Challenges in obtaining research ethics and governance approvals for an Australian national intersector, multisite audit study.

Abstract

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 governance approvals for a non-interventional multicentre study involving three health sectors (hospital, aged care, general practice), both private and public services and all eight Australian jurisdictions. Previous examinations of Australian multicentre studies have considered only one health sector, focused on the public system and/or were not national in scope. What are the implications for practitioners? Researchers and funders need to be aware of the considerable time, resources and costs involved in gaining research ethics and governance approvals for multicentre studies and include this in budgets and study timelines. Policy makers and administrators of ethics and governance review processes must address barriers to conducting multicentre research in Australia.