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Table 1 Analysis of results using an ethical framework as proposed by Dickert and Sugarman

From: “Losing the tombola”: a case study describing the use of community consultation in designing the study protocol for a randomised controlled trial of a mental health intervention in two conflict-affected regions

Ethical goals Grozny Kitchanga
Protection of the community from unforeseen harm Achieved. Lack of respect to individuals due to waiting list identified as a potential harm. Solutions suggested to mitigate this: clear explanations of trial design, compensation for time, travel, psychological first aid on presentation, etc. Achieved. The previously unrecognized risk of randomization leading to harm to individuals or the community was identified. Solutions to mitigate potential harms that might accrue from the original design were identified and adopted.
Enhanced benefits to the study participants, the community the research is meant to serve or the community where it took place Achieved. Wait list period was shortened and compensation to reduce barriers to follow up added, both of which are likely to increase recruitment and retention. A successful trial will ultimately improve chance of benefits to the community through benefits of the research. Achieved. Design changed to improve uptake of participants and decrease chance of negative individual and community perceptions.
Ethical or political legitimacy Partially achieved, as consultation prior to finalization of study design allowed the community to have influence on the design. Limited by lack of access to community leaders. Achieved. As per Grozny, with the added benefit that broad consultation with religious, administration, and political leaders helped achieve political legitimacy.
Shared responsibility Partially achieved through active engagement with community members in the design and conduct of the trial. Achieved. Evidence of this was in the spontaneous offer of assistance with the task of informing community members about the trial in 9 out of 11 non-MSF groups.