美国FDCA框架下临床研究者造假的刑事责任研究

Study of enforcement of criminal liability for clinical investigator fraud under FDCA

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。

Objective： To make clear the pathway of FDA enforcement of criminal liability for clinical investigator fraud under Food, Drug and Cosmetic Act （FDCA）. Methods： Analysis of three court precedents was conducted to make clear how FDA can use various provisions in the FDCA to seek criminal liability against clinical investigators who commit fraud and the application of relevant doctrines. Results： Clinical investigators＇ liability is pursued in the US. Through promulgating regulations prohibiting investigator fraud, FDA set up the way to pursue the criminal liability of investigators. Conclusion： Investigators play a key role in containing fraud. In China, investigators＇ criminal liability has not been pursued. The government should increase the illegal cost by applying the Park doctrine in clinical research, which can form the restriction mechanism of fraud.