title: Are US informed consent requirements driving resuscitation research overseas?
abstract: Following a 2-year federally imposed moratorium on acute resuscitation research due to concern regarding the inability of patients in cardiac arrest to provide prospective, informed consent to participate in such research, the United States federal government in 1996 released regulations with provisions for exemption of prospective informed consent in certain types of emergency research. While very few acute resuscitation research studies have been attempted in the United States since that time, such research has continued overseas. We discuss one large multi-center, out-of-hospital trial of a device intended to improve the hemodynamics of cardiopulmonary resuscitation. After pilot implementation overseas, this trial could not be conducted in the United States, largely due to the difficulties and costs involved in implementing the requirements of the 1996 regulations. A recent European Union directive on the conduct of clinical trials may halt European research on patients who are unable to provide prospective, informed consent. The directive contains no provisions for exceptions or waiver of informed consent, and may hinder acute resuscitation research in Europe to an even greater degree than the 1996 regulations have in the United States.
authors.affiliation: Yale University School of Medicine, Suite 260, 464 Congress Avenue, New Haven, CT 06519-1315, USA. david.cone@yale.edu
authors.forename: David C
authors.initials: DC
authors.lastname: Cone
authors.forename: Robert E
authors.initials: RE
authors.lastname: O'Connor
mesh_terms: D016887:Cardiopulmonary Resuscitation / Q000592:standards; D005062:European Union; D005260:Female; D033161:Government Regulation; D006323:Heart Arrest / Q000628:therapy*; D006801:Humans; D007258:Informed Consent; D008297:Male; D012106:Research; D012151:Resuscitation / Q000592:standards*; D014481:United States