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The Utility of Rapid Ethical Assessment

Our colleagues have been working on a trial of into a pragmatic intervention for podoconiosis in Ethiopia, which has been described here

The have recently published a paper in PLoS Neglected Tropical Diseases outlining the utility of a rapid ethical assessment during study conceptualisation. 

From the paper:

Author Summary

Community-based randomised controlled trials in developing countries, especially in settings with no research experience, are faced with significant challenges around approaching the community and obtaining informed consent. We conducted a Rapid Ethical Assessment, a simple and quick qualitative technique involving interviews and focus group discussions with researchers, experts, community leaders, and community members of both gender, with and without podoconiosis, the condition being studied. We aimed to explore optimal methods to provide information about the trial and approaches to the consent process preferred by the community. Overall, suggestions were grouped into five domains: approaching patients, information provision and comprehension, decision making, constraints to participation and ways of explaining randomisation and the control group. These recommendations were used to design the information sheet and consent form and to make other changes before and during the trial. This study highlights the utility of rapid ethical assessment prior to clinical trials involving complex procedures and concepts. (p.2/17)

You can access the whole paper at the link below, or on the top right of this article. 

Negussie H, Addissie T, Addissie A, Davey G (2016) Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia: The Utility of Rapid Ethical Assessment. PLoS Negl Trop Dis 10(3): e0004531. doi:10.1371/journal.pntd.0004531