Informed consent in the intensive care unit: ensuring understanding in a complex environment.
OBJECTIVE
Informed consent in the intensive care unit continues to receive marked attention. As greater numbers of patients enter into the intensive care unit with devastating illness, patients and families are faced with more complex medical problems and decisions regarding therapy. Furthermore, research investigations of critical illness add a level of complexity to informed consent and decision making that mandates a careful approach.


RESULTS
Publications in the past year evidence the potential obstacles for appropriate informed consent. Physicians demonstrate variability in interpretation for the need for informed consent and frequently lack formal training in communicating informed consent. Critical care researchers must communicate the goals and benefits of trial participation carefully, avoiding the demonstrably common pitfall of therapeutic misconception. Excellent consensus statements now exist to guide the researcher in pursuing critical care research, creating informed consent documentation, and recognizing the appropriate setting for waiver of consent. As expected, extended discussion is the most effective tool for improving the quality of informed consent.


CONCLUSIONS
Quality of informed consent for the critically ill improves as attention is paid to standardizing indications and formalizing training for physicians. In research, conflicts of interest should be recognized and used to guide the investigator's dialogue on research benefits and risks. Patient safety must be maintained as the primary priority; however, waiver of consent may be considered in situations in which the benefit to medical knowledge far exceeds patient risk.
Schweickert
William
W
Section of Pulmonary/Critical Care Medicine, University of Chicago Hospitals, Chicago, Illinois 60637, USA.
Hall
Jesse
J
D002986:Clinical Trials as Topic / Q000941:ethics; D032882:Comprehension; D003657:Decision Making; D032984:Ethics, Research; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D007362:Intensive Care Units; D011786:Quality Control