Final Joint Review Guidelines and Framework

The document is a comprehensive set of national guidelines developed under the ACCESSAFRICA 2 project to streamline and enhance the Joint Scientific and Ethical Review (JoSER) process for research in Uganda. Led by the Uganda National Council for Science and Technology (UNCST), in collaboration with UNHRO and NDA, the guidelines aim to improve coordination, efficiency, and quality in the review of complex and sensitive research proposals, especially those involving public health emergencies, investigational products, and emerging technologies. The guidelines define the roles and responsibilities of key stakeholders—including National Regulatory Agencies, Institutional Committees, Principal Investigators, and subject matter experts—and outline the criteria for studies requiring joint review. They provide a detailed step-by-step procedure for initiating, conducting, and finalizing the JoSER process, including timelines, documentation requirements, and mechanisms for appeals. The document also includes administrative fee structures, monitoring and inspection protocols, and appendices such as assessment forms, confidentiality agreements, and conflict of interest declarations. Overall, the guidelines serve as a national framework to ensure ethical and scientifically rigorous oversight of research, promote collaboration among regulatory bodies, and support Uganda’s growing research landscape.