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Ethics review of COVID-19 human challenge studies: A joint HRA/WHO workshop.
Williams, Eloise; Craig, Kathrine; Chiu, Christopher; Davies, Hugh; Ellis, Stephanie; Emerson, Claudia; Jamrozik, Euzebiusz; Jefford, Monica; Kang, Gagandeep; Kapulu, Melissa; Kolstoe, Simon E; Littler, Katherine; Lockett, Anthony; Messer, Janet; McShane, Helen; Saenz, Carla; Selgelid, Michael J; Shah, Seema; Smith, Peter G; Yamazaki, Naho.
  • Williams E; Department of Microbiology, Royal Melbourne Hospital, Melbourne, Victoria, Australia; Department of Microbiology and Immunology, University of Melbourne at the Peter Doherty Institute, Melbourne, Victoria, Australia. Electronic address: eloise.williams@mh.org.au.
  • Craig K; Specialist Ad-Hoc Research Ethics Committee for COVID-19 Human Challenge Studies, Health Research Authority, London, UK.
  • Chiu C; Department of Infectious Disease, Imperial College London, London, UK.
  • Davies H; Specialist Ad-Hoc Research Ethics Committee for COVID-19 Human Challenge Studies, Health Research Authority, London, UK.
  • Ellis S; Specialist Ad-Hoc Research Ethics Committee for COVID-19 Human Challenge Studies, Health Research Authority, London, UK.
  • Emerson C; Institute on Ethics & Policy for Innovation, Department of Philosophy, McMaster University, Hamilton, Ontario, Canada.
  • 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
  • Jefford M; Specialist Ad-Hoc Research Ethics Committee for COVID-19 Human Challenge Studies, Health Research Authority, London, UK.
  • 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.
  • Kolstoe SE; Specialist Ad-Hoc Research Ethics Committee for COVID-19 Human Challenge Studies, Health Research Authority, London, UK; School of Health & Care Professions, University of Portsmouth, Portsmouth, UK.
  • Littler K; Global Health Ethics Unit, World Health Organization, Geneva, Switzerland.
  • Lockett A; Specialist Ad-Hoc Research Ethics Committee for COVID-19 Human Challenge Studies, Health Research Authority, London, UK; King's College London, London, UK.
  • Elena Rey; Centro Internacional de Entrenamiento e Investigaciones Médicas - CIDEIM, Cali, Colombia; Universidad Icesi, Cali, Colombia.
  • Messer J; Health Research Authority, London, UK.
  • McShane H; Department of Paediatrics, University of Oxford, Oxford, UK.
  • Saenz C; Regional Program on Bioethics, Department of Health Systems and Services, Pan American Health Organization, Washington D.C., USA.
  • Selgelid MJ; Institute on Ethics & Policy for Innovation, Department of Philosophy, McMaster University, Hamilton, Ontario, Canada.
  • Shah S; Lurie Children's Hospital & Northwestern University Feinberg School of Medicine, Chicago, USA.
  • Smith PG; MRC International Statistics and Epidemiology Group, London School of Hygiene and Tropical Medicine, London, UK.
  • Yamazaki N; Health Research Authority, London, UK.
Vaccine ; 40(26): 3484-3489, 2022 06 09.
Article in English | MEDLINE | ID: covidwho-1740252
ABSTRACT
This report of a joint World Health Organization (WHO) and United Kingdom (UK) Health Research Authority (HRA) workshop discusses the ethics review of the first COVID-19 human challenge studies, undertaken in the midst of the pandemic. It reviews the early efforts of international and national institutions to define the ethical standards required for COVID-19 human challenge studies and create the frameworks to ensure rigorous and timely review of these studies. This report evaluates the utility of the WHO's international guidance document Key criteria for the ethical acceptability of COVID-19 human challenge studies (WHO Key Criteria) as a practical resource for the ethics review of COVID-19 human challenge studies. It also assesses the UK HRA's approach to these complex ethics reviews, including the formation of a Specialist Ad-Hoc Research Ethics Committee (REC) for COVID-19 Human Challenge Studies to review all current and future COVID-19 human challenge studies. In addition, the report outlines the reflections of REC members and researchers regarding the ethics review process of the first COVID-19 human challenge studies. Finally, it considers the potential ongoing scientific justification for COVID-19 human challenge studies, particularly in relation to next-generation vaccines and optimisation of vaccination schedules. Overall, there was broad agreement that the WHO Key Criteria represented an international consensus document that played a powerful role in setting norms and delineating the necessary conditions for the ethical acceptability of COVID-19 human challenge studies. Workshop members suggested that the WHO Key Criteria could be practically implemented to support researchers and ethics reviewers, including in the training of ethics committee members. In future, a wider audience may be engaged by the original document and potential additional materials, informed by the experiences of those involved in the first COVID-19 human challenge studies outlined in this document.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Ethical Review / COVID-19 Type of study: Experimental Studies / Qualitative research Topics: Vaccines Limits: Humans Language: English Journal: Vaccine Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Ethical Review / COVID-19 Type of study: Experimental Studies / Qualitative research Topics: Vaccines Limits: Humans Language: English Journal: Vaccine Year: 2022 Document Type: Article