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Project Topic
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Clinical research oversight in Uganda is done by the National Drug Authority, Uganda National Council for Science & Technology, Uganda National Health Research Organization, Office of the President and accredited Research Ethics Committees. Clinical research is important and ought to be of high quality and relevant so that research participants are not exposed to unnecessary harms and inconveniences. Their safety, rights, interests and values should be protected. A transparent and efficient clinical research regulatory system enhances human research protection. Clinical research regulation should not impede, but facilitate research progress and aim for the right balance. The Consortium for Clinical Research Regulation and Ethics Capacity Development in Uganda (CREDU), a 24 month project, was implemented by the National Drug Authority, Uganda National Council for Science & Technology, Uganda National Health Research Organization, Infectious Diseases Institute-Makerere University and Mbale Regional Referral Hospital. The project objectives included; i) Strengthening capacity of national regulatory agencies (UNCST, UNHRO, NDA, OoP) in the review and approval of clinical research; ii) Establishing a coordinated framework for clinical research management in Uganda; iii) Improving the quality of ethical review of clinical research by RECs and the NRAs; and iv) Increasing opportunities for information sharing, dialogue, knowledge translation and networking among researchers, regulatory officials, RECs and the wider community within Uganda and abroad. Improving the capacities of individual staff of the agencies has been accomplished through ethics and regulatory training as well as mentorship and placements at more advanced institutions. Also exchange visits of regulatory staff to more advanced regulatory facilities abroad have been conducted. Such visits have enhanced the capacity of the regulatory staff to review drugs and biologics that are intended for human testing, as well as capacity to review preclinical and clinical research data for licensing. Under the CREDU project, we developed a one week good regulatory practice course for REC professionals and staff of the regulatory agencies. With regard to institutional capacity development, equipment which is mainly ICT infrastructure (hardware and software) was purchased and provided to the regulatory agencies to improve systems and standard work processes. An important aspect of this has been the development of an electronic clinical research information management system within the agencies, and across the RECs to facilitate communication and networking in the review, approval and monitoring of clinical research protocols. The Clinical Research Information Management System (CRIMS) is an online platform that supports the National Regulatory Agencies, NDA/UNHRO/UNCST/OoP and Research Ethics Committees in the regulatory oversight of clinical research conducted in the country. The system is intended to provide efficient reviews of research and provide researchers with an interface with the regulatory agencies in the data capture, data management, data validation, quality control and overall regulatory compliance in clinical research management processes. CRIMS is a tool for assisting national research regulatory agencies and the RECs to manage research related records and interact with investigators more effectively and this will further improve the human research protection system in Uganda. In order to improve the quality of ethical review of clinical research protocols by RECs and the national regulatory agencies, the REC accreditation system has been strengthened to have better tools. The Accreditation Committee has engaged in more active monitoring of REC performance through conducting site monitoring visits to the accredited REC. The Accreditation Committee at UNCST has also been equipped with skills through benchmarking visits with other more advanced accreditation systems in the US. Over three hundred REC members, administrative staff and institutional heads have been trained in research ethics, REC administration and review of research protocols. With regard to increased opportunities for information sharing, dialogue, knowledge translation and networking among researchers, regulatory officials, RECs, and the wider community within Uganda and abroad; UNHRO’s capacity to disseminate and translate results of clinical research into policy and practice has been strengthened partly by creating a shared online system. The online system allows researchers to submit their publications and clinical research reports, where NDA, UNCST and UHNRO can simultaneously access these reports in real time. Furthermore, capacity has been built at UNHRO to undertake research dissemination activities, hold dialogues and facilitate research policy forums in the health sector. In this regard, national symposia and research dissemination meetings were held. In order to promote cross REC networks, learning and exchange visits with more advanced RECs in and out of the country, relevant REC members and staff from regulatory agencies from Kenya, Tanzania, Rwanda, Burundi, Ethiopia, Malawi South Sudan and Congo Brazzaville participated in the 27th Forum for Research Ethics Committee Chairpersons in Uganda (FRECU) and the 10th Annual National Research Ethics Conference (ANREC) on 9 -11 July 2018 at Kampala Serena Hotel. The CREDU project has established higher quality ethical review of clinical research protocols leading to better human research protection, greater harmony and improved efficiency of the national regulatory framework, making Uganda a competitive place for research. [https://uncst.go.ug/credu-project/]
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Project Results
(after finalisation)
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• Capacity development (Human resources): Ethics and regulatory trainings for regulatory agencies’ staff and placements at more advanced institutions.
• Capacity development (Systems and Infrastructure, enabling environment): Purchasing of ICT infrastructure and development of the Clinical Research Information Management System (CRIMS) - an online platform to support the national regulatory agencies in the regulatory oversight of clinical research in Uganda.
• Capacity development (Human resources, Systems and Infrastructure, Enabling environment): Training of over three hundred REC members in research ethics, REC administration and review of research protocols.
Onf ot the expected outcomes- the etablishment of coordinated framework has not been accomplished because the consensus among the national regulatory agencies (National drug Athority-NDA, Uganda National Council for Science & Technology-UNCST, Uganda National Health Research Organisation & Office of the President-OP) was not reached to enable signing of a MOU for technical cooperation.
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