Beyond the protocol: navigating ethics and governance in the multisite QASC Australasia trial.

Abstract

Background: Multicentre studies require ethics and governance approvals from individual sites with the potential for duplication and costly delays. Aim(s): To describe the ethics and governance approval processes for a multicentre international stroke randomised controlled trial (QASC Australasia Trial). Findings were compared to our previous Australian multicentre T3 Trial. Method(s): Prospective, descriptive analysis (November 2021 - April 2024) for Australian sites. Result(s): We required lead ethics approval from NSW (n=1), ethics approvals from Western Australia (n=1) and Northern Territory (n=2), with n=52 individual site governance applications. Lead ethics took 4.3 weeks (median), requiring one revision; all three ethics approvals took 1.6 weeks (median) (range: 0.6- 4.3 weeks). Median time for 45 governance approvals was 13.1 weeks (range: 0.9-54.3 weeks) excluding 6 sites awaiting approval (median 51.9 weeks, range: 12-72.6 weeks to-date). Median time for Clinical Trials Research Agreement execution (n=45 sites) was 7.4 weeks (range: 0.9-44.4 weeks). The 2012-2014 T3 Trial processes were longer: lead ethics took 10 weeks (median); all five ethics approvals took 6 weeks (median) (range: 3-10 weeks); 21 governance approvals took 16 weeks (median) (range: 7-28 weeks). According to the recommended 8.6-week timeframe1, ethics review time was met for all applications but exceeded in 68.9% (n=31/45) of governance applications. Conclusion(s): While there are notable improvements in obtaining ethics approval, the governance process for multicentre studies continues to be time consuming, contributing to delays in translation of research into practice. It is hoped the National One Stop Shop initiative will eradicate delays and better utilise scarce research resources.