Published: 24-06-2024 15:37 | Updated: 24-06-2024 15:37

Strengthening research ethics in clinical trials in Rwanda

Group picture two rows.
Bioethics Training for Clinical Research Stakeholders under BREEDIME Project. Photo: Breedime Project.

Considering the urgent need to address emerging health crises, the Rwanda Food and Drug Authority (FDA) has intensified efforts to strengthen regulatory activities, particularly in the area of clinical trial monitoring. The Rwanda FDA has collaborated with regional and international partners on important partnerships aimed at building capacity for clinical research and promoting ethical conduct.

These efforts were reflected in the recent implementation of the BREEDIME project funded by the European Union through the European and Developing Countries Clinical Trials Partnership (EDCTP). Professor Eleni Aklillu at Karolinska Institutet coordinates the project with a respected group of researchers from Tanzania Medicine and Drugs Authority, Rwanda FDA and other institutions, aiming at strengthening policy implementation in clinical trials.

As part of the BREEDIME project, Rwanda FDA and Kilimanjaro Clinical Research Institute (KCRI) in Tanzania, conducted a comprehensive training program for stakeholders on clinical research design, April 22-26. This training program is produced especially in the implementation of the project. KCRI was tasked with adapting a brief bioethics course specifically designed to meet the needs of the Rwandan clinical research environment.

Rwanda Food and Drug Authority.
Rwanda Food and Drug Authority. Photo: Breedime Project.

The main aim of the training was to equip participants in clinical trials with the necessary competencies in research ethics to adhere to ethical principles and legal framework. Notably, Rwandan FDA staff played a key role in coordinating and facilitating several training sessions, using their expertise to contribute to theoretical training and scenarios, which enabled participants to explore different situations and strengthen theoretical skills, and equip them with skills to apply strategies that ensure ethical principles are upheld in real-world situations.

The training attracted a team of around 20 stakeholders involved in the implementation and supervision of clinical trials in Rwanda, including university teaching hospitals, district hospitals under Ministry of Health, Rwanda Biomedical Centre which is the implementing agency of the Ministry of Health, contract research organisations, Rwanda National Research Ethics Committee and staff from the institutional review boards, Rwanda FDA staff involved in monitoring clinical trials and trainers from KCRI - Tanzania including Prof. Blandina Mmbaga, Ms Beatrice Temba, Mr Lazaro Haule, Ms Irene Evance, Dr. Hadidja Semvua. 

By enhancing collaboration in clinical research and enhancing ethical standards, programs such as this training program are critical to achieving the integrity and quality of clinical research implementation and health care delivery development in Rwanda and beyond.