Secret
Summary
There is an increase in the number of clinical trials conducted in Sub-Saharan Africa (SSA), which has not been matched with an increase in regulatory support and ethical review for such studies. The gaps that exist include: few Research Ethics Committees (RECs) with the capacity to review and provide oversight for clinical trials in the region and a lack of national accreditation systems that guarantee the quality of review by these RECs.
The SECRET project seeks to address these challenges by:
Establishing national research ethics committees accreditation systems
Building the capacity of research ethics committees to review clinical trials
Establishing national clinical trials registries linked to the Pan African Clinical trial registry,
Developing digital protocol submission systems in Uganda and Ethiopia
Objectives
To support the accreditation of research ethics committees in Ethiopia: We propose to establish a system of national accreditation for RECs in Ethiopia. The system will establish quality standards that guide the operations of the RECs in the respective countries.
To equip RECs with skills and knowledge to review and provide oversight of clinical trials: We will develop a methodology to equip RECs in the partner countries with the capacity to review clinical trials, and we will strengthen the capacity of selected RECs.
To link NRECs to Pan African Clinical Trials Registry to foster research integrity and registration of clinical trials: We propose to link the UNCST registry with PACTR, which is a critical step towards enhancing research integrity and transparency in Africa. This linkage will make registration of clinical trials much easier and more accessible to local investigators who conduct clinical trials that are not multi-country.
To establish and improve utilisation of digital technologies in the submission and review of clinical trials: There is a need to develop a digital submission system for Ethiopia and support the increased uptake and adoption of the NRIMS in Uganda. The system in Ethiopia will be designed in such a way that it allows for the offline development of documents, which can later be uploaded into the system.
Project
Boosting Ethics Committee Accreditation and Creation of National Clinical Trial Registry
Period
July 2024 – June 2027
Contact (ITM)
Raffaella Ravinetto
ITM Principal Investigator
✉ rravinetto@itg.be
Carine Dochez
Researcher
✉ cdochez@itg.be
Partners
Work packages (WP)
(1) Accreditation and improved functionality of RECs
WP1 will be led by Uganda National Council for Science and Technology and include partners from Ethiopia and Belgium, including SPHMMC, NRERB and ITM.
Leader
Winfred Nazziwa (UNCST)
✉ winnfry@gmail.com
(2) Improved clinical trial review and oversight
WP2 will be led by NDA and supported by Makerere University. Other participants will be UNHRO, SPHMMC, NRERB and ITM.
Leader
Hellen Ndagije (NDA)
✉ hndagije@nda.or.ug
(3) National registry and linkage to PACTR
WP4 will be led by SAMRC-PACTR. UNCST will be a partner.
Leader
Duduzile Ndandwe (SAMRC/PACTR)
✉ duduzile.Ndwandwe@mrc.ac.za
(4) Use of digital technologies
WP3 will be led by SPHMMC and supported by Nuvoteq. Other partners will be UNCST and NRERB. In Uganda, UNCST will support the increased utilisation of the already available digital submission system.
Leader
Ewenat Gebrehanna (SPHMMC)
✉ gewenat@gmail.com
(5) Scientific leadership
WP5 is responsible for the overall implementation of the project, providing scientific leadership and oversight to the partners. It will be led by UNHRO, who will work closely with ITM to implement the activities of this work package.
Leader
Bernard Kikaire (Makere University)
✉ bkikaire@uvri.go.ug
(6) Project coordination and management
WP6 will be led by ITM with close support from UNHRO. All partners will be involved in this WP, which oversees the coordination of activities, reporting obligations to EDCTP, and all the management structures of the project.
Leader
Raffaella Ravinetto (ITM)
✉ rravinetto@itg.be
Project team
Raffaella Ravinetto
Institute of Tropical Medicine (Belgium)
Raffaella Ravinetto is a public health pharmacist with thirty years of experience in commercial and non-commercial clinical research, humanitarian programmes, pharmaceutical policies, and research ethics review. She is Head of the Department of Public Health and a professor in Pharmaceutical Public Health at the Institute of Tropical Medicine (ITM) in Antwerp. She is also the chairperson of the ITM Institutional Review Board; the chairperson of the Ethics Review Board of the international charity Doctors Without Borders (2017-2024); an extraordinary professor at the School of Public Health, University of the Western Cape, Cape Town, South Africa; a former senior editor of the BMC Medical Ethics; and an ethics advisor to different research programmes.
Bernard Kikaire
Makere University (Uganda)
Bernard Kikaire is a medical doctor who trained at Makerere University and holds an MSc in Epidemiology from London School of Hygiene & Tropical Medicine (UK) and a PhD in HIV Nutrition and Immunology from Trinity College Dublin. With over 18 years of clinical research experience in HIV, he has broadened his focus to include emerging and re-emerging diseases, such as COVID-19. He is the project manager of the ALERRT and PANDORA projects and principal investigator of AccessAfrica I & II at UVRI. The AccessAfrica projects were dedicated to strengthening research ethics capacity across Sub-Saharan Africa. AccessAfrica I enhanced ethical and regulatory frameworks for post-trial access to investigational medicinal products, while AccessAfrica II advanced joint review processes and improved pharmacovigilance in clinical research.
Telahun Teka Wolde
Ministry of Education (Ethiopia)
Telahun Teka Wolde is an academic, teacher, researcher, and pediatrician with thirty years of experience in undergraduate and postgraduate training. His main research and teaching areas include infectious diseases, clinical nutrition, and vaccination. Based at the Ministry of Education, he plays a leading role in the EDCTP-funded AccessAfrica projects. He is a key independent ethics advisor and has conducted and participated in numerous research projects, including clinical trials, epidemiological studies, operational research, and programme assessments. He is the chairperson and a member of the National Research Ethics Review Board at the Ministry of Education and has also contributed significantly to the development of national guidelines for childhood illnesses and research ethics.
Adriaan Kruger
Nuvoteq (South Africa)
Adriaan Kruger is a blind optimist and serial entrepreneur who leads by example. He has more than 20 years of experience in ideating, building, growing (and sometimes breaking) companies – a failure/crisis is never wasted. His passion revolves around digitising the clinical research and public health space surrounded and supported by the gifted colleagues around him which he calls his friends. He’s the co-founder and leader of a group of committed and remarkably talented people at nuvoteQ and Scigenix. Their mission is to make a positive impact in the world of clinical research, and help inspire others to join the cause!
Duduzile Ndwandwe
South African Medical Research Council (South Africa)
Duduzile Ndwandwe is a distinguished professional with a PhD in Molecular Mycobacteriology from the University of the Witwatersrand. Currently serving as a Specialist Scientist at Cochrane South Africa, within the South African Medical Research Council (SAMRC), she leads vaccine implementation research and clinical trial registration projects. Her research in vaccinology and public health has been published in numerous high-impact, peer-reviewed journals. Actively engaged in national and international scientific committees, she contributes critical insights that guide global public health policies and research. She is a member of the GloPID-R Data Sharing Working Group and the National Advisory Group on Immunisation. Her leadership and expertise are further demonstrated by her involvement in various boards, including serving as the Board Chair for Eh! Woza and participating in advisory and working groups focused on infectious diseases and clinical trials.
Helen Byomire Ndagije
National Drug Authority (Uganda)
Helen Byomire Ndagije is a distinguished pharmaco-epidemiologist with over two decades of experience in medicines regulation and clinical research. Holding a PhD in Public Health from the Université Catholique de Louvain, Belgium, she has significantly enhanced pharmacovigilance and regulatory systems across Africa. As the President of the Africa Chapter of the International Society of Pharmacovigilance (ISoP) and Director of Product Safety at the National Drug Authority, her leadership and commitment have been pivotal in promoting regulatory reliance, developing comprehensive guidelines, and implementing robust pharmacovigilance programmes. Through her contributions to the African Vaccine Regulatory Forum (AVAREF), she has fostered collaboration and mutual trust among regulatory authorities, streamlining processes and enhancing efficiency. Her work with AVAREF and the WHO Global Benchmarking Tool assessments underscores her dedication to strengthening regulatory frameworks and ensuring the safety and efficacy of pharmaceutical products in Sub-Saharan Africa.
Winfred Nazziwa
Uganda National Council For Science and Technology (Uganda)
Winfred Nazziwa heads the Research Compliance and Quality Assurance Unit at Uganda National Council For Science and Technology (UNCST). Generally, her work involves a range of human research participants’ protection programmes. She has more than 10 years of experience in research oversight and protection of research participants. Over the years, she has contributed to the establishment of a coherent system for the conduct of research and advancement of research ethics in Uganda. Winfred has championed the implementation of two EDCTP-funded projects (CREDU & CCRREEA) as the Principal Investigator and two EDCTP projects (AccessAfrica & SCIEN-U) as a Co – Investigator. She is a member of the Technical Coordinating Committee of the WHO- African Vaccine Regulatory Forum (AVAREF) Network. Also, serves on the National HIV/AIDS Research Committee (NARC) as a REC/IRB member. Currently pursuing a PhD in Bioethics, her research interests are around the ethics of controlled human infection studies in low-resource settings.
Funding
This project (101145783) is supported by the Global Health EDCTP3 Joint Undertaking and its members.
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