Critical care research and pre-emptive informed consent: a practical approach used in Chris Hani Baragwanath ICU.
OBJECTIVE
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.


METHODS
Prospective descriptive study.


METHODS
Multidisciplinary ICU in a community-based university teaching hospital.


METHODS
Following approval by the University Ethics Committee and Hospital Review Board, patients admitted between January and May 1996 were assessed on weekdays for potential enrollment 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 enrollment 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.


METHODS
None


RESULTS
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 enrollment in critical care research. Although overall recruitment remained low, predictions for future enrollment can be made from this study.
Pinder
M
M
Intensive Care Unit, Chris Hani Baragwanath Hospital, Department of Anaesthesia, University of the Witwatersrand, Soweto, South Africa. franhast@netspace.com.au
Tshukutsoane
S
S
Scribante
J
J
Piccolo
R
R
Lipman
J
J
D000465:Algorithms; D002986:Clinical Trials as Topic; D003422:Critical Care / Q000331:legislation & jurisprudence; D003663:Decision Trees; D004992:Ethics, Medical; D017408:Guidelines as Topic; D006785:Hospitals, University; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D007362:Intensive Care Units; D016134:Organizational Policy; D011446:Prospective Studies; D012106:Research; D013019:South Africa