CAJ | 학술논문

2013年新修订的《赫尔辛基宣言》对宣言的结构进行了调整，在内容上对部分条款进行了增删和修改，并在细节上对部分用词进行了修改。新版《赫尔辛基宣言》的修订改进了宣言的架构，完善了宣言的内容，加强了对受试者的保护，提高了对研究者的要求，并明确了国家、研究机构、申办方的义务。这对我国的启示有：不断修订涉及人体临床试验的相关法规，切实保护受试者权益；提出国家对受试者保护的义务，探索建立国家临床试验赔偿体系；明确伦理委员会职责和定位，探索建立相对独立的伦理审查主体。
2013년신수정적《혁이신기선언》대선언적결구진행료조정，재내용상대부분조관진행료증산화수개，병재세절상대부분용사진행료수개。신판《혁이신기선언》적수정개진료선언적가구，완선료선언적내용，가강료대수시자적보호，제고료대연구자적요구，병명학료국가、연구궤구、신판방적의무。저대아국적계시유：불단수정섭급인체림상시험적상관법규，절실보호수시자권익；제출국가대수시자보호적의무，탐색건입국가림상시험배상체계；명학윤리위원회직책화정위，탐색건립상대독립적윤리심사주체。
The new revision of Declaration of Helsinki in 2013 has adjusted the structure, added or deleted some provisions on the content and modification, and modificated on the details of some words.Revision of the new version has improved the architecture, perfected the content of the declaration, strengthened the protection of the subjects, increased demand for researchers, and cleared the duty of country, research institutions and bidders.The enlighten-ment to our country are:constantly revised involving human clinical trials of the relevant laws and regulations , to pro-tect rights and interests of the subjects;National obligations for protection of the subjects, clinical trials explore the establishment of national compensation system;Ethics committee responsibilities and clearly positioning, exploring to establish an independent ethical review body.