Study of enforcement of criminal liability for clinical investigator fraud under FDCA
YUAN Li
YANG Yue
Abstract：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.
Keywords：clinical investigatorfraudmisconductcriminal liabilityPark doctrine
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 1873-1879 )