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2.
Vaccine ; 39(4): 633-640, 2021 01 22.
Artículo en Inglés | MEDLINE | ID: mdl-33341309

RESUMEN

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.


Asunto(s)
Investigación Biomédica/ética , /prevención & control , Experimentación Humana/ética , Consentimiento Informado/ética , /patogenicidad , Antivirales/administración & dosificación , /inmunología , Comités de Ética en Investigación/organización & administración , Voluntarios Sanos , Experimentación Humana/legislación & jurisprudencia , Humanos , Selección de Paciente/ética , Vacunación/ética , Organización Mundial de la Salud
4.
Washington; Organización Panamericana de la Salud; nov. 16, 2020. 7 p.
No convencional en Inglés, Español | LILACS | ID: biblio-1150949

RESUMEN

La investigación relacionada con la salud con seres humanos es un componente esencial de la respuesta a la pandemia de COVID-19. Este documento tiene como objetivo orientar el análisis ético y los procedimientos que se deben seguir para llevar a cabo la supervisión de las investigaciones relacionadas con la COVID-19 ante la producción rápida de evidencia durante la pandemia.


Health-related research with human subjects is an essential component of the response to the COVID-19 pandemic. This document aims to guide the ethics analysis and procedures for the oversight of COVID-19-related research in light of the rapid production of evidence during the pandemic.


Asunto(s)
Humanos , Neumonía Viral/prevención & control , Infecciones por Coronavirus/prevención & control , Ética en Investigación , Pandemias/prevención & control , Experimentación Humana/ética
8.
Biologicals ; 67: 69-74, 2020 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-32829985

RESUMEN

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).


Asunto(s)
Betacoronavirus , Infecciones por Coronavirus/prevención & control , Desarrollo de Medicamentos/ética , Experimentación Humana/ética , Pandemias/prevención & control , Neumonía Viral/prevención & control , Vacunas Virales/uso terapéutico , Desarrollo de Medicamentos/legislación & jurisprudencia , Experimentación Humana/legislación & jurisprudencia , Humanos , Control de Calidad , Estándares de Referencia
10.
Lancet Infect Dis ; 20(8): e198-e203, 2020 08.
Artículo en Inglés | MEDLINE | ID: mdl-32479747

RESUMEN

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.


Asunto(s)
Betacoronavirus/inmunología , Infecciones por Coronavirus/prevención & control , Desarrollo de Medicamentos/ética , Experimentación Humana/ética , Pandemias/prevención & control , Neumonía Viral/prevención & control , Vacunas Virales/inmunología , Vacunas Virales/aislamiento & purificación , Betacoronavirus/patogenicidad , Desarrollo de Medicamentos/métodos , Humanos
11.
Zhonghua Yi Shi Za Zhi ; 50(1): 15-20, 2020 Jan 28.
Artículo en Chino | MEDLINE | ID: mdl-32564532

RESUMEN

"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.


Asunto(s)
Armas Biológicas/ética , Epidemias/prevención & control , Experimentación Humana/ética , Informe de Investigación , Humanos , Japón , Principios Morales , Facultades de Medicina
12.
Arch Med Res ; 51(6): 572-573, 2020 08.
Artículo en Inglés | MEDLINE | ID: mdl-32387041

RESUMEN

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.


Asunto(s)
Ensayos Clínicos como Asunto/ética , Infecciones por Coronavirus/diagnóstico , Infecciones por Coronavirus/prevención & control , Ética en Investigación , Pandemias/prevención & control , Neumonía Viral/diagnóstico , Neumonía Viral/prevención & control , Vacunas Virales/uso terapéutico , África , Betacoronavirus , Colonialismo , Países en Desarrollo , Relativismo Ético , Francia , Experimentación Humana/ética , Humanos , Obligaciones Morales , Equipo de Protección Personal , Sujetos de Investigación
14.
J Med Ethics ; 46(8): 502-504, 2020 08.
Artículo en Inglés | MEDLINE | ID: mdl-32461245

RESUMEN

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.


Asunto(s)
Investigación Biomédica/ética , Infecciones por Coronavirus/prevención & control , Guías como Asunto , Experimentación Humana/ética , Pandemias/ética , Neumonía Viral/prevención & control , Proyectos de Investigación , Vacunas Virales , Betacoronavirus , Investigación Biomédica/métodos , Infecciones por Coronavirus/virología , Análisis Ético , Revisión Ética , Comités de Ética en Investigación , Ética en Investigación , Humanos , Consentimiento Informado , Intención , Pandemias/prevención & control , Neumonía Viral/virología , Investigadores , Sujetos de Investigación , Vacunación , Voluntarios
15.
Plast Reconstr Surg ; 145(5): 1323-1330, 2020 05.
Artículo en Inglés | MEDLINE | ID: mdl-32332559

RESUMEN

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.


Asunto(s)
Investigación Biomédica/ética , Comités de Ética en Investigación/normas , Experimentación Humana/ética , Proyectos de Investigación/normas , Cirugía Plástica/ética , Academias e Institutos/ética , Academias e Institutos/normas , Investigación Biomédica/normas , Medicina Basada en la Evidencia/ética , Medicina Basada en la Evidencia/normas , Experimentación Humana/normas , Consentimiento Informado/ética , Consentimiento Informado/normas , Cirugía Plástica/normas , Estados Unidos
16.
Isr Med Assoc J ; 22(4): 219-223, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32286023

RESUMEN

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.


Asunto(s)
Campos de Concentración/historia , Epinefrina/efectos adversos , Color del Ojo , Experimentación Humana/historia , Enfermedades del Iris/inducido químicamente , Trastornos de la Pigmentación/inducido químicamente , Epinefrina/administración & dosificación , Femenino , Alemania , Historia del Siglo XX , Experimentación Humana/ética , Humanos , Masculino , Prisioneros , Violencia/historia , Segunda Guerra Mundial
17.
Ethics Hum Res ; 42(2): 34-40, 2020 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-32233115

RESUMEN

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.


Asunto(s)
Decepción , Ética , Experimentación Humana/ética , Investigadores/ética , Sujetos de Investigación , Medición de Riesgo/normas , Humanos , Consentimiento Informado
20.
J Nepal Health Res Counc ; 17(4): 548-552, 2020 Jan 21.
Artículo en Inglés | MEDLINE | ID: mdl-32001865

RESUMEN

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.


Asunto(s)
Investigación Biomédica/organización & administración , Experimentación Humana/ética , Experimentación Humana/normas , Investigación Biomédica/ética , Investigación Biomédica/normas , Compensación y Reparación/ética , Compensación y Reparación/legislación & jurisprudencia , Declaración de Helsinki , Humanos , Consentimiento Informado , Nepal , Placebos , Poblaciones Vulnerables/legislación & jurisprudencia
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