title: "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.
abstract: BACKGROUND
  Community consultation is increasingly recommended, and in some cases, required by ethical review boards for research that involves higher levels of ethical risk such as international research and research with vulnerable populations. In designing a randomised control trial of a mental health intervention using a wait list control, we consulted the community where the research would be undertaken prior to finalising the study protocol. The study sites were two conflict-affected locations: Grozny in the Chechen Republic and Kitchanga in eastern Democratic Republic of Congo.
  
  
  METHODS
  Group discussions with a range of community members were held in both study sites. Facilitators used a prepared set of questions to guide the discussions and to solicit feedback on the value of the research as well as on the study design. Specific questions were asked about enablers and barriers to participation in the research.
  
  
  RESULTS
  Six groups were held in Grozny and thirteen in Kitchanga. The majority of individuals and groups consulted supported the research, and understood the purpose. In Grozny, the main concern raised was the length of the waiting period. Barriers to both waiting and returning for follow up were identified. In Kitchanga, there was a strong reaction against the wait list control and against randomisation. The consultations provided information on unanticipated harms to the community, allowing changes to the study design to mitigate these harms and increase acceptability of the study. It also served to inform the community of the study, and through engaging with them early, helped promote legitimacy and joint responsibility.
  
  
  CONCLUSIONS
  Community consultation prior to finalising the study design for a mental health intervention trial in two humanitarian settings proved feasible. Our experience reinforces the importance of community consultation before the study design is finalised and the importance of broad consultation that includes both community leaders and the potential study participants.
authors.affiliation: Médecins Sans Frontières-Operational Centre Amsterdam, Amsterdam, Netherlands. Leslie.shanks@amsterdam.msf.org.
authors.forename: Leslie
authors.initials: L
authors.lastname: Shanks
authors.affiliation: Médecins Sans Frontières-Operational Centre Amsterdam, Amsterdam, Netherlands. claudio.moroni870@gmail.com.
authors.forename: Claudio
authors.initials: C
authors.lastname: Moroni
authors.affiliation: Médecins Sans Frontières-Operational Centre Amsterdam, Amsterdam, Netherlands. rivisa20@hotmail.com.
authors.forename: Isabel Cristina
authors.initials: IC
authors.lastname: Rivera
authors.affiliation: Médecins Sans Frontières-Operational Centre Amsterdam, Amsterdam, Netherlands. Debbie.price@amsterdam.msf.org.
authors.forename: Debbie
authors.initials: D
authors.lastname: Price
authors.affiliation: Médecins Sans Frontières-Operational Centre Amsterdam, Amsterdam, Netherlands. clementsifa@gmail.com.
authors.forename: Sifa Banzira
authors.initials: SB
authors.lastname: Clementine
authors.affiliation: Médecins Sans Frontières-Operational Centre Amsterdam, Amsterdam, Netherlands. Giovanni.pintaldi@amsterdam.msf.org.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Pintaldi
mesh_terms: D000533:Altruism; D000068337:Armed Conflicts; D035843:Biomedical Research / Q000941:ethics*; D002985:Clinical Protocols; D003256:Community Participation; D015023:Democratic Republic of the Congo; D033061:Ethics Consultation; D005240:Feasibility Studies; D006801:Humans; D008603:Mental Health; D012017:Referral and Consultation; D012107:Research Design; D012426:Russia; D014850:Waiting Lists