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Deferred consent in emergency intensive care research: what if the patient dies early? Use the data or not?

Intensive Care Medicine
Publication Date
DOI: 10.1007/s00134-007-0580-8
  • Legal And Ethical Issues In Clinical Research
  • Philosophy


Intensive Care Med (2007) 33:894–900 DOI 10.1007/s00134-007-0580-8 LEGAL AND ETHICAL ISSUES IN CLINICAL RESEARCH T. C. Jansen E. J. O. Kompanje C. Druml D. K. Menon C. J. Wiedermann J. Bakker Deferred consent in emergency intensive care research: what if the patient dies early? Use the data or not? Received: 18 January 2007 Accepted: 5 February 2007 Published online: 7 March 2007 © Springer-Verlag 2007 T. C. Jansen · E. J. O. Kompanje (�) · J. Bakker Erasmus MC University Medical Center, Department of Intensive Care, P.O. Box 2040, 3000 CA Rotterdam, The Netherlands e-mail: [email protected] C. Druml Medical University of Vienna, Ethics Committee of the Medical University of Vienna and the Vienna General Hospital, Borschkegasse 8b, 1090 Vienna, Austria D. K. Menon University of Cambridge, Division of Anaesthesia, Addenbrooke’s Hospital, CB2 2QQ Cambridge, UK C. J. Wiedermann Central Hospital of Bolzano, Department of Medicine l, Böhler Street 5, 39100 Bolzano, Italy Introduction Respect for individual autonomy, expressed in the concept of informed consent, is the basic ethical principle in re- search with humans. Many ICU patients are unable to give consent as a consequence of mental incapacity, and this can be further complicated in emergency situations, in which treatment needs to be initiated without delay. Various ap- proaches are used as surrogate to subject consent: waiver of consent, consent by an independent physician and de- ferred consent. Deferred consent involves randomization at the investigator’s discretion according to criteria that have been explicit during ethical review of the protocol, followed by the request for patient’s (deferred subject con- sent) or representative’s (deferred proxy consent) informed consent in a later phase. Several emergency trials have used deferred consent [1, 2, 3, 4]. During the enrolment process in an ongoing Dutch multi-centre randomized controlled trial using deferred consent the situation arose that no deferred (subjec

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