title: Exploring ethical conflicts in emergency trauma research: the COMBAT (Control of Major Bleeding after Trauma) study experience.
abstract: BACKGROUND
  Up to 25% of severely injured patients develop trauma-induced coagulopathy. To study interventions for this vulnerable population for whom consent cannot be obtained easily, the Food and Drug Administration issued regulations for emergency research with an exception from informed consent (ER-EIC). We describe the community consultation and public disclosure (CC/PD) process in preparation for an ER-EIC study, namely the Control Of Major Bleeding After Trauma (COMBAT) study.
  
  
  METHODS
  The CC/PD was guided by the four bioethical principles. We used a multimedia approach, including one-way communications (newspaper ads, brochures, television, radio, and web) and two-way communications (interactive in-person presentations at community meetings, printed and online feedback forms) to reach the trials catchment area (Denver County's population: 643,000 and the Denver larger metro area where commuters reside: 2.9 million). Particular attention was given to special-interests groups (eg, Jehovah Witnesses, homeless) and to Spanish-speaking communities (brochures and presentations in Spanish). Opt-out materials were available during on-site presentations or via the COMBAT study website.
  
  
  RESULTS
  A total of 227 community organizations were contacted. Brochures were distributed to 11 medical clinics and 3 homeless shelters. The multimedia campaign had the potential to reach an estimated audience of 1.5 million individuals in large metro Denver area, the majority via one-way communication and 1900 in two-way communications. This resource intensive process cost more than $84,000.
  
  
  CONCLUSIONS
  The CC/PD process is resource-intensive, costly, and complex. Although the multimedia CC/PD reached a large audience, the effectiveness of this process remains elusive. The templates can be helpful to similar ER-EIC studies.
authors.affiliation: University of Colorado Denver, Aurora, CO.
authors.forename: Theresa L
authors.initials: TL
authors.lastname: Chin
authors.affiliation: University of Colorado Denver, Aurora, CO; Denver Health Medical Center, Denver, CO.
authors.forename: Ernest E
authors.initials: EE
authors.lastname: Moore
authors.affiliation: University of Colorado Denver, Aurora, CO.
authors.forename: Marilyn E
authors.initials: ME
authors.lastname: Coors
authors.affiliation: University of Colorado Denver, Aurora, CO.
authors.forename: James G
authors.initials: JG
authors.lastname: Chandler
authors.affiliation: University of Colorado Denver, Aurora, CO; Denver Health Medical Center, Denver, CO.
authors.forename: Arsen
authors.initials: A
authors.lastname: Ghasabyan
authors.affiliation: University of Colorado Denver, Aurora, CO.
authors.forename: Jeffrey N
authors.initials: JN
authors.lastname: Harr
authors.affiliation: University of Colorado Denver, Aurora, CO.
authors.forename: John R
authors.initials: JR
authors.lastname: Stringham
authors.affiliation: University of Colorado Denver, Aurora, CO.
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Ramos
authors.affiliation: University of Colorado Denver, Aurora, CO; Denver Health Medical Center, Denver, CO.
authors.forename: Sarah
authors.initials: S
authors.lastname: Ammons
authors.affiliation: University of Colorado Denver, Aurora, CO.
authors.forename: Anirban
authors.initials: A
authors.lastname: Banerjee
authors.affiliation: University of Colorado Denver, Aurora, CO; University of Colorado School of Medicine, Aurora, CO. Electronic address: Angela.sauaia@ucdenver.edu.
authors.forename: Angela
authors.initials: A
authors.lastname: Sauaia
mesh_terms: D001778:Blood Coagulation Disorders / Q000209:etiology / Q000517:prevention & control*; D055812:Community-Based Participatory Research; D004632:Emergency Medical Services / Q000941:ethics*; D006801:Humans; D033181:Information Dissemination; D007258:Informed Consent; D014947:Wounds and Injuries / Q000209:etiology / Q000628:therapy*