title: Exception from informed consent for emergency research: consulting the trauma community.
abstract: BACKGROUND
  Research investigating the resuscitation and management of unstable trauma patients is necessary to improve care and save lives. Because informed consent for research is impossible in emergencies, the Federal Drug Administration has established an Exception from Informed Consent (EFIC) Policy that mandates "community consultation" as a means of protecting patient autonomy. We hypothesized that the trauma community represents a heterogeneous population whose attitudes regarding EFIC and willingness to participate in emergency research are influenced by status as a patient, family, or geographic community member.
  
  
  METHODS
  In the context of an upcoming trial, trauma patients as well as family and community members were asked to rank statements regarding EFIC and willingness to participate in emergency research using a 5-point Likert-type scale. Higher total scores reflected a more positive attitude regarding EFIC (range, 4-20; neutral = 12) and willingness (range, 21-105, neutral = 63). The influence of demographics, education, and interpersonal violence were evaluated by Kruskal-Wallis and Mann-Whitney U-tests (p < 0.05).
  
  
  RESULTS
  Overall, the 309 participants (trauma patients, n = 172; family, n = 73; community, n = 64) were positive about EFIC (median, 16; interquartile range, [IQR], 14-18) and demonstrated high willingness scores (median, 82; IQR, 76-88.5). EFIC and willingness were not influenced by age, sex, race, or education. Victims of interpersonal violence and their family members had lower EFIC scores than those with other mechanisms (median [IQR], 16 [14-18] vs. 16 [13-16]; p = 0.04) but similar willingness. Although EFIC scores were similar between groups, trauma patients had significantly lower willingness than family (median [IQR], 74 [68-77] vs. 77 [70-85]; p = 0.03) or community members (median [IQR], 76 [70-84]; p = 0.01).
  
  
  CONCLUSIONS
  Trauma patients, families, and the geographic community expressed a high degree of support for EFIC and willingness to participate in emergency research, although support was influenced by injury mechanism and group status. Consultation efforts for emergency research should extend beyond the geographic community to include trauma victims and their families.
  
  
  METHODS
  Epidemiologic, level III.
authors.affiliation: Center for Resuscitation Science, Trauma Center at Penn, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania 19104, USA. carrie.sims@uphs.upenn.edu
authors.forename: Carrie A
authors.initials: CA
authors.lastname: Sims
authors.forename: Joshua A
authors.initials: JA
authors.lastname: Isserman
authors.forename: Daniel
authors.initials: D
authors.lastname: Holena
authors.forename: Latha Mary
authors.initials: LM
authors.lastname: Sundaram
authors.forename: Nikolai
authors.initials: N
authors.lastname: Tolstoy
authors.forename: Sarah
authors.initials: S
authors.lastname: Greer
authors.forename: Seema
authors.initials: S
authors.lastname: Sonnad
authors.forename: Jose
authors.initials: J
authors.lastname: Pascual
authors.forename: Patrick
authors.initials: P
authors.lastname: Reilly
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001290:Attitude; D035843:Biomedical Research / Q000941:ethics; D003256:Community Participation / Q000523:psychology; D004630:Emergencies; D005190:Family / Q000523:psychology; D005260:Female; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D008297:Male; D008875:Middle Aged; D026684:Personal Autonomy; D014481:United States; D014486:United States Food and Drug Administration; D014947:Wounds and Injuries / Q000628:therapy*; D055815:Young Adult