CAJ | 학술논문

目的：分析与探讨药物临床试验中受试者损害赔偿方案现状，推动临床试验为受试者提供损害赔偿的实施与规范化。方法回顾性调查某院2008年1月～2014年12月药物临床试验对受试者提供赔偿情况，调查资料主要包括试验协议、知情同意书和保险。结果试验协议中均声明由试验药物引起的受试者损害赔偿由申办方承担，但缺乏细则。部分知情同意书中缺失受试者损害赔偿的告知。70项试验项目中，17项提供保险，综合参保率为24．3％。国际多中心项目的参保率（100％）显著高于国内项目（9．1％）。对国内项目进行分析，其参保率逐年增加，但不同分期的参保率无差别。17项保险中，有13项为临床试验责任保险，其余为产品和一般责任保险；有5项提供了保险说明书，其余只备有保险证明或保单；有2个项目的保险单为外文，无中文版本。结论该院通过项目准入制度、加强伦理审批、强化试验质量管理来预防受试者损害发生，发生损害事件后应充分保障受试者的健康及权益，以及积极宣传临床试验保险来完善受试者损害赔偿机制，保障受试者的权益，降低临床试验风险。
목적：분석여탐토약물림상시험중수시자손해배상방안현상，추동림상시험위수시자제공손해배상적실시여규범화。방법회고성조사모원2008년1월～2014년12월약물림상시험대수시자제공배상정황，조사자료주요포괄시험협의、지정동의서화보험。결과시험협의중균성명유시험약물인기적수시자손해배상유신판방승담，단결핍세칙。부분지정동의서중결실수시자손해배상적고지。70항시험항목중，17항제공보험，종합삼보솔위24．3％。국제다중심항목적삼보솔（100％）현저고우국내항목（9．1％）。대국내항목진행분석，기삼보솔축년증가，단불동분기적삼보솔무차별。17항보험중，유13항위림상시험책임보험，기여위산품화일반책임보험；유5항제공료보험설명서，기여지비유보험증명혹보단；유2개항목적보험단위외문，무중문판본。결론해원통과항목준입제도、가강윤리심비、강화시험질량관리래예방수시자손해발생，발생손해사건후응충분보장수시자적건강급권익，이급적겁선전림상시험보험래완선수시자손해배상궤제，보장수시자적권익，강저림상시험풍험。
Objective:To investigate the current situation of damage compensation for subjects in drugs clinical trials.Methods: Retrospective analyzes was conducted on 70 drug clinical trail from January 2008 to December 2014 in our hospital , including protocols、informed consent and insurance .Results: It was written in most proto-cols that sponsor undertook damage compensation due to experimental drugs , however , lack of detailed rules .Dam-age compensation for subjects was missed in some informed consents .17 drugs clinical trials provided insurance , the rate of jointing insurance 24 .3%.In international trail , the rate of jointing insurance ( 100%) was higher than that in domestic trail (9.1%).As to domestic trail, the rate of jointing insurance increased gradually .There was no difference between insurance of different periods .In 17 insurance , 13 were clinical trial liability insurance , oth-ers were product and general liability insurance;5 provided insurance instruction , only insurance certificate or poli-cy in others;2 insurance applied foreign language .Conclusion:Through project access system , strengthening the ethical approval , strengthening quality management to prevent the damage occurred , participants damage happened after fully protect the health and rights and interests of the subjects , and actively promote clinical trial insurance to perfect our subjects′damage compensation mechanism , the protection of the rights of the subjects , and reduce the risk of clinical trials .