Driscoll Andrea, Currey Judy, Worrall-Carter Linda, Stewart Simon
Department of Epidemiology and Preventative Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Victoria, Australia.
J Clin Nurs. 2008 Aug;17(16):2212-20. doi: 10.1111/j.1365-2702.2007.02219.x.
To examine the impact and obstacles that individual Institutional Research Ethics Committee (IRECs) had on a large-scale national multi-centre clinical audit called the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study.
Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects.
The National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes study used an investigator-developed questionnaire concerning a clinical audit for heart failure programmes throughout Australia. Ethical guidelines developed by the National governing body of health and medical research in Australia classified the National Benchmarks and Evidence-based National Clinical guidelines for Heart failure management programmes Study as a low risk clinical audit not requiring ethical approval by IREC.
Fifteen of 27 IRECs stipulated that the research proposal undergo full ethical review. None of the IRECs acknowledged: national quality assurance guidelines and recommendations nor ethics approval from other IRECs. Twelve of the 15 IRECs used different ethics application forms. Variability in the type of amendments was prolific. Lack of uniformity in ethical review processes resulted in a six- to eight-month delay in commencing the national study.
Development of a national ethics application form with full ethical review by the first IREC and compulsory expedited review by subsequent IRECs would resolve issues raised in this paper. IRECs must change their ethics approval processes to one that enhances facilitation of multi-centre research which is now normative process for health services.
The findings of this study highlight inconsistent ethical requirements between different IRECs. Also highlighted are the obstacles and delays that IRECs create when undertaking multi-centre clinical audits. However, in our clinical practice it is vital that clinical audits are undertaken for evaluation purposes. The findings of this study raise awareness of inconsistent ethical processes and highlight the need for expedient ethical review for clinical audits.
探讨各个机构研究伦理委员会（IREC）对一项名为“心力衰竭管理项目的国家基准与循证国家临床指南”的大规模全国多中心临床审计产生的影响及障碍。
多中心研究在医疗保健系统中很常见。然而，IREC 仍未能区分研究项目和质量审计项目。
“心力衰竭管理项目的国家基准与循证国家临床指南”研究使用了由研究人员自行设计的问卷，该问卷涉及澳大利亚各地心力衰竭项目的临床审计。澳大利亚健康与医学研究国家管理机构制定的伦理准则将“心力衰竭管理项目的国家基准与循证国家临床指南”研究归类为低风险临床审计，无需 IREC 的伦理批准。
27 个 IREC 中有 15 个规定该研究提案需进行全面伦理审查。没有一个 IREC 认可：国家质量保证指南和建议，也不认可其他 IREC 的伦理批准。15 个 IREC 中有 12 个使用了不同的伦理申请表格。修正案类型的差异非常多。伦理审查过程缺乏统一性导致全国性研究的启动延迟了六到八个月。
制定一份由首个 IREC 进行全面伦理审查并由后续 IREC 进行强制快速审查的国家伦理申请表格，将解决本文提出的问题。IREC 必须将其伦理批准流程改为能够促进多中心研究的流程，而多中心研究如今已成为卫生服务的规范流程。
本研究结果凸显了不同 IREC 之间伦理要求的不一致。还强调了 IREC 在进行多中心临床审计时造成的障碍和延迟。然而，在我们的临床实践中，为了评估目的进行临床审计至关重要。本研究结果提高了对不一致伦理流程的认识，并强调了对临床审计进行便捷伦理审查的必要性。
