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

2007; Springer Science+Business Media; Volume: 33; Issue: 5 Linguagem: Inglês

10.1007/s00134-007-0580-8

1432-1238

Tim C. Jansen, Erwin J. O. Kompanje, Christiane Druml, David Menon, Christian J. Wiedermann, Jan Bakker,

Ethics in medical practice

Respect for individual autonomy, expressed in the concept of informed consent, is the basic ethical principle in research 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 approaches are used as surrogate to subject consent: waiver of consent, consent by an independent physician and deferred 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 consent) 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 (subject or proxy) consent was obtained from patients who died early after start of the study. Should data of these patients be used or not? In this article we analyse this practical and ethical problem.