Enhancing informed consent for research and treatment

Increased scrutiny of informed consent calls for further research into deci sion making by patients who may be at risk for impairments. We review inter ventions designed to improve patient understanding of informed consent. A n umber of studies, within as well as outside psychiatry, have evaluated the effectiveness of specific interventions, as well as possible "predictors" o f understanding of consent, such as subject characteristics, psychiatric sy mptoms, and cognitive impairment. Deficits in patients' understanding of in formed consent may be partially related to poorly conceived, written, or or ganized informed consent materials; these deficits may be remediable with e ducational interventions. We find that effective interventions include corr ected feedback, multiple learning trials, and more organized or simplified consent forms. Educational levels of patients generally correlate with leve ls of understanding. Even among individuals with psychiatric illness or cog nitive impairment, deficits in understanding can be remedied with certain e ducational interventions. A variety of interventions can enhance understand ing of informed consent. (C) 2001 American College of Neuropsychopharmacolo gy. Published by Elsevier Science. Inc.