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A forensic review and evaluation of the regulatory and ethical framework governing health-related research in post-ebola Liberia.

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2021

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ABSTRACT BACKGROUND The end of the deadly 2014 Ebola outbreak in Liberia has seen a noticeable influx of western researchers into the country. Given the vulnerable nature of the majority of Liberians (impoverished and poorly educated), this raises a lot of ethical concerns. This study sought to gauge the local research governance frameworks to discover what protective structures and documented stipulations exist, since there has never been any such assessment. METHODOLOGY The study made use of a triangulated qualitative design, involving a desk review of fifteen (15) national guidelines, policies, procedures, and regulations, coupled with eleven (11) in-depth key informant interviews with purposively-identified oversight institutions and some researchers. RESULTS Key documents (Public Health Law, National Research for Health Policy, and the Clinical Trial Guidelines, National Research Ethics Board Guidelines, and the University of Liberia – Pacific Institute for Research and Evaluation IRB Handbook), along with key institutions (Ministry of Health, the National Public Health Institute of Liberia, the Liberia Medicines and Health Products Regulatory Authority, the National Research Ethics Board, and the University of Liberia – Pacific Institute for Research and Evaluation (UL-PIRE) IRB) were found to be critical to the overall governance, review, approval, and monitoring of health research in Liberia. The frameworks governing health research were found to contain most of the traditional protective stipulations, though significant gaps were also identified from the desk review and in-depth interview with the major stakeholders. Stipulations on emerging issues (stored samples, bio-banks, genetic/genomic research, and data ownership and sharing) and contextually relevant issues (post-trial access, ancillary care, and consent in local languages) are evidently absent or only fleetingly mentioned. CONCLUSION Overall, Liberia appears to have in place the relevant foundational frameworks for acceptable governance of health research. However, the documents are in need of substantial overhaul and contextualisation, especially given the rapidity with which legal and ethical governance of health research has advanced over the past few decades. The local institutional governance is also in need of reorganisation, something that will enhance adequate coordination and management of health research.

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Masters Degree. University of KwaZulu-Natal, Pietermaritzburg.

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