Adult Cancer Program, Lowy Cancer Research Centre and Prince of Wales Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
Intern Med J. 2012 Feb;42(2):127-31. doi: 10.1111/j.1445-5994.2011.02431.x.
In 2007, New South Wales Health mandated the separation of ethical and scientific review from research governance at all New South Wales public health sites based on their distinction in the National Health and Medical Research Council National Statement. This separation allowed for single-site ethical review of multicentre studies.
To investigate the time taken for governance approval of multicentre studies through the site-specific approval (SSA) process.
A retrospective audit of the SSA process for five non-interventional studies proposed by a university cancer research unit.
The median total governance approval time for all submissions (n= 28) was 12 weeks (range 2.5-64); median time from starting the SSA to submission was 8 weeks (range 1-48) and median time for governance approval was 5 weeks (range 0.3-40). Approval times were shorter for public compared to private institutions. Reasons for delays in finalising submissions for approval were the absence of institutional governance officers, lack of clarity regarding signatories, the need to identify a principal investigator employed by the institution, and lack of recognition of ethical approval by private institutions. The need to develop legal agreements between the university and hospital was the main reason for lengthy delays in obtaining approval.
The advantages of a harmonised single ethical review process were undermined by the coexistence of a fragmented, complex and lengthy governance approval process. This experience has implications for the success of the national Harmonisation of Multi-Centre Ethical Review (HoMER) model. A harmonised and fully supported national approach to research governance should be developed contemporaneously with HoMER.
2007 年，新南威尔士州卫生署基于澳大利亚国家卫生与医学研究委员会国家声明中对伦理和科学审查的区分，要求新南威尔士州所有公共卫生机构将伦理和科学审查从研究治理中分离出来。这种分离允许对多中心研究进行单一站点的伦理审查。
调查通过特定站点批准（SSA）程序对多中心研究进行治理批准所需的时间。
对大学癌症研究单位提出的五项非干预性研究的 SSA 过程进行回顾性审核。
所有提交材料（n=28）的总治理批准时间中位数为 12 周（范围 2.5-64）；从开始 SSA 到提交的中位数时间为 8 周（范围 1-48），治理批准的中位数时间为 5 周（范围 0.3-40）。与私立机构相比，公立机构的批准时间更短。最终确定提交材料以获得批准的延迟原因是缺乏机构治理官员、对签署人缺乏明确性、需要确定机构雇用的主要研究者以及私立机构对伦理批准缺乏认可。在大学和医院之间制定法律协议是获得批准的主要原因。
尽管存在分散、复杂和冗长的治理批准过程，但单一的协调伦理审查过程的优势受到了破坏。这一经验对国家多中心伦理审查协调（HoMER）模式的成功产生了影响。应该同时制定协调和充分支持的国家研究治理方法，以配合 HoMER。
