title: A burn center paradigm to fulfill deferred consent public disclosure and community consultation requirements for emergency care research.
abstract: BACKGROUND
  To fulfill Food and Drug Administration and Department of Health and Human Services emergency care research informed consent requirements, our burn center planned and executed a deferred consent strategy gaining Institutional Review Board (IRB) approval to proceed with the clinical study. These federal regulations dictate public disclosure and community consultation unique to acute care research.
  
  
  OBJECTIVE
  Our regional burn center developed and implemented a deferred consent public notification and community consultation paradigm appropriate for a burn study.
  
  
  METHODS
  Published accounts of deferred consent strategies focus on acute care resuscitation practices. We adapted those strategies to design and conduct a comprehensive public notification/community consultation plan to satisfy deferred consent requirements for burn center research.
  
  
  RESULTS
  To implement a robust media campaign we engaged the hospital's public relations department, distributed media materials, recruited hospital staff for speaking engagements, enlisted community volunteers, and developed initiatives to inform "hard-to-reach" populations. The hospital's IRB determined we fulfilled our obligation to notify the defined community.
  
  
  CONCLUSIONS
  Our communication strategy should provide a paradigm other burn centers may appropriate and adapt when planning and executing a deferred consent initiative.
authors.affiliation: Division of Clinical Pharmacology and Toxicology, Children's Hospital Medical Center of Akron, Akron, OH 44308-1062, USA.
authors.forename: Martha G
authors.initials: MG
authors.lastname: Blackford
authors.forename: Lynn
authors.initials: L
authors.lastname: Falletta
authors.forename: David A
authors.initials: DA
authors.lastname: Andrews
authors.forename: Michael D
authors.initials: MD
authors.lastname: Reed
mesh_terms: D002053:Burn Units / Q000331:legislation & jurisprudence*; D002056:Burns / Q000628:therapy*; D003159:Community-Institutional Relations; D030881:Disclosure; D033161:Government Regulation; D006302:Health Services Research / Q000458:organization & administration*; D006801:Humans; D007258:Informed Consent; D014481:United States