South Australian Trainees Audit and Research Collaborative (STARC), Adelaide, South Australia, Australia.
VERITAS Collaborative, Department of Surgery, Austin Hospital, Melbourne, Victoria, Australia.
ANZ J Surg. 2021 Nov;91(11):2263-2268. doi: 10.1111/ans.16842. Epub 2021 Apr 13.
In Australia, ethics committees across different states vary in application, requirement and process for the ethical review and approval for clinical research. This may lead to confusion and delays in the enablement of multicentre research projects. This study explores the effect of differing processes for Ethics and Governance in the establishment of the CovidSurg-Cancer study during the global COVID-19 pandemic.
An anonymous, structured web-based questionnaire was designed using the Research Electronic Data Capture application (REDCap) platform to capture consultant surgeons, fellows, and trainees experience in the ethics application process. 'CovidSurg-Cancer' was an international multicentre collaborative study to assess the impact of COVID-19 on the outcomes of patients undergoing cancer surgery. The ethics process to set up this observational study was used as to explore the differing processes applied across Australia.
The CovidSurg-Cancer study was successfully set up in 14 hospitals. Four hospitals approved the study directly as an audit. Of the remaining sites, 10 ethics applications underwent Human Research Ethics Committee review following which two (14%) were subsequently approved as an audit activity and eight hospitals (57%) were given formal ethical approval with waiver of consent. Ethics application acceptance from another Australian Human Research Ethics Committee was provided with six applications; however, only three were reciprocated without the requirement for further agreements. A third of (30%) respondents suggested that the details of the application pathway, process and documentation were unclear.
Ethics processes are varied across Australia with considerable repetition. A centralized, harmonized application process would enhance collaborative research.
在澳大利亚，不同州的伦理委员会在临床研究的伦理审查和批准方面的应用、要求和程序各不相同。这可能导致多中心研究项目的开展出现混乱和延误。本研究旨在探讨在全球 COVID-19 大流行期间，不同的伦理和治理程序对 CovidSurg-Cancer 研究设立的影响。
使用 Research Electronic Data Capture 应用程序（REDCap）平台设计了一份匿名、结构化的网络问卷，以捕获顾问外科医生、研究员和学员在伦理申请过程中的经验。'CovidSurg-Cancer' 是一项国际多中心合作研究，旨在评估 COVID-19 对接受癌症手术患者结局的影响。该观察性研究的伦理程序被用来探索澳大利亚各地应用的不同程序。
CovidSurg-Cancer 研究成功在 14 家医院设立。其中 4 家医院直接批准该研究作为审计。其余的 10 家医院的伦理申请经过人类研究伦理委员会审查，其中 2 家（14%）随后被批准作为审计活动，8 家医院（57%）获得正式的伦理批准并豁免同意。另一家澳大利亚人类研究伦理委员会提供了 6 份伦理申请的接受，但只有 3 份无需进一步协议即可接受。三分之一（30%）的受访者表示，申请途径、流程和文件的详细信息不清楚。
澳大利亚的伦理程序存在差异，且存在大量重复。一个集中化、协调一致的申请程序将有助于加强合作研究。
