, Volume 34, Issue 7, pp 1330-1332
Date: 04 Apr 2008

Clinical research in critically ill patients: the situation in Italy

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Introduction

Clinical research in critically ill patients is a particularly complex issue, due to the frequent incompetence of such patients and their consequent inability to give valid consent. Under the European Parliamentary Directive 2001/20/EC, informed consent may be granted either by the patient or by the legal representative of the incompetent patient [1]. In Italy, a legislative decree gave implementation to such directive; yet, it failed to specify who should be identified as legal guardian [2]. Concerns have been expressed that such a directive would bring research to a halt in critically ill incompetent patients [3], i.e., the majority of ICU patients [4].

Research studies in cancer patients have demonstrated an unacceptably low patients' comprehension of the protocols they had consented to enter [5, 6]. The competence of critically ill patients is much less adequate. This is an even more troubling issue in patients declining recommended life-saving treatments. In a well-docu