Challenges in obtaining research ethics and governance approvals for an Australian national inter-sector multisite audit study

Objective: The aim of this study was to describe timelines and challenges encountered in obtaining ethics and governance approvals for an Australian multicentre audit study involving 100 public (n = 22) and private (n = 78) sites from three health sectors and all eight Australian states and territories. Methods: We determined and compared the processes, documentation and number of business days required to prepare applications and obtain research ethics and governance approvals. Results: In total, the full ethics and governance process (calculated from the date the first application was started to the date the final approval was granted) took 203 business days (79% of the study timeline). Standard risk ethics applications (n = 4) took a median of 17 business days (range 3-35 days) to prepare and 32 business days (range 17-67 days) to be approved; expedited ethics applications (n = 4) took a median of 5 business days (range 1-20 days) to prepare and 10 business days (range 1-44 days) to be approved. Governance approvals (n = 23) took a median of 27 business days (range 4-63 days) to prepare and 20 business days (range 4-61 days) to be approved. Challenges included the lack of a nationwide single-site ethical review process, the extensive time required to duplicate content across applications, variability in application requirements and submission systems, and contract negotiations. Conclusion: Further improvements are needed to reduce duplication and increase the efficiency of Australian ethics and governance review processes. What is known about the topic?: The process for obtaining ethics approval for multicentre research has been streamlined through the introduction of single-site ethics review. However, the process of gaining ethics and governance approvals for national multicentre research continues to be time-consuming, resource-intensive and duplicative. What does this paper add?: This is the first study to examine the challenges of obtaining ethics and gov