胎儿染色体非整倍体检测临床试验面临的伦理状况  

The ethical issues in the clinical trials of fetal chromosomal aneuploidy detection

作　　者：赵轶[1] 张莉[1] ZHAO Yi;ZHANG Li(Women’s Hospital,School of Medicine,Zhejiang University,Hangzhou 310006,Zhejiang Province,China)

机构地区：[1]浙江大学医学院附属妇产科医院,浙江杭州310006

出　　处：《中国临床药理学杂志》2020年第20期3398-3400,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：胎儿染色体非整倍体检测试剂盒在当前体外诊断试剂领域内研发申报集中,临床试验数量激增。该类试剂的临床试验具有受试人群特殊,遗传资源体量大等伦理问题。本文总结了无创产前基因检测技术(NIPT)临床试验相关的伦理状况,结合临床试验实施过程中发现的常见问题进行分析和探讨。对胎儿染色体非整倍体检测试剂盒临床试验应遵循的受试者知情同意、尊重隐私的伦理原则,以及对遗传资源的利用和保护提出了相应的对策和建议。Fetal chromosomal aneuploidy detection kits are currently concentrated in the field of in vitro diagnostic reagents.And recent years the number of these clinical trials has surged.This type of clinical trial has ethical issues such as the particular population being tested and the large volume of human genetic resources.This article summarizes the ethical challenges associated with Non-invasive Prenatal Testing(NIPT)clinical trials,and analyzes and discusses the common problems found during the implementation of clinical trials.We should follow the informed consent,respect the ethical principles of privacy,and put forward corresponding countermeasures and suggestions on the utilization and protection of genetic resources in the clinical trials above.

关 键 词：胎儿染色体非整倍体 临床试验 伦理学 知情同意 人类遗传资源 

分 类 号：R97[医药卫生—药品]