title: Emergency research: only possible if consent is waived?
abstract: OBJECTIVE
  Emergency research is possible only if informed consent is waived. Recent legislations have specifically addressed this issue, both in the US and in Europe.
  
  
  RESULTS
  In the US, a specific regulation was enacted in 1996. Due to the added complexity, few trials have used this design. The necessity to inform the community in which a trial is supposed to take place, though feasible, is burdensome and time consuming. In the EU, directive 2001/20/CE forgot to specify particular rules for research in emergency conditions. After 2004, national legislations were supposed to implement the directive in order to enhance homogeneity within Europe, but actually showed an extreme diversity, with some countries allowing waiver of consent in emergency situations and others refusing it.
  
  
  CONCLUSIONS
  Due to the active lobbying of emergency and intensive care specialists, the situation is slowly improving, with most national legislations recognizing the specificities and difficulty of emergency research.
authors.affiliation: Assistance Publique Hôp de Paris, Hôpital H. Mondor, Paris 12 University, Créteil, France. francois.lemaire@hmn.aphp.fr
authors.forename: Francois
authors.initials: F
authors.lastname: Lemaire
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D003422:Critical Care / Q000941:ethics*; D004638:Emergency Treatment / Q000941:ethics*; D032984:Ethics, Research; D005060:Europe; D020408:Health Insurance Portability and Accountability Act; D006801:Humans; D007258:Informed Consent; D014481:United States