Challenges in Obtaining Research Ethics and Governance Approvals for an Australian National Intersector, Multisite Audit Study
Australian Health Review, 44(5), 799-805. https://doi.org/10.1071/AH20022
20 Pages Posted: 15 Dec 2020
Date Written: september 18, 2020
Objective: To describe timelines and challenges encountered in obtaining ethics and governance approvals for an Australian multi-centre 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) to prepare and 32 business days (range 17-67) to be approved; expedited ethics applications (n=4) a median of 5 business days (range 1-20) to prepare and 10 business days (range 1-44) to be approved. Governance approvals (n=23) took a median of 27 business days (range 4-63) to prepare and 20 business days (range 4-61) 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.
Keywords: research ethics, ethics committee, human research, health research, ethics review committee, human research ethics, multicentre study
JEL Classification: I1, I10, I19, C9, C90, C99, C83
Suggested Citation: Suggested Citation