Abstract

Background: Previous studies have found lapses in ethical safeguards for subjects of critical-care research. Objective: To assess recently published empiric critical-care research conducted in the United States for the reporting of research protections as they relate to informed consent and surrogate decision-making. Methods: Systematic review of a sample of empiric critical-care research studies published between 2000 and 2004. Results: Of 51 studies reviewed, consent was reported as having been obtained in 44. Assessment of subjects' decision-making capacity was noted in 35% of studies. Assessments of subjects' capacity was less likely to be reported in studies in which researchers accepted consent from either subjects or from third parties, compared to studies with only subjects' consent. Five studies did not report securing Institutional Review Board approval. Conclusion: Lapses in the reporting of critical-care research are prevalent.