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

RESUMO

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.


Assuntos
Bioética , Comissão de Ética/organização & administração , Inquéritos e Questionários , Estudos Transversais , Governo , Humanos , Internacionalidade
3.
Cuad Bioet ; 31(102): 167-182, 2020.
Artigo em Espanhol | MEDLINE | ID: mdl-32910670

RESUMO

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.


Assuntos
Betacoronavirus , Controle de Doenças Transmissíveis/legislação & jurisprudência , Direitos Humanos/ética , Pandemias/prevenção & controle , Saúde Pública/ética , Controle de Doenças Transmissíveis/métodos , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/prevenção & controle , Comissão de Ética , União Europeia , Liberdade , Recursos em Saúde/ética , Recursos em Saúde/provisão & distribução , Acesso aos Serviços de Saúde/ética , Direitos Humanos/legislação & jurisprudência , Humanos , Pandemias/ética , Pandemias/legislação & jurisprudência , Direitos do Paciente/ética , Direitos do Paciente/legislação & jurisprudência , Autonomia Pessoal , Pneumonia Viral/epidemiologia , Pneumonia Viral/prevenção & controle , Guias de Prática Clínica como Assunto , Saúde Pública/legislação & jurisprudência , Quarentena/ética , Quarentena/legislação & jurisprudência , Sujeitos da Pesquisa , Alocação de Recursos/ética , Espanha , UNESCO
4.
Cuad Bioet ; 31(102): 231-243, 2020.
Artigo em Espanhol | MEDLINE | ID: mdl-32910674

RESUMO

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.


Assuntos
Betacoronavirus , Casas de Saúde/ética , Pandemias/ética , Idoso , Infecções por Coronavirus/prevenção & controle , Comissão de Ética , Política de Saúde , Recursos em Saúde/ética , Recursos em Saúde/provisão & distribução , Humanos , Disseminação de Informação , Pandemias/prevenção & controle , Pessoalidade , Pneumonia Viral/prevenção & controle , Guias de Prática Clínica como Assunto , Alocação de Recursos/ética , Justiça Social , UNESCO , Populações Vulneráveis
6.
Rom J Morphol Embryol ; 61(1): 277-281, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32747923

RESUMO

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.


Assuntos
Ensaios Clínicos como Assunto/ética , Ensaios Clínicos como Assunto/legislação & jurisprudência , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Revisão Ética , Ética em Pesquisa , Política de Saúde , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Comissão de Ética , União Europeia , Humanos , Consentimento Livre e Esclarecido , Pandemias , Segurança do Paciente , Saúde Pública , Projetos de Pesquisa
9.
Rev. méd. hondur ; 88(1): 33-37, ene.- jun. 2020. tab
Artigo em Espanhol | LILACS | ID: biblio-1128542

RESUMO

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)


Assuntos
Humanos , Comissão de Ética/ética , Publicação Periódica , Revisão de Integridade Científica , Comitês de Ética em Pesquisa
11.
Med Intensiva ; 44(7): 439-445, 2020 10.
Artigo em Espanhol | MEDLINE | ID: mdl-32402532

RESUMO

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.


Assuntos
Betacoronavirus , Tomada de Decisão Clínica , Infecções por Coronavirus/epidemiologia , Cuidados Críticos/ética , Unidades de Terapia Intensiva , Pandemias , Pneumonia Viral/epidemiologia , Infecções por Coronavirus/terapia , Cuidados Críticos/métodos , Cuidados Críticos/psicologia , Cuidados Críticos/normas , Comissão de Ética , Necessidades e Demandas de Serviços de Saúde , Número de Leitos em Hospital , Humanos , Pneumonia Viral/terapia , Medicina de Precisão , Alocação de Recursos/ética , Alocação de Recursos/normas , Respiração Artificial , Sociedades Científicas , Espanha/epidemiologia , Triagem/ética , Triagem/normas
12.
Harefuah ; 159(5): 360-363, 2020 May.
Artigo em Hebraico | MEDLINE | ID: mdl-32431128

RESUMO

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.


Assuntos
Comissão de Ética , Ética Médica , Humanos , Pacientes
13.
J Clin Ethics ; 31(1): 42-47, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32213690

RESUMO

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.


Assuntos
Esgotamento Profissional , Comitês de Ética Clínica , Médicos , Comissão de Ética , Humanos
14.
Rev. bioét. derecho ; (48): 127-137, mar. 2020.
Artigo em Espanhol | IBECS | ID: ibc-192082

RESUMO

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


Assuntos
Humanos , Ética em Pesquisa , Sepse/epidemiologia , Comissão de Ética/ética , Unidades de Terapia Intensiva/ética , Comissão de Ética/legislação & jurisprudência , Big Data , Unidades de Terapia Intensiva/legislação & jurisprudência
15.
Fertil Steril ; 113(2): 270-294, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32106974

RESUMO

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.


Assuntos
Comitês Consultivos/ética , Pesquisas com Embriões/ética , Comissão de Ética/ética , Medicina Reprodutiva/ética , Edição de Genes , Humanos , Estados Unidos
16.
Tex Med ; 116(2): 22-23, 2020 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-32083712

RESUMO

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.


Assuntos
Comissão de Ética/legislação & jurisprudência , Ética Médica , Decisões da Suprema Corte , Humanos , Texas , Estados Unidos
17.
Bioethics ; 34(3): 223-227, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31943263

RESUMO

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.


Assuntos
Pesquisas com Embriões/ética , Células Germinativas Embrionárias , Edição de Genes/ética , Direitos Humanos/legislação & jurisprudência , Comitês Consultivos , Comissão de Ética , Humanos , Relatório de Pesquisa , Reino Unido
18.
BMC Med Ethics ; 21(1): 4, 2020 01 10.
Artigo em Inglês | MEDLINE | ID: mdl-31924199

RESUMO

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.


Assuntos
Pesquisa Biomédica/ética , Tomada de Decisões , Consentimento Livre e Esclarecido/ética , Sujeitos da Pesquisa/psicologia , Adulto , Criança , Estudos Transversais , Dengue/terapia , Comissão de Ética , Família/psicologia , Feminino , Humanos , Entrevistas como Assunto , Masculino , Corpo Clínico Hospitalar/psicologia , Pessoa de Meia-Idade , Recursos Humanos de Enfermagem no Hospital/psicologia , Encaminhamento e Consulta , Inquéritos e Questionários , Vietnã
19.
Artigo em Alemão | MEDLINE | ID: mdl-31773175

RESUMO

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.


Assuntos
Ensaios Clínicos como Assunto , Tomada de Decisões , Comitês de Ética em Pesquisa , Consentimento Livre e Esclarecido , Adulto , Comissão de Ética , Alemanha , Humanos , Inquéritos e Questionários
20.
Epidemiol Prev ; 44(5-6 Suppl 2): 113-118, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33412801

RESUMO

BACKGROUND: ethics committees (ECs) protect the rights, safety, and well-being of research participants and ensure the scientific correctness of clinical research. COVID-19 pandemic and the lockdown from 9 March to 16 May 2020 have potentially influenced several activities, including ECs. OBJECTIVES: to assess the impact of COVID-19 outbreak on Italian ECs and their performance during the lockdown. DESIGN: cross-sectional survey. SETTING AND PARTICIPANTS: the survey was conducted in mid-June 2020 in Italy contacting all the 90 local ECs. MAIN OUTCOME MEASURES: amount and kind of activities performed during the lockdown, characteristics of submitted studies and adoption of standard protocols of evaluation of research applications during the pandemic. Chi-square test was used to estimate the differences between territories with higher incidence (HI) and lower incidence (LI) of COVID-19. RESULTS: 258 questionnaires were collected from 46 ECs that participated in the study. Ten were excluded due to missing substantial data. Responses were divided into two groups according to location of EC: the HI (125 responses) and the LI (123 responses). Seventy-five percent of the HI describe an increase in the number of studies submitted, while 53% of the LI does not (p=0.001). Due to the pandemic and its effects on research, the 15% of participants belonging to HI territories reported that consideration and respect of research-related and general ethical principles could have decreased, as well the adoption of standard protocols of evaluation of research applications. EC secretariats located in HI Regions moved to smart working more than in LI ones (75% vs 59%; p=0.001). Where the EC workload increased significantly, it was reported that it was impossible to perform an accurate analysis of the submitted documentation, with the effect of providing a favorable opinion to studies of not excellent quality, though always ensuring the respect of ethical principles and patients' safety. CONCLUSIONS: COVID-19 impact on ECs has been heavier in HI territories, but smart working has been effective in ensuring EC activities and the subsequent activation of clinical studies potentially useful to face the pandemic. Clear differences arise between ECs belonging to the Italian Regions that have recorded a HI of COVID-19 cases compared to those located in Regions with a LI of cases. In some EC members' perception, the high number of studies in the most affected Regions together with the emergency experienced during the lockdown may have exposed ECs to the risk of decreasing the adoption of ethical principles and standard protocols of evaluation of research applications.


Assuntos
Comissão de Ética , Pandemias , Quarentena , /epidemiologia , Comissão de Ética/estatística & dados numéricos , Comitês de Ética em Pesquisa , Ética em Pesquisa , Pesquisas sobre Serviços de Saúde , Humanos , Itália/epidemiologia , Avaliação de Resultados em Cuidados de Saúde , Carga de Trabalho
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