Perioperative beta blockade.
Perioperative beta blockade.
复制标题
围手术期β阻断。
DOI：
10.1016/s0140-6736(08)61475-0
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发表时间：
2008
期刊：
影响因子：
168.9
通讯作者：
F. Messerli
中科院分区：
文献类型：
--
作者：
S. Bangalore;C. Gluud;J. Wetterslev;F. Messerli
作为伊斯法罕地区生物伦理委员会 (IRBC) 的秘书，我想就 POISE 试验的网络附录 1 提供以下澄清。 1 我们地区的一个研究中心参加了 POISE。正如网络附录中所强调的，该中心不幸发生了数据伪造事件。欺诈行为曝光后，我们立即获悉了这一事件。调查已启动，并联系了 POISE 的首席研究员和协调员。我们的调查显示，一名刚毕业的医生被 POISE 研究小组聘为研究助理，他是这起欺诈案的中心人物。我们发现对该人的监管力度不够。同样不幸的是，之前代表主要研究者和协调员进行的审计缺乏足够的严格性来发现欺诈行为。这违反了 26 项保护研究参与者的国家道德准则。 2 IRBC 对伊朗首席研究员以及协调研究中心发出了正式的学术处罚。调查结果显示，IRBC 要求争议研究中心所属大学对所有其他正在进行的项目进行审计。审计没有发现任何其他重大问题，IRBC 确信，此次欺诈中心的研究助理没有参与该研究中心或该国其他任何地方的任何其他项目。根据研究中心对其他国际研究主要研究者的要求，进行了审计，得出了类似的结果。自该事件发生以来，IRBC 建议该大学校长将外部审计费用纳入所有申请伦理审批的研究的预算中。这已被总理接受并实施。伊朗团队竭尽全力为外部审计提供便利，该地区最高层的行政当局也参与了合作。我们IRBC将继续加强和审查我们的保障措施，以防止未来发生类似事件，将努力推广从我们丰富的文化遗产中汲取的良好研究实践原则，并希望少数人的错误行为不会给许多人的值得赞扬的活动蒙上阴影。
As Secretary of the Isfahan Regional Bioethics Committee (IRBC), I would like to provide the following clarifications with regard to webappendix 1 of the POISE trial. 1 One of the research centres in our region participated in POISE. As highlighted in the webappendix, there was the unfortunate occasion of data falsification in this centre. We were informed of the incident immediately after the fraud came to light. An investigation was launched and the principal investigator and coordinator of POISE were contacted. Our investigation revealed that a recently graduated doctor who was employed as a research assistant by the POISE Study Group was at the centre of the fraud. We found that inadequate supervision had been given to this person. It was also unfortunate that a previous audit on behalf of the principal investigator and coordinator lacked sufficient rigour to detect the fraud. This was a breach of the 26-item National Ethical Codes for Protection of Research Participants. 2 IRBC issued official academic penalties against the Iranian principal investigator as well as the coordinating research centre. As a result of the investigation, IRBC asked the university to which the research centre in dispute was affiliated to do an audit of all other projects underway. The audit did not reveal any other major problems and IRBC was assured that the research assistant at the centre of this fraud had not been involved in any other projects at this research centre or anywhere else in the country. On the basis of a request by the research centre to other principal investigators of international studies, audits were done that gave similar results. Since the occurrence of this incident, IRBC recommended to the chancellor of the university that external audit costs be included in the budget of all studies applying for ethics approval. This has been accepted by the chancellor and implemented. The Iranian team did its utmost to facilitate the external audit, and the highest levels of executive authorities in the region were engaged in the collaboration.We at the IRBC will continue to strengthen and review our safeguards to prevent similar events happening in the future, will endeavour to promote principles of good research practice drawn from our rich cultural heritage, and hope that the wrongdoings of a few do not cast a shadow on the commendable activities of the many.