Access Africa presented the project during a plenary session on Ethics in public health care, at the 5th Ethiopia-Norway Health and Higher Education Conference in Addis Ababa, Ethiopia in June 2022. The goal of the session was to discuss achievements, effects and lessons from COVID-19, perspectives, gaps in competence, strengthen accountability, and identify research gaps. Access Africa is an EDCTP-funded project coordinated by Prof. Rosemarie Bernabe from the Center for Medical Ethics. The project aims to explore and provide guidance in Sub-Saharan Africa on integrating post-clinical trial access arrangements (PTA) among the tasks and responsibilities of clinical trial stakeholders, including regulators and ethics committees.
The session was moderated by Prof. Rosemarie de La Cruz Bernabe with Dr. Ewanat Gebrehanna as rapporteur, assistant professor of Public Health and Reproductive Health at the School of public health department of St. Paul's Hospital Millennium Medical College.
Access Africa presenting research on PTA in Africa
The session started with a status update from the Access Africa project on Post-Trial Access (PTA) in Ethiopia and Sub-Saharan Africa, by Dr. Martha Zewdie from the Armauer Hansen Research Institute (AHR), Yemisrach Zewdie Seralenge from AHRI, Dr. Ewanat Gebrehanna of St. Paul Hospital, and Diribe Makonene from Jimma University. The researchers found that clear description of PTA was lacking in protocols and on trial registration sites and that clinical trial regulators/ethics committee members would benefit from PTA training.
Yemisrach Zewdie from AHRI presented the results of her related research entitled, “Composition and capacity of Institutional Review Boards, and challenges experienced by members in ethics review processes in Addis Ababa, Ethiopia: An exploratory qualitative study”. The study is based on interviews with IRB members in Addis Ababa, Ethiopia. The study showed that the member’s challenges were lack of training, competing tasks, need for rapid review and approval by study investigators, and investigators not submitting required documentation for ethics approval.
Presenting the study “Access Africa and ethics regulations in the future” Dr. Telahun Teka calls for future awareness creation and policy formulations with key partners in research and clinical trials, community engagement, active participation in policy formulations and legislations, and updating National Ethics Review Guidelines to include PTA.
Lastly, Diribe Makonene Kumsa, Assistant Professor at Jimma University presented the results so far of work package 3 which focuses on stakeholder inputs on PTA arrangements for Sub-Saharan Africa. Confirming the results of earlier presentations, the presentation stressed the need for increased understanding on the knowledge and experiences of arranging PTA.