Patients in Trials Often Forget Risks
Study suggests informed consent may need to be revisited as trials progress
FRIDAY, Dec. 8, 2006 (HealthDay News) -- Many critically ill patients who consent to participate in a clinical trial soon forget the risks and purpose of the trial, a small Swiss study finds.
The findings suggest that obtaining informed consent from patients should be a process that's revisited a number of times, rather than just once at the start of a trial. Patients need to be given information repeatedly during a trial, the study authors wrote in the Dec. 7 issue of Critical Care.
The study of 44 intensive care unit (ICU) patients at the University Hospital of Geneva who agreed to take part in a clinical trial on inflammatory responses found that two-thirds of the patients no longer remembered the purpose or risks of the trial 10 days after they'd given their informed consent.
Before they agreed to take part in the trial, the patients were given a 20-minute presentation about the trial, its purpose and its risks. They were also given a leaflet to read.
Ten days into the trial, 35 of the 44 patients remembered having taken part in the trial. However, only 20 of them remembered the purpose of the trial, and 21 remembered the risks. Only 14 remembered both the purpose and the risks. Those 14 patients did not differ from the other patients, except that they had read the information leaflet or had asked at least one question during the pretrial presentation.
The U.S. National Institutes of Health has more about clinical trials and informed consent.