title: Protecting research subjects under the waiver of informed consent for emergency research: experiences with efforts to inform the community.
abstract: OBJECTIVE
  The US Food and Drug Administration (FDA) and Department of Health and Human Services created a method for obtaining a waiver of informed consent to permit research in emergency settings when patients are not competent. One of the requirements to obtain a waiver is public disclosure about the research. We describe approaches used to meet the public disclosure requirement.
  
  
  METHODS
  We performed a qualitative content analysis of the FDA's repository for mandatory documentation of public disclosure efforts as of November 1999. Data from 4 studies were analyzed: 2 multi-institutional trials involving trauma and 2 smaller trials involving cardiac arrest. These efforts included both 1-way communications, such as announcements, and 2-way communications, such as focus groups and public meetings. Participation in and common concerns expressed during 2-way communications were noted, as was evidence of mechanisms of advance refusal and the collection of quantitative data on public opinion.
  
  
  RESULTS
  One-way communications were the predominant method of disclosure. Many 2-way communications were not directed toward lay persons. Those that were often involved fewer than 15 participants. Concerns regarding inability to refuse study participation, racial biases affecting study design and execution, and ambiguity with regard to how community input would be used in study decision making were raised in several 2-way communications. A minority of participating hospitals announced mechanisms of advance refusal or collected quantitative data on public opinion concerning proposed research.
  
  
  CONCLUSIONS
  Initial experience with obtaining a waiver of informed consent for emergency research suggests that community involvement and specific public concerns should be carefully considered in future applications for such a waiver.
authors.affiliation: Duke University School of Medicine and the Department of Medicine, Duke University Medical Center, Durham, NC 27710, USA.
authors.forename: Amit Navin
authors.initials: AN
authors.lastname: Shah
authors.forename: Jeremy
authors.initials: J
authors.lastname: Sugarman
mesh_terms: D016887:Cardiopulmonary Resuscitation; D003142:Communication; D003657:Decision Making; D030881:Disclosure; D004311:Double-Blind Method; D004554:Electric Countershock; D004635:Emergency Medicine; D017144:Focus Groups; D006323:Heart Arrest / Q000628:therapy; D006801:Humans; D007258:Informed Consent; D015337:Multicenter Studies as Topic; D011639:Public Opinion; D016032:Randomized Controlled Trials as Topic; D012106:Research; D012771:Shock, Hemorrhagic / Q000628:therapy; D014481:United States; D014486:United States Food and Drug Administration