2016
DOI: 10.1371/journal.pntd.0004531
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Preparing for and Executing a Randomised Controlled Trial of Podoconiosis Treatment in Northern Ethiopia: The Utility of Rapid Ethical Assessment

Abstract: BackgroundCommunity-based randomized controlled trials are often complex pieces of research with significant challenges around the approach to the community, information provision, and decision-making, all of which are fundamental to the informed consent process. We conducted a rapid ethical assessment to guide the preparation for and conduct of a randomized controlled trial of podoconiosis treatment in northern Ethiopia.MethodsA qualitative study was carried out in Aneded woreda, East Gojjam Zone, Amhara Regi… Show more

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Cited by 15 publications
(26 citation statements)
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“…However, in one kebele , misinformation spread by one individual alarmed patients. Acting on suggestions made during the Rapid Ethical Assessment [ 12 ] about quashing community rumours, the trial coordinator and data manager arranged an emergency kebele meeting to negotiate with gatekeepers and prevent further rumours being spread. The team made the decision to offer further enrollment sessions in the original 9 kebeles and to extend listing and screening to 9 of the 10 less-accessible kebeles .…”
Section: Resultsmentioning
confidence: 99%
See 3 more Smart Citations
“…However, in one kebele , misinformation spread by one individual alarmed patients. Acting on suggestions made during the Rapid Ethical Assessment [ 12 ] about quashing community rumours, the trial coordinator and data manager arranged an emergency kebele meeting to negotiate with gatekeepers and prevent further rumours being spread. The team made the decision to offer further enrollment sessions in the original 9 kebeles and to extend listing and screening to 9 of the 10 less-accessible kebeles .…”
Section: Resultsmentioning
confidence: 99%
“…Of these, only one trial had a single site in a low-income setting (the Philippines), and, unsurprisingly, few of the interventions were relevant to a remote rural setting like Gojjam. We experienced lower-than-anticipated recruitment in the nine most accessible kebeles , and used results from the Rapid Ethical Assessment [ 12 ] to mitigate this by quashing negative rumours and extending recruitment to more remote kebeles . The move to quash rumours might be construed as a departure from pragmatism, but as a team we considered the need to complete recruitment to outweigh efforts to preserve pragmatism during trial set-up.…”
Section: Discussionmentioning
confidence: 99%
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“…Potential approaches to enhancing community input include involving community advisory boards or similar community structures in the study protocol design ( 28 , 29 ); carrying out a preliminary qualitative study to investigate the perception of local policy makers and members of the community about the mobility data collection; or carrying out a rapid ethics assessment, a brief qualitative intervention used to examine the ethics terrain of a research setting before recruiting participants ( 30 ). Such participatory research approaches engage communities in the research process and take local perception into account during research planning ( 29 ).…”
Section: Involving Communities As Research Stakeholdersmentioning
confidence: 99%