PURPOSE: 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.
PURPOSE: 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.
Authors: Liselotte N Dyrbye; Matthew R Thomas; Alex J Mechaber; Anne Eacker; William Harper; F Stanford Massie; David V Power; Tait D Shanafelt Journal: Acad Med Date: 2007-07 Impact factor: 6.893
Authors: Massimo Antonelli; Elie Azoulay; Marc Bonten; Jean Chastre; Giuseppe Citerio; Giorgio Conti; Daniel De Backer; François Lemaire; Herwig Gerlach; Goran Hedenstierna; Michael Joannidis; Duncan Macrae; Jordi Mancebo; Salvatore M Maggiore; Alexandre Mebazaa; Jean-Charles Preiser; Jerôme Pugin; Jan Wernerman; Haibo Zhang Journal: Intensive Care Med Date: 2010-02-23 Impact factor: 17.440