Challenges in obtaining research ethics and governance approvals for an Australian national intersector, multisite audit study
Kimberly Buck
A K , Linda Nolte A , Helana Kelly A B , Karen Detering A C D , Craig Sinclair E F G , Ben P. White H and Marcus Sellars A I J
A Advance Care Planning Australia, Austin Health, PO Box 5555, Heidelberg, Vic. 3084, Australia. Email: linda.nolte@austin.org.au
B Present address: Peter MacCallum Cancer Centre, Locked Bag 1, A’Beckett Street, Melbourne, Vic. 3006, Australia. Email: helana.kelly@petermac.org
C Faculty of Medicine, Dentistry and Health Sciences, The University of Melbourne, Parkville, Vic. 3010, Australia.
D Present address: Faculty of Health, Arts and Innovation, Swinburne University of Technology, John Street, Hawthorn, Vic. 3121, Australia. Email: kdetering@swin.edu.au
E Australian Research Council Centre of Excellence in Population Ageing Research, UNSW Sydney, 223 Anzac Parade, Kensington, NSW 2033, Australia.
F Neuroscience Research Australia (NeuRA), Barker Road, Randwick, NSW 2031, Australia.
G Present address: School of Psychology, UNSW Sydney, High Street, Kensington, NSW 2052, Australia. Email: c.sinclair@unsw.edu.au
H Australian Centre for Health Research Law, Faculty of Law, Queensland University of Technology, GPO Box 2434, Brisbane, Qld 4001, Australia. Email: bp.white@qut.edu.au
I Kolling Institute, Northern Clinical School, Faculty of Medicine, The University of Sydney, 10 Westbourne Street, St Leonards, Sydney, NSW 2064, Australia.
J Present address: Australian Centre for Health Research Law, Faculty of Law, Queensland University of Technology, GPO Box 2434, Brisbane, Qld 4001, Australia. Email: marcus.sellars@qut.edu.au
K Corresponding author. Email: kim.buck@austin.org.au
Australian Health Review 44(5) 799-805 https://doi.org/10.1071/AH20022
Submitted: 8 February 2020 Accepted: 20 March 2020 Published: 18 September 2020
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.
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