基因相关临床研究中的伦理审查要点  

Ethical Review Points of Gene-related Clinical Research

作　　者：陈晓云[1] 李久辉[1,2] 樊民胜[1,2] 

机构地区：[1]上海中医药大学附属龙华医院医学伦理委员会,上海200032 [2]上海中医药大学医学伦理教研室,上海200032

出　　处：《世界科学技术-中医药现代化》2013年第4期735-738,共4页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：科学技术部国家科技重大专项重大新药创制(2011ZX09302-006-04):中药新药临床评价研究技术平台-中药新药(恶性肿瘤等疾病)临床评价研究技术平台,总课题负责人:田金洲,子课题负责人:王拥军

摘　　要：根据我院伦理委员会在临床科研中遇到的涉及人的基因相关性研究中凸显的问题,总结了基因临床研究在伦理审查时的要点,即受试者自主选择权,体现在研究结果的知晓权及生物样本库捐赠者的自主权。基因临床研究同时应注意遗传资源的保护,研究成果的公平原则,同时应便于研究者实际操作。归纳了基因相关研究项目在设计方案及知情同意书时应注意的基本要点,阐述了基因相关性临床研究规范性制度建设的重要性。Through the problem of gene-related clinical and scientific studies reviewed by the Institutional Review Board（IRB）,Shanghai Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,this article discussed and summarized main points of clinical gene-related studies such as participants have independent rights,which were the choice of being told the research results and the donors of Biobank have rights for option in or out.The clinical gene-related studies should pay attention to the protection of genetic resources during the study,fairness of genetic research findings＇ usage.And on this basis,in order to facilitate the effective operation of the researchers,key elements of the gene-related research projects were developed in the design plan and informed consent.Finally,the importance and implementation of relevant standardization system construction were also emphasized.

关 键 词：基因研究 伦理审查 知情同意 临床研究 

分 类 号：O52[理学—高压高温物理]