美国FDCA框架下临床研究者造假的刑事责任研究

发布时间：2018-07-14 22:34

【摘要】：目的:研究美国《食品药品化妆品法案》(Food,Drug and Cosmetic Act,FDCA)框架下追究临床研究者造假刑事责任的路径。方法:通过3起法院判例的分析,理清FDCA框架下追究临床研究者造假刑事责任的路径及相关法律原则的适用。结果:美国将临床试验造假的法律责任落实到研究者个人。通过颁布限定研究者维护准确试验记录责任的条款,建立了FDCA框架下追究研究者造假刑事责任的路径。结论:临床研究者在造假的制约机制中发挥着关键的作用,目前我国并未将临床试验造假的法律责任真正落实到研究者个人,通过追究临床研究者造假的刑事责任,提高违法成本,运用Park原则能够形成良好的制约机制,有效遏制临床试验造假的发生。
[Abstract]:Objective: to study the way to investigate the criminal liability of clinical researchers for fraud under the framework of Food Drug and Cosmetic Act (FDCA). Methods: through the analysis of three court cases, the path of investigating clinical researchers' criminal liability for fraud and the application of relevant legal principles under the framework of FDCA were clarified. Results: in the United States, the legal liability for fraud in clinical trials was extended to individual researchers. By promulgating the provisions that limit the researchers' responsibility to maintain accurate records of experiments, this paper establishes the way to investigate the criminal liability of the researchers for fraud under the framework of FDCA. Conclusion: clinical researchers play a key role in the restraint mechanism of forgery. At present, the legal liability of clinical trial fraud has not been truly implemented to individual researchers, and the criminal liability of clinical researchers is investigated. Increasing the illegal cost and applying Park principle can form a good restriction mechanism and effectively curb the occurrence of clinical trial fraud.
【作者单位】：沈阳药科大学工商管理学院;
【基金】：国家食品药品监督管理总局委托课题“药物临床试验管理法律制度研究”资助项目(20160003)
【分类号】：D971.2;R95

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