• Curr Opin Crit Care · Apr 2007

    Review

    Emergency research: only possible if consent is waived?

    • Francois Lemaire.
    • Assistance Publique Hôp de Paris, Hôpital H. Mondor, Paris 12 University, Créteil, France. francois.lemaire@hmn.aphp.fr
    • Curr Opin Crit Care. 2007 Apr 1;13(2):122-5.

    Purpose Of The ReviewEmergency research is possible only if informed consent is waived. Recent legislations have specifically addressed this issue, both in the US and in Europe.Recent FindingsIn 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.SummaryDue 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.

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