临床研究中的欺诈与不当行为：一个值得关注的问题。
Fraud and misconduct in clinical research: A concern.
作者信息
Gupta Ashwaria
机构信息
Sr. CRA Group Head, Novartis Health Care Private Limited, Sandoz House, Worli, Mumbai, India.
出版信息
Perspect Clin Res. 2013 Apr;4(2):144-7. doi: 10.4103/2229-3485.111800.
Abstract
Fraud and misconduct in clinical research is widespread. Good clinical practice is a guideline adopted internationally as standard operating procedure for conduct of clinical research. Despite these guidelines being available, unavailability of internationally harmonized framework for managing research fraud and misconduct makes clinical research a highly vulnerable area to commit fraud. Fraud could be of various types and due to various reasons. Whatever the circumstances be, any fraud should be dealt with strictly and regulations should be in place to prevent its occurrence.
摘要
临床研究中的欺诈和不当行为普遍存在。良好临床实践是国际上采用的作为临床研究操作标准程序的指南。尽管有这些指南，但由于缺乏管理研究欺诈和不当行为的国际统一框架，临床研究成为极易发生欺诈的领域。欺诈可能有多种类型且原因各异。无论情况如何，任何欺诈行为都应受到严厉处理，并且应制定相关规定以防止其发生。
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2
Research coordinators' experiences with scientific misconduct and research integrity.研究协调员在科学不端行为和研究诚信方面的经验。
Nurs Res. 2010 Jan-Feb;59(1):51-7. doi: 10.1097/NNR.0b013e3181c3b9f2.
3
Repairing research integrity.修复研究诚信。
Nature. 2008 Jun 19;453(7198):980-2. doi: 10.1038/453980a.
4
Fraud, conflict of interest, and other enforcement issues in clinical research.临床研究中的欺诈、利益冲突及其他执法问题。
Cleve Clin J Med. 2007 Mar;74 Suppl 2:S63-7; discussion S68-9. doi: 10.3949/ccjm.74.suppl_2.s63.
5
The effect of scientific misconduct on the results of clinical trials: a Delphi survey.科研不端行为对临床试验结果的影响：一项德尔菲调查
Contemp Clin Trials. 2005 Jun;26(3):331-7. doi: 10.1016/j.cct.2005.01.011.
6
Dishonesty, misconduct and fraud in clinical research: an international problem.临床研究中的不诚实、不当行为和欺诈：一个国际性问题。
J Int Med Res. 2002 Jul-Aug;30(4):357-65. doi: 10.1177/147323000203000401.
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