– The main goal of AccessAfrica2 is to improve ethical review and regulatory capacity for clinical trials in two Sub-Saharan Africa countries, with specific focus on the review and oversight of reported adverse events during clinical trials, Rosemarie de La Cruz Bernabe, professor at the Centre for Medical Ethics (CME), says.
– I am looking forward to what the AccessAfrica2 project can do, she continues.
The research project “AccessAfrica2 – Strengthening Clinical Trial Regulatory and Ethical Review Oversight in East Africa” receives 600.000 Euros in support from Horizon Europe, through the European and Developing Countries Clinical Trials Partnership (EDCTP3) programme.
The project will be coordinated from Centre for Medical Ethics (CME) at the University of Oslo, with Professor Rosemarie de La Cruz Bernabe as the project leader, and UiO as the main project coordinator.
The project aims to improve efficiencies of the national regulatory authorities (NRAs) and national ethics committees (NECs) and equip them with skills and knowledge for improved operations during outbreaks and epidemics. The goal is to strengthen the foundation for regulators and ethics committees in Sub-Saharan Africa.
– Today there is a dependency on clinical trials and a lot of ethical issues. The ethics committees should be equipped to handle ethical issues that arise, Bernabe explains.
– Post-clinical trials in Africa are increasing, with more private corporate sponsors entering Africa. The capacity of the ethics committees should be at par with that. Today it is not, she continues.
The AccessAfrica2 consortium will consist of six partners
The AccessAfrica2 research consortium will consist of six partners: The University of Oslo (UiO), Uganda National Health Research Organisation/ Uganda Virus Research Institute (UNHRO/UVRI), Jimma University, Uganda National Council of Science and Technology, the National Drug Authority of Uganda, and the Ethiopian national research ethics committee.
– The AccessAfrica2-project will be ongoing for three years, but we have yet to specify the start date for the project, Bernabe says.
The project builds upon the existing research project AccessAfrica (uio.no), also coordinated from UiO. AccessAfrica is an EDCTP2-funded project, that aims to improve regulation and ethical review for post-trial access of investigative medicinal products clinical trials in Africa.
– The AccessAfrica2-project includes several partners from the AccessAfrica-project, but will be focusing on improving the capacity of the national regulatory authority and ethics committees in Uganda and Ethiopia, Bernabe explains.
– You can say that AccessAfrica2 is a prequel to the AccessAfrica project, aiming to strengthen collaboration between regulators and ethics oversight committees in East Africa, she continues.
AccessAfrica2 aims to bring regulators and ethics committee members together
Through joint effort the AccessAfrica2 research consortium will work towards strengthening knowledge among members of ethics committees by giving them training. They will also pioneer a joint effort to bring regulators and ethics committees together.
– In this way regulators and ethics committees will be forced to talk. One of the weaknesses in Africa, and in the world today, is lack of communication between regulators and ethics committees, Bernabe explains.
– When someone flags something as problematic, the other is not listening. This creates an avenue for errors to happen, Bernabe concludes.