Flack Felicity, Adams Carolyn, Allen Judy
Manager, Policy and Client Services, Population Health Research Network (PHRN), The University of Western Australia, Crawley.
Senior Lecturer, Macquarie Law School, Macquarie University, Sydney.
J Law Med. 2019 Apr;26(3):655-680.
In Australia, access to administrative data for research without consent invokes a plethora of governance requirements. Whether these requirements are met is assessed by at least one human research ethics committee (HREC) and each of the custodians of the relevant data collections. In this article, we examined and compared the decision-making processes of data custodians and HRECs. These processes were investigated using three case studies and qualitative interviews with data custodians around Australia. The investigation demonstrated that there was significant overlap and duplication in the review of applications for access to data without consent between HRECs and data custodians. This was the result of overlapping requirements in the relevant legislation and policies with those in the National Statement for Ethical Conduct in Human Research 2007 (updated 2018) as well as confusion about the distinct roles of HRECs and data custodians.
在澳大利亚，未经同意获取用于研究的行政数据会引发大量治理要求。这些要求是否得到满足由至少一个人类研究伦理委员会（HREC）以及相关数据收集的每个保管人进行评估。在本文中，我们研究并比较了数据保管人和HREC的决策过程。通过三个案例研究以及对澳大利亚各地数据保管人的定性访谈对这些过程进行了调查。调查表明，HREC和数据保管人在审查未经同意获取数据的申请时存在显著的重叠和重复。这是相关立法和政策与《2007年人类研究伦理行为国家声明》（2018年更新）中的要求重叠以及对HREC和数据保管人的不同角色存在混淆的结果。
