujetos de Investigación , Asignación de Recursos/ética , España , UNESCO
4.
Cuad Bioet ; 31(102): 231-243, 2020.
Artículo en Español | MEDLINE | ID: mdl-32910674

RESUMEN

The crisis in the health system caused by COVID-19 has left some important humanitarian deficits on how to care for the sick in their last days of life. The humanization of the dying process has been affected in three fundamental aspects, each of which constitutes a medical and ethical duty necessary. In this study, I analyze why dying accompanied, with the possibility of saying goodbye and receiving spiritual assistance, constitutes a specific triad of care and natural obligations that should not be overlooked - even in times of health crisis - if we do not want to see human dignity violated and violated some fundamental rights derived from it.


Asunto(s)
Betacoronavirus , Casas de Salud/ética , Pandemias/ética , Anciano , Infecciones por Coronavirus/prevención & control , Comités de Ética , Política de Salud , Recursos en Salud/ética , Recursos en Salud/provisión & distribución , Humanos , Difusión de la Información , Pandemias/prevención & control , Personeidad , Neumonía Viral/prevención & control , Guías de Práctica Clínica como Asunto , Asignación de Recursos/ética , Justicia Social , UNESCO , Poblaciones Vulnerables
6.
Rom J Morphol Embryol ; 61(1): 277-281, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32747923

RESUMEN

PURPOSE: The study considers the ethical review of the European Union (EU) clinical trials (CTs) legislation, namely the Clinical Trials Regulation (CTR) (EU) 2014∕536, the Directive 2001∕20∕EC and the "Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic" (GMCT) (version 3) issued on 28 April 2020 by the European authorities in the field. BACKGROUND: The Directive 2001∕20∕EC focuses the legal provisions for the conduct of CTs by acknowledging the screening role of the Ethics Committees (ECs) and of the national competent authorities (NCA) in the Member States (MS) to protect the CT subject and the personal data. CONTENT: The present article displays the ethical requirements for conducting, monitoring and reporting of the CTs by raising awareness on the: (i) new conceptual framework of the "clinical trial", "low-intervention clinical trial", "non-interventional study" and "ethics committee"; (ii) ethical considerations addressed in Part I and Part II of the assessment report; (iii) evaluation of the coronavirus disease 2019 (COVID-19) pandemic on the current regulatory framework. CONCLUSIONS: The CTR stimulates the EU clinical research and enables an independent control with regard to the respect of the interests of the CT subject.


Asunto(s)
Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/legislación & jurisprudencia , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/terapia , Revisión Ética , Ética en Investigación , Política de Salud , Neumonía Viral/epidemiología , Neumonía Viral/terapia , Comités de Ética , Unión Europea , Humanos , Consentimiento Informado , Pandemias , Seguridad del Paciente , Salud Pública , Proyectos de Investigación
9.
Rev. méd. hondur ; 88(1): 33-37, ene.- jun. 2020. tab
Artículo en Español | LILACS | ID: biblio-1128542

RESUMEN

Antecedentes: La ética de la investigación tiene el fin de proteger los derechos, la integridad y la confidencialidad de los participantes en investigaciones. La integridad científica se refiere a la conducta responsable en la investigación. Objetivo: Describir la incorporación de la temática de ética de la investigación y la integridad científica entre las publicaciones de la Revista Médica Hondureña. Métodos: Análisis bibliométrico de las publicaciones en los números de cada volumen utilizando los términos investigación, integridad científica y ética (buscador temático http://www.bvs.hn/RMH/html5, revisión de los artículos publicados en la sección Ética y búsqueda temática por personal de la Biblioteca Médica Nacional). Resultados: De 54 artículos, en 28 (51.8%), 1996-2019, se hace referencia a la ética de la investigación y/o integridad científica. Hasta 2010, se habían publicado tres artículos. El tipo de artículo fue sección Ética 17, Editorial 5, Original 3, Opinión 2 y Especial 1. De acuerdo al área temática general, los artículos abordaron Promoción 2, Capacitación 2, Aplicación de los principios éticos de la investigación 16, Comités de ética en investigación 4 e Integridad científica 4. Discusión: A través de la Revista Médica Hondureñahemos visualizado los avances en investigación a través de la aplicación de buenas prácticas como lo es la ética de la investigación y la integridad científica. Ya que la publicación es el final del ciclo de la investigación, es necesario impulsar su fortalecimiento desde otros espacios de gestión. En Honduras existe la necesidad urgente de contar con un sistema nacional de investigación para la salud...(AU)


Asunto(s)
Humanos , Comités de Ética/ética , Publicación Periódica , Revisión de Integridad Científica , Comités de Ética en Investigación
11.
Med Intensiva ; 44(7): 439-445, 2020 10.
Artículo en Español | MEDLINE | ID: mdl-32402532

RESUMEN

In view of the exceptional public health situation caused by the COVID-19 pandemic, a consensus work has been promoted from the ethics group of the Spanish Society of Intensive, Critical Medicine and Coronary Units (SEMICYUC), with the objective of finding some answers from ethics to the crossroads between the increase of people with intensive care needs and the effective availability of means.In a very short period, the medical practice framework has been changed to a 'catastrophe medicine' scenario, with the consequent change in the decision-making parameters. In this context, the allocation of resources or the prioritization of treatment become crucial elements, and it is important to have an ethical reference framework to be able to make the necessary clinical decisions. For this, a process of narrative review of the evidence has been carried out, followed by a unsystematic consensus of experts, which has resulted in both the publication of a position paper and recommendations from SEMICYUC itself, and the consensus between 18 scientific societies and 5 institutes/chairs of bioethics and palliative care of a framework document of reference for general ethical recommendations in this context of crisis.


Asunto(s)
Betacoronavirus , Toma de Decisiones Clínicas , Infecciones por Coronavirus/epidemiología , Cuidados Críticos/ética , Unidades de Cuidados Intensivos , Pandemias , Neumonía Viral/epidemiología , Infecciones por Coronavirus/terapia , Cuidados Críticos/métodos , Cuidados Críticos/psicología , Cuidados Críticos/normas , Comités de Ética , Necesidades y Demandas de Servicios de Salud , Capacidad de Camas en Hospitales , Humanos , Neumonía Viral/terapia , Medicina de Precisión , Asignación de Recursos/ética , Asignación de Recursos/normas , Respiración Artificial , Sociedades Científicas , España/epidemiología , Triaje/ética , Triaje/normas
12.
Harefuah ; 159(5): 360-363, 2020 May.
Artículo en Hebreo | MEDLINE | ID: mdl-32431128

RESUMEN

INTRODUCTION: An ethics committee is a quasi-judicial committee whose basis is its law. The Ethics Committee's actions in the area of coercive treatment and prevention of information from the patient have been clarified, but creative solutions can sometimes be used without compromising the spirit of the law, causing patients to receive treatment or non-treatment with a minimum of harm to their values and wishes. An experienced ethics committee, with members capable of breaking out of the box, combined with innovative professionals, will also solve complex ethical dilemmas to reach solutions agreed upon by all concerned.


Asunto(s)
Comités de Ética , Ética Médica , Humanos , Pacientes
13.
J Clin Ethics ; 31(1): 42-47, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-32213690

RESUMEN

This article provides a brief background of key issues in physician burnout, a significant problem in the healthcare industry. The extent and severity of burnout are not well understood; and those seeking help are often stigmatized. A number of different approaches to alleviating burnout have been suggested, but the problem lacks any single or simple solution. We posit that an ethics committee may be well positioned to help address this issue because of its unique position within an institution. An ethics committee serves the entire hospital staff regardless of department. As such it may be able to identify common elements in the development of burnout, and can serve as a conduit to administration in identifying these. An ethics committee can obtain information about the extent of burnout by conducting surveys to assess the extent and severity of burnout in aninstitution, and serve as a central resource to help address and alleviate it. Finally, an ethics committee may be able to act as an intermediary between practitioners and the administration, in advising the administration of the extent of the problem and offer suggestions for alleviating it.


Asunto(s)
Agotamiento Profesional , Comités de Ética Clínica , Médicos , Comités de Ética , Humanos
14.
Rev. bioét. derecho ; (48): 127-137, mar. 2020.
Artículo en Español | IBECS | ID: ibc-192082

RESUMEN

La investigación clínica en sepsis es una prioridad y una obligación cuyo objetivo primordial ha de ser tanto el conocimiento de su compleja fisiopatología como la búsqueda de herramientas diagnósticas precoces y eficaces para mejorar el tratamiento y disminuir la tasa de mortalidad. Los principios éticos de la investigación biomédica ayudan a determinar el equilibrio entre el avance de la ciencia y la protección de los derechos y bienestar de los sujetos de la investigación


Clinical research in sepsis is a priority and an obligation whose primary objective must be both knowledge of its complex pathophysiology and the search for early and effective diagnostic tools to improve treatment and reduce the mortality rate. The ethical principles of biomedical research help to determine the balance between the advancement of science and the protection of the rights and welfare of research subjects


La recerca clínica en la sèpsia és una prioritat I una obligació l'objectiu primordial de la qual ha de ser tant el coneixement de la seva complexa fisiopatología, com la cerca d'eines diagnòstiques precoces I eficaces per a millorar-ne el tractament I disminuir la taxa de mortalitat. Els principis ètics de la recerca biomèdica ajuden a determinar l'equilibri entre l'avanç de la ciència I la protecció dels drets I benestar dels subjectes de la recerca


Asunto(s)
Humanos , Ética en Investigación , Sepsis/epidemiología , Comités de Ética/ética , Unidades de Cuidados Intensivos/ética , Comités de Ética/legislación & jurisprudencia , Macrodatos , Unidades de Cuidados Intensivos/legislación & jurisprudencia
15.
Fertil Steril ; 113(2): 270-294, 2020 02.
Artículo en Inglés | MEDLINE | ID: mdl-32106974

RESUMEN

Scientific research using human embryos advances human health and offspring well-being and provides vital insights into the mechanisms for reproduction and disease. Research involving human embryos is ethically acceptable if it is likely to provide significant new knowledge that may benefit human health, well-being of the offspring, or reproduction.


Asunto(s)
Comités Consultivos/ética , Investigaciones con Embriones/ética , Comités de Ética/ética , Medicina Reproductiva/ética , Edición Génica , Humanos , Estados Unidos
16.
Tex Med ; 116(2): 22-23, 2020 Feb 01.
Artículo en Inglés | MEDLINE | ID: mdl-32083712

RESUMEN

Twenty years after it took effect, Texas' medical ethics committee review law has withstood challenge after challenge. The Texas Supreme Court is on the verge of ending the latest high-profile attack on the law that ensures physicians can uphold their professional obligation to "do no harm." In October 2019, the state's high court declined to take up Kelly v. Houston Methodist Hospital, in which the mother of a deceased patient attempted to overturn a provision of the Texas Advance Directives Act. Justices' action leaves intact an appeals court decision that preserves physicians' ability to use their medical judgment in end-of-life cases.


Asunto(s)
Comités de Ética/legislación & jurisprudencia , Ética Médica , Decisiones de la Corte Suprema , Humanos , Texas , Estados Unidos
17.
Bioethics ; 34(3): 223-227, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-31943263

RESUMEN

In July 2018, the Nuffield Council on Bioethics released the report Genome editing and human reproduction: Social and ethical issues, concluding that human germline modification of human embryos for implantation is not 'morally unacceptable in itself' and could be ethically permissible in certain circumstances once the risks of adverse outcomes have been assessed and the procedure appears 'reasonably safe'. The Nuffield Council set forth two main principles governing anticipated uses and envisions applications that may include health enhancements as a public health measure. This essay provides a critique of three aspects in the Nuffield Council's Report: its presumption of therapeutic efficacy, its inflation of parental rights to create a certain type of child, and its reliance on a specially commissioned report that appears to distort key definitions in international law.


Asunto(s)
Investigaciones con Embriones/ética , Células Germinales Embrionarias , Edición Génica/ética , Derechos Humanos/legislación & jurisprudencia , Comités Consultivos , Comités de Ética , Humanos , Informe de Investigación , Reino Unido
18.
BMC Med Ethics ; 21(1): 4, 2020 01 10.
Artículo en Inglés | MEDLINE | ID: mdl-31924199

RESUMEN

BACKGROUND: Within the research community, it is generally accepted that consent processes for research should be culturally appropriate and tailored to the context, yet researchers continue to grapple with what valid consent means within specific stakeholder groups. In this study, we explored the consent practices and attitudes regarding essential information required for the consent process within hospital-based trial communities from four referral hospitals in Vietnam. METHODS: We collected surveys from and conducted semi-structured interviews with study physicians, study nurses, ethics committee members, and study participants and family members regarding their experiences of participating in research, their perspectives toward research, and their views about various elements of the consent process. RESULTS: In our findings, we describe three interrelated themes related to the consent process: (1) words and regulation; (2) reimbursement, suspicions, and joining; and (3) responsibilities. In general, stakeholders had highly varied perspectives of nghiên cuu (Eng.: research) and researchers used varying levels of detail regarding all aspects of the study in the consent process to build trust with and/or promote potential research participants' choices about taking part in research. Findings additionally highlight how researchers felt that offering financial reimbursements in a hospital setting, where payment for services was routine, would be unfamiliar to participants and could raise suspicions about the research. Participants, however, focused their discussions on reimbursement or alternative reasons for joining the study, such as health related benefits or altruism. Finally, participants often relied on their physician to help them decide about joining a study or not. CONCLUSION: Further research is needed to understand how researchers and participants make sense of and practice consent, and how that impacts participants' decision-making about research participation. To promote valid consent within this context, it is important to engage with hospital-based trial communities as a whole. The data from this study will inform future research on consent, guide the revisions of consent related policies within our research sites and point to several larger issues surrounding researcher-participant expectations, communication, and trust.


Asunto(s)
Investigación Biomédica/ética , Toma de Decisiones , Consentimiento Informado/ética , Sujetos de Investigación/psicología , Adulto , Niño , Estudios Transversales , Dengue/terapia , Comités de Ética , Familia/psicología , Femenino , Humanos , Entrevistas como Asunto , Masculino , Cuerpo Médico de Hospitales/psicología , Persona de Mediana Edad , Personal de Enfermería en Hospital/psicología , Derivación y Consulta , Encuestas y Cuestionarios , Vietnam
19.
Artículo en Alemán | MEDLINE | ID: mdl-31773175

RESUMEN

BACKGROUND: In Germany, the drug law was revised in 2016 to include new regulations on clinical drug trials with adults who lack decision-making capacity. For the first time, trials with a merely indirect benefit (benefit for other patients with similar characteristics) will be possible if several safeguards are respected. The ethical justification and practicality of this regulation are controversially discussed. OBJECTIVES: (1) Eliciting the current pertinent practice of research ethics committees in Germany regarding research with indirect benefit on adults without decision-making capacity; (2) exploring the possibilities and difficulties of implementing the new law. METHODS: Semiquantitative, anonymous questionnaire among 249 members of all 53 human research ethics committees in Germany. RESULTS: Eighty-four questionnaires were analyzed (response rate 34%). The participants disagreed on assigning research projects to the categories of research with direct benefit to the subject, with an indirect benefit, and without any benefit. Moreover, the criteria of minimum risk and minimum burden were interpreted heterogeneously. More than half of the participants judged the newly introduced research advance directive to be unnecessary, given the legal safeguards in place. The applicability of these directives was doubted because of the strict requirements for anticipatory informed consent and the restricted predictability of future research. CONCLUSION: In spite of the new legal regulation, significant ethical uncertainties remain concerning research with indirect benefit on adults without decision-making capacity. It remains an open question whether we need a better explanation of the law, additional legal regulation, practice evaluation, or a completely new law.


Asunto(s)
Ensayos Clínicos como Asunto , Toma de Decisiones , Comités de Ética en Investigación , Consentimiento Informado , Adulto , Comités de Ética , Alemania , Humanos , Encuestas y Cuestionarios
20.
Artículo en Español | LILACS, BINACIS, ARGMSAL | ID: biblio-1117062

RESUMEN

La incorporación al Código Civil y Comercial de la Nación del requerimiento de evaluación de toda investigación en seres humanos por un Comité de Ética en Investigación (CEI) acreditado, junto a las acciones de la Dirección de Investigación en Salud (DIS) para fortalecer la regulación y vigilancia de los CEI por parte de las autoridades sanitarias de las provincias, originaron una serie de intervenciones de la Dirección de Investigación, Ciencia y Técnica (DICyT) del Ministerio de Salud de la Provincia de Mendoza. El objetivo del presente artículo es describir las intervenciones ejecutadas para la acreditación y regulación de los CEI de Mendoza mediante un trabajo colaborativo con la DIS


Asunto(s)
Comités de Ética , Ética en Investigación
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