title: Variation of community consultation and public disclosure for a pediatric multi-centered "Exception from Informed Consent" trial.
abstract: BACKGROUND
  The US federal regulation "Exception from Informed Consent for Emergency Research," 21 Code of Federal Regulations 50.24, permits emergency research without informed consent under limited conditions. Additional safeguards to protect human subjects include requirements for community consultation and public disclosure prior to starting the research. Because the regulations are vague about these requirements, Institutional Review Boards determine the adequacy of these activities at a local level. Thus, there is potential for broad interpretation and practice variation.
  
  
  OBJECTIVE
  To describe the variation of community consultation and public disclosure activities approved by Institutional Review Boards, and the effectiveness of this process for a multi-center, Exception from Informed Consent, pediatric status epilepticus clinical research trial.
  
  
  METHODS
  Community consultation and public disclosure activities were analyzed for each of the 15 participating sites. Surveys were conducted with participants enrolled in the status epilepticus trial to assess the effectiveness of public disclosure dissemination prior to study enrollment.
  
  
  RESULTS
  Every Institutional Review Board, among the 15 participating sites, had a varied interpretation of Exception from Informed Consent regulations for community consultation and public disclosure activities. Institutional Review Boards required various combinations of focus groups, interviews, surveys, and meetings for community consultation, and news releases, mailings, and public service announcements for public disclosure. At least 4335 patients received information about the study from these efforts. In all, 158 chose to be included in the "Opt Out" list. Of the 304 participants who were enrolled under Exception from Informed Consent, 12 (5%) had heard about the study through community consultation or public disclosure activities. The activities reaching the highest number of participants were surveys and focus groups associated with existing meetings. Public disclosure activities were more efficient and cost-effective if they were part of an in-hospital resource for patients and families.
  
  
  CONCLUSIONS
  There is substantial variation in Institutional Review Boards' interpretations of the federal regulations for community consultation and public disclosure. One of the goals of community consultation and public disclosure efforts for emergency research is to provide community members an opportunity to opt out of Exception from Informed Consent research; however, rarely do patients or their legally authorized representatives report having learned about a study prior to enrollment.
authors.affiliation: Department of Pediatrics, University of Utah, Salt Lake City, UT, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA Maija.holsti@hsc.utah.edu.
authors.forename: Maija
authors.initials: M
authors.lastname: Holsti
authors.affiliation: Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, ON, Canada.
authors.forename: Roger
authors.initials: R
authors.lastname: Zemek
authors.affiliation: Department of Emergency Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
authors.forename: Jill
authors.initials: J
authors.lastname: Baren
authors.affiliation: Department of Emergency Medicine, University of Michigan, Ann Arbor, MI, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
authors.forename: Rachel M
authors.initials: RM
authors.lastname: Stanley
authors.affiliation: Department of Pediatrics, Wayne State University School of Medicine, Detroit, MI, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
authors.forename: Prashant
authors.initials: P
authors.lastname: Mahajan
authors.affiliation: University of California, Davis, Davis, CA, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
authors.forename: Cheryl
authors.initials: C
authors.lastname: Vance
authors.affiliation: Division of Emergency Medicine, Children's National Medical Center, Washington, DC, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Brown
authors.affiliation: Baylor College of Medicine, Houston, TX, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
authors.forename: Victor
authors.initials: V
authors.lastname: Gonzalez
authors.affiliation: The EMMES Corporation, Rockville, MD, USA.
authors.forename: Denise
authors.initials: D
authors.lastname: King
authors.affiliation: Department of Pediatrics, University of Utah, Salt Lake City, UT, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
authors.forename: Kammy
authors.initials: K
authors.lastname: Jacobsen
authors.affiliation: Division of Emergency Medicine, Children's National Medical Center, Washington, DC, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
authors.forename: Kate
authors.initials: K
authors.lastname: Shreve
authors.affiliation: University of Texas, Southwestern, Dallas, TX, USA.
authors.forename: Katrina
authors.initials: K
authors.lastname: van de Bruinhorst
authors.affiliation: University of Texas, Southwestern, Dallas, TX, USA.
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Jones
authors.affiliation: Division of Emergency Medicine, Children's National Medical Center, Washington, DC, USA The Pediatric Emergency Care Applied Research Network, Salt Lake City, UT, USA.
authors.forename: James M
authors.initials: JM
authors.lastname: Chamberlain
mesh_terms: D000293:Adolescent; D035843:Biomedical Research / Q000331:legislation & jurisprudence; D002648:Child; D002675:Child, Preschool; D030881:Disclosure / Q000331:legislation & jurisprudence*; D004311:Double-Blind Method; D004632:Emergency Medical Services / Q000331:legislation & jurisprudence / Q000458:organization & administration; D005260:Female; D017144:Focus Groups; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D008297:Male; D015337:Multicenter Studies as Topic / Q000379:methods*; D010372:Pediatrics; D011159:Population Surveillance; D016032:Randomized Controlled Trials as Topic / Q000331:legislation & jurisprudence*; D012017:Referral and Consultation / Q000458:organization & administration; D012107:Research Design; D020458:Third-Party Consent / Q000331:legislation & jurisprudence; D014481:United States
keywords: Emergency research; Exception from Informed Consent; community consultation; multi-centered randomized double-blinded controlled study; pediatrics; public disclosure