Working group objectives
- Support investigators with ethics questions in the development, review and/or validation of study protocols, informed consent forms, and other documents for COVID-19 studies.
- Provide inputs to support wider ethics capacity building in the context of COVID-19 studies.
Working group members
- Cleo Albertus (Working Group Coordinator) – University of Cape Town, South Africa
- Jennyfer Ambe – Capella University, USA
- Caesar Atuire – University of Ghana, Ghana
- Anant Bhan – Kasturba Medical College, India
- Elizabeth Bukusi – KEMRI, Kenya
- Phaik Yeong Cheah – Mahidol Oxford Tropical Medicine Research Unit, University of Oxford, Thailand
- Francis Crawley – Good Clinical Practice Alliance – Europe (GCPA) & Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), Belgium
- Leonardo de Castro – University of the Philippines, Philippines
- Jantina de Vries (Working Group Co-chair) – University of Cape Town, South Africa
- Deborah Dinez – University of Brasilia, Brazil
- Sarah Edwards – University College London, UK
- Shymaa Enany – Suez Canal University, Egypt
- Rita H Giacaman – Birzeit University, Palestine
- Anastasia Guantai – University of Nairobi, Kenya
- Dorcas Kamuya – KEMRI WELLCOME Trust Programme, Kenya
- Patricia Kingori – Ethox Centre, University of Oxford, UK
- Shai Linn – University of Haifa, Israel
- Katherine Littler (Working Group Observer) – WHO, Switzerland
- Vicki Marsh (Working Group Co-chair) – KEMRI WELLCOME Trust Programme, UK
- Cheryl Cox Macpherson – St. George’s University School of Medicine, Grenada
- Elysee Nouvet – Western University, Canada
- Ricardo Palacios – Instituto Butantan, Brazil
- Michael Parker – Ethox Centre, University of Oxford, UK
- Sofia Salas – Universidad del Desarollo, Chile
- Paulina Tindana – University of Ghana, Ghana
- Aissatou Toure – Pasteur Institute Dakar, Senegal
- Wangari Waweru Siika – Aga Khan University Hospital, Kenya
- Katharine Wright – Nuffield Council on Bioethics, UK
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.