• IRB: ETHICS & HUMAN RESEARCH

Medical device research in resource-poor settings: A pediatric case study in Ghana.

The authors of this paper and others collaborated in conducting a randomized controlled trial of continuous positive airway pressure (CPAP) to support ventilation in children in four district hospitals in rural Ghana, where endotracheal intubation and mechanical ventilation are not generally available. CPAP is comparably simple to use and has been successfully used in the neonatal population in resource-poor areas, but its use had not previously been evaluated in older children in these settings. In resource-rich settings, CPAP has been shown to improve respiratory rates, oxygen saturations, and blood pH in older children with respiratory distress. The study demonstrated that the nursing staff was able to properly and safely apply CPAP and that use of CPAP decreases respiratory rate in the population that was involved.

In this case study, we discuss pragmatic questions that engendered debate among the investigators and ethics review boards, with particular attention to those issues that manifest differently in the context of a medical device study rather than a drug study. Specifically, we discuss selection of an appropriate medical device to study, choice of comparator group, informed consent, compensation for research-related injury, reasonable availability of a study intervention post-trial, and local capacity building.

Morris MC, Wilson PT. Medical device research in resource-poor settings: A pediatric case study in Ghana. IRB: Ethics & Human Research 2014;36(4):1-7.