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...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。展开更多
The balance of the interests between the relative civil subjects is not only the essential basis for establishing the tort liability law with justice,but also a key approach to resolving many theoretical disputes in t...The balance of the interests between the relative civil subjects is not only the essential basis for establishing the tort liability law with justice,but also a key approach to resolving many theoretical disputes in the lawmaking process. On the basis of insisting on the theory of balancing interests in the lawmaking process,the author analyzes the basic contradiction regulated by the tort liability law and the conflicts of general and specific interests in the tort liability law field. Certain suggestions for system design are made by the author in this article.展开更多
文摘目的: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。
文摘The balance of the interests between the relative civil subjects is not only the essential basis for establishing the tort liability law with justice,but also a key approach to resolving many theoretical disputes in the lawmaking process. On the basis of insisting on the theory of balancing interests in the lawmaking process,the author analyzes the basic contradiction regulated by the tort liability law and the conflicts of general and specific interests in the tort liability law field. Certain suggestions for system design are made by the author in this article.
