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1.
Camb Q Healthc Ethics ; 30(1): 59-68, 2021 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-32498742

RESUMO

The world awaits a SARS-CoV-2 virus (i.e., COVID-19 disease) vaccine to keep the populace healthy, fully reopen their economies, and return their social and healthcare systems to "normal." Vaccine safety and efficacy requires meticulous testing and oversight; this paper describes how despite grandiose public statements, the current vaccine development, testing, and production methods may prove to be ethically dubious, medically dangerous, and socially volatile. The basic moral concern is the potential danger to the health of human test subjects and, eventually, many vaccine recipients. This is further complicated by economic and political pressures to reduce government oversight on rushed vaccine testing and production, nationalistic distribution goals, and failure to plan for the widespread immunization needed to produce global herd immunity. As this paper asserts, the public must be better informed to assess promises about the novel vaccines being produced and to tolerate delays and uncertainty.


Assuntos
Pesquisa Biomédica , /prevenção & controle , Desenvolvimento de Medicamentos/ética , /imunologia , Ensaios Clínicos como Assunto/ética , Humanos , Programas de Imunização
5.
J Infect Dev Ctries ; 14(9): 968-970, 2020 09 30.
Artigo em Inglês | MEDLINE | ID: mdl-33031082

RESUMO

The COVID-19 pandemic has created new challenges on multiple fronts including a few ethical concerns. Timely and appropriate access to health services and the need to protect vulnerable people are some of them. An important aspect to consider, at the global level, is the frailty of health systems in many developing countries and the constant threat of these collapsing due to shortage of resources and medical supply. Special attention should be placed towards protecting the health of care workers who are highly exposed to SARS-CoV-2 infection. Research and clinical trials involving COVID-19 patients and healthy human volunteers must be done in strict adherence to the fundamental principles of bioethics, even if finding a solution is an urgent need. Shared responsibility must be assumed as we collectively face a common problem and ethical conflicts must be resolved using, as reference, the guidelines developed by the World Health Organization and other relevant international and national organizations. This would allow responsible action in the face of the pandemic without harming human rights, the individual and collective well-being.


Assuntos
Betacoronavirus , Saúde Global/ética , Pandemias/ética , Ensaios Clínicos como Assunto/ética , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/terapia , Países em Desenvolvimento , Pessoal de Saúde/ética , Disparidades em Assistência à Saúde/ética , Direitos Humanos/ética , Humanos , Pneumonia Viral/diagnóstico , Pneumonia Viral/epidemiologia , Pneumonia Viral/terapia , Triagem/ética
11.
Pan Afr Med J ; 36: 206, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32963672

RESUMO

The intense global efforts are directed towards development of vaccines to halt the COVID-19 virus pandemic. There are 160 candidate vaccines under clinical trials across the world using different molecular targets and techniques. This race for the vaccine has several challenges and ethical issues like compressed timelines, generation and proper management of resources and finances, risks to the participating volunteers due to curtailed research trial processes, geopolitical contentions, misinformation through social media and parallel race with drugs. We feel that the fundamental principles of ethics: autonomy, beneficence, non-maleficence and justice should not be violated in this hastened vaccine development process. We recommend constitute a Consortium on a global platform to formulate, provide and monitor a comprehensive ethical umbrella to the process of vaccine development.


Assuntos
Betacoronavirus/imunologia , Ensaios Clínicos como Assunto/ética , Infecções por Coronavirus/prevenção & controle , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vacinas Virais/uso terapêutico , Temas Bioéticos , Comunicação , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/economia , Infecções por Coronavirus/epidemiologia , Voluntários Saudáveis , Humanos , Internacionalidade , Pneumonia Viral/tratamento farmacológico , Pneumonia Viral/epidemiologia , Alocação de Recursos , Mídias Sociais , Fatores de Tempo , Vacinas Virais/economia , Vacinas Virais/provisão & distribução
14.
Daru ; 28(2): 807-812, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32851596

RESUMO

BACKGROUND: The pandemic associated with the new SARS-CoV-2 coronavirus continues to spread worldwide. The most favorable epidemic control scenario, which provides long-term protection against COVID-19 outbreak, is the development and distribution of an effective and safe vaccine. The need to develop a new COVID-19 vaccine is pressing; however, it is likely to take a long time, possibly several years. This is due to the time required to demonstrate the safety and efficacy of the proposed vaccine. and the time required to manufacture and distribute millions of doses. OBJECTIVES: To accelerate this development and associated safety testing, the deliberate infection of healthy volunteers has been suggested. The purpose of this short communication is to describe the ethical aspects of this type of testing, RESULTS: Deliberate infection of volunteers with a dangerous virus such as SARS-CoV-2 was initially considered unethical by researchers; but the current pandemic is so different from previous ones that these studies are considered ethical if certain criteria are met. Participants in human challenge studies must be relatively young, in good health and must receive the highest quality medical care, with frequent monitoring. Tests should also be performed with great caution and specialized medical supervision. Besides, the fact that obtaining vaccines faster through deliberate infection studies of healthy people has greater benefits than risks, has been demonstrated by obtaining other vaccines in other historical pandemics such as: smallpox, influenza, malaria, typhoid fever, Dengue fever and Zika. CONCLUSIONS: One possibility to shorten the time required for the development of COVID-19 vaccines is to reduce clinical phases II and III by using human challenge studies through eliberate infection of healthy volunteers with SARS-CoV-2 after administration of the candidate vaccine. Accelerating the development of a COVID-19 vaccine even for a few weeks or months would have a great beneficial impact on public health by saving many lives.


Assuntos
/administração & dosagem , /imunologia , Animais , /virologia , /imunologia , Ensaios Clínicos como Assunto/ética , Experimentação Humana/ética , Humanos , Fatores de Tempo
17.
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
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