NATIONAL GUIDELINES FOR RESEARCH INVOLVING HUMANS AS RESEARCH PARTICIPANTS

Abstract

Participants, Edition 2025 provide a national ethical and regulatory framework for the planning, review, conduct, monitoring and reporting of research involving human participants in Uganda. The Guidelines are a revised version of the 2014 National Guidelines and respond to changes in research practices, emerging scientific developments, new information and evolving ethical and regulatory requirements. They seek to ensure that research is scientifically sound and ethically conducted while protecting the rights, safety, dignity and welfare of research participants and their communities. The Guidelines provide guidance on informed consent, community engagement, privacy and confidentiality, research ethics review, research integrity, data management and transfer, vulnerable populations, genetic and genomic research, biological materials, emerging technologies and other areas requiring ethical and regulatory oversight. They also strengthen coordination among researchers, Research Ethics Committees, regulatory agencies and other stakeholders. The Guidelines are intended to promote high-quality, responsible and trustworthy research in Uganda while supporting national development, innovation and evidence-based policy. Their development was informed by national and international ethical standards and frameworks, including the Sustainable Development Goals, African Union Agenda 2063, STISA and Uganda Vision 2040, and involved broad stakeholder consultation.