(p. 104) Research ethics in the ICU 

In no context is rigorous clinical research more important than in ICU care. However, clinical research in the ICU poses numerous ethical challenges, some of which are unique or particularly problematic in the ICU setting. Significant barriers exist to informed consent, and existing approaches to consent challenges are limited and lack evidence. Moreover, some studies can only be done in the absence of consent. Additionally, high levels of acuity and variable levels of evidence for both current and innovative treatments often make assessments of equipoise and control group selection particularly difficult. Finally, studies evaluating systems-based approaches to ICU care are integral to advancing the field. However, these studies can be difficult to distinguish from quality improvement activities and require careful consideration given their potential impact on major patient outcomes and the impracticability of informed consent in this context. This chapter discusses these prominent ethical issues in ICU research, and argues that there is a need for further research on ethical dimensions of clinical research in the ICU as well as a need for innovative, context-sensitive solutions.