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Intensive Care Medicine
Published in: Intensive Care Medicine 4/2009

01-04-2009 | Special Article

Protocols in expedited review: tackling the workload of ethics committees

Authors: Michael Wolzt, Christiane Druml, Daniela Leitner, Ernst A. Singer

Published in: Intensive Care Medicine | Issue 4/2009

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Abstract

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.
Literature
1.
Vick CC, Finan KR, Kiefe C, Neumayer L, Hawn MT (2005) Variation in institutional review processes for a multisite observational study. Am J Surg 190:805–809PubMedCrossRef
2.
Green LA, Lowery JC, Kowalski CP, Wyszewianski L (2006) Impact of institutional review board practice variation on observational health services research. Health Serv Res 41:214–230PubMedCrossRef
3.
Dyrbye LN, Thomas MR, Mechaber AJ et al (2007) Medical education research and IRB review: an analysis and comparison of the IRB review process at six institutions. Acad Med 82:654–660PubMedCrossRef
4.
Larson E, Bratts T, Zwanziger J, Stone P (2004) A survey of IRB process in 68 US hospitals. J Nurs Scholarsh 36:260–264PubMedCrossRef
5.
6.
7.
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (2001) J Eur Commun L 121:34–44
Metadata
Title
Protocols in expedited review: tackling the workload of ethics committees
Authors
Michael Wolzt
Christiane Druml
Daniela Leitner
Ernst A. Singer
Publication date
01-04-2009
Publisher
Springer-Verlag
Published in
Intensive Care Medicine / Issue 4/2009
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-008-1343-x

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