CAJ | 학술논문

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。
근거아원윤리위원회재림상과연중우도적섭급인적기인상관성연구중철현적문제，총결료기인림상연구재윤리심사시적요점，즉수시자자주선택권，체현재연구결과적지효권급생물양본고연증자적자주권。기인림상연구동시응주의유전자원적보호，연구성과적공평원칙，동시응편우연구자실제조작。귀납료기인상관연구항목재설계방안급지정동의서시응주의적기본요점，천술료기인상관성림상연구규범성제도건설적중요성。
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 indepen-dent 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 dur-ing 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 .