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Project Topic
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The project ‘Improved Governance and Research Capacities in Diagnostics for Infectious Diseases of the LMHRA (IGORCADIA) aims at building capacities of the LMHRA to develop its capacity to regulate the use of and research in diagnostics and implement these regulations for a rational use of diagnostics. In addition, the principal beneficiary of the project will receive training on good clinical practice, good laboratory practice, fundamentals of medical ethics and diagnostics research. The project started in December 2017 and is led by the Barcelona Institute of Global Health (ISGlobal) in collaboration with the FJC NGO, LMHRA and the SJCH, in Monrovia, where all activities take place. The specific objectives of this 24 month-project are: 1) To strengthen LMHRA capacity as a governmental organisation with mandate to regulate, register and license individuals/entities engaged in the importation, storage, and use of diagnostics for infectious diseases alongside the supervision and inspection of access to and use of diagnostics in the frame of clinical trials and clinical research. 2) To build LMHRA capacity in the revision, design, conduct, analysis and dissemination of research on novel diagnostics for poverty-related infectious diseases with epidemic potential in Liberia (i.e. Lassa, Ebola, HIV, tuberculosis, hepatitis C, malaria, Zika). 3) To enhance LMHRA’s capacity to establish inter - agencies collaboration through skilfull sensitisation, mobilisation, and active engagement of relevant authorities and civil society in methods of appropriate handling and rational use of diagnostics. Main results achieved during the first period of the project: A set of three Technical Working Groups and Diagnostics Steering Committee meetings have been conducted, with LMHRA, SJCH, ISGlobal staff and invited key members of the National Research Ethics Board and Ministry of Health. The developed regulatory framework (guidelines and procedures for registration has been developed and revised in order to facilitate a transparent process for investigators and research institutions to apply for revision. In order to review the development of the regulatory framework for the four regulatory documentation guidelines (Guidelines for Registration, Importation, Labelling, Packaging and Distribution and on Post Market Surveillance of in vitro diagnostics), two Technical Working Groups and Diagnostics Steering Committee Meetings will be held during the second period of the project. Continuous communication between LMHRA and the Liberian members of parliament, legislators and interministerial committees has been established based on regulatory framework and information exchange. Newsletters, national newspapers, radio programmes and the LMHRA webpage have been used to update the drafts of developed legislations on new diagnostics for infectious diseases available in Liberia. A set of three, three-day hands-on workshops (Training on Diagnostics Research (Good Clinical and Laboratory Practice, Quantitative Approaches in Diagnostics Research, Fundamentals of Health Research and Medical Ethics) have been held with the participation of 10 LMHRA and five SJCH trainees in order to acquire competencies in diagnostics research. The LMHRA and SJCH staff who participated in the regulatory and training activities of the programme have shown great interest and motivation to engage in health research. With the aim of consolidating SJCH as a reference laboratory partner for LMHRA, education sessions on new diagnostic technologies and refreshment hands-on training on quality control are being conducted by the project manager. Additionally, the SJCH General Director has attended an advanced ten-days training in several Spanish health facilities and the RTPCR Unit at the ISGlobal-Centre Esther Koplowitz Laboratory in Barcelona. During the first period of the project, the IGORCADIA team has been highly committed to promoting equal opportunities in science and research from a gender perspective among participating institutions, contributing to improve the quality of life, the health of women and girls and the participation of women in all the activities developed within the project. No selection process to become a member of the research team has presented any type of barrier or limitation from a gender perspective. Moreover, a monitoring system has been developed to ensure equal opportunities among the research team and participants. Expected Impact The activities carried out in the frame of IGORCADIA will have an impact on four main areas: strengthening LMHRA capacity as a governmental organisation to regulate IVD medical devices, developing SJCH capacity as a LMHRA reference laboratory, and networking with other institutions involved in Research and Development of investigational medicines and vaccines; and community education and engagement. Beyond its direct impact on the LMHRA and SJCH, we expect that IGORCADIA will contribute to restore health care, management and research capacities in a country that has suffered enormously from the recent Ebola outbreak. Importantly, we hope it will contribute to help the neighbouring communities regain confidence in the health system and engage in clinical trials that will aim at finding vaccines and/or treatments for emerging infectious diseases that pose a threat to the region, such as Ebola, Marburg or Lassa fever, and other highly prevalent infectious diseases such as malaria, HIV and tuberculosis. Project website: https://www.isglobal.org/es/-/igorcadia
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