Informed consent for research in ICU obtained before ICU admission

Objective: To analyze the procedure of the informed consent for ICU research obtained before ICU admission. Design: Prospective, open, observational study. Setting: 20-bed surgical ICU of a tertiary teaching university hospital and the ward before and after ICU. Patients: Patients, scheduled for elective cardiac surgery, who accepted to participate in a coagulation study. Interventions: Patients underwent the same informed consent procedure, including an oral presentation of the coagulation study and an informative leaflet the day before surgery on the ward. Measurements and results: Between January and August 2001, we included 38 patients; 36 survived ICU. Ten to 12 days after surgery, 8/36 (22%) patients did not know they had participated in a study, and 9/36 (25%) could not recall the study purpose and the related risk. Patients with incomplete recall stayed longer in ICU [median (range): 4 (3-6) vs 3 (1-5) days; p = 0.004]. None of these patients (0/9 vs 10/27; p < 0.04) had read the informative leaflet AND asked at least one question during the informed consent procedure. Conclusions: Even when the informed consent is obtained in the most optimal conditions for ICU research, its ethical value remains questionable. Indeed, a substantial number of patients were unaware of their study participation, or of the related purpose and risks. When the ICU stay is prolonged, we should at least repeatedly and actively (re)-inform patients about their study participation.