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1.
Vaccine ; 39(4): 633-640, 2021 01 22.
Artigo em Inglês | MEDLINE | ID: mdl-33341309

RESUMO

This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable.


Assuntos
Pesquisa Biomédica/ética , /prevenção & controle , Experimentação Humana/ética , Consentimento Livre e Esclarecido/ética , /patogenicidade , Antivirais/administração & dosagem , /imunologia , Comitês de Ética em Pesquisa/organização & administração , Voluntários Saudáveis , Experimentação Humana/legislação & jurisprudência , Humanos , Seleção de Pacientes/ética , Vacinação/ética , Organização Mundial da Saúde
6.
Biologicals ; 67: 69-74, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32829985

RESUMO

This second International Alliance for Biological Standardization COVID-19 webinar brought together a broad range of international stakeholders, including academia, regulators, funders and industry, with a considerable participation from low- and middle-income countries, to discuss the use of controlled human infection models to accelerate development and market authorization assessment of a vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).


Assuntos
Betacoronavirus , Infecções por Coronavirus/prevenção & controle , Desenvolvimento de Medicamentos/ética , Experimentação Humana/ética , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vacinas Virais/uso terapêutico , Desenvolvimento de Medicamentos/legislação & jurisprudência , Experimentação Humana/legislação & jurisprudência , Humanos , Controle de Qualidade , Padrões de Referência
8.
Lancet Infect Dis ; 20(8): e198-e203, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32479747

RESUMO

COVID-19 poses an extraordinary threat to global public health and an effective vaccine could provide a key means of overcoming this crisis. Human challenge studies involve the intentional infection of research participants and can accelerate or improve vaccine development by rapidly providing estimates of vaccine safety and efficacy. Human challenge studies of low virulence coronaviruses have been done in the past and human challenge studies with severe acute respiratory syndrome coronavirus 2 have been proposed. These studies of coronaviruses could provide considerable benefits to public health; for instance, by improving and accelerating vaccine development. However, human challenge studies of severe acute respiratory syndrome coronavirus 2 in particular might be controversial, in part, for ethical reasons. The ethical issues raised by such studies thus warrant early consideration involving, for example, broad consultation with the community. This Personal View provides preliminary analyses of relevant ethical considerations regarding human challenge studies of severe acute respiratory syndrome coronavirus 2, including the potential benefits to public health and to participants, the risks and uncertainty for participants, and the third-party risks (ie, to research staff and the wider community). We argue that these human challenge studies can reasonably be considered ethically acceptable insofar as such studies are accepted internationally and by the communities in which they are done, can realistically be expected to accelerate or improve vaccine development, have considerable potential to directly benefit participants, are designed to limit and minimise risks to participants, and are done with strict infection control measures to limit and reduce third-party risks.


Assuntos
Betacoronavirus/imunologia , Infecções por Coronavirus/prevenção & controle , Desenvolvimento de Medicamentos/ética , Experimentação Humana/ética , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Vacinas Virais/imunologia , Vacinas Virais/isolamento & purificação , Betacoronavirus/patogenicidade , Desenvolvimento de Medicamentos/métodos , Humanos
9.
Zhonghua Yi Shi Za Zhi ; 50(1): 15-20, 2020 Jan 28.
Artigo em Chinês | MEDLINE | ID: mdl-32564532

RESUMO

"The Research Report on Epidemic Prevention of Army Medical School Ⅱ: Vol.1, No.36" , the report named "various symptoms and serological responses of human body after receiving ultrasonic cholera vaccine" is one of the declassified materials of Japanese biological warfare. The author is M. D. Watanabe Be. Through detailed analysis of its contents, such as institute of report, test method, test results, and so forth, conclusion is reached that Unit 731 did conduct scientific research based on human-subject experiment to launch biological warfare on human beings. The report mentioned above is one of the most important evidence of crime that Japan conducts biological warfare which violates international convention and contempt bottom line of human basic morals and ethics.


Assuntos
Armas Biológicas/ética , Epidemias/prevenção & controle , Experimentação Humana/ética , Relatório de Pesquisa , Humanos , Japão , Princípios Morais , Faculdades de Medicina
11.
Arch Med Res ; 51(6): 572-573, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32387041

RESUMO

A TV debate in April 2020 between two French doctors regarding the benefits of testing a coronavirus vaccine in Africa where there are no masks or treatments available has led to international criticism. This case highlights a problematic ethical double standard in multinational clinical research: trials that would be considered unethical in high income countries (e.g., placebo-controlled where there is an existing treatment) are nonetheless justified in low-and-middle-income countries because the existing standards of care are less (i.e., no access to a treatment). Underlying this ethical double standard in some multinational clinical trials is a moral imperialism and persistent colonialist thinking that must be rejected.


Assuntos
Ensaios Clínicos como Assunto/ética , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/prevenção & controle , Ética em Pesquisa , Pandemias/prevenção & controle , Pneumonia Viral/diagnóstico , Pneumonia Viral/prevenção & controle , Vacinas Virais/uso terapêutico , África , Betacoronavirus , Colonialismo , Países em Desenvolvimento , Relativismo Ético , França , Experimentação Humana/ética , Humanos , Obrigações Morais , Equipamento de Proteção Individual , Sujeitos da Pesquisa
12.
J Med Ethics ; 46(8): 502-504, 2020 08.
Artigo em Inglês | MEDLINE | ID: mdl-32461245

RESUMO

Global fatalities related to COVID-19 are expected to be high in 2020-2021. Developing and delivering a vaccine may be the most likely way to end the pandemic. If it were possible to shorten this development time by weeks or months, this may have a significant effect on reducing deaths. Phase II and phase III trials could take less long to conduct if they used human challenge methods-that is, deliberately infecting participants with COVID-19 following inoculation. This article analyses arguments for and against such methods and provides suggested broad guidelines for regulators, researchers and ethics committees when considering these matters. It concludes that it may be possible to maintain current ethical standards yet still permit human challenge trials in a context where delay is critical. The implications are that regulators and researchers need to work together now to design robust but short trials and streamline ethics approval processes so that they are in place when applications for trials are made.


Assuntos
Pesquisa Biomédica/ética , Infecções por Coronavirus/prevenção & controle , Guias como Assunto , Experimentação Humana/ética , Pandemias/ética , Pneumonia Viral/prevenção & controle , Projetos de Pesquisa , Vacinas Virais , Betacoronavirus , Pesquisa Biomédica/métodos , Infecções por Coronavirus/virologia , Análise Ética , Revisão Ética , Comitês de Ética em Pesquisa , Ética em Pesquisa , Humanos , Consentimento Livre e Esclarecido , Intenção , Pandemias/prevenção & controle , Pneumonia Viral/virologia , Pesquisadores , Sujeitos da Pesquisa , Vacinação , Voluntários
13.
Plast Reconstr Surg ; 145(5): 1323-1330, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32332559

RESUMO

Clinical research remains at the forefront of academic practice and evidence-based medicine. Unfortunately, history has shown that human subjects are vulnerable to experimentation without regard for their own dignity and informed decision-making. Subsequently, it is vital for research institutes to uphold safeguards and ethical conscientiousness toward human subjects. The establishment of federal regulations and the development of institutional review boards have set guidance on these processes. On January 21, 2019, final revisions to the Federal Policy for the Protection of Human Subjects (the "Common Rule") went into effect. The purpose of this article is to review changes to the Common Rule and discuss their impact on plastic surgery research.


Assuntos
Pesquisa Biomédica/ética , Comitês de Ética em Pesquisa/normas , Experimentação Humana/ética , Projetos de Pesquisa/normas , Cirurgia Plástica/ética , Academias e Institutos/ética , Academias e Institutos/normas , Pesquisa Biomédica/normas , Medicina Baseada em Evidências/ética , Medicina Baseada em Evidências/normas , Experimentação Humana/normas , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/normas , Cirurgia Plástica/normas , Estados Unidos
14.
Ethics Hum Res ; 42(2): 34-40, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-32233115

RESUMO

The use of deception is typically prohibited in studies that pose greater than minimal risk overall. This approach prevents researchers from using deception to conceal significant risks or to deceive participants about the purpose, potential benefits, or other aspects of a study that are relevant to deciding whether to accept such risks. Yet this approach also mistakenly blocks appropriate research. In particular, it keeps researchers from using deception in studies that pose greater than minimal risk, even when participants are informed accurately about the risks and other aspects of the study that are relevant to deciding whether to participate. Rather than prohibiting deception when the overall study poses greater than minimal risk, policies should prohibit deception when the aspect of the study about which participants are deceived poses greater than minimal risk.


Assuntos
Decepção , Ética , Experimentação Humana/ética , Pesquisadores/ética , Sujeitos da Pesquisa , Medição de Risco/normas , Humanos , Consentimento Livre e Esclarecido
15.
Isr Med Assoc J ; 22(4): 219-223, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-32286023

RESUMO

BACKGROUND: In an effort to alter eye color during World War II, devout Nazi researcher Karin Magnussen had adrenaline eye drops administered to inmates at the concentration camp Auschwitz-Birkenau. A Sinti family, with a high prevalence of heterochromia iridis, was forced to participate in this study. Members of this family, as well as other victims, were later killed and had their eyes enucleated and sent to Magnussen for examination. Magnussen articulated the findings of these events in a manuscript that has never been published. The author is the first ophthalmologist to review this manuscript. The generation who experienced the atrocities of World War II will soon be gone and awareness of what happened during this tragic chapter of world history is fading. OBJECTIVES: To describe these events to raise awareness among future generations. METHODS: A literature review and archival search was conducted. RESULTS: Magnussen's research was based on an animal study published in 1937. For Magnussen's study, adrenaline drops were administered to inmates, including a 12-year-old girl from the Sinti family. As there was a reported case of deaf-mutism within the family, Waardenburg syndrome seems to be the most plausible explanation for this family's heritable heterochromia. CONCLUSIONS: The effort to change eye color was doomed to fail from the beginning because there was a probable diagnosis of Waardenburg syndrome. Extinction of humans for ophthalmological research is an insane act beyond imagination. For the sake of these victims, and for the generations who still feel their pain, it is imperative to tell their stories.


Assuntos
Campos de Concentração/história , Epinefrina/efeitos adversos , Cor de Olho , Experimentação Humana/história , Doenças da Íris/induzido quimicamente , Transtornos da Pigmentação/induzido quimicamente , Epinefrina/administração & dosagem , Feminino , Alemanha , História do Século XX , Experimentação Humana/ética , Humanos , Masculino , Prisioneiros , Violência/história , II Guerra Mundial
18.
J Nepal Health Res Counc ; 17(4): 548-552, 2020 Jan 21.
Artigo em Inglês | MEDLINE | ID: mdl-32001865

RESUMO

The pinnacle of success achieved by the medical science and the benefits accrued to the patients have become possible through the medical research where human participants in the research are exposed to hazards inherent to the experiments. To protect the human subjects and to maintain high ethical standards, the World Medical Association has adopted "The Declaration of Helsinki" in 1964. After two years of consultation with the experts throughout the world, the seventh revision of the Declaration was adopted on 19th October 2013 in Brazil. The aim of this article is to review the seventh revision of the Declaration of Helsinki in relation to medical research involving human subjects and highlight the amendments made in the latest revision which are relevant to clinical research in human subjects. The latest revision has made four substantial changes on the existing Declaration, whch include dealing with the compensation of the trial-related injuries, approval of use of placebos in the clinical trials, protection of vulnerable groups and the post-trial provisions. The implications of these amendments in the clinical research are highlighted. Keywords: Consent; Declaration of Helsinki; ethics; experimental medicine; research; seventh revision.


Assuntos
Pesquisa Biomédica/organização & administração , Experimentação Humana/ética , Experimentação Humana/normas , Pesquisa Biomédica/ética , Pesquisa Biomédica/normas , Compensação e Reparação/ética , Compensação e Reparação/legislação & jurisprudência , Declaração de Helsinki , Humanos , Consentimento Livre e Esclarecido , Nepal , Placebos , Populações Vulneráveis/legislação & jurisprudência
19.
Med Law Rev ; 28(1): 65-92, 2020 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-30668764

RESUMO

Prisoners are often excluded from participating in clinical research (ie clinical trials and clinical investigations related to medicinal products and medical devices) due to the historical precedent of their abuse and exploitation. The exclusion of prisoners from clinical research is often deemed necessary to guarantee their protection from such abuse and exploitation. However, in this article, we argue that the right to science, which encompasses the right to access the benefits of science and research participation, is an emerging human right that is applicable to prisoners and may only be limited when this is necessary and proportionate. Whether this is necessary depends in part on the validity of a prisoner's informed consent. We discuss the importance of prison conditions for voluntary consent and examine the relationship between prison overcrowding and sub-par prison conditions by analysing the jurisprudence of the European Court of Human Rights on Article 3 of the European Convention on Human Rights on the prohibition of torture and inhuman treatment. We contend that the special circumstances of being in prison warrant additional protective measures, concurring with the Belgian Advisory Committee on Bioethics that research without the explicit aim of improving the situation of the individual prisoner or the prison community should be excluded. Given the complexity of the question of whether prisoners can give valid informed consent, rigorous oversight by an ethics committee with expertise concerning the prison system is necessary to provide a proportional balance between offering prisoners access to research and protection from abuse and exploitation.


Assuntos
Experimentação Humana/ética , Experimentação Humana/legislação & jurisprudência , Consentimento Livre e Esclarecido/ética , Consentimento Livre e Esclarecido/legislação & jurisprudência , Prisioneiros , Prisões/ética , Comitês Consultivos , Bioética , Ensaios Clínicos como Assunto , União Europeia , Direitos Humanos/ética , Direitos Humanos/legislação & jurisprudência , Humanos
20.
Buenos Aires; Ministerio de Salud; 2020.
Não convencional em Espanhol | LILACS | ID: biblio-1116482

RESUMO

Ante la pandemia de COVID-19 la primera obligación es responder a las necesidades de atención de salud de las personas y comunidades afectadas. Al mismo tiempo, resulta un deber realizar investigaciones que generen evidencia para mantener, promover y mejorar la atención de la salud, la toma de decisiones y la definición de políticas en salud para el tratamiento y mitigación de la pandemia. La conducción de investigación durante la emergencia sanitaria conlleva mayores desafíos que los habituales. Demanda generar conocimiento rápidamente para dar respuesta a la pandemia, asegurar la validez científica de las investigaciones, respetar los principios éticos en su realización y mantener la confianza de la comunidad. Esta tarea requiere de la colaboración y solidaridad de la comunidad científica, investigadores, patrocinadores, comités evaluadores, personal de salud, autoridades sanitarias y la sociedad, para encontrar el mejor modo de evitar retrasos en la realización de las investigaciones. En este contexto, los comités de ética en investigación (CEI) deberían formular procedimientos para una evaluación ética rigurosa de las investigaciones en seres humanos que, a su vez, aseguren la existencia de mecanismos rápidos y flexibles para dar una respuesta eficiente a los tiempos y necesidades de una emergencia sanitaria. Estas recomendaciones buscan orientar a los CEI en el desarrollo de procedimientos operativos para una evaluación acelerada de proyectos de investigación relacionados con el COVID-19.


Assuntos
Pneumonia Viral/prevenção & controle , Pessoal de Saúde/ética , Infecções por Coronavirus/prevenção & controle , Ética Institucional , Pandemias/prevenção & controle , Betacoronavirus , Experimentação Humana/ética , Serviços Médicos de Emergência/ética , Políticas Públicas de Saúde , Atenção à Saúde
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