Centralized and Non-Centralized Ethics Review: A Five Nation Study

The research ethics review process is now an inherent part of conducting research and a topic of much discussion. On the negative side it has been presented as cumbersome, expensive, time consuming, and potentially a system that does not adequately deal with the concerns it was set up to address. One common, but often controversial, proposal to address some of these concerns has been the institutionalization of centralized systems of review. This paper uses data on the review systems in place in five countries (Australia, Canada, New Zealand, the USA and the U.K.), some with and some without versions of centralized review, to explore issues related to centralization of the review process. It suggests that there are at least three types of systems (fully centralized, dual, and decentralized or multicommittee) in place; all are made up of two, interrelated components (the administrative and the ethics review). We suggest that both components need to be considered in discussions about centralized review. Serious consideration of centralization of the administrative component may address many concerns. Centralization of the ethics review may provide a context that deals with other issues and may encourage reviews that more effectively focus on the ethical issues involved.

The authors are both researchers on a project on the ethics review process funding by an Australian Research Council (ARC) Discovery Project grant (DP0343014).

The project upon which this paper is based has IRB approvals, including approval from the University of Sydney’s Human Ethics Committee.

Keywords:

• centralized research ethics review
• multisite review
• ethics review administration
• IRBs
• ethics committees

Acknowledgments

We would like to thank Elisa Yule who, as a Project Assistant, contributed to data collection and early analyses of the data. We would also like to thank the many people and committees who so generously shared their time, thoughts, and experiences with us, in particular the key informants who reviewed a draft of the article. This project was funded in part by a University of Sydney Study Leave Grant and an ARC (Australian Research Council) Discovery Project grant (DP0343014).

Notes

The authors are both researchers on a project on the ethics review process funding by an Australian Research Council (ARC) Discovery Project grant (DP0343014).

The project upon which this paper is based has IRB approvals, including approval from the University of Sydney’s Human Ethics Committee.

¹Some may have projects that involved higher numbers of reviews, but specific numbers did not come out in all interviews where this topic was discussed.

²One key informant suggested that system may not be the appropriate term. What we have called systems are really just an accumulation of practices that have resulted from responses to other imperatives, such as the need for ethics review before institutions can have access to public funding.

³The New Zealand observational data were collected in 2003. New Zealand instituted changes in its ethics review of health research in 2005.

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