Introduction & Background

Clinical research remains cardinal in advancing our knowledge of disease, human biology and behaviour and informing our health care practice. However, clinical research, especially that involve invasive procedures and interventions may carry risks to human health or may compromise the rights, values and interests of research participants or volunteers. Nonetheless, human participation in clinical research is important, and every effort should be made to minimise harm to research participants. Research Ethics Committees (RECs) and National Regulatory Agencies (NRAs) oversee and regulate the conduct of clinical research with the aim of minimizing risk to human health and ensuring respect for the research participants’ rights, values and interests.

The Uganda National Council for Science and Technology (UNCST) in collaboration with the National Drug Authority (NDA), the Uganda National Health Research Organisation (UNHRO), Infectious Diseases Institute (IDI) of Makerere University and Mbale Regional Referral Hospital (MRRH) is implementing a two-year project funded by the European and Developing Countries Clinical Trials Partnership (EDCTP) titled, “Consortium for Clinical Research Regulation and Ethics Capacity Development in Uganda (CREDU)”.

Project Objectives

The project objectives are,(i) Strengthening capacity of the national regulatory agencies (UNCST, UNHRO, NDA, and Office of the President) in the review and approval of clinical research in Uganda, (ii)Establishing a coordinated framework for clinical research management in Uganda, (iii)Improving the quality of ethical review of clinical research protocols by the RECs and the national regulatory agencies, (iv) Increasing opportunities for information sharing, dialogue, knowledge translation and networking among researchers, regulatory officials, RECs, and the wider community within Uganda and abroad.

Expected impact

The expected Impact is (i)Higher quality of ethical review of clinical research protocols leading to better human research protection and (ii) Greater harmony, improved efficiency of the national regulatory framework, making Uganda a competitive place for research.