The Misguided Regulation of Cardiac Emergencies: The Rise of the IRB-Industrial Complex and the Increasing Risk to Cardiovascular Research and Our Patients.
The Misguided Regulation of Cardiac Emergencies: The Rise of the IRB-Industrial Complex and the Increasing Risk to Cardiovascular Research and Our Patients.
复制标题
心脏急症的误导性监管：IRB-工业综合体的兴起以及心血管研究和患者的风险不断增加。
DOI：
10.1161/circresaha.116.309893
复制
发表时间：
2016
影响因子：
20.1
通讯作者：
Traverse,JayH
中科院分区：
文献类型：
--
作者：
Traverse,JayH
1064 Circulation Research 2016年10月28日标准化4，30秒经皮腔内冠状动脉成形术充盈/回缩可在初始血管造影确认存在闭塞动脉后在导管插入实验室进行口头同意过程。当患者病情稳定并且能够理解15页的文件时，在24小时内获得了完整的知情同意书。不幸的是，在2014年，我们的卫生系统开始利用外部IRB机构批准临床试验的更新。这些IRB现在规定，我们最初的口头同意程序以及第二天的完全知情同意不再被允许，我们继续试验的唯一方法是获得紧急豁免知情同意。因此，我们的试验被置于临床暂停，尽管没有一个单一的并发症或不良事件。当时，我们招募了90名患者，数据安全和监测委员会没有发现任何安全性问题。
1064 Circulation Research October 28, 2016 standardizing 4, 30-second percutaneous transluminal coronary angioplasty inflations/deflations could qualify for a verbal consent process in the catheterization laboratory after initial angiography confirmed the presence of an occluded artery. Full, informed consent was obtained within 24-hour when the patient was stable and could comprehend a 15-page document.Unfortunately, in 2014, our Health System began utilizing outside IRB agencies to approve the renewals of clinical trials. These IRBs now stipulated that our initial verbal consent process followed by full, informed consent the next day was no longer permissible and that the only way we could continue the trial was by obtaining an emergency waiver of informed consent. As a result, our trial was placed on clinical hold despite not having a single complication or adverse event. At that time, we had enrolled 90 patients and had no safety issues identified by the Data Safety and Monitoring Board.