NATIONAL GUIDELINES FOR JOINT SCIENTIFIC AND ETHICAL REVIEW OF RESEARCH

Abstract

The National Guidelines for Joint Scientific and Ethical Review of Research in Uganda provide a comprehensive framework for coordinating and streamlining the scientific and ethical review of research studies that require joint regulatory oversight. Developed by the Uganda National Council for Science and Technology (UNCST), in collaboration with the Uganda National Health Research Organization (UNHRO) and the National Drug Authority (NDA), the guidelines respond to the increasing volume and complexity of research proposals in Uganda and the need for efficient, coordinated regulatory review. The Joint Scientific and Ethical Review (JoSER) mechanism brings together national regulatory agencies, institutional committees, subject matter experts and relevant stakeholders to undertake a coordinated review of eligible research proposals. The guidelines establish the roles and responsibilities of participating institutions, criteria for studies that may require joint review, procedures for submission, pre-screening, scheduling and conduct of JoSER meetings, review of revised proposals, regulatory decision-making, monitoring and inspection. They particularly address complex and emerging research areas, including innovative treatments, new and emerging technologies, public health emergencies, genetic testing and modification, potentially hazardous materials, and research involving human stem cells or fetal tissues. The guidelines aim to improve the quality and consistency of research review, reduce duplication, optimize approval timelines, strengthen coordination among regulators and safeguard research participants. They apply to qualifying research across health, agriculture and environmental sciences, physical and biological sciences, humanities and social sciences, industrial and engineering sciences, and information sciences.