title: Improving community understanding of medical research: audience response technology for community consultation for exception to informed consent.
abstract: BACKGROUND
  The Department of Health and Human Services and Food and Drug Administration described guidelines for exception from informed consent (EFIC) research. These guidelines require community consultation (CC) events, which allow members of the community to understand the study, provide feedback and give advice. A real-time gauge of audience understanding would allow the speaker to modify the discussion. The objective of the study is to describe the use of audience response survey (ARS) technology in EFIC CCs.
  
  
  METHODS
  As part of the Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART), 13 CC events were conducted. We prepared a PowerPoint™ presentation with 4 embedded ARS questions,according to specific IRB guidelines to ensure that the pertinent information would reach our targeted audience. During 6 CCs, an ARS was used to gauge audience comprehension. Participants completed paper surveys regarding their opinion of the study following each CC.
  
  
  RESULTS
  The ARS was used with minimal explanation and only one ARS was lost. Greater than 80% of the participants correctly answered 3 of the 4 ARS questions with 61% correctly answering the question regarding EFIC. A total of 105 participants answered the paper survey; 80-90% of the responses to the paper survey were either strongly agree or agree. The average scores on the paper survey in the ARS sites compared to the non-ARS sites were significantly more positive.
  
  
  CONCLUSIONS
  The use of an audience response system during the community consultation aspects of EFIC is feasible and provides a real-time assessment of audience comprehension of the study and EFIC process. It may improve the community's opinion and support of the study.
authors.affiliation: Henry Ford Health System, Wayne State University, Department of Emergency Medicine, Detroit, Michigan.
authors.forename: Taher
authors.initials: T
authors.lastname: Vohra
authors.affiliation: Henry Ford Health System, Wayne State University, Department of Emergency Medicine, Detroit, Michigan.
authors.forename: Raphe Bou
authors.initials: RB
authors.lastname: Chebl
authors.affiliation: Henry Ford Health System, Wayne State University, Department of Emergency Medicine, Detroit, Michigan.
authors.forename: Joseph
authors.initials: J
authors.lastname: Miller
authors.affiliation: Henry Ford Health System, Wayne State University, Department of Neurology, Detroit, Michigan.
authors.forename: Andrew
authors.initials: A
authors.lastname: Russman
authors.affiliation: Henry Ford West Bloomfield Hospital, Department of Neurology, Oakland County, Michigan.
authors.forename: Anna
authors.initials: A
authors.lastname: Baker
authors.affiliation: Henry Ford Health System, Wayne State University, Department of Emergency Medicine, Detroit, Michigan.
authors.forename: Christopher
authors.initials: C
authors.lastname: Lewandowski
mesh_terms: D000328:Adult; D035843:Biomedical Research; D003159:Community-Institutional Relations; D032882:Comprehension; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D007258:Informed Consent; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D014481:United States