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

See all articles by Kim Buck

Kim Buck

affiliation not provided to SSRN

Linda Nolte

Austin Health

Helana Kelly

affiliation not provided to SSRN

Karen Detering

Austin Health

Craig Sinclair

University of New South Wales (UNSW) - ARC Centre of Excellence in Population Ageing Research (CEPAR)

Ben White

Queensland University of Technology - Faculty of Law

Marcus Sellars

affiliation not provided to SSRN

Date Written: september 18, 2020

Abstract

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

Buck, Kim and Nolte, Linda and Kelly, Helana and Detering, Karen and Sinclair, Craig and White, Ben and Sellars, Marcus, Challenges in Obtaining Research Ethics and Governance Approvals for an Australian National Intersector, Multisite Audit Study (september 18, 2020). Australian Health Review, 44(5), 799-805. https://doi.org/10.1071/AH20022, Available at SSRN: https://ssrn.com/abstract=3714470 or http://dx.doi.org/10.2139/ssrn.3714470

Kim Buck

affiliation not provided to SSRN

Linda Nolte

Austin Health ( email )

145 Studley Rd
Heidelberg VIC 3084, Melbourne
Australia

Helana Kelly

affiliation not provided to SSRN

Karen Detering

Austin Health ( email )

145 Studley Rd
Heidelberg VIC 3084, Melbourne
Australia

Craig Sinclair

University of New South Wales (UNSW) - ARC Centre of Excellence in Population Ageing Research (CEPAR) ( email )

Kensington
High St
Sydney, NSW 2052
Australia

Ben White (Contact Author)

Queensland University of Technology - Faculty of Law ( email )

Level 4, C Block Gardens Point
2 George St
Brisbane, QLD 4000
Australia

HOME PAGE: http://staff.qut.edu.au/staff/whiteb/

Marcus Sellars

affiliation not provided to SSRN

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