title: Researchers' understanding of the federal guidelines for waiver of and exception from informed consent.
abstract: The survival of patients who present to the emergency department with severe injury or illness is dismal. Resuscitation researchers are interested in advancing the science of resuscitation, and clinical studies must be conducted to determine the best treatment protocols. These studies must reflect good science and must balance individual patient autonomy and safety with scientific progress that benefits society as a whole. Researchers find the present federal guidelines on waiver of and exception from informed consent to be time consuming and expensive. They see variability in the requirements as interpreted by institutional review boards. There is confusion regarding the requirements for public notification and response to community consultation. They believe that the majority of the public, as well as health care professionals, want resuscitation research to progress, but a minority of people and governmental regulators are uncomfortable with waiver of and exception from informed consent for research studies. There is concern and some evidence that the federal guidelines have impeded the advancement of resuscitation science. Several strategies have been suggested to improve the situation. These include 1) better education of resuscitation researchers regarding the federal guidelines, 2) a toolbox for resuscitation researchers clarifying the guidelines, 3) advocacy for the advancement of resuscitation science as a public good, and 4) a national research advisory board that provides unbiased reviews of clinical studies and guidelines for local institutional review boards regarding risks, benefits, and communication strategies for waiver of and exception from consent proposals.
authors.affiliation: Department of Emergency Medicine, University of Arizona, Tucson, AZ, USA. art@aemrc.arizona.edu
authors.forename: Arthur B
authors.initials: AB
authors.lastname: Sanders
authors.forename: Kathy
authors.initials: K
authors.lastname: Hiller
authors.forename: John
authors.initials: J
authors.lastname: Duldner
mesh_terms: D003159:Community-Institutional Relations; D003245:Consensus Statements as Topic; D004635:Emergency Medicine / Q000941:ethics / Q000592:standards*; D035082:Federal Government; D019983:Guideline Adherence / Q000941:ethics / Q000592:standards*; D017408:Guidelines as Topic; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D007258:Informed Consent / Q000941:ethics / Q000592:standards*; D012151:Resuscitation / Q000941:ethics / Q000592:standards; D014481:United States