Obstacles in establishing a national disease registry in Australia: lessons from the development of the CHAANZ Congenital Heart Disease Registry
Larissa K. Lloyd A B C , Reeja Nasir B C , Calum Nicholson A B C , Geoff Strange A B C and David S. Celermajer A B C *A Clinical Research Group, Heart Research Institute, Sydney, NSW, Australia.
B Cardiology Department, Royal Prince Alfred Hospital, Camperdown, Sydney, NSW 2050, Australia.
C Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
Australian Health Review 47(4) 410-417 https://doi.org/10.1071/AH23063
Submitted: 14 March 2023 Accepted: 26 April 2023 Published: 16 May 2023
© 2023 The Author(s) (or their employer(s)). Published by CSIRO Publishing on behalf of AHHA. This is an open access article distributed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND)
Abstract
Objectives To provide insights into the obstacles which pose challenges to the set-up of any National Registry in Australia.
Methods An analysis of our experience in executing a Multi-Institutional Agreement (MIA) and obtaining ethics and governance approvals, post-award of a large Medical Research Futures Fund grant in June 2020.
Results From July 2020, our timeline to an executed MIA was 283 days, despite full-time staff working towards this goal. Subsequently, after lead site ethics approval, time to site governance approvals ranged from 9 to 291 days. A total of 214 emails were sent during the MIA development and signing. There were 11–71 emails sent to individual governance offices and the number of requested points of additional information ranged from 0 to 31 queries.
Conclusions There were considerable time delays in executing the initial (pre-research) stages of a National Federal Government funded Registry project which required substantial time and resources. We report a wide variation in requirements between different states and institutions. We propose several strategies which could be implemented to facilitate a more streamlined approach to research ethics and governance. This centralised approach would allow for better use of funding and facilitate better progress in medical research.
Keywords: ethics, governance, multi-institutional agreement, registry, research.
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