Benefit Sharing in Health Research in Africa: A Scoping Review

Benefit Sharing in Health Research in Africa: A Scoping Review is a research project under the broader Strengthening Health Systems Capacity in Africa for Pandemic Equity and Responsiveness (SHARPER) initiative. The project seeks to systematically examine the conceptual, ethical, legal, and governance dimensions of benefit sharing in health research across Africa, with particular emphasis on clinical trials, post-trial access, and equitable distribution of research benefits. Benefit sharing is a core ethical principle in health research, particularly in low- and middle-income countries where concerns regarding exploitative or extractive research practices have historically been documented. Although African countries host an increasing number of clinical trials and contribute substantially to global health research through participant recruitment, biological samples, and data generation, these contributions do not always translate into equitable access to resulting health technologies, medicines, vaccines, or broader health system benefits. This inequity was especially highlighted during the COVID-19 pandemic, when many African countries that participated in vaccine trials experienced delayed access to vaccines, diagnostics, and therapeutics. This scoping review responds to the need for a structured synthesis of literature on benefit sharing, post-trial access, and research governance in African contexts. The project will systematically review both peer-reviewed and grey literature published between 1995 and 2025, including journal articles, policy documents, legislative texts, regulatory guidelines, institutional reports, and other relevant materials. Databases to be searched include PubMed/MEDLINE, Scopus, Web of Science, EBSCO, Cochrane Library, and Google Scholar, alongside searches of government and institutional repositories. Methodologically, the review follows the scoping review framework developed by Hilary Arksey and Lisa O'Malley and refined by the Joanna Briggs Institute. Reporting will align with the PRISMA Extension for Scoping Reviews (PRISMA-ScR) to ensure methodological transparency and rigor. The review adopts the Population–Concept–Context (PCC) framework to guide eligibility criteria, data extraction, and synthesis. The specific objectives of the project are to: clarify how research benefits are defined in the literature; examine how benefits are shared in practice, particularly in clinical trials; analyse how ethics committees, regulators, and research sponsors interpret benefit-sharing obligations; identify trends, gaps, inequities, and opportunities in African research governance ecosystems; explore benefit-sharing practices in both routine and public health emergency research settings. Expected outcomes of the project include a comprehensive mapping of conceptual and policy discourses on benefit sharing in Africa, identification of regulatory and implementation gaps, and synthesis of common models for benefit sharing and post-trial access. Findings from the review will directly inform the next phase of the SHARPER project, including the design of key informant interviews and focus group discussions, and will contribute to the development of an Afro-centric, Ubuntu-informed ethical framework for equitable health research governance. Ultimately, this project is expected to generate evidence-based recommendations to strengthen research governance systems, improve ethical oversight, promote equitable access to health innovations, and enhance pandemic preparedness and health system resilience across African countries.