ABSTRACT

Research involving critically ill patients presents special ethical challenges, largely due to such patients having deadly diseases, being vulnerable, and having cognitive impairments that preclude obtaining their valid, informed consent. Several publications have outlined the basic ethical principles of autonomy, beneficence, nonmaleficence, and justice [1] that govern the conduct of clinical research. These principles have also been further specified into ethical requirements that provide a systematic and coherent framework for determining whether research is ethical [2] (Fig. 1). We address several of these requirements that we believe need further clarification, especially when applied in the critical care context. Also, the recent introduction of the European Directive [3] warrants further examination and its applicability to critical care research.