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Masters Degrees (Health Research Ethics)

Permanent URI for this collectionhttps://hdl.handle.net/10413/14453

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Browsing Masters Degrees (Health Research Ethics) by Author "Mkhize, Nhlanhla Jerome."

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    A forensic review and evaluation of the regulatory and ethical framework governing health-related research in post-ebola Liberia.
    (2021) Franklin, Kokulo.; Mkhize, Nhlanhla Jerome.
    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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    Systematic review of an African bioethics framework: conception of person-hood and its influence in improving the process of informed consent in health research.
    (2020) Ndimuangu, Nchotou Hilton.; Mkhize, Nhlanhla Jerome.
    Cultural pluralism is vital to the understanding of bioethics in different societies. The principles that guide research ethics decision-making have a cultural basis derived from the west. These principles are drawn from just one worldview out of the many existing worldviews and they are often presented as universal. When these principles are implemented internationally, they are not sufficient to address rising concerns around informed consent. The challenges of implementing these principles in Africa are not an exception. It has been very challenging to obtain genuine informed consent for research, as the procedures of decision-making, in addition to the implementation of community engagement, are always accompanied by the importation of a western ethical philosophy, some of which differs from that of the African people. The western conception of the process of informed consent is premised on the idea of individuality and an abstract self that is not encumbered by culture and society. Culturally embedded semiotic aspects of ethical decision-making are often neglected. A systematic review was conducted on how the African understandings of personhood and community have influenced decision-making in the process of informed consent and community engagement, using keywords to recruit research papers published in English via the HINARI and Google Scholar electronic databases. Among the 322 papers identified, 46 were eligible to be recruited for the study. The results from this study indicate the community plays a critical role in the successful implementation of a truly informed consent. The findings indicate the process of informed consent and decision-making varies with the level of risk and complexity associated with the research, as well as the category of the participants who will be involved in the study. The study recommends that research ethics committees should take into consideration the level of community engagement and the process of informed consent when making a decision on a particular protocol.