Australian health review : a publication of the Australian Hospital Association
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Multicenter Study
Challenges in obtaining research ethics and governance approvals for an Australian national intersector, 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). ⋯ 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.