Project: Ethics equivalence in multi-country ethics submissions in resource-limited settings
Research ethics committees (RECs) review proceeds largely on an institution-by-institution basis in most low- and middle-income countries (LMICs), a model which has shown to be both inefficient and costly for collaborative multi-site research. The current pandemic exemplifies this. The sudden and dramatic increase in COVID-19-related protocols requires multiple RECs to review the same study as researchers try to collaborate across institutional and international borders. Duplicative reviews as a result of procedural inefficiency strain limited human and material resources in LMICs, and they delay time-sensitive research efforts that could guide pandemic management – without measurably improving participant protections.
Several national and international approaches have been proposed for a system of mutual recognition of ethics review, but none specific to research during pandemics nor in LMICs, specifically. There is therefore a pressing need to explore whether, and how, ethics approval could be harmonized among LMICs to accelerate rigorous Covid-19 research.
In this Covid-19 Clinical Research Coalition project we aim to:
- Describe the current opportunities for, and obstacles to, ethics review equivalency by synthesizing the current empirical and grey literature;
- Identify how COVID-19 researchers and RECs currently approach multi-site ethics review through hosting regional consultative meetings; and
- Develop priority areas, propose tools, and practical strategies for operationalizing ethics review equivalency for COVID research in LMICs.
Please contact Dr Vasiliki Rahimzadeh to learn more about the project, share your insights, and participate in regional discussions.
Written by working group members linked to or informed by coalition efforts.
- COVID-19 vaccine trials with children: ethics pointers BMJ Global Health 2022
by , Ambe JR, de Vries J.
Selected and recommended by the working group
Browse all resources selected by the coalition’s topic-specific groups
If you would like to submit a query to the Ethics working group, please send us an email.
Working group members
Jennyfer Ambe has a keen interest in Emerging Infectious Diseases, health security and bioethics. She supports education and training in sub-Saharan Africa and uses a socio-cultural lens to build health equity. She is with the Safe Mother and Childhood Research Initiative (SAMOCRI) in Nigeria and supports Project 1808 in Sierra Leone and Youth Empowerment (#YE254) in Kenya. Her current research is focused on challenges surrounding maternal and reproductive health as well as, pregnant women and clinical trials.
Affiliations: E.D., Safe Mother and Childhood Research Initiative (SAMOCRI), Nigeria.
Caesar Atuire is a philosopher and bioethicist based at the Department of Philosophy and Classics in the University of Ghana, Legon. He is a Visiting Fellow of All Souls College, Oxford University. He is also a member of the lead team of the NYU-UG Training Programme in Research Ethics and a founding member of the Ghana Research Ethics Consortium. In 2019, Dr Atuire co-edited the volume Bioethics in Africa: theories and praxis. He is a member of the Planning Committee of the Global Forum on Bioethics in Research, 2020. Atuire’s philosophical research interests and publications are on the African and global sources of normative thinking. He has carried out research on the frameworks informing attitudes towards mental disorder and suicide in Ghana. Outside academia, Atuire leads an NGO that delivers healthcare to persons in marginalized rural communities in the coastal areas of Ghana.
Clinical researcher interested in ethics, improved research systems and capacity building.
Prof. Cheah holds an Erasmus Mundus Masters in Bioethics and PhD in Pharmaceutics. She is a Professor at Oxford University and head of Bioethics & Engagement at the Bangkok based Mahidol Oxford Tropical Medicine Research Unit. Her research focuses on the ethics of research in low- and middle-income settings, data sharing, and the intersection between ethics and community engagement. She is a member of the Steering Committee of Global Forum for Bioethics in Research. She is currently leading an international survey and qualitative study on the social and ethical aspects of public measures in COVID-19.
Cheryl Macpherson, PhD is Professor of Bioethics in the Department of Clinical Skills at St George’s University School of Medicine in Grenada, Senior Research Fellow in the Windward Islands Research and Education Foundation (WINDREF), and Principle Investigator on the NIH-Fogarty-funded Caribbean Research Ethics Education initiative (CREEi) to design and offer a regionally relevant masters degree curriculum for building research ethics capacity in low and middle income countries of the Caribbean basin. She is Past President of the Bioethics Society of the English-speaking Caribbean (BSEC); has consulted for PAHO and WHO on ethics of vector-borne diseases; aand edited the book Bioethical Insights into Values and Policy: Climate Change and Health (Springer Press, 2016). Her recent publications include Energy, Emissions, and Public Health Ethics in the Oxford Handbook of Public Health Ethics (2019) and Research ethics guidelines and moral obligations to developing countries: Capacity‐building and benefits (Bioethics, 2019).
Leonardo D. De Castro, PhD, is a professorial lecturer at the Department of Philosophy, University of the Philippines, Diliman, where he previously served as Department Chair and Centennial Professor. He chairs the Philippine Health Research Ethics Board, a national body that sets policies and regulates research ethics committees in the country. He sits on the National Ethics Committee. He has served on the National Bioethics Advisory Committee and the National Transplant Ethics Committee. He was Senior Research Fellow at the Center for Biomedical Ethics, National University of Singapore and Editor-in-Chief of the Asian Bioethics Review. He also was President of the Asian Bioethics Association, Vice-Chair of the UNESCO International Bioethics Committee, Vice-Chair of the Forum for Ethics Review Committees in Asia and the Pacific, and a Bioethics Consultant to the United Nations, the World Health Organization, the European Union and the European Commission. He represented the Philippines in the UNESCO Inter-Governmental Bioethics Committee. His research interests include research ethics, responsible conduct of research, bioethics teaching, organ transplantation, healthcare worker migration and resource allocation.
Jantina de Vries is an Associate Professor in Bioethics at the Department of Medicine of the University of Cape Town. Her work focuses on developing ethical best practice for genomics research in Africa. She has contributed to developing an evidence base for best practice in informed consent for African genomics research, investigating ethical challenges relating to the sharing of African samples and data, exploring what constitutes fairness in African genomics research collaborations, and studying how genomic research may impact on stigma relating to disease. A second and equally important output relates to the translation of her work into forward-looking policies and best practice guidelines.Jantina obtained her DPhil through The Ethox Centre at the University of Oxford (2011), and an MSc degree in sociology at Wageningen University (2003). She was at the European University Institute between 2003-2004. She is a member of the WHO Expert Advisory Board on Gene Editing.
Dr. Shymaa Enany is an associate professor of Microbiology, Suez Canal University, Egypt. She received her PhD from School of Medical Sciences, Niigata University, Japan. Her postdoc was in USA and Japan. She was the first Arab scientist applying microbial proteomic techniques helping in revealing good markers for bacteria spreading in community.
She received many awards for her scientific contributions. Recently, she awarded the most prestigious award in Egypt; the state encouragement prize for women in the field of health and pharmaceutical sciences, 2019. Also, she was awarded The World Academy of Sciences (TWAS) Young Arab Scientist Prize 2018 for Scientific Achievement in Medical Sciences. She was selected as a member of Egyptian Young Academy of Science, an evaluator on Academy of Scientific Research and Technology, a reviewer in International Exhibition of Innovation, and an affiliate of The World Academy of Sciences.
Dr Shymaa is also one of scientific committee of World Forum for Women in Science, a selected young leader in STS and WSF, a member in the global Open Science Group, and a collaborator in Global Burden of Disease.
She is one of Microbiology National Committee working for achieving sustainable development goals for a better future. She was appointed as an Egyptian ambassador in Next Einstein Forum (NEF), which showcase the global contribution and potential of scientists from Africa that enabling Africa to get onto the global scientific stage. Latterly, she is selected as an African science leadership program fellow.
Virology, Immunology & Diagnostics
Dr Melanie Etti is a clinical research fellow in paediatric infectious diseases and microbiology and is based in Kampala, Uganda. She is currently working under the supervision of the MNCH Working Group co-chair, Professor Kirsty Le Doare, on a large, Bill & Melinda Gates Foundation-funded study, which is focused towards reducing the incidence of Group B Streptococcal disease among neonates in Uganda. Following the emergence of the COVID-19 pandemic, she worked to set up periCOVID Africa. This international, multi-site study aims to understand the sero-epidemiology of SARS-CoV-2 among the pregnant population in five Sub-Saharan African countries (The Gambia, Kenya, Malawi, Mozambique and Uganda). Her research interests include the development and evaluation of targeted and population-based strategies for infectious disease prevention and control, particularly in resource-limited settings.
She joined the COVID-19 Clinical Research Coalition’s Ethics Working Group as an observer.
Maternal, Newborn & Child Health
Thirty-two years of service under the Ministry of Health Bangladesh in different capacities: Assistant Surgeon, Chittagong Medical College Hospital 1978 – 1979 and Successively Consultant Medicine, Cox’s Bazar District Hospital and Chittagong Medical College Hospital 1982 – 1988; Assistant Professor Medicine, Institute of Post Graduate Medicine and Research Dhaka 1988 – 1993; Associate Professor and Professor of Medicine, Chittagong Medical College 1993 – 2003; Professor and Head of Medicine, Principal, Dhaka Medical College and Dean, Faculty of Medicine, University of Dhaka, Director General of Health Services (DGHS, Govt. of Bangladesh) 2008 – 2009; Professor and Head of Medicine, Sir Salimullah Medical College & Mitford Hospital 2009 – 2010.
Rita Giacaman is a professor of public health at the Institute of Community and Public Health, Birzeit University, occupied Palestinian territory. She has chronicled the effects of Israeli military occupation on the life and health of Palestinians under occupation. Since 2000, she has been focusing on the impact of chronic war-like conditions and exposure to violence on the health and well-being of Palestinians, with an emphasis on psychosocial health among adolescents and young people; and the development of measures to assess health and well-being in conditions of protracted violence. She has published extensively locally and internationally. Rita was awarded an Honorary PhD from LSE in 2011 for having made an “outstanding contribution to the increased understanding or appreciation of ‘the causes of things’…” She was also awarded the International Fellow of the Society for Research on Adolescence title in 2018 for her ‘internationally and culturally sensitive approach to the understanding of adolescence worldwide’, and an Honorary Doctor of Science degree (honoris causa) from King’s College London, for her work which ‘has set a standard for the provision of health care in war and post-war contexts in the Middle East and globally,’ in 2019.
Nkwan Jacob is a nurse working with the Cameroon Baptist Convention Health Services, in Cameroon. He has 19 years of experience in infection prevention and control (IPC) as well as in water, sanitation, and hygiene (WASH). He served as the pioneer IPC/WASH nurse and chair of the IPC committee of Banso Baptist Hospital (BBH) from 2002 to 2007, and then as IPC supervisor and chair of the Cameroon Baptist Convention Health Services CBCHS) IPC committee from 2011 to 2019.
As the lead IPC nurse, he conceived and implemented several IPC/WASH projects that raised IPC/WASH practices in BBH and other facilities of the Cameroon Baptist Convention Health Services to acceptable standards. The introduction of local ABHR production and improvement in hand hygiene practices in general led to the successful elimination of neonatal sepsis in the maternity unit of BBH in 2006. ABHR, now used in all the health facilities of the CBCHS, has contributed significantly to improved hand hygiene practices in all the facilities of the CBC Health Services.
Nkwan Jacob and his team have received several national and international awards including the third IFIC sponsorship award in 2004, OXIOID infection control team of the year in 2006, CBCHS cleanest hospital award in 2006, APIC International Ambassador Award in 2018 as well as the SHEA Hero of Infection Control in 2019.
He is a current member of several IPC and professional associations including:
• Infection Prevention and Control Association of Cameroon
• Infection Control African Network (ICAN)
• Infection Prevention and Control Association (IPAC) of Canada
• Association of Professional in Infection Control and Epidemiology (APIC)
• Society for Health Care Epidemiology of America (SHEA)
• Cameroon Bioethics Association (CAMBIN)
• Cameroon Nurses Association (CNA)
Nkwan Jacob has a bachelor’s degree in Nursing Sciences from the University of Buea and a master’s degree in Public Health (MPH) from the University of Roehampton. He is currently doing a post graduate course in infection prevention and control with the University of Radboud, Netherlands. He has published several articles.
Maternal, Newborn & Child Health
Dorcas Kamuya is the Head of Health Systems and Research Ethics (HSRE) Department at the KEMRI-Wellcome Trust Research Programme in Kenya. She holds a Wellcome-Trust funded fellowship that aims to examine ethical and social-cultural issues on complex ethical topics, with bio-banking as a case study. Her research interests span several interrelated areas including developing ethical frameworks for Controlled Human Infection Studies in LMIC; the value of community and public engagement in health research, and ethical dilemmas for frontline research workers.
Patricia Kingori is a Wellcome Senior Investigator at the Wellcome Centre for Ethics and Humanities (WEH) at the University of Oxford. Patricia is sociologist and her research has focused on ethical issues in the practice of global health. She has spent most of her career researching and documenting the ethical dilemmas of fieldworkers and frontline workers such as nurses and doctors in research, clinical and humanitarian settings including more recently the ethical issues which emerge after the conduct of Ebola clinical trials in West Africa. She has had held a number of advisory positions related to the ethical issues involved in research including the Nuffield Council of Bioethics Research in Global Health Emergencies Expert Working Group, Safeguarding Expert Advisory Group (UKCDR) and more recently the Expert Group on an Ethical Framework for COVID-19 testing for NHS workers lead by the THIS institute, University of Cambridge.
Shai Linn – Full Professor, University of Haifa, Israel.Physician and epidemiologist. Two medical specialties: Public Health and Health Management. Received an M.D. degree from Hebrew University, MPH, and Dr PH both from Harvard University in Boston, Massachusetts, USA.Deputy Medical Director of the Rambam Hospital (1982-1985), head of the medical record committee at the Rambam Medical Center (1982-1989, 1992-1998), head of the Unit of Epidemiology (1993-2010) at the Rambam Medical Center and head of medical informatics at the Faculty of Medicine of the Technion in various capacities. Served as a Visiting Scientist at the U.S. National Institutes of Health in Bethesda, Maryland (USA). Received a grant from the well known MacArthur Foundation, Social Science Research Council for studying the human cost of war injuries (1990-1992). Visiting Professor at the University of North Carolina, USA (1986) and the University of British Columbia, Canada (1990-1992). Consultant at the U.S. National Center for Health Statistics in Maryland, USA (1985-1986) and to the World Bank (1998) and the AIDS Center in Vancouver, British Columbia, Canada (2000). Epidemiologist of the Israel Transplant Center (1999). Was a member of several Israel National Medical Councils. Founder and Chair of the Department of Epidemiology at the Technion (1992-1999). Founder and Chair of the Department of Public Health at the University of Haifa (2003-2007). Dean of the Faculty for Social Welfare and Health Sciences at the University of Haifa (2010-2016). Published extensively in leading journals, an instructor of 67 students for higher degrees.
Vicki Marsh is an Associate Professor in Public Health at the Centre for Tropical Medicine and Global Health (CTMGH), Oxford University, UK and the KEMRI Wellcome Trust Research Programme (KWTRP) in Kenya. Both roles involve research, teaching, mentorship and Science and Ethics Governance. Her research draws on empirical ethics approaches towards strengthening policy and practice in international health research. Originally trained in medicine and General Practice, Vicki’s early research on Malaria Home Care informed the Kenya National Malaria Control Programme and the WHO/TDR Roll Back Malaria strategy.
Faith Mary Musvipwa obtained a PhD in Sociology from the University of Venda in 2020. She did a one-year pre-doctoral fellowship at the University of Virginia (UVA) at the Centre for Global Health in 2017. Faith has a Master of Arts in Sociology degree and Honors in Sociology degree and an undergraduate B.A Social Sciences degree from the University of Limpopo. She has more than 6 years of experience working on different research projects for both national and international organizations.
Sofía P. Salas is a Chilean medical doctor, appointed as Full Professor (Senior stage of the career) at the Center of Bioethics, Faculty of Medicine, Clínica Alemana- Universidad del Desarrollo (Santiago, Chile; https://medicina.udd.cl/centro-bioetica/). Since 1994 she has participated as member of the local IRB at the Faculty of Medicine Universidad Católica (up to 2009), at Universidad Diego Portales (2013 to March 2018), and since 2018 at the Faculty of Medicine, Universidad del Desarrollo. She teaches research ethics at pre and postgraduate levels and also conducts bioethics research on different topics. During 2014, Dr Salas was awarded a training Program in Research Ethics at FLACSO, Argentina, a program supported by Fogarty International Center from the NIH. She is a member of the Ethics Department of the Chilean Medical Association (Colegio Médico de Chile) and Chair of the National Commission for Research Ethics, an advisory Commission for the Chilean Ministry of Health in research ethics. In December 2018 she was awarded the “Premio de Ética” by the Chilean Medical Association for her work “Conscientious objectors in Chilean medical education”. She has published extensively both locally and internationally related to bioethics research.
Maternal, Newborn & Child Health
Paulina Tindana, MHSc, DPhil, is a Senior Lecturer and Bioethicist at the Department of Health Policy, Planning and Management, School of Public Health University of Ghana. Previously, she worked at the Navrongo Health Research Centre in Northern Ghana as a Deputy Chief Health Research Officer. Her work focuses on the ethical, social, cultural, and policy implications of biomedical research including genetics and genomics studies. She has been an active member of the H3Africa Consortium since 2013 and chaired the Community Engagement Working Group between 2015 to 2018. She is also involved in research ethics capacity building initiatives for researchers and members of research ethics committees in Africa.
Wangari Waweru-Siika is an assistant professor of anaesthesia and critical care at the Aga Khan University (AKU) Nairobi. She has been a member of the AKU Institutional Ethics Review Committee (IERC) since 2017 and was appointed Chair in 2019. As an early career researcher, her research interests are quality of care in low and middle-income countries, with a focus on identifying cost-effective interventions that guarantee good outcomes among the critically ill in low resource settings. She is a member of the COVID Research Coordination Committee at the Aga Khan University, Principal Investigator (PI) for a research project assessing the care and outcomes of critically ill COVID-infected patients in Kenya and co-investigator on a COVID convalescent plasma trial at AKU. She is currently a part-time DPhil student in Evidence-Based Healthcare at the University of Oxford.
Katharine is a freelance ethics consultant, specialising in the field of global health ethics. She has over thirty years of experience working at the intersection of ethics, law and policy, including over fifteen years at the UK-based Nuffield Council on Bioethics where she directed a number of projects concerned with the ethical inclusion of research participants traditionally classed as ‘vulnerable’. These included major inquiries exploring the ethical conduct of research with children (2015), and the challenge of conducting research ethically in the context of global health emergencies (2020). She now works with a number of partners, including the WHO and the Multi-Regional Clinical Trials Center.