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Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group.
Jamrozik, Euzebiusz; Littler, Katherine; Bull, Susan; Emerson, Claudia; Kang, Gagandeep; Kapulu, Melissa; Rey, Elena; Saenz, Carla; Shah, Seema; Smith, Peter G; Upshur, Ross; Weijer, Charles; Selgelid, Michael J.
Afiliação
  • Jamrozik E; The Ethox Centre & Wellcome Centre for Ethics and the Humanities, Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK; Monash Bioethics Centre, Monash University, Clayton, Victoria, Australia; Royal Melbourne Hospital Department of Medicine, University of Melb
  • Littler K; Global Health Ethics Unit, World Health Organization, Geneva, Switzerland.
  • Bull S; The Ethox Centre & Wellcome Centre for Ethics and the Humanities, Nuffield Department of Population Health, University of Oxford, Oxford, Oxfordshire, UK.
  • Emerson C; Institute on Ethics & Policy for Innovation, Department of Philosophy, McMaster University, Hamilton, Ontario, Canada.
  • Kang G; The Wellcome Trust Research Laboratory, Division of Gastrointestinal Sciences, Christian Medical College, Vellore, India.
  • Kapulu M; KEMRI-Wellcome Trust Research Programme, Centre for Geographic Medicine Research-Coast, Kilifi, Kenya; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
  • Rey E; Centro Internacional de Entrenamiento e Investigaciones Médicas - CIDEIM. Cali, Colombia; Universidad Icesi. Cali, Colombia.
  • Saenz C; Department of Health Systems and Services, Pan American Health Organization, USA.
  • Shah S; Lurie Children's Hospital & Northwestern University Feinberg School of Medicine, Chicago, USA.
  • Smith PG; London School of Hygiene and Tropical Medicine, London, UK.
  • Upshur R; Division of Clinical Public Health, Dalla Lana School of Public Health, Toronto, Canada.
  • Weijer C; Departments of Medicine, Epidemiology & Biostatistics, and Philosophy, Western University, London, Canada.
  • Selgelid MJ; Monash Bioethics Centre, Monash University, Clayton, Victoria, Australia.
Vaccine ; 39(4): 633-640, 2021 01 22.
Article em En | MEDLINE | ID: mdl-33341309
ABSTRACT
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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pesquisa Biomédica / Vacinas contra COVID-19 / SARS-CoV-2 / COVID-19 / Experimentação Humana / Consentimento Livre e Esclarecido Tipo de estudo: Guideline / Prognostic_studies Limite: Humans Idioma: En Ano de publicação: 2021 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Pesquisa Biomédica / Vacinas contra COVID-19 / SARS-CoV-2 / COVID-19 / Experimentação Humana / Consentimento Livre e Esclarecido Tipo de estudo: Guideline / Prognostic_studies Limite: Humans Idioma: En Ano de publicação: 2021 Tipo de documento: Article