伦理委员会审查与相互认可：一项试点研究。
Ethics committee reviews and mutual acceptance: a pilot study.
作者信息
Rosenthal M A, Sarson-Lawrence M, Alt C, Arkell K, Dodds M
机构信息
Cancer Trials Australia, Melbourne, Victoria, Australia.
出版信息
Intern Med J. 2005 Nov;35(11):650-4. doi: 10.1111/j.1445-5994.2005.00927.x.
AIMS
To develop a human research ethics committee (HREC) mutual acceptance (MA) model, based on the National Health and Medical Research Council's guidelines. The MA model aims to facilitate aspects of multicentre research and decrease the time taken to finalise the HREC review process.
METHODS
Four HREC (The Alfred Hospital, Austin Health, Peter MacCallum Cancer Centre and Melbourne Health) agreed to participate in a 13-month pilot project to evaluate the MA model. Evaluation included times from submission to approval and stakeholder surveys.
RESULTS
Seventeen consecutive studies were submitted to the MA pilot project. Stakeholders agreed that the MA model was efficient and effective and that submission and review processes had improved, with a demonstrable reduction in the levels of duplication. There was a 27% improvement in approval times for multicentre studies.
CONCLUSIONS
Our (MA) model resulted in clear improvements in HREC processes and timelines. Stakeholder acceptance was high. This model provides a framework for a broader program of MA.
目的
根据澳大利亚国家卫生与医学研究委员会的指南，建立一种人体研究伦理委员会（HREC）相互认可（MA）模式。该相互认可模式旨在促进多中心研究的各个方面，并减少完成HREC审查过程所需的时间。
方法
四个HREC（阿尔弗雷德医院、奥斯汀健康中心、彼得·麦卡勒姆癌症中心和墨尔本健康中心）同意参与一个为期13个月的试点项目，以评估相互认可模式。评估内容包括从提交到批准的时间以及对利益相关者的调查。
结果
连续17项研究提交至相互认可试点项目。利益相关者一致认为，相互认可模式高效且有效，提交和审查流程得到了改进，重复程度明显降低。多中心研究的批准时间缩短了27%。
结论
我们的相互认可模式使HREC流程和时间安排有了显著改善。利益相关者的接受度很高。该模式为更广泛的相互认可计划提供了一个框架。
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