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.


METHODS
Prospective, open, observational study.


METHODS
20-bed surgical ICU of a tertiary teaching university hospital and the ward before and after ICU.


METHODS
Patients, scheduled for elective cardiac surgery, who accepted to participate in a coagulation study.


METHODS
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.


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.
Chenaud
Catherine
C
Geneva University Hospital, Service des Soins Intensifs de Chirurgie, Département APSIC, Rue Micheli-du-Crest 24, 1211, Geneva 14, Switzerland. catherine.chenaud@hcuge.ch
Merlani
Paolo
P
Ricou
Bara
B
D000368:Aged; D035843:Biomedical Research / Q000458:organization & administration*; D005260:Female; D006784:Hospitals, Teaching; D006801:Humans; D007258:Informed Consent; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D010343:Patient Admission; D011446:Prospective Studies; D013557:Switzerland