Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency
Ethical dilemmas of a large national multi-centre study in Australia: time for some consistency
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DOI：
10.1111/j.1365-2702.2007.02219.x
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发表时间：
2008-08-01
影响因子：
4.2
通讯作者：
Stewart, Simon
中科院分区：
文献类型：
--
作者：
Driscoll, Andrea;Currey, Judy;Stewart, Simon
目的和目标。研究单个机构研究伦理委员会（IREC）对一项名为心力衰竭管理项目国家基准和循证国家临床指南研究的大规模国家多中心临床审计的影响和障碍。多中心研究在医疗保健系统中很常见。然而，独立评审委员会仍然未能区分研究和质量审计项目。心力衰竭管理项目的国家基准和循证国家临床指南研究使用了一份由医生开发的关于澳大利亚心力衰竭项目临床审计的问卷。澳大利亚国家健康和医学研究管理机构制定的道德指南将心力衰竭管理项目研究的国家基准和循证国家临床指南归类为低风险临床审核，不需要IREC的道德批准。结果。27个IREC中有15个规定研究提案要经过全面的伦理审查。没有一个国际伦理委员会承认：国家质量保证指南和建议，也没有其他国际伦理委员会的伦理批准。15个IREC中有12个使用不同的伦理申请表。修正案的种类多种多样。缺乏统一的伦理审查过程导致了6至8个月的延迟开始的国家研究。制定国家伦理申请表，由第一个IREC进行全面的伦理审查，并由随后的IREC进行强制性快速审查，将解决本文提出的问题。IRECs必须改变其伦理审批程序，以促进多中心研究，这是目前卫生服务的规范程序。这项研究的结果突出了不同IREC之间不一致的道德要求。还强调了独立评审委员会在进行多中心临床审核时造成的障碍和延误。然而，在我们的临床实践中，进行临床稽查以进行评价至关重要。这项研究的结果提高了人们对不一致的伦理过程的认识，并强调了对临床审计进行权宜伦理审查的必要性。
Aims and objectives. 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.Background. Multi-centre research is commonplace in the health care system. However, IRECs continue to fail to differentiate between research and quality audit projects.Methods. 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.Results. 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.Conclusions. 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.Relevance to clinical practice. 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.