【摘要】：目的:研究美國《食品藥品化妝品法案》(Food,Drug and Cosmetic Act,FDCA)框架下追究臨床研究者造假刑事責(zé)任的路徑。方法:通過3起法院判例的分析,理清FDCA框架下追究臨床研究者造假刑事責(zé)任的路徑及相關(guān)法律原則的適用。結(jié)果:美國將臨床試驗造假的法律責(zé)任落實到研究者個人。通過頒布限定研究者維護準(zhǔn)確試驗記錄責(zé)任的條款,建立了FDCA框架下追究研究者造假刑事責(zé)任的路徑。結(jié)論:臨床研究者在造假的制約機制中發(fā)揮著關(guān)鍵的作用,目前我國并未將臨床試驗造假的法律責(zé)任真正落實到研究者個人,通過追究臨床研究者造假的刑事責(zé)任,提高違法成本,運用Park原則能夠形成良好的制約機制,有效遏制臨床試驗造假的發(fā)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.
【作者單位】： 沈陽藥科大學(xué)工商管理學(xué)院;
【基金】：國家食品藥品監(jiān)督管理總局委托課題“藥物臨床試驗管理法律制度研究”資助項目(20160003)
【分類號】：D971.2;R95

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