Protocols in expedited review: tackling the workload of ethics committees.
OBJECTIVE
This paper describes the experience of the Ethics Committee of the Medical University of Vienna, Austria, while managing the workload of clinical study applications.


METHODS
An expedited review process was introduced for initial review of study protocols regarded as minimal risk interventions in March 2004.


RESULTS
A total of 504 study protocols were submitted for review in 2003 and this number has increased to 743 in 2007. Two hundred sixty eight studies were classified as minimal risk in 2007 and allocated to a subgroup of the Committee for review. The time to full approval was shorter for these studies as compared to other protocols.


CONCLUSIONS
Implementation of initial expedited review can improve the performance of an Ethics Committee. A framework to achieve a single opinion for multisite research of minimal risk interventions should be considered to facilitate these low risk studies.
Wolzt
Michael
M
Ethics Committee of the Medical University of Vienna, Vienna, Austria. michael.wolzt@meduniwien.ac.at
Druml
Christiane
C
Leitner
Daniela
D
Singer
Ernst A
EA
D000046:Academic Medical Centers; D001317:Austria; D002985:Clinical Protocols / Q000592:standards*; D017041:Ethics Committees / Q000331:legislation & jurisprudence*; D006801:Humans; D012308:Risk Management / Q000331:legislation & jurisprudence*; D014495:Universities; D035862:Vulnerable Populations / Q000331:legislation & jurisprudence; D016526:Workload