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WHO R&D Blueprint COVID-19 WHO Ethics & COVID-19 Working Group Achievements February 2020 – May 2021 WHO reference number © World Health Organization 2021. All rights reserved. This is a draft. The content of this document is not final, and the text may be subject to revisions before publication. The document may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means without the permission of the World Health Organization. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letter
WHO Ethics & COVID-19 Working Group - Achievements Table of Contents 1. Introduction ............................................................................................................... 3 2. Research priorities and questions........................................................................... 4 3. Publications – Overview ........................................................................................... 5 4. Events and Outreach ................................................................................................ 7 5. Advisory Roles ........................................................................................................ 10 6. Sub-Working Groups Established ......................................................................... 11 7. Funded Projects ...................................................................................................... 12 Annex 1. Members of the WHO Ethics & COVID-19 Working Group ...................... 19 Annex 2. Sub-Working Groups Established ............................................................. 20 Annex 3. Publications - Full List ................................................................................ 24 2
WHO Ethics & COVID-19 Working Group - Achievements 1. Introduction The promotion of ethical values such as equity, fairness, and solidarity must be central to COVID- 19 R&D and the broader response to the pandemic. These ideas are ubiquitous in the language used to describe global commitments in research, resource allocation, and measures taken in response to the pandemic, and so it is crucial that meaningful effort is made to examine the ethical commitments entailed by these values and understand what this requires in practice, whether it is in the design and implementation of global clinical trials for COVID-19 therapeutics or the global distribution of vaccines. The Ethics & COVID-19 Working Group aims to examine and produce guidance with respect to the ethical considerations and dimensions associated with COVID-19 R&D and the pandemic response. In particular, the objectives for the Ethics & COVID-19 Working Group are: Objective 1: Build on pre-existing ethics guidance to develop guidance materials fit for purpose in COVID-19 Objective 2: Identify principles for research and their application (SOPs, Solidarity trials, human challenge studies) Objective 3: Develop allocation principles for clinical management, vaccines, diagnostics, & therapeutics Objective 4: Build ethical preparedness for the subsequent waves and future infectious disease threats In order to effectively guide action, the Ethics & COVID-19 Working Group recognizes that it must be responsive to the needs of other R&D Blueprint working groups and technical units at WHO and its regional and country offices. However, ethics plays a critical function in identifying issues of moral concern, and so the Ethics & COVID-19 Working Group must also play a role in setting agendas and highlighting important ethical issues that might otherwise be overlooked. Attention to ethics (and prominent ethical values like equity, fairness, and solidarity) is a shared responsibility across the R&D Blueprint and broader pandemic response. The Ethics & COVID- 19 Working Group is aware that it is not able to provide guidance on every issue of ethical significance. However, by articulating ethical commitments and frameworks, and by establishing guidance applicable to a plurality of issues, the Working Group has aimed to have an expanding sphere of influence that may be applicable to a multitude of areas and issues. The Ethics & COVID-19 Working Group has also frequently revisited its roadmap so as to set priorities in anticipation of evolving needs for ethical guidance. 3
WHO Ethics & COVID-19 Working Group - Achievements Moreover, WHO and Epidemic Ethics (a WHO-led global community of bioethicists providing support to communities, policy makers, researchers, and responders in relation to the ethical issues arising out of global health emergencies, with a current focus on the COVID-19 pandemic) has initiated highly successful calls for proposals to leverage a broader, global network of expertise to research significant ethical issues related to COVID-19, covering topics from surveillance and monitoring to research prioritization and political responsibility. In addition, a successful seminar series hosted by Epidemic Ethics has stimulated a global conversation, fostered cross-disciplinary collaboration, and engaged the ethics, health, and broader scientific community on pressing ethical issues raised by COVID-19. Epidemic Ethics has evolved to become a trusted source for global discussion on ethics and COVID-19. An enduring priority for the Ethics & COVID-19 Working Group is to ensure commitments to key values like equity, fairness, and solidarity are meaningfully reflected in policy and practice. Stated commitments to these values are meaningless if not reflected in practice and the outcomes of R&D and the pandemic response. Similarly, ethical guidance is irrelevant if it does not meaningfully inform and impact the decisions that are made in R&D and pandemic response. This extends far beyond the ethical review of research to the ethical decision-making involved in the prioritization and design of research, the allocation of medical resources, the implementation of public health and social measures, and the ways in which global leaders and communities treat one another as we collectively take steps to end this pandemic. 2. Research priorities and questions Research priorities for 2021 • Unequal access to COVID-19 vaccines: the need for global solidarity and justice • Ethics of vaccination certification/adjusting public health and social measures in light of increasing rates of vaccination • Monitored emergency use of unregistered and investigational interventions (MEURI) / emergency use of unproven interventions outside of research contexts / expanded access (“compassionate use”) / off-label use • Input into ACT Accelerator Ethics & COVID-19 Working Group: vaccine allocation, diagnostics, therapeutics, health system strengthening • Research design and prioritization, and ethical oversight • Ethics and migrant / refugee health • Ethics and the opportunity costs of focusing on COVID-19 • Ethical aspects of managing COVID-19 mutations • Ethical implications of post-COVID-19 conditions (i.e., ‘long COVID’) • Knowledge translation and outreach of Epidemic Ethics research findings 4
WHO Ethics & COVID-19 Working Group - Achievements 3. Publications – Overview The WHO Ethics & COVID-19 Working group has produced a number of publications as WHO guidance documents, in scholarly journals, and in popular media. The following provides a high- level overview of key publications. A full list of over 100 publications produced by the Working Group and its members, organized thematically, can be found in Annex 2. WHO Guidance Documents Title Brief description 1. Ethical Standards for Research during Public Summarizes key universal ethical Health Emergencies: Distilling Existing Guidance standards that should be adhered to to Support COVID-19 R&D (WHO/RFH/20.1) by researchers, review bodies, funders, publishers, and manufacturers during the COVID-19 pandemic. 2. Guidance for Research Ethics Committees for Provides guidance for research ethics Rapid Review of Research During Public Health committees regarding the rapid Emergencies (ISBN 978-92-4-000621-8) review of research during public health emergencies. 3. Key Criteria for the Ethical Acceptability of Provides guidance to scientists, COVID-19 Human Challenge Studies research ethics committees, funders, (WHO-2019-nCoV Ethics_criteria 2020.1) policy-makers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining key criteria that would need to be satisfied in order for such studies to be ethically acceptable. 4. Ethical Considerations to Guide the Use of Digital Provides policy-makers and other Proximity Tracking Technologies for COVID-19 stakeholders with guidance as to the Contact Tracing (WHO/2019- ethical and appropriate use of digital nCoV/Ethics_Contact_tracing_apps/2020.1) proximity tracking technologies for COVID-19. 5
WHO Ethics & COVID-19 Working Group - Achievements 5. Ethics, Resource Allocation and Priority Setting Provides a high-level ethical (WHO/RFH/20.2) framework that can be used to guide decision-making regarding the allocation and priority setting of scarce resources during the pandemic. 6. COVID-19 and Mandatory Vaccination: Ethical Identifies important ethical Considerations and Caveats (WHO/2019- considerations and caveats that nCoV/Policy_brief/Mandatory_vaccination/2021.1) should be explicitly evaluated and discussed through ethical analysis by governments and/or institutional policy-makers who may be considering mandates for COVID-19 vaccination. Selected External Publications by the Working Group Title Publisher 1. Fair Allocation of Scarce Medical Resources in the New England Journal of Medicine Time of Covid-19 2. Publication Ethics During Public Health American Journal of Public Health Emergencies Such as the COVID-19 Pandemic 3. Ethics & SARS-CoV-2 – Restrictive Measures and Epidemic Ethics Physical Distancing 4. Key Ethical Concepts and their Application to Public Health Ethics COVID-19 Research 5. Allocating Scarce Unproven Interventions during American Journal of Bioethics Public Health Emergencies: Insights from the WHO MEURI Framework 6. Ethical Considerations for Accelerating COVID-19 Wellcome Open Research Vaccine Research 7. Top Five Ethical Lessons of COVID-19 that the Wellcome Open Research World Must Learn 6
WHO Ethics & COVID-19 Working Group - Achievements 4. Events and Outreach 19 webinars have been organised and delivered through the Epidemic Ethics Platform. A number of additional presentations have been given across multiples platforms, including at Asia Pacific Network of Ethics Committess (APNEC) regional meetings and Regional and Global Summits of National Ethics Committees. Epidemic Ethics Webinars Title Panelists Why Should Ethics be Front and Centre to the • Katherine Littler (World Health Response to COVID-19. Is it? (April 20, 2020) Organization) • Emily Chan (Chinese University of Hong Kong) • Jerome Singh (University of KwaZulu- Natal) • Ross Upshur (University of Toronto) • Michael Parker (chair) (University of Oxford) COVID-19 Immunity Passports: Inevitable? • Sylvie Briand (World Health Organization) Ethical? (May 4, 2020) • Samia Hurst (University of Geneva) • Voo Teck Chuan (National University of Singapore) • Jeffrey Kahn (chair) (Johns Hopkins University) COVID-19 Human Challenge Studies: Is it OK • Euzebiusz Jamrozik (Monash University) for Research Participants to Volunteer to be • Joshua Morrison (1Day Sooner) Infected? (May 18, 2020) • Seema K. Shah (Northwestern University) • Claudia Emerson (chair) (McMaster University) Digital Technologies and their Ethical • Joseph Ali (Johns Hopkins University) Application during the COVID-19 Pandemic • Effy Vayena (ETH Zürich) (June 1, 2020) • Yi Zeng (Beijing Academy of Artificial Intelligence) • Michael Parker (chair) (University of Oxford) 7
WHO Ethics & COVID-19 Working Group - Achievements Ethics Beyond ‘Good Enough’: How to Engage • John Marshall (University of Toronto) Communities with COVID-19 Research • Noni Mumba (KEMRI-Wellcome Trust Quickly and Effectively (June 15, 2020) Research Programme) • Phaikyeong Cheah (University of Oxford) • Alun Davies (KEMRI-Wellcome Trust Research Program) • Lisa Schwartz (chair) (McMaster University) An Epidemic of Research: Publication Ethics • Ezekiel J. Emanuel (University of during a Public Health Emergency (June 29, Pennsylvania) 2020) • Laragh Gollogly (International Committee of Medical Journal Ethics) • Ross Upshur (chair) (University of Toronto) Ethicists Advising Public Health Authorities: • Alena Buyx (Technical University Munich) Opportunities and Challenges (July 27, 2020) • Florencia Luna (Facultad Latinoamericana de Ciencias Sociales (FLACSO)) • Maxwell J. Smith (Western University) • Michael Parker (chair) (University of Oxford) COVID: A Case for Research Exceptionalism? • Clement Adebamowo (University of (August 10, 2020) Maryland) • Alex John London (Carnegie Mellon University) • Katharine Wright (Nuffield Council on Bioethics) • Ross Upshur (chair) (University of Toronto) Setting Priorities for COVID-19 Vaccine • Anant Bhan (Yenepoya University) Allocation (September 21, 2020) • Ruth Faden (Johns Hopkins University) • Sophie Mathewson (GAVI) • Michael Parker (chair) (University of Oxford) COVID-19 Vaccination in an Era of Vaccine • Maya Goldenberg (University of Guelph) Hesitancy (August 10, 2020) • Heidi Larson (London School of Hygiene and Tropical Medicine) • Charles Shey Wiysonge (South African Medical Research Council) • Katherine Littler (chair) (World Health Organization) 8
WHO Ethics & COVID-19 Working Group - Achievements Ethics of Data Sharing in Health Research • Phaik Yeong Cheah (University of Oxford) (November 2, 2020, hosted jointly with the • Gloria Mason (National Research Ethics Global Forum for Bioethics in Research) Board, Liberia) • Oommen John (The George Institute for Global Health) • Robert Terry (chair) (World Health Organization) Ethics of Adaptive Trial Designs (November • Srinivas Murthy (University of British 16, 2020, hosted jointly with the Global Forum Columbia) for Bioethics in Research) • Fyezah Jehan (Aga Khan University) • Jerome Singh (University of KwaZulu- Natal) • Ross Upshur (chair) (University of Toronto) Ethics of Research in Pregnancy (November • Marian Knight (University of Oxford) 30, 2020, hosted jointly with the Global Forum • Loulou Kobeissi (World Health for Bioethics in Research) Organization) • Sonali Kochhar (University of Washington) • Maggie Little (chair) (Georgetown University) Effective COVID-19 Vaccine(s)? Ethical • Beatriz Thomé (Federal University of São Implications for Vaccine Research in 2021 Paulo) (December 14, 2020) • Joseph Millum (National Institutes of Health) • Dorcas Kamuya (KEMRI-Wellcome Trust Research Programme) • Ross Upshur (chair) (University of Toronto) Mandates and Special Privileges for COVID- • Effy Vayena (ETH Zürich) 19 Vaccination (March 15, 2021) • Jonathan Montgomery (University College London) • Maya Peled-Raz (University of Haifa) • Maxwell J. Smith (chair) (Western University) A Grand Experiment: Ethical Responsibilities • Marc Lipsitch (Harvard University) in the Global Rollout of COVID-19 Vaccines • Dirceu Greco (Federal University of Minas (March 29, 2021) Gerais) • Pearson Nkhoma (Malawi-Liverpool- Wellcome Trust Clinical Research Unit) • Gagandeep Kang (chair) (Christian Medical College) 9
WHO Ethics & COVID-19 Working Group - Achievements Vaccine Diplomacy during the COVID-19 • Annelien Bredenoord (University Medical Pandemic (April 12, 2021) Center Utrecht) • Keymanthri Moodley (Stellenbosch University) • Françoise Baylis (Dalhousie University) • Michael Parker (chair) (University of Oxford) Ethical Considerations in Alternative COVID- • Raji Tajudeen (Africa Centres for Disease 19 Vaccination Strategies: Delayed Second Control and Prevention) Doses, Mixing Vaccines and Partial Doses • Jonathan Wolff (University of Oxford) (April 26, 2021) • Cassandra J. Opikokew Wajuntah (First Nations University of Canada) • Ross Upshur (chair) (University of Toronto) Adapting Ethics Review to the COVID-19 • Maureen Kelley (University of Oxford) Pandemic (May 10, 2021) • Roli Mathur (Indian Council of Medical Research) • Raffaella Ravinetto (Institute of Tropical Medicine) • Carla Saenz (chair) (Pan American Health Organization) 5. Advisory Roles The role of ethics is not simply about knowledge production, where that knowledge is then expected to be applied in various contexts or to different issues. As such, in addition to the guidance provided by the WHO Ethics & COVID-19 Working Group itself, the sphere of influence of its members, in their role as experts in ethics, has extended to numerous governments and other organizations, including: • Asia Pacific Network of Ethics Committees (APNEC) • Australian Health Ethics Committee • Australia’s National COVID-19 Health and Research Advisory Committee • Australian Technical Advisory Group on Immunisation (ATAGI) COVID-19 Vaccine Prioritisation and Implementation sub-committee • Central Ethics Committee on Human Research (CECHR), Indian Council of Medical Research (ICMR) • Central Medical Ethics Committee of Latvia 10
WHO Ethics & COVID-19 Working Group - Achievements • Clinical Ethics Malaysia’s online clinical ethics consultation service for COVID-19 • Council for International Organisations of Medical Sciences • Data Sharing Working Group, COVID-19 Clinical Research Coalition • Ethics Advisory Council, International COVID-19 Data Research Alliance (ICODA) • FLASCO Argentina • France’s COVID-19 Scientific Council • France’s National Consultative Ethics Committee • Indian COVID-19 National Ethics Committee (CoNEC) • Indian Department of Health Research National Registry of Ethics Committees • National Accreditation board for hospitals and Healthcare Providers Committee for Accreditation of Ethics Committees in India • Nepal’s National Ethics Review Board, Nepal Health Research Council, Ministry of Health & Population • UNESCO International Bioethics Committee • Working Group for the development of national recommendations on prioritization of intensive care patients during Covid-19 pandemic in Latvia • Ontario’s COVID-19 Bioethics Table • Ontario’s COVID-19 Vaccine Distribution Task Force • Public Health Agency of Canada Public Health Ethics Consultative Group • South Africa’s COVID-19 Ethics Consultation and Review for the Mediclinic Hospital Group and Tygerberg Hospital • Sydney Clinical Ethics Network • United Kingdom’s Scientific Advisory Group on Emergencies (SAGE) • University of Sydney Faculty of Medicine and Health’s COVID Management Committee • WHO ACT Accelerator Ethics & Governance Working Group • WHO Ethics and Governance of Use of Artificial Intelligence in Health • WHO Western Pacific Regional Office (WPRO) Futures Foresight Think Tank on Ethics and Human Rights viz. COVID- 19 Non-Pharmaceutical Interventions • WHO Working Group to Establish Technical Specifications for a Digital Vaccination Certificate to Support COVID-19 Vaccination 6. Sub-Working Groups Established A number of sub-working groups of the WHO Ethics & COVID-19 Working Group have been established to address particular issues. These working groups and their members are listed in the Annex. 11
WHO Ethics & COVID-19 Working Group - Achievements 7. Funded Projects Epidemic Ethics Projects1 In October 2020, the WHO Health Ethics & Governance Unit issued an international call for research proposals addressing the ethics of COVID-19 public health preparedness and response to support both the work of the Unit and the Epidemic Ethics Network (formerly the Public Health Emegrency Preparedness and Response Ethics Network). Themes of interest mentioned in the call included: • Vulnerabilities & inequalities • Resource allocation • Political responsibilities • Containment approaches • Surveillance & monitoring • Engagement & communication • Health systems • Data & sample sharing • Research prioritisation & oversight Project title Institution Ethics recommendations for data and biological sample University of Kwazulu-Natal use and sharing Casebook of ethical issues in epidemic health research Ethox Centre and Wellcome Centre for Ethics and Humanities, University of Oxford Exploring ethical challenges faced during the COVID-19 Asia School of Business in pandemic in Malaysia collaboration with MIT Sloan Management Why we need public health-focused end-to-end Els Torreele (Individual) governance for epidemic preparedness and response R&D: an ethics and access perspective 1 The Epidemic Eithics initiative is supported by FCDO/Wellcome Grant 214711/Z/18/Z 12
WHO Ethics & COVID-19 Working Group - Achievements Project title Institution Global health justice and equitable vaccine allocation Binghamton University A Review of COVID-19 Regulation: Research Ethics Ana Palmero (Individual) Review and Oversight in Latin America An Investigation of ethical issues in long-term care (LTC) Ethics Quality Improvement Lab, during COVID-19: A Survey of stakeholders in low, middle, William Osler Health System and high income countries Solidarity Model: Community’s Ethical Response for Reach Out Mbuya Community Managing COVID-19 epidemic in Kampala Uganda Health Initiative (ROM) Palliative care in poor resource settings – the ethical Monash University Malaysia questions and challenges faced during a global pandemic COVID-19 and the International Health Regulations: Ethical University of Toronto and Legal Considerations for Travel Restrictions in 2021 and Beyond From Theory to Practice: Integrating Ethics into Scarce Kaiser Foundation Health Plan, Resource Allocation for COVID-19. Inc (Kaiser Permanente), Exploratory Discourse Analysis of Herd-Immunity as a The University of Alberta COVID-19 Management Strategy in Eight Countries: Communication Networks, Misinformation, and Health Literacy ‘The Ethics of Public Health Emergency Preparedness and Australasian College for Response: Experiences and lessons learnt from Emergency Medicine (ACEM) frontline clinicians in low- and middle-income countries in the Indo-Pacific region during the COVID-19 pandemic’ Racing to respond: Race and resource allocation in the University of Oxford COVID-19 pandemic Fostering global conversations around COVID-19 clinical Western University research with ethics committees: exploring the utility of the Nuffield Council’s Ethical Compass in supporting ethics review (GUINEA project) 13
WHO Ethics & COVID-19 Working Group - Achievements Project title Institution Responsibility for Public Health in the Lusophone World: University of Coimbra Institute for Doing Justice in and beyond the COVID Emergency Legal Research The Lived Experience of Participants in COVID-19 Clinical The Botswana Harvard AIDS Studies in Gabarone, Botswana Institute Partnership Developing Recommendations for Ethics Committees and Astana Medical University, Nur- Policy Guidance for Eastern European / Central Asian Sultan, Kazakhstan Countries to Support Public Health Emergency Preparedness and Response Ethical challenges and considerations in the rationing of Jimma University health commodities and provision of high-risk clinical services in resource-limited settings: Adjusting conventional pillars of medical ethics to guide services during COVID-19 pandemic Strengthening the ethics review capacities in the University of Kinshasa, Kinshasa; Democratic Republic of Congo, with a focus on Institute of Tropical Medicine preparedness for research conducted in the context of (ITM), Antwerp; & National Ethics outbreaks and other public health emergencies Committee, Kinshasa Community Appraisal for COVID-19 Vaccine Allocation Uganda National Academy of Ethical Principles in Uganda and Kenya (CACVAEP) Sciences. Who Gets the Last Ventilator? Disability, Discrimination Miami University and Distributing Resources Pandinference: How do values and evidence interact with Dalla Lana School of Public policy discourse in the SARS-CoV-2/ COVID-19 pandemic Health, University of Toronto Decolonizing COVID-19 vaccine distribution through a SeeChange Initiative CommunityFirst approach: prioritizing vulnerable and isolated communities Development of Clinical Ethics Framework (CEF): A Global Institute for participatory approach to deliver evidence based ethical Interdisciplinary Studies (GIIS) guideline for COVID19 care 14
WHO Ethics & COVID-19 Working Group - Achievements Project title Institution Assessing health system readiness/preparedness and The University of Zambia ethical concerns in implementation of COVID-19 interventions in Zambia Citizens’ perceptions on moral issues in the COVID-19 Vrije Universiteit Amsterdam crisis in The Netherlands and Indonesia Clinical use of unproven interventions outside of research NYU Grossman School of during a public health emergency: Ethical issues and policy Medicine guidance Situating Communities at the Centre of Shaping a Mary Kasule (Individual) Sustainable Ethical Response to COVID-19: a Case of Botswana International migrants in quarantine facilities in Chile during Instituto de Ciencias e Innovación the COVID-19 pandemic: towards an ethical response to en Medicina, Facultad de deeply rooted challenges Medicina, Clínica Alemana – Universidad del Desarrollo Challenges to Global Equitable COVID-19 Vaccine Access University of Zurich through the COVAX Facility Community Responses to COVID-19 restrictions and Amref International University Containment Measures in Kenya To strengthen the utility of ethical guidance for Marc DuBois (Individual) humanitarian aid agencies responding to public health outbreak emergencies such as COVID-19 Comparative Analysis of the Digitalization of Public Health Faculty of Law, The University of Interventions in India and China Hong Kong Strengthening research ethics governance and regulatory Julio Canario (individual) oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic The Ethics of Public Health Emergency Preparedness and University of Augsburg Response: Migrant Workers’ Health and Covid-19 15
WHO Ethics & COVID-19 Working Group - Achievements Project title Institution Do No Harm Framework for Future Quarantine or Fordham University Institute for Lockdown Consideration in Public Health Emergencies International Humanitarian Affairs Ethical, social, cultural, and human rights (ESCHR) Pawfect Nation and University of implications of subjecting individuals to mandatory KwaZulu-Natal, Durban vaccination with COVID-19 candidate vaccines issued under WHO or local Emergency Use Listing (EUL) regulatory mechanisms Other funded Projects2 Project Title Institution Public perception of surveillance and certification strategies National University of Singapore for safe movement and travel during COVID-19 COVID-19 and digital contact tracing: moving the ethical ETH Zurich debate forward The ethical dimensions of collecting and using geolocation Johns Hopkins Berman Institute data during infectious disease outbreaks: Learning from of Bioethics COVID-19 An Ethical Framework for COVID-19 Vaccine Allocation in Western University Canada Ethics of emergency use of unproven intervention outside BioThera Research Institute for research (MEURI) Philosophy of Translational Medicine How have South African Research Ethics Committees Stellenbosch University coped with reviewing health research during the COVID-19 pandemic? 2 These projects were funded by the German Federal Ministry of Health (BMG) through the COVID-19 Research and development funding. https://www.who.int/news-room/articles-detail/call-for-proposals-ethics-support-for-COVID-19 16
WHO Ethics & COVID-19 Working Group - Achievements Project Title Institution Experiences of Malawian REC members in reviewing Malawi University of Science and research protocols during the COVID 19 pandemic Technology Assessment of the effects of COVID-19 Pandemic on Kenya Medical Research Research Regulation: The Case of the Scientific and Ethics Institute Review Unit, Kenya Medical Research Institute CERC. Health System Responses and Ethical Challenges to the University of Zambia Health Needs of Refugees: The Case of COVID-19 pandemic in Zambia Ethical and social issues for COVID-19 vaccine access in Makerere University Uganda Ethics and uncertainties in accelerated COVID-19 vaccine University of Oxford pathways Adapting national research review process during Covid- Shifa Tameer-e-Millat University 19: Reviewers’ perspectives from Pakistan Clinical Ethics Consultations in Covid-19. Current and University of Erlangen- future Challenges Nuremberg PubliCo – an experimental online platform for COVID-19 University of Zurich related public perception Ethics review mutual recognition and multinational Vasiliki Rahimzadeh (Individual) research collaboration in pandemic response settings COVID-19: Ethics, Computing, and Resource Allocation University of Miami and A Global Capacity-Building Project Strengthening health data access for health systems University of Oxford, Mahidol resilience and evidence informed policy for COVID-19 Oxford Tropical Medicine response (SHARE) Research Unit (MORU) Data sharing practices in the context of COVID-19 The George Institute for Global Health, UNSW, India 17
WHO Ethics & COVID-19 Working Group - Achievements Project Title Institution Towards harmonization of data sharing information Infectious Disease Data requirements in ICTRP registries. An analysis of trials for Observatory, University of diseases with the potential for public health epidemics Oxford & including Covid-19 trials. South African Medical Research Council. What capacity is needed for researchers to share and Mahidol Oxford Tropical reuse data? A training needs assessment through online Medicine Research Unit, workshops to determine existing gaps in knowledge and University of Oxford skills among researchers in LMICs, to effectively share and use COVID-19 research data Rapid systematic reviews to explore broad consent in Heidelberg University relation to sharing of clinical data in the context of the Covid-19 pandemic Examining the role of evolving evidence in pandemic University of Washington decision-making Ethical issues arising from vaccine development and Eric Meslin & Jim Lavery evaluation (Individuals) 18
WHO Ethics & COVID-19 Working Group - Achievements Annex 1. Members of the WHO Ethics & COVID-19 Working Group Beatriz Thomé (co-chair) Federal University of São Paulo PAHO Ross Upshur (co-chair) University of Toronto PAHO Aasim Ahmad The Kidney Centre, Karachi EMRO Thalia Arawi American University of Beirut EMRO Oumou Bah Sow Comité National d’Ethique pour la AFRO Recherche en Santé (CNERS) Angus Dawson University of Sydney WPRO Jean-François Delfraissy French National Bioethics Committee EURO Ezekiel J. Emanuel University of Pennsylvania PAHO Tina Garanis-Papadatos University of West Attica EURO Prakash Ghimire National Ethics Review Board, Kathmandu SEARO Zubairu Iliyasu National Health Research Ethics AFRO Committee, Abuja Sharon Kaur University of Malaya WPRO Ruipeng Lei Huazhong University of Science and WPRO Technology Ignacio Mastroleo Facultad Latinoamericana de Ciencias PAHO Sociales (FLACSO) Roli Mathur Indian Council of Medical Research SEARO Signe Mezinska University of Latvia EURO Keymanthri Moodley Stellenbosch University AFRO Kaori Muto University of Tokyo WPRO Michael Parker University of Oxford EURO Maxwell J. Smith (rapporteur) Western University PAHO Teck Chuan Voo National University of Singapore WPRO Xiaomei Zhai Peking Union Medical College WPRO 19
WHO Ethics & COVID-19 Working Group - Achievements Annex 2. Sub-Working Groups Established Digital Health and COVID-19 Ross Upshur University of Toronto Beatriz Thomé Universidade Federal de Sao Paulo Jerome Singh University of KwaZulu-Natal Tze-Yun Leong National University of Singapore Yi Zeng Chinese Academy of Sciences Najeeb Al-Shorbaji eHealth Development Association Effy Vayena, (chair) ETH Zürich Maxwell J. Smith Western University Timo Minssen University of Copenhagen Michael Parker University of Oxford Rasha Abdul Rahim Amnesty International Maria Paz Canales Derechos Digitales Jeroen van den Hoven Delft University of Technology Ezekeil J. Emanuel University of Pennsylvania Partha Majumder National Institute of Biomedical Genomics Public Health and Migration Talia Arawi American University of Beirut Ann Burton UNHCR Lisa Eckenwiler George Mason University Deborah Zion Victoria University Kristine Onarheim University of Bergen Gabrielle Berman UNICEF Kol Wickramage IOM Philippines Miriam Orcutt Lancet Migrant Health Commission 20
WHO Ethics & COVID-19 Working Group - Achievements WHO regional observers: Carla Saenz PAHO Camilla Plinori Tasnim Azim SEARO Lin Aung Pem Namgyal Joseph Okeibunor AFRO Ernest Dabire Jozef Bartovic EURO Darryl Barret WPRO Kira Fortune Isabel Espinosa WHO Katherine Littler Health Ethics & Governance Unit Liz Mumford Rifat Hossain People’s Health Movement Human Challenge Studies Susan Bull University of Oxford Claudia Emerson McMaster University Euzebiusz Jamrozik Monash University Gagandeep Kang Christian Medical College Melissa Kapulu KEMRI-Wellcome Trust Research Programme Elena Ray Universidad Icesi Michael Selgelid Monash University Seema Shah Northwestern University Peter G. Smith London School of Hygiene and Tropical Medicine Ross Upshur University of Toronto Charles Weijer Western University 21
WHO Ethics & COVID-19 Working Group - Achievements Katherine Littler WHO Lee-Anne Pascoe Carla Saenz PAHO Immunity Certificates Juan P. Beca Universidad del Desarrollo Ezekiel J. Emanuel University of Pennsylvania Nina Gobat University of Oxford Calvin W.L. Ho University of Hong Kong Samia Hurst University of Geneva Nancy Kass Johns Hopkins University Cassandra Kelly-Cirino Foundation for Innovative New Diagnostics Ruipeng Lei Huazhong University of Science and Technology Sody Munsaka University of Zambia Michael Parker University of Oxford Maxwell J. Smith Western University Clarence C. Tam National University of Singapore Beatriz Thomé Federal University of São Paulo Ross Upshur University of Toronto Voo Teck Chuan National University of Singapore Katherine Littler WHO Andreas Reis WHO 22
WHO Ethics & COVID-19 Working Group - Achievements Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI) Ross Upshur University of Toronto Beatriz Thomé Federal University of São Paulo Ignacio Mastroleo Facultad Latinoamericana de Ciencias Sociales (FLACSO), National Scientific and Technical Research Council (CONICET), Argentina Voo Teck Chuan National University of Singapore Tina Garani-Papadatos University of West Attica Roli Mathur Indian Council of Medical Research Aasim Ahmad The Kidney Centre, Karachi Maxwell J. Smith Western University Keymanthri Moodley Stellenbosch University Stéphanie Dagron University of Geneva Arthur Caplan New York University Lembit Rägo Council for International Organizations of Medical Sciences (CIOMS) Agnes Sagfors Imperial College London Phiippe Calain (observer) Médecins Sans Frontières Yaseen Arabi King Abdullah International Medical Research Center John Marshall University of Toronto Dereck Angus University of Pittsburgh Neill Adhikari University of Toronto Le Van Tan Hospital for Tropical Diseases, Vietnam Srinivas Murthy University of British Columbia Steve Webb Monash University Virginie Pirard Institut Pasteur Marie Valentin WHO Katherine Littler Andreas Reis Carla Saenz PAHO 23
WHO Ethics & COVID-19 Working Group - Achievements Annex 3. Publications - Full List Research Ethics (general) Carracedo, S., Palmero, A., Neil, M., Hasan-Granier, A., Saenz, C., & Reveiz, L. (2020). The landscape of COVID-19 clinical trials in Latin America and the Caribbean: assessment and challenges. Revista Panamericana de Salud Pública, 44, 1. https://doi.org/10.26633/RPSP.2020.177 Dal-Ré, R., LG Bekker, Gluud, C., Holm, S., Jha, V., Poland, G., et al. (forthcoming). Ongoing and Future Covid-19 Vaccine Clinical Trials: Challenges and Opportunities. The Lancet Infectious Diseases. Dawson, A., Emanuel, E. J., Parker, M., Smith, M. J., & Voo, T. C. (2020). Key Ethical Concepts and Their Application to COVID-19 Research. Public Health Ethics, 13(2), 127–132. https://doi.org/10.1093/phe/phaa017 Emanuel, E. J., & Boyle, C. W. (2021). Assessment of Length and Readability of Informed Consent Documents for COVID-19 Vaccine Trials. JAMA Network Open, 4(4), e2110843. https://doi.org/10.1001/jamanetworkopen.2021.10843 Indian Council of Medical Research. (2020a). National Guidelines for Ethics Committees Reviewing Biomedical & Health Research During COVID-19 Pandemic. https://ethics.ncdirindia.org/asset/pdf/EC_Guidance_COVID19.pdf Indian Council of Medical Research. (2020b). SOP Template for Ethics Review of Biomedical and Health Research During COVID-19 Pandemic. https://ethics.ncdirindia.org/asset/pdf/EC_Guidance_COVID19.pdf Ghimire, N., Hamal, P. K., Panthee, A., Vaidya, A., Khadka, M., Mahato, N. K., et al. (2021). Ethical Characteristics of Research Proposals Related to COVID-19 Pandemic in Nepal: A Retrospective Review. Journal of Nepal Health Research Council, 19(1), 148–153. https://doi.org/10.33314/jnhrc.v19i1.3373 Kaur, S. (in progress). Issues and challenges associated with data sharing in COVID-19 research: exploring the experiences of Malaysian researchers. Mathur, R. (2020a). Ethics preparedness for infectious disease outbreaks research in India: A case for novel coronavirus disease 2019. The Indian Journal of Medical Research, 151(2–3), 124–131. https://doi.org/10.4103/ijmr.IJMR_463_20 Moodley, K., Allwood, B. W., & Rossouw, T. M. (2020). Consent for critical care research after death from COVID-19: Arguments for a waiver. South African Medical Journal, 110(7), 629–634. https://doi.org/10.7196/SAMJ.2020.v110i7.14918 Pan American Health Organization. (2020a). Considerations for Regulatory Oversight of Clinical Trials in the COVID-19 Pandemic. https://iris.paho.org/handle/10665.2/52266 Pan American Health Organization. (2020c). Guidance and strategies to streamline ethics review and oversight of COVID-19-related research. https://iris.paho.org/handle/10665.2/52089 24
WHO Ethics & COVID-19 Working Group - Achievements Pan American Health Organization. (2020d). Guidance for Ethics Oversight of COVID-19 Research in Response to Emerging Evidence. https://iris.paho.org/handle/10665.2/53021 Pan American Health Organization. (2020e). How Can Research Transparency Be Promoted? Actions for National Health Authorities During the COVID-19 Pandemic. https://iris.paho.org/handle/10665.2/52768 Pan American Health Organization. (2020f). Template and operational guidance for the ethics review and oversight of COVID-19-related research. https://iris.paho.org/handle/10665.2/52086 Moodley, K. (2020). Research imperialism resurfaces in South Africa in the midst of the COVID- 19 pandemic - this time, via a digital portal. South African Medical Journal = Suid- Afrikaanse Tydskrif Vir Geneeskunde, 110(11), 1068–1069. Moodley, K., & Rossouw, T. South African COVID-19 vaccine trials hold key lessons for future partnerships. The Conversation. http://theconversation.com/south-african-covid-19- vaccine-trials-hold-key-lessons-for-future-partnerships-154676. Accessed 5 May 2021 Schveitzer, M. C., & Thome, B. da C. (2021). Research ethics and resource allocation in times of covid-19. Revista Bioética, 29(1). https://revistabioetica.cfm.org.br/index.php/revista_bioetica/article/view/2761. Accessed 5 May 2021 Smith, M. J. (2020a). A COVID-19 vaccine is needed as soon as possible – how can this be accomplished in the most ethical way possible? Epidemic Ethics. https://epidemicethics.tghn.org/community/blogs/post/258785/2020/09/a-covid-19- vaccine-is-needed-as-soon-as-possib/. Accessed 4 May 2021 Smith, M. J., Emanuel, E. J., Thomé, B., & Upshur, R. E. G. (2020). Ethical conditions for accelerating COVID-19 vaccine research. Wellcome Open Research, 5, 249. https://doi.org/10.12688/wellcomeopenres.16361.1 World Health Organization. (2020b). Ethical standards for research during public health emergencies: distilling existing guidance to support COVID-19 R&D. https://apps.who.int/iris/handle/10665/331507. Accessed 4 May 2021 World Health Organization. (2020c). Guidance for research ethics committees for rapid review of research during public health emergencies. https://www.who.int/publications/i/item/9789240006218. Accessed 4 May 2021 Wright, K., & Parker, M. (2020). In emergencies, health research must go beyond public engagement toward a true partnership with those affected. Nature Medicine, 26(3), 308– 309. https://doi.org/10.1038/s41591-020-0758-y Human Challenge Studies Jamrozik, E., Littler, K., Bull, S., Emerson, C., Kang, G., Kapulu, M., et al. (2021). Key criteria for the ethical acceptability of COVID-19 human challenge studies: Report of a WHO Working Group. Vaccine, 39(4), 633–640. https://doi.org/10.1016/j.vaccine.2020.10.075 25
WHO Ethics & COVID-19 Working Group - Achievements Moodley, K., Maasdorp, E., & Rennie, S. (2021). Could human challenge studies for COVID-19 vaccines be justified in South Africa? South African Medical Journal, Online first. http://www.samj.org.za/index.php/samj/article/view/13241. Accessed 5 May 2021 Schaefer, G. O., Tam, C. C., Savulescu, J., & Voo, T. C. (2020). COVID-19 vaccine development: Time to consider SARS-CoV-2 challenge studies? Vaccine, 38(33), 5085– 5088. https://doi.org/10.1016/j.vaccine.2020.06.007 World Health Organization, Working Group for Guidance on Human Challenge Studies in COVID-19. (2020). Key criteria for the ethical acceptability of COVID-19 human challenge studies. Geneva, Switzerland: World Health Organization. https://apps.who.int/iris/bitstream/handle/10665/331976/WHO-2019-nCoV- Ethics_criteria-2020.1-eng.pdf Vaccine Trial Unblinding and Placebo Controls Ahmad, A., & Dhrolia, M. F. (2021). “No” to placebo-controlled trials of Covid-19 vaccines. Indian Journal of Medical Ethics, 6(2), 100–102. https://doi.org/10.20529/IJME.2021.019 Singh, J. A., Kochhar, S., Wolff, J., & WHO ACT-Accelerator Ethics & Governance Working Group. (2021). Placebo use and unblinding in COVID-19 vaccine trials: recommendations of a WHO Expert Working Group. Nature Medicine, 27(4), 569–570. https://doi.org/10.1038/s41591-021-01299-5 Singh, J. A., & Upshur, R. E. G. (2021). The granting of emergency use designation to COVID- 19 candidate vaccines: implications for COVID-19 vaccine trials. The Lancet. Infectious Diseases, 21(4), e103–e109. https://doi.org/10.1016/S1473-3099(20)30923-3 World Health Organization, ACT Accelerator Ethics & Governance Working Group. Emergency use designation of COVID-19 candidate vaccines: ethical considerations for current and future COVID-19 placebo-controlled vaccine trials and trial unblinding. Geneva, Switzerland. https://www.who.int/publications-detail-redirect/emergency-use-designation- of-covid-19-candidate-vaccines-ethical-considerations-for-current-and-future-covid-19- placebo-controlled-vaccine-trials-and-trial-unblinding. Accessed 4 May 2021 Public Health and Social Measures Moodley, K., Obasa, A. E., & London, L. (2020). Isolation and quarantine in South Africa during COVID-19: Draconian measures or proportional response? South African Medical Journal = Suid-Afrikaanse Tydskrif Vir Geneeskunde, 110(6), 456–457. https://doi.org/10.7196/SAMJ.2020v110i6.14842 Obasa, A. E., Singh, S., Chivunze, E., Burgess, T., Masiye, F., Mtande, T., et al. (2020). Comparative strategic approaches to COVID-19 in Africa: Balancing public interest with civil liberties. South African Medical Journal, 110(9), 858–863. https://doi.org/10.7196/SAMJ.2020.v110i9.14934 26
WHO Ethics & COVID-19 Working Group - Achievements Silva, D. S., & Smith, M. J. (2020). Social distancing, social justice, and risk during the COVID- 19 pandemic. Canadian Journal of Public Health, 111(4), 459–461. https://doi.org/10.17269/s41997-020-00354-x Smith, M. J. (2020c). Failure to combat COVID-19 can have economic consequences, too. Impact Ethics. https://impactethics.ca/2020/12/08/failure-to-combat-covid-19-can-have- economic-consequences-too/. Accessed 4 May 2021 Thomé, B. C., Matta, G. C., & Rego, S. T. A. (2020). Ethical Considerations for Restrictive and Physical Distancing Measures in Brazil During COVID-19: Facilitators and Barriers. Journal of Bioethical Inquiry, 17(4), 627–631. https://doi.org/10.1007/s11673-020-10023- w Voo, T. C., Ballantyne, A., Jenn, N. C., Cowling, B. J., Xiao, J., Chang, P. K., et al. (2021). Public perception of ethical issues related to COVID-19 control measures in Singapore, Hong Kong, and Malaysia: A cross-sectional survey. medRxiv, 2021.03.01.21252710. https://doi.org/10.1101/2021.03.01.21252710 World Emergency COVID19 Pandemic Ethics (WeCope) Committee. (2020d). Statement on individual autonomy and social responsibility within a public health emergency. https://www.eubios.info/yahoo_site_admin/assets/docs/WeCopeStatementAutonomyand Responsibility.199134724.pdf World Emergency COVID19 Pandemic Ethics (WeCope) Committee. (2020e). Wearing Masks and Face Covers as Social Responsibility during COVID-19 pandemic. https://www.eubios.info/yahoo_site_admin/assets/docs/WECOPEStatement_on_Public_ Use_of_Masks.151164039.pdf Voo, T. C., & Kaur, S. (2020). Understanding public perception of digital contact tracing, monitoring devices and vaccination measures for international travel: An online survey (Funded Research Project). WHO Rapid Funding to support the work of the WHO Global Health Ethics & Governance Unit on Ethics & COVID-19. World Health Organization. (2020a). Ethical considerations to guide the use of digital proximity tracking technologies for COVID-19 contact tracing. https://www.who.int/publications- detail-redirect/WHO-2019-nCoV-Ethics_Contact_tracing_apps-2020.1. Accessed 4 May 2021 World Health Organization Working Group on Ethics & SARS-CoV-2. (2020). Ethics & SARS- CoV-2 - Restrictive Measures and Physical Distancing. Geneva, Switzerland: World Health Organization. https://media.tghn.org/articles/Ethics__COVID- 19__Restrictive_Measures_-_Apr_14.pdf Allocation of Scarce Clinical Resources Antiel, R. M., Curlin, F. A., Persad, G., White, D. B., Zhang, C., Glickman, A., et al. (2020). Should Pediatric Patients Be Prioritized When Rationing Life-Saving Treatments During COVID-19 Pandemic. Pediatrics, 146(3). https://doi.org/10.1542/peds.2020-012542 27
WHO Ethics & COVID-19 Working Group - Achievements Emanuel, E. J., Persad, G., Upshur, R., Thome, B., Parker, M., Glickman, A., et al. (2020). Fair Allocation of Scarce Medical Resources in the Time of Covid-19. The New England Journal of Medicine, 382(21), 2049–2055. https://doi.org/10.1056/NEJMsb2005114 Hassan, B., & Arawi, T. (2020). The Care for Non-COVID-19 Patients: A Matter of Choice or Moral Obligation? Frontiers in Medicine, 7, 564038. https://doi.org/10.3389/fmed.2020.564038 López, E. R., Abal, F., Rekers, R., Holzer, F., Melamed, I., Salmún, D., et al. (2020). Propuesta para la elaboración de un protocolo de triaje en el contexto de la pandemia de COVID- 19. Revista de Bioética y Derecho, 0(50), 37–61. https://doi.org/10.1344/rbd2020.50.31816 Moodley, K. Tough choices about who gets ICU access: the ethical principles guiding South Africa. The Conversation. http://theconversation.com/tough-choices-about-who-gets-icu- access-the-ethical-principles-guiding-south-africa-135227. Accessed 5 May 2021 Moodley, K., Ravez, L., Obasa, A. E., Mwinga, A., Jaoko, W., Makindu, D., et al. (2020). What Could “Fair Allocation” during the Covid-19 Crisis Possibly Mean in Sub-Saharan Africa? Hastings Center Report, 50(3), 33–35. https://doi.org/10.1002/hast.1129 Moodley, K., Rennie, S., Behets, F., Obasa, A. E., Yemesi, R., Ravez, L., et al. (2021). Allocation of scarce resources in Africa during COVID-19: Utility and justice for the bottom of the pyramid? Developing World Bioethics, 21(1), 36–43. https://doi.org/10.1111/dewb.12280 Organización Panamericana de la Salud. Orientación ética para el uso de recursos limitados en los servicios críticos de salud durante la pandemia de COVID-19. https://iris.paho.org/handle/10665.2/52092 Satomi, E., Souza, P. M. R. de, Thomé, B. da C., Reingenheim, C., Werebe, E., Troster, E. J., et al. (2020). Fair allocation of scarce medical resources during COVID-19 pandemic: ethical considerations. Einstein (Sao Paulo)., 18. https://doi.org/10.31744/einstein_journal/2020AE5775 Singh, J. A., & Moodley, K. (2020). Critical care triaging in the shadow of COVID-19: Ethics considerations. South African Medical Journal, 110(5), 355–359. https://doi.org/10.7196/SAMJ.2020.v110i5.14778 World Emergency COVID19 Pandemic Ethics (WeCope) Committee. (2020c). Statement on Ethical Triage Guidelines for COVID-19. https://www.eubios.info/yahoo_site_admin/assets/docs/WECOPETriage_Statement_for_ COVID.151172039.pdf World Health Organization, Working Group on Ethics and COVID-19. (2020a). Coronavirus disease (COVID-19): Ethics, resource allocation and priority setting. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/question-and- answers-hub/coronavirus-disease-covid-19-ethics-resource-allocation-and-priority- setting. Accessed 4 May 2021 28
WHO Ethics & COVID-19 Working Group - Achievements Monitored emergency use of unregistered & investigational interventions (MEURI) / emergency use of unproven internvetions outside research context / expanded access (“compassionate use”) / off-label use Caplan, A. L., & Upshur, R. (2020). Panic prescribing has become omnipresent during the COVID-19 pandemic. The Journal of Clinical Investigation, 130(6), 2752–2753. https://doi.org/10.1172/JCI139562 Goyal, P. K., Mathur, R., & Medhi, B. (2020). Understanding the challenges and ethical aspects of compassionate use of drugs in emergency situations. Indian Journal of Pharmacology, 52(3), 163–171. https://doi.org/10.4103/ijp.IJP_665_20 Mastroleo, I. (2021a). Cómo defenderse cuando un médico ofrece un fármaco no probado contra el COVID-19. /salud/2021/01/31/como-defenderse-cuando-un-medico-ofrece-un- farmaco-no-probado-contra-el-covid-19/. Accessed 5 May 2021 Mastroleo, I. (2021b). Final report on ethics of emergency use of unproven intervention outside research (MEURI) during COVID-19 pandemic: literature review & a case study of inhalable ibuprofen from Argentina. WHO Health Ethics & Governance Unit on Ethics & COVID-19. Mastroleo, I. (2021c). The Role of ethics committees in emergency use of unproven interventions outside research. In E. Valdes & J. A. Lecaros (Eds.), Handbook of Bioethical Decisions (Vol. 2). New York: Springer. Mastroleo, I., & Holzer, F. (2020). New non-validated practice: an enhanced definition of innovative practice for medicine. Law, Innovation and Technology, 12(2), 318–346. https://doi.org/10.1080/17579961.2020.1815405 Mastroleo, I., Smith, M. J., & The WHO MEURI Working Group (2020). Allocating Scarce Unproven Interventions during Public Health Emergencies: Insights from the WHO MEURI Framework. The American Journal of Bioethics, 20(9), 41–44. https://doi.org/10.1080/15265161.2020.1795539 Pan American Health Organization (PAHO). (2020a). Emergency use of unproven interventions outside of research: ethics guidance for the COVID-19 pandemic. https://covid19- evidence.paho.org/handle/20.500.12663/1189 Pan American Health Organization (PAHO). (2020b). PAHO Does Not Recommend Taking Products that Contain Chlorine Dioxide, Sodium Chlorite, Sodium Hypochlorite, or Derivatives, 16 July 2020. Pan American Health Organization. https://iris.paho.org/handle/10665.2/52515 Saenz, C. (2021). Broadening the Scope of Moral Responsibility of Clinicians: What Medical Ethics Can Learn from Public Health Ethics. The American Journal of Bioethics, 21(1), 17–19. https://doi.org/10.1080/15265161.2020.1845871 World Health Organization, MEURI Working Group. (in progress). Emergency use of unproven clinical interventions outside research: ethical considerations. Policy document. 29
WHO Ethics & COVID-19 Working Group - Achievements World Health Organization (WHO). (2020a, March 31). Off-label use of medicines for COVID-19. https://www.who.int/news-room/commentaries/detail/off-label-use-of-medicines-for- covid-19. WHO reference number: WHO/2019-nCoV/Sci_Brief/Off-label_use/2020.1 World Health Organization (WHO). (2020b). Bacille Calmette-Guérin (BCG) vaccination and COVID-19. World Health Organization. https://www.who.int/news- room/commentaries/detail/bacille-calmette-guérin-(bcg)-vaccination-and-covid-19 World Health Organization (WHO). (2020c). Guidance on maintaining a safe and adequate blood supply during the coronavirus disease 2019 (COVID-19) pandemic and on the collection of COVID-19 convalescent plasma: Interim guidance, 10 July 2020. https://apps.who.int/iris/handle/10665/333182 Migrant Health Arawi, T. (2020c, March 21). Forgetting “refugees” during COVID-19. Beirut Today. https://beirut-today.com/2020/03/21/forgetting-refugees-during-covid19/. Accessed 4 May 2021 Arawi, T., Hatab, T., & Mikati, D. (2020). COVID-19 and Refugees’ Status of Permanent “Out-of- Placeness”: A Necropolitical Neoliberal Construct. In I. Laher (Ed.), Handbook of Healthcare in the Arab World (pp. 1–22). Cham: Springer International Publishing. https://doi.org/10.1007/978-3-319-74365-3_222-1 Clinical Care Bekelman, J. E., Emanuel, E. J., & Navathe, A. S. (2020). Outpatient Treatment at Home for Medicare Beneficiaries During and After the COVID-19 Pandemic. JAMA, 324(1), 21–22. https://doi.org/10.1001/jama.2020.9017 GE2P2 Global Foundation. COVID Vaccine. The Informed Choice/Consent/Right-to-Refuse Imperative. http://www.ge2p2.org/the-informed-choice/consent/right-to-refuse-imperative. Accessed 4 May 2021 Kaur, S. (in progress). Ethical Challenges in Clinical Practice during the COVID-19 pandemic in Malaysia. Mathur, R. (2020b). ICMR Consensus Guidelines on “Do Not Attempt Resuscitation.” The National Medical Journal of India, 33(2), 107–112. https://doi.org/10.4103/0970- 258X.284970 Voo, T. C., Lederman, Z., & Kaur, S. (2020). Patient Isolation during Infectious Disease Outbreaks: Arguments for Physical Family Presence. Public Health Ethics, 13(2), 133– 142. https://doi.org/10.1093/phe/phaa024 Voo, T. C., Senguttuvan, M., & Tam, C. C. (2020). Family Presence for Patients and Separated Relatives During COVID-19: Physical, Virtual, and Surrogate. Journal of Bioethical Inquiry, 17(4), 767–772. https://doi.org/10.1007/s11673-020-10009-8 Vaccine Distribution, Prioritization, and Access 30
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