遗传学与干细胞研究的伦理学问题Ethical Isues in Genetic Research_Chinese.pptVIP

June 2008 FERCAP Human Participant Protection Course Ethical Issues in Genetic and Stem Cell Research 遗传学与干细胞研究的伦理学问题 Genetic Research Types遗传学研究类型 Genetic Testing Genetic disease 基因检测与遗传性疾病 Behavioral Genetic Studies 行为基因学研究 Data and Tissue storage 数据与组织标本储存 Gene Transfer Research 转基因研究 Human Genome project 人类基因组计划 Ethical Issues in Genetic Research遗传研究中的伦理问题 Respect for person 尊重 Informed consent 知情同意 Respect for vulnerable person 尊重弱势人群 Beneficence 有益 Balancing harm and benefits 均衡伤害和获益 Justice 公平 Distribution of benefit and risk 利益和风险的分配 Gene Transfer Research转基因研究 Technique to substitute absent or faulty genes (causing the disease) 用功能基因替补导致特定疾病的基因缺失或基因缺陷　 Carrying the gene fragment to the cells 特定基因片段转入细胞 Use of vectors (viral or bacterial) 利用病毒或细菌载体 Gene Therapy 基因治疗– Jesse Gelsinger case What they were testing?检测什么？ A new way to replace defective genes in order to treat enzyme disorder. 替换缺陷基因是酶缺陷性疾病新的治疗途径 Whom they tried it on?受试者是谁？ Eighteen patients with mild deficiencies 18名轻型酶缺乏的病人 Gene Therapy 基因治疗– Jesse Gelsinger case What went wrong? 问题在哪？ Injection of the genes - modified cold viruses 注射经修饰的感冒病毒携带的基因 The immune system fought against the wildly proliferating viruses. Next day, he slipped into a coma 免疫系统对极度增殖的病毒产生反应。注射次日，患者渐入昏迷。 Gene Transfer Research Regulations转基因研究 Subject to FDA regulations as biological products 需要遵守FDA有关生物产品的法规 IRB responsible for ensuring that recombinant DNA research is conducted according to the NIH guidelines 伦理委员会负责保证重组DNA研究遵照NIH指南实施 General concepts for consent form associated with gene transfer trial转基因研究相关知情同意的一般概念 What measures have been taken to minimize the risks of transmission? 什么措施能使转基因研究风险最小化？ If transmission were to occur, what would be the consequences? 如果实施转基因，后果将会是什么？ The use of the terms “therapy/treatment/drug” should be avoided, “agent” is preferred 避免使用“疗法/治疗/药物”的字眼，代之以“制剂” The use of recombinant DNA should b