CRITICAL CARE RESEARCH AND PREEMPTIVE INFORMED CONSENT - A PRACTICAL APPROACH USED IN CHRIS-HANI-BARAGWANATH-ICU

Objectives: 1) To establish a protocol within international and local ethical guidelines to obtain in formed consent for critical care resea rch, overcoming constraints previously described and 2) To evaluate ev entual recruitment using this protocol. Design: Prospective descriptiv e study. Setting: Multidisciplinary ICU in a community-based universit y teaching hospital. Patients and participants: Following approval by the University Ethics Committee and Hospital Review Board, patients ad mitted between January and May 1996 were assessed on weekdays for pote ntial enrolment into existing clinical trials. Discussion with potenti al candidates and/or next-of-kin occurred at the earliest opportunity and informed consent was obtained preemptively. Next-of-kin was notifi ed if enrolment subsequently occurred. We evaluated the number of pati ents screened, the number of potential study candidates, the number fo r whom consent was obtained or refused and the number subsequently enr olled. Interventions: None. Results: Of 249 patients screened, 149 (60 %) did not meet the inclusion criteria. Of 100 potential study candida tes (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 patie nts or next-of-kin were counselled (28% of all patients screened). In all, 30 patients (12% of all patients screened) were subsequently enro lled into a study. Conclusions: A policy of pre-emptive informed conse nt enabled us to overcome some of the problems previously experienced in our unit with regards to patient enrolment in critical care researc h. Although overall recruitment remained low, predictions for future e nrolment can be made from this study.