1) To establish a protocol within international and local ethical guidelines to obtain informed consent for critical care research, overcoming constraints previously described and 2) To evaluate eventual recruitment using this protocol.Design:
Prospective descriptive study.Setting:
Multidisciplinary ICU in a community-based university teaching hospital.Patients and participants:
Following approval by the University Ethics Committee and Hospital Review Board, patients admitted between January and May 1996 were assessed on weekdays for potential enrolment into existing clinical trials. Discussion with potential candidates and/or next-of-kin occurred at the earliest opportunity and informed consent was obtained preemptively. Next-of-kin was notified if enrolment subsequently occurred. We evaluated the number of patients screened, the number of potential study candidates, the number for whom consent was obtained or refused and the number subsequently enrolled.Interventions:
Of 249 patients screened, 149 (60 %) did not meet the inclusion criteria. Of 100 potential study candidates (40 % of all patients screened), we failed to make contact with the next-of-kin in 29 cases (12 % of all patients screened). Thus 71 patients or next-of-kin were counselled (28 % of all patients screened). In all, 30 patients (12% of all patients screened) were subsequently enrolled into a study.Conclusions:
A policy of pre-emptive informed consent enabled us to overcome some of the problems previously experienced in our unit with regards to patient enrolment in critical care research. Although overall recruitment remained low, predictions for future enrolment can be made from this study.