SERCEA

The challenge

An increasing number of clinical trials are being carried out in sub-Saharan Africa, and in East Africa in particular. The complexity of these trials is also increasing, with new and innovative trial designs being adopted. 

Governance of clinical studies is the shared responsibility of ethics review committees and regulatory authorities. Many efforts are being made, including through Global Health EDCTP3-funded projects, to build the capacity of these bodies to address new challenges. 

However, it is also important that clinical researchers and members of ethics review committees and regulatory authorities have a shared understanding of what constitutes ethical and appropriate practice in clinical research, and of the general principles that should underpin the design of clinical studies and researcher practice. Currently, there is a lack of national and regional guidelines and codes of conduct covering scientific integrity.

The project

The SERCEA project is addressing this gap and also carrying out a range of activities to strengthen the infrastructure for ensuring commitment to and compliance with such codes of conduct and ethical frameworks.

It has a specific focus on:

• Developing a regional research ethics and integrity framework, based on a landscaping exercise and consultation. Key sites will be supported to develop research integrity liaison offices.
• Establishing an open data access framework and trial data platform, to encourage and facilitate the sharing of data from clinical trials.
• Creating an e-learning platform focused on good research regulatory practice, based on a course developed by the EDCTP2-funded CREDU project, which is being used in multiple countries in the region.
• Establishing research ethics committees at regional hospitals, to strengthen ethics review capacity across the country, ensure alignment with the national research ethics committee, and, in particular, to enhance safety monitoring of clinical trials.

To promote consistency in approach, the project team will liaise with key regional bodies, including the African Regulatory Forum (AVAREF) and the East African Health Research Commission (EAHRC), a coordinating structure for health-related research issues across multiple East African countries.

Impact

The SERCEA project is creating a foundation for further strengthening of ethics review and regulatory practice in East Africa. It will:

• Raise awareness of the importance of scientific integrity and create a shared understanding of the obligations of clinical researchers.
• Strengthen mechanisms for monitoring adherence to core principles of scientific integrity and ethical conduct of research.
• Ensure consistent standards are applied across multiple East African countries.
• Promote and facilitate open data practices and transparency. 

Through these efforts, the project will help to embed a culture of commitment to scientific integrity, enhance ethics review and regulatory capacity, and strengthen safeguards protecting research participants, all of which will act to sustain public trust in clinical research.