Clinical Research Group, Heart Research Institute, Sydney, NSW, Australia; and Cardiology Department, Royal Prince Alfred Hospital, Camperdown, Sydney, NSW 2050, Australia; and Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
Cardiology Department, Royal Prince Alfred Hospital, Camperdown, Sydney, NSW 2050, Australia; and Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.
Aust Health Rev. 2023 Aug;47(4):410-417. doi: 10.1071/AH23063.
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.
目的 为澳大利亚任何国家登记处的设立所面临的障碍提供深入了解。
方法 分析我们在执行多机构协议（MIA）和获得伦理和治理批准方面的经验，该协议是在 2020 年 6 月获得大型医学研究未来基金拨款后执行的。
结果 自 2020 年 7 月以来，尽管全职员工为此目标而努力，但我们达成执行 MIA 的时间线为 283 天。此后，在主要站点获得伦理批准后，获得站点治理批准的时间范围为 9 至 291 天。在 MIA 的制定和签署过程中总共发送了 214 封电子邮件。向各个治理办公室发送了 11-71 封电子邮件，请求的额外信息点数量从 0 到 31 个查询不等。
结论 在执行联邦政府资助的国家登记处项目的初始（研究前）阶段，需要大量的时间和资源，因此存在相当长的时间延迟。我们报告了不同州和机构之间要求的巨大差异。我们提出了一些可以实施的策略，以促进研究伦理和治理的更简化方法。这种集中的方法将允许更好地利用资金，并促进医学研究的更好进展。
