title: International variation in policies and practices related to informed consent in acute cardiovascular research: Results from a 44 country survey.
abstract: BACKGROUND
  Research in an emergency setting such as that with an acute cardiovascular event is challenging because the window of opportunity to treat may be short and may preclude time to obtain informed consent from the patient or their representative. Some perceive that requiring informed consent in emergency situations has limited improvements in care. Vulnerable populations including minorities or residents of low-income countries are at greatest risk of need for resuscitation. Lack of enrollment of such patients would increase uncertainties in treatment benefit or harm in those at greater risk of need for resuscitation. We sought to assess international variation in policies and procedures related to exception from informed consent (EFIC) or deferred consent for emergency research.
  
  
  METHODS
  A brief survey instrument was developed and modified by consensus among the investigators. Included were multiple choice and open-ended responses. The survey included an illustrative example of a hypothetical randomized study. Elicited information included the possibility of conducting such a study in the respondent's country, as well as approvals required to conduct the study. The population of interest was emergency physicians or other practitioners of acute cardiovascular event research.
  
  
  RESULTS
  Usable responses were obtained from 44 countries (76% of surveyed). Community opposition to EFIC was noted in 6 (14%) countries. Emergency Medical Services (EMS) providers in 8 (20%) countries were judged unable or unwilling to participate. A majority of countries (36, 82%) required approval by a Research Ethics Committee or similar. Government approval was required in 25 (57%) countries.
  
  
  CONCLUSIONS
  There is international variation in practices and policies related to consent for emergency research. There is an ongoing need to converge regulations based on the usefulness of multinational emergency research to benefit both affluent and disadvantaged populations.
authors.affiliation: Clinical Trial Center, Department of Biostatistics, University of Washington, Seattle, WA, USA.
authors.forename: Gerald
authors.initials: G
authors.lastname: van Belle
authors.affiliation: University of Athens Medical School, Athens, Greece.
authors.forename: Spyros D
authors.initials: SD
authors.lastname: Mentzelopoulos
authors.affiliation: Medical College of Wisconsin, Milwaukee, WI, USA.
authors.forename: Tom
authors.initials: T
authors.lastname: Aufderheide
authors.affiliation: Clinical Trial Center, Department of Biostatistics, University of Washington, Seattle, WA, USA.
authors.forename: Susanne
authors.initials: S
authors.lastname: May
authors.affiliation: Clinical Trial Center, Department of Biostatistics, University of Washington, Seattle, WA, USA; University of Washington-Harborview Center for Prehospital Emergency Care, Department of Medicine, University of Washington, Seattle, WA, USA. Electronic address: nichol@uw.edu.
authors.forename: Graham
authors.initials: G
authors.lastname: Nichol
mesh_terms: D035843:Biomedical Research; D004635:Emergency Medicine / Q000941:ethics*; D032984:Ethics, Research; D005260:Female; D006323:Heart Arrest / Q000628:therapy*; D006801:Humans; D007258:Informed Consent / Q000941:ethics*; D008297:Male; D057766:Policy; D012151:Resuscitation / Q000941:ethics*; D011795:Surveys and Questionnaires
keywords: Cardiac arrest; Consent; Emergency medicine; Research; Survey