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Considerations for stakeholder engagement and COVID-19 related clinical trials conduct in sub-Saharan Africa #MMPMID32798320
Folayan MO; Brown B; Haire B; Babalola CP; Ndembi N
Dev World Bioeth 2021[Mar]; 21 (1): 44-50 PMID32798320show ga
The aim of this study is to determine how stakeholder engagement can be adapted for the conduct of COVID-19-related clinical trials in sub-Saharan Africa. Nine essential stakeholder engagement practices were reviewed: formative research; stakeholder engagement plan; communications and issues management plan; protocol development; informed consent process; standard of prevention for vaccine research and standard of care for treatment research; policies on trial-related physical, psychological, financial, and/or social harms; trial accrual, follow-up, exit trial closure and results dissemination; and post-trial access to trial products or procedures. The norms, values, and practices of collectivist societies in Sub-Saharan Africa and the low research literacy pose challenges to the conduct of clinical trials. Civil-society organizations, members of community advisory boards and ethics committees, young persons, COVID-19 survivors, researchers, government, and the private sector are assets for the implementation and translation of COVID-19 related clinical trials. Adapting ethics guidelines to the socio-cultural context of the region can facilitate achieving the aim of stakeholder engagement.
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Dev+World+Bioeth 2021 ; 21 (1): 44-50
