药物临床试验中受试者损害补偿问题探讨(一)

Approach of compensation to subjects' impairment in clinical drug trial (Ⅰ)

本文介绍我国目前药物临床试验中受试者损害补偿存在的问题和对策。提出应完善我国受试者的损害补偿相关法规,在知情同意书设计、执行和伦理审查委员审查时要明确补偿问题。呼吁建立补偿基金和相关的意外保险,并成立专门的机构进行分析和判定后予以适当的补偿,从而保证药物临床试验的顺利进行。

This issue introduces the existing problems and corresponding countermeasure about the compensation to the subjects＇ impairment in Chinese clinical drug trial nowadays. It suggests that the corresponding laws of impairment compensation should be perfected. Moreover, during the designation, the inspection of ethics inspection committee, the execution of informed consent and the compensation problem must be clarified. It also appeals the establishment of compensation fund and related accidence insurance, from which the compensation shall be made after the analysis and assessment of professional institute, thus the clinical drug trials can be guaranteed successfully.