Ethical Review Points of Gene-related Clinical Research

VernacularTitle:基因相关临床研究中的伦理审查要点
Author: Xiaoyun CHEN ; Jiuhui LI ; Minsheng FAN
Publication Type:Journal Article
Keywords: Genetic research; ethical review; informed consent; clinical research
From: World Science and Technology-Modernization of Traditional Chinese Medicine 2013;(4):735-738
CountryChina
Language:Chinese
Abstract: 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 .