NATIONAL GUIDELINES FOR JOINT SCIENTIFIC AND ETHICAL REVIEW OF RESEARCH

Abstract

The National Guidelines for Joint Scientific and Ethical Review of Research in Uganda were developed by the Uganda National Council for Science and Technology in collaboration with the Uganda National Health Research Organization and the National Drug Authority to provide a coordinated framework for the joint review of research proposals in Uganda. The guidelines aim to streamline and harmonize the scientific and ethical review processes conducted by multiple national regulatory agencies and institutional committees, thereby improving efficiency, reducing duplication, and enhancing the quality and timeliness of research approvals. The document outlines the institutional roles and responsibilities of regulatory bodies, institutional committees, subject matter experts, and researchers in the joint review mechanism known as Joint Scientific and Ethical Review (JoSER). It provides criteria for identifying research studies that may require joint review, particularly complex, high-risk, innovative, or multidisciplinary studies, including those involving emerging technologies, public health emergencies, investigational products, genetic research, and hazardous materials. The guidelines also describe the procedural steps involved in initiating, conducting, and concluding the joint review process, including prescreening, convening review meetings, decision-making, and post-review regulatory approvals. In addition, the guidelines address administrative procedures such as documentation requirements, timelines, conflict-of-interest management, confidentiality obligations, monitoring and inspection of approved studies, and mechanisms for appeals. By establishing a coordinated review framework, the guidelines aim to strengthen research governance in Uganda, safeguard the rights and welfare of research participants, promote ethical and scientifically rigorous research practices, and support the country’s growing research ecosystem.