title: Learning from experience: a systematic review of community consultation acceptance data.
abstract: OBJECTIVE
  Federal regulations permitting an exception from informed consent for research in emergency settings require community consultation before study approval. Rates of acceptance of exception from informed consent in community consultation are often reported, but predictors of acceptance are not well understood, and investigators and institutional review boards struggle to interpret and use acceptance data.
  
  
  METHODS
  We systematically reviewed empirical literature on community consultation for exception from informed consent trials in the PubMed, EMBASE, and Web of Science databases. We included peer-reviewed articles reporting acceptance data from community consultation for US exception from informed consent trials. Questions were categorized by enrollment focus (eg, personal enrollment versus more general exception from informed consent acceptance), and observed acceptance was compared across studies. We also compared potential predictors of acceptance, including demographic factors, consultation method, and target community.
  
  
  RESULTS
  Nine studies (total n=9,036 participants) were included in the final analysis. Personal acceptance of enrollment in the proposed exception from informed consent study ranged from 45% to 93% and clustered in the range of 64% to 80%. Acceptance of the exception from informed consent mechanism in general (without reference to personal inclusion) was lower (35% to 84%) than personal acceptance. The effect of demographic characteristics on acceptance was inconsistent, and meeting-based consultation methods were associated with greater acceptance than survey-based methods. Finally, acceptance rates varied substantially according to the phrasing of the question.
  
  
  CONCLUSIONS
  Personal acceptance clustered between 64% and 80%. This range may be informative for institutional review boards and investigators evaluating community consultation results. However, numerous factors affect acceptance, and there is a need for considerable caution against overreliance on acceptance data.
authors.affiliation: Department of Medicine, Division of Cardiology, Emory University School of Medicine, Atlanta, GA.
authors.forename: Alexandra E
authors.initials: AE
authors.lastname: Fehr
authors.affiliation: Department of Hematology and Oncology, Emory University School of Medicine, Atlanta, GA.
authors.forename: Rebecca D
authors.initials: RD
authors.lastname: Pentz
authors.affiliation: Department of Medicine, Division of Cardiology, Emory University School of Medicine, Atlanta, GA; Emory Clinical Cardiovascular Research Institute, Emory University School of Medicine, Atlanta, GA; Department of Epidemiology, Emory University Rollins School of Public Health, and Atlanta VA Medical Center, Atlanta, GA. Electronic address: njr@emory.edu.
authors.forename: Neal W
authors.initials: NW
authors.lastname: Dickert
mesh_terms: D001294:Attitude to Health; D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D055812:Community-Based Participatory Research; D004635:Emergency Medicine / Q000941:ethics*; D004636:Emergency Service, Hospital; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D020458:Third-Party Consent; D014481:United States