目的:研究澳大利亚临床登记处的数据流程的土著治理。
方法:从2022年1月17日至2023年4月30日对澳大利亚临床注册登记处的注册登记处进行审核(通过桌面审核和访谈)。
方法:收集种族数据的临床注册数量,报告原住民和/或托雷斯海峡岛民在登记处治理或指导委员会的代表,并报告人类研究伦理委员会的批准。
结果:共审查了107个临床登记处。在这些登记处中,65(61%)收集了种族数据;当这些数据按地理覆盖范围分组时,最有可能收集种族数据的人是两国(24/40[60%]),国家(19/26[73%])或州基(19/26[73%])。在收集种族数据的登记处中,29(45%)将他们的种族项目归类为原住民和/或托雷斯海峡岛民。只有八个临床注册机构(7%)报告了原住民和/或托雷斯海峡岛民在其治理或指导委员会中的代表。94个注册管理机构(88%)报告了人类研究伦理批准,只有11人(12%)获得原住民人类研究伦理委员会的批准。
结论:在土著数据治理的临床注册记录中,显著的变异性是明显的,这意味着原住民和托雷斯海峡岛民社区在用于告知政策的数据中仍然不可见,临床护理模式,卫生服务和倡议。需要进行彻底更改,以促进全国临床注册质量指标的有意义的更改。
OBJECTIVE: To examine Indigenous Governance of Data processes in Australian clinical registries.
METHODS: Audit (via desktop review and interviews) of registries in the Australian Register of Clinical Registries from 17 January 2022 to 30 April 2023.
METHODS: The number of clinical registries collecting ethnicity data, reporting Aboriginal and/or Torres Strait Islander representation on registry governance or steering committees, and reporting human research ethics committee approval.
RESULTS: A total of 107 clinical registries were reviewed. Of these registries, 65 (61%) collected ethnicity data; when these were grouped by geographical coverage, those most likely to collect ethnicity data were binational (24/40 [60%]), national (19/26 [73%]) or state based (19/26 [73%]). Of the registries that collected ethnicity data, 29 (45%) classified their ethnicity item as Aboriginal and/or Torres Strait Islander. Only eight clinical registries (7%) reported Aboriginal and/or Torres Strait Islander representation on their governance or steering committees. Human research ethics approval was reported in 94 registries (88%), with only 11 (12%) having Aboriginal human research ethics committee approval.
CONCLUSIONS: Significant variability is evident in clinical registry recording of Indigenous governance of data, meaning that Aboriginal and Torres Strait Islander communities remain invisible in data which is used to inform policy, clinical models of care, health services and initiatives. Radical change is required to facilitate meaningful change in quality indicators for clinical registries nationally.