Research ethics project for Benin, the Gambia, Ivory CoastEthiXpert – have secured a €1.5 million (about US$1.62 million) grant that will be used to build the capacity of research ethics committees, or RECs, in these countries.
The funding from the European and Developing Countries Clinical Trials Partnership (EDCTP) will also help the RECs to install the Research for Health and Innovation Organiser (RHInnO) software, a cloud-based platform which could make the work of the committees more efficient, while allowing them to deliver better quality standardised ethical reviews of research.
The grant will support the implementation of three projects in the West African countries, namely, the Ivory Coast Ethics Capacity Building Initiative, the Enhancing Research Ethics and Regulatory Capacities in Benin, and the Building a Robust Ethics and Regulatory Capacity in the Gambia, all broadly meant to enhance ethical research review processes.
In addition, a part of the funding will also help EthiXpert, which owns the software, to upgrade the platform. A new user-friendly version has been developed.
“The €1.5 million is the cumulative budget for the three projects, that have many partners and deliverables, including capacity-building, governance and oversight, good clinical practice, research ethics, and installation of RHInnO Ethics, training and its upgrading, project management and monitoring, among others,” EthiXpert CEO Francis Kombe said.
He noted that the platform automates the entire ethics review process, making RECs more efficient, and uses standardised questionnaires and checklists for submission and review, which enhances the harmonisation of reviews across all the RECs that use the platform.
It provides information management functionality, allowing ethics review committees not just to operate “paperlessly”, but also to have the ability to track and retrieve applications. This renders traditional filing systems that are “prone to natural hazards” redundant, Kombe explained.
Harmonisation of health research
Harmonisation of health research ethics and regulatory systems, he noted, is a critical aspiration of the African Union’s vision 2063.
“As a cloud web-based platform, all users can access it anywhere and anytime, as long as they have access to the internet, making it user-friendly and easily accessible,” he told University World News.
Medical research conducted in Africa has advanced tremendously in scope, volume and complexity, Kombe noted, adding that, on the global stage, health research is increasingly becoming technologically driven.
The AU’s 2063 agenda, he observed, called for a unified approach to tackling health challenges and underscores the need for the harmonisation of health research ethics and regulatory systems, to speed up health medical interventions discovery in and for Africa.
“The platform is made for Africa. We envision RHInnO Ethics as the bona fide pan-African research ethics review and information management platform by 2030,” said Kombe.
The upgraded version of the platform, in addition, will be more user-friendly, with the ability to allow the RECs administrator to easily communicate to users, customise templates and adjust questions, based on their needs and expectations, among other benefits, he added.
The RHInnO platform is currently in use by RECs in Kenya, Zambia, the Gambia, Ivory Coast, Uganda, Nigeria, Zambia, Eswatini, South Africa and Togo, mainly in universities and research institutions.
Kenya’s Strathmore University has been using the platform since 2015 and, according to Brenda Odero of the university’s scientific and ethics committee, one of the biggest advantages is the simplicity of the software.
“It is very easy for all parties to navigate the platform, and the cloud-based storage ensures security and safety of all research proposals, besides being a good archival support system,” she noted.
The platform allows REC’s secretariats to be more efficient and diligent in their work, which has had the ripple effect of reducing the turnaround time by reviewers, and ethical conduct and research integrity have been made “very transparent” as a result, she explained.
She suggested: “It would also be awesome if responses received from different researchers would clearly state who has sent them. There is the use of one application form page for different REC applications from clinical trials, non-clinical trials, animal studies for the application form, and this needs to be separated.”
It is now easier to catch dishonesty and “short cuts” on the platform as there is “nowhere to hide” – since the platform allows for a series of triage phases to ensure a study is ready for review, Odero noted.
According to Lorna Mwale of the University of Zambia’s ethics committee, the RHInnO platform has improved management of “information flow”, and taken away the complex process of creating paper-based data collection, making its use as simple as using an “application such as Gmail”.
The platform, she observed, brought about “efficiency and speed and has increased integration and coordination between research information systems.
“Before, we used to work with paper. RHInnO’s introduction has enhanced control of research activities and has standardised and harmonised the research review process, unlike before [when] work used to be overcrowded with a lot of backlog, and would take more time to complete and give feedback,” Mwale added.
As an advanced application, it has also improved the quality of information, speeding up the review process and, thereby, improving efficiency.
Health research in Africa ‘vital’
An introduction to study on the status of RECs and ethical review protocols in Africa, submitted in 2021, states that health research in low-income and middle-income countries, which face the greatest burden of disease, is a vital component of efforts to combat global health inequity.
It states that the benefit of increased research, however, comes with major challenges for research governance, adding that international collaboration and external funding can skew priorities.
“External investigators may lack knowledge of the local context and local researchers may have had limited exposure to research methodology and ethics training,” notes the ‘Strengthening ethics committees for health-related research in Sub-Saharan Africa: a scoping review protocol’ published by BMJ Open.
It adds that ethical and regulatory bodies in Sub-Saharan Africa face challenges in their capacity to perform their work, and are limited by a range of factors, including a lack of infrastructure such as ICT resources, limited financial and administrative support, a small pool of REC members and regulators, lack of theoretical training in ethics and regulatory affairs, and a lack of comprehensive governance structures.
“There has been ongoing concern about ethical and regulatory issues and the state of RECs in Sub-Saharan Africa, with various attempts to strengthen them,” it observed. “A large-scale survey of research ethics policies and practices in Sub-Saharan Africa concluded that there are extensive gaps in the capacity of research institutions in Africa to undertake ethical reviews of studies,” it added.