A case study evaluation of ethics review systems for multicentre clinical trials

To the Editor: Hicks and colleagues are to be commended for reporting the benefits of the single ethics review system for multicentre trials in reducing the time taken for review, reducing unnecessary duplication of effort, and standardising documentation.1 They based their analysis on the overall time to approval, which included both an ethics and a governance component.

The single ethics review model introduced by NSW Health in July 2007 separates scientific and ethics review from business or governance review (which requires site-specific approval). The Australian Research Ethics Database, developed by Infonetica for NSW Health, is used by the Cancer Institute NSW Clinical Research Ethics Committee (CREC) to track and manage multicentre research projects. It uses a 60-calendar-day clock to measure the time from submission to approval.2 The 60-day period sets a benchmark and represents a reasonable target review time. This clock stops, for example, when the CREC has sent a letter to the investigator and is awaiting a response. This method of measurement makes the total number of days for ethics review even shorter — for example, for the CO.20 trial described by Hicks and colleagues,1 the total number of days would be 66 rather than the 77 days they reported.

It should be noted that if the CREC, which I chaired, sought changes to the participant information sheet after the first review of a research submission, the response was approved by the executive of the committee between full committee meetings. We used executive review more extensively than other committees to save time. This and other efficiencies, such as reducing the time between submission and the first ethics committee review and using a paperless review system, make it more likely that we will achieve a review time of less than 60 days as the committee becomes more experienced. This makes the adoption of a single ethics review system even more attractive.