, Volume 33, Issue 10, pp 1819-1822
Date: 10 Aug 2007

Evaluating benefits and harms in intensive care research

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Introduction

Intensive care research is essential if we are to further our understanding of the mechanisms of disease and develop safe and effective treatments for acutely ill patients. However, the ethics of intensive care research remains hotly debated. In the USA, an investigation of ARDSNet clinical trials centering on issues of informed consent and study design led to a prolonged suspension of the FACCT clinical trial [1]. In Europe, debate has focused on the recent European Clinical Trials Directive [2]. In both instances, it seems clear that heightened ethical scrutiny stems from the widespread perception that intensive care research poses serious risk to a vulnerable patient population. The consequences of this sort of risk anxiety are weighty. In the words of one commentator, “[i]f current trends continue, within several years it could become impossible to conduct research in critical care medicine” [3].

Central to current controversies is the question of whether benefits and ha ...