Strong ethics and regulatory oversight of clinical trials is essential to protect the interests and health of participants and to maintain public confidence in research. National regulatory authorities (NRAs) need to approve clinical studies involving investigational products and use of registered products for potential label extension or different disease indications. Moreover, NRAs need to coordinate with the institutional and national ethics review committees that evaluate the ethical aspects of research studies.

By the end of 2019, EDCTP had awarded 31 grants to support the development of regulatory and ethics review capacity in 27 countries in sub-Saharan Africa. Projects have focused on training and skills development of regulatory agency staff and members of ethics review committees, enhancing coordination between national agencies, and improving processes, including the introduction of electronic systems for managing clinical research proposals.

Despite significant progress made in these areas, many countries in sub-Saharan Africa have critical capacity gaps in their ethics and regulatory bodies. This is an issue of ever-growing importance, as the number of clinical trials in the region increases and trials become even more complex, including studies on vulnerable populations and innovative new trial designs. Inadequate national regulatory capacity can deter sponsors of clinical trials and delay the start of clinical studies.

Several projects have promoted regional collaborations to share experience and coordinate development, or taken advantage of European links to learn from systems with more mature regulatory environments. Projects have also focused on specific topical issues, such as gender representation in clinical research (BCA-WA-ETHICS project), oversight of diagnostics research (IGORCADIA) and community engagement in research oversight (SCINE-U project).

Collectively, these projects will help to create an enabling environment for clinical research, with more efficient processing of applications and better safeguarding of participants’ interests. As well as attracting more clinical studies, they will also ultimately accelerate the introduction of new medical interventions into the region.

The project has been working to build the capacity of Senegal’s national research ethics committee (CNERS) to consider gender-related issues in clinical research. Why is this important and what is the project doing to address this issue?

Gender is a significant social determinant of health, especially in countries with a high gender inequality index such as Senegal. Considering gender issues in clinical research produces more generalisable and valid medical evidence for women, men and gender minorities. The BCA-WA-ETHICS project, through its gender equality training for the CNERS, is ensuring that the specific needs and experiences of women, men and gender minorities are considered in research.

What progress was made in 2019?

BCA-WA-ETHICS was launched in August of 2019 through a kick-off meeting that took place at the Ministry of Health and Social Action in Dakar. A gender landscape analysis was then conducted to map the gender gaps in the national research ethics committees of West Africa, as well as sex- and gender-related issues in West African health research.  After that, the protocol evaluation tools of the CNERS were adapted by the BCA-WA-ETHICS Gender Mainstreaming Secretariat to include sex and gender considerations.

What comes next?

The BCA-WA-ETHICS team is working on the organisation of the 2nd BCA-WA-ETHICS International Congress to take place in mid-2021 in Dakar, where a white paper on the harmonisation of gender mainstreaming in research ethics in West Africa will be presented. The gender gap in West African research and academia will be tackled through the publication of the results of BCA-WA-ETHICS research on ‘Barriers and Opportunities for West African Women Health Scientists to Build and Consolidate a Career in Research’.

The SCINE-U project is supporting activities to enhance community input into national ethics review processes in Uganda. Why is this important and how will it impact the ethics review process in Uganda?

Advancing research ethics knowledge and human participant protection through capacity building of Community Advisory Boards (CABs) will promote ethical conduct, scientific integrity and meaningful engagement of communities involved in research.

Developing and standardising guidelines for the functionality and performance of CABs will streamline the operations of the CABs and facilitate their integration into ethics review and regulation in Uganda. This will ensure they assume their rightful place in the country’s ethics regulatory framework.

Our project will, for the first time, provide an online platform for tracking the performance and functionality of CABs in Uganda. Efficiency achieved through this digital engagement will improve systems and standard work processess through communication and networking in the review, approval and monitoring of community engagement aspects of clinical research protocols.

What progress was made in 2019?

We launched the project in October 2019 at an event held at the Uganda National Council for Science and Technology. The event was attended by national research ethics regulators, research institutions, investigators, CAB members and liaisons, academics and representatives from ethics committees.  

Project management and coordination committees were set up and the first meetings held, and communication and dissemination activities have been launched. The project also began procurements, recruitment of project staff and other operational activities.

The protocol for the situational analysis of existing CABs and other community engagement structures in Uganda was developed, research tools designed and consent forms finalised. An incidental findings policy was also developed. Ethics approvals were secured from the local and National Ethics Committee.

The project also undertook community and stakeholder engagement activities. These included presentations on the project to about 17 research institutions, investigators, national ethics regulators and gatekeepers to local communities.

What comes next?

The first phase of the situational analysis, which focuses on mapping clinical trials in Uganda and their community engagement approaches, was begun in December 2019 and will continue through 2020.

Data collection, analysis and report-writing activities are on-going, and we hope to share the final report by the end of September 2020. Further outputs, such as an academic paper, will also be published.

We are also planning to hold a national consultative meeting of the task force group for the development of guidelines for CABs and other community engagement structures in Uganda in October 2020. We also plan to hire a consultant to develop the eCAB Management Information System (eCABMIS).