Grinding to a Halt: The Effects of the Increasing Regulatory Burden on Research and Quality Improvement Efforts
Grinding to a Halt: The Effects of the Increasing Regulatory Burden on Research and Quality Improvement Efforts
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DOI：
10.1086/605454
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发表时间：
2009-08-01
影响因子：
11.8
通讯作者：
Natarajan, Padma
中科院分区：
文献类型：
--
作者：
Burman, William;Daum, Robert;Natarajan, Padma
美国传染病学会担心，过度的监管正在严重影响转化研究和质量改进的努力。对研究监督问题的仔细研究记录了监管负担对临床、流行病学和卫生系统研究的不利影响。我们确定了5个问题领域。首先，将《健康保险流通与责任法案》应用于研究使机构审查委员会（irb）负担过重，使潜在的研究参与者感到困惑，并减缓了研究速度，增加了研究成本。其次，多中心研究的本地审查延迟了研究，并没有改进协议或同意表格。第三，向当地irb报告非现场不良事件是对发起人、研究者和当地irb资源的浪费，并且不会增加参与者的安全。第四，儿科研究法规中关键术语的不确定性导致地方审查委员会审查涉及儿童的研究的方式存在显著差异。第五，对于质量改进工作何时需要IRB审查缺乏共识正在减缓这一关键领域的进展。相对简单的步骤，不需要立法或改变共同规则，可以改善这些问题领域的监管监督。
The Infectious Diseases Society of America is concerned that excessive regulatory oversight is seriously affecting translational research and quality improvement efforts. Careful studies on the subject of research oversight have documented the adverse effects of regulatory burden on clinical, epidemiological, and health systems research. We identified 5 problem areas. First, the application of the Health Insurance Portability and Accountability Act to research has overburdened institutional review boards ( IRBs), confused prospective research participants, and slowed research and increased its cost. Second, local review of multicenter studies delays research and does not improve protocols or consent forms. Third, reporting of off-site adverse events to local IRBs is wasteful of the resources of sponsors, investigators, and local IRBs and does not add to participant safety. Fourth, uncertainties about key terms in the regulations governing pediatric research lead to marked differences in the ways that local IRBs review research involving children. Fifth, the lack of consensus on when IRB review is required for quality improvement efforts is slowing progress in this critical area. Relatively simple steps, which do not require legislation or a change in the Common Rule, could improve regulatory oversight in these problem areas.