School of Pharmacy, University of Queensland, 20 Cornwall Street, Woolloongabba, Qld 4102, Australia. Email:
Princess Alexandra Hospital, 199 Ipswich Road, Woolloongabba, Qld 4102, Australia. Email:
Aust Health Rev. 2021 Jun;45(3):389-392. doi: 10.1071/AH20129.
Objective There is much interest in examining the use of medicines and their real-world benefits and harms using routinely collected data sources such as patients' electronic medical records in hospitals in order to optimise use and health outcomes. This study aimed to describe the process and challenges involved in obtaining ethical approval and research governance authorisation for a research project that started on 7 December 2018 in Queensland and make recommendations for improving the process. Methods There were three aspects: (a) ethics approval; (b) governance - site-specific assessment (SSA); and (c) governance - Public Health Act (PHA) Application Assessment. Results The process to satisfy all requirements took more than 1 year (371 days); ethics took 16 days and PHA approval 16 days. The major hurdle was the SSA, which took 98-274 days across five sites. The main issues were opaqueness in processes and inconsistences in approach leading to considerable frustration. Discussion It is recommendeded that Research Governance Offices should be clear on the process and requirements. All Local Hospital Networks (LHN, Hospital and Health Services in Queensland) should develop and adopt a standardised low and negligible risk SSA approval process. Frustration of government officials and researchers led the National Health and Medical Research Council to streamline ethics approval processes, but the same cannot be said for the governance process. It is appreciated that LHN processes were developed for good and valid reasons, but the onerous and inconsistent application of these processes hinder timely and relevant research. It is time for action: follow the success of the ethics process to redesign governance. What is known about the topic? Researchers are interested in examining the use of medicines and their real-world benefits and harms using routinely collected data sources such as patients' electronic medical records in hospitals in order to optimise use and health outcomes. There are challenges in obtaining ethical approval and research governance authorisation for research projects. What does this paper add? We identified that the main hurdle was obtaining site-specific agreements across numerous hospital sites. What are the implications for practitioners? We recommend that Research Governance Offices should be clear on the process and requirements. All Local Hospital Networks (LHN, Hospital and Health Services in Queensland) should develop and adopt a standardised low and negligible risk SSA approval process. The ethics approval process has been streamlined in recent years so we need to follow this success to redesign governance.
目的
利用患者在医院的电子病历等常规收集的数据源，研究药物的使用情况及其真实世界的疗效和危害，从而优化药物的使用并改善健康结果，这方面的研究引起了广泛关注。本研究旨在描述 2018 年 12 月 7 日在昆士兰州开始的一个研究项目，从获得伦理批准和研究治理授权的角度，描述其过程和挑战，并为改进这一过程提出建议。
方法
（a）伦理批准；（b）治理-特定地点评估（SSA）；（c）治理-公共卫生法（PHA）应用评估。
结果
满足所有要求的过程耗时超过 1 年（371 天）；伦理审查耗时 16 天，PHA 批准耗时 16 天。主要障碍是 SSA，五个地点的耗时分别为 98-274 天。主要问题是流程不透明以及方法不一致，导致大量的挫败感。
讨论
建议研究治理办公室明确流程和要求。所有当地医院网络（LHN，昆士兰的医院和卫生服务）应制定并采用标准化的低风险和零风险 SSA 审批流程。政府官员和研究人员的挫折感促使国家卫生和医学研究委员会简化了伦理审批流程，但治理流程却没有。虽然 LHN 的流程是出于良好和有效的原因而制定的，但这些流程的繁重和不一致的应用阻碍了及时和相关的研究。是时候采取行动了：遵循伦理审批流程的成功经验来重新设计治理。
关于该主题已知的内容是什么？
研究人员有兴趣利用患者在医院的电子病历等常规收集的数据源，研究药物的使用情况及其真实世界的疗效和危害，从而优化药物的使用并改善健康结果。
获得研究项目的伦理批准和研究治理授权存在挑战。
这篇论文增加了什么新内容？
我们发现，主要障碍是在众多医院站点之间获得特定站点的协议。
对从业者有什么影响？
我们建议研究治理办公室应明确流程和要求。所有当地医院网络（LHN，昆士兰的医院和卫生服务）应制定并采用标准化的低风险和零风险 SSA 审批流程。近年来，伦理审批流程已经得到简化，因此我们需要借鉴这一成功经验来重新设计治理。
