Investigation and Research on the law and the ethics in the research on the human genome and its applications-from an international viewpoint-

人类基因组及其应用研究的法律与伦理调查研究——国际视角——

• 批准号: 11420006
• 负责人: IDA Ryuichi
• 金额: $ 8.45万
• 依托单位: KYOTO UNIVERSITY
• 依托单位国家: 日本
• 项目类别: Grant-in-Aid for Scientific Research (B).
• 财政年份: 1999
• 资助国家: 日本
• 起止时间: 1999 至 2000
• 项目状态: 已结题
• 来源: https://kaken.nii.ac.jp/en/grant/KAKENHI-PROJECT-11420006/
• 关键词: Human Genome; Human Right; Bioethics; Human Dignity; Genetic Therapy; Cloning; Freedom ofResearch; Informed Consent; 遺伝子解析; 倫理指針; ゲノム特許; 遺伝情報; 倫理委員会

1) This research consists of the study on the various impacts on the society of the research on the human genome, "blueprint of human life", and its applications in their legal and ethical aspects and from an international viewpoint. It also offered some concrete policy proposals in Japan.2) The report examines at the beginning the whole range of issues which would arise in the human genome research and its applications, so as to clarify the current status of law and ethics in this field (Ch.1). The question concerning the rights and the duties of participants and researchers is then analyzed (Ch.2), together with the international ethical standards enshrined in the UNESCO's Human Genome Declaration of 1997 in its drafting process and its substance (Ch.3). As there exist only quite few legal regulations in the world, the state-of-art of the ethical norm-setting and the system of ethical review of research projects are exposed, with special reference to foreign countries (Ch.4). Also, the Japanese Law on the Ban of Human Reproductive Cloning is studied in comparison with the UNESCO's Human Genome Declaration, in particular on the issues of the human dignity and and the necessity of legal instruments (Ch.5). The most urgent need of the ethical guidelines comes up from the genetic testing and therapy (Ch. 6). The significance and the power of the life sciences and the works of the International Bioethics Committee ofUNESCO are presented in English (Chs.7 and 8, respectively).3) The second part is relevant documentation in this field : Japanese "Fundamental Principles on the Research on the Human Genome" and the "Ethical Guidelines on the Human Genome Research", and some other international documents.

1)这项研究包括从国际角度研究"人类生活蓝图"人类基因组研究及其在法律的和伦理方面的应用对社会的各种影响。2）报告一开始就对人类基因组研究及其应用中可能出现的各种问题进行了探讨，以澄清该领域的法律和伦理现状（第1章）。然后分析了参与者和研究人员的权利和义务问题（第2章），以及教科文组织1997年《人类基因组宣言》在起草过程中所体现的国际伦理标准及其实质内容（第3章）。由于国际上的法律的规定比较少，因此本文着重介绍了国外在伦理规范制定和伦理审查制度方面的最新进展（第四章）。此外，还将日本《禁止人的生殖性克隆法》与教科文组织《人类基因组宣言》进行了比较研究，特别是在人的尊严问题和法律的文书的必要性方面（第5章）。最迫切需要的伦理准则来自基因检测和治疗（第6章）。3）第二部分是该领域的相关文献：日本的"人类基因组研究基本原则"和"人类基因组研究伦理准则"，以及其他一些国际文献。

项目成果

上田國寛,清水章: "神経変性疾患の分子診断"臨床病理. 43,47(補冊). (1999)

Kunihiro Ueda，Akira Shimizu：“神经退行性疾病的分子诊断”临床病理学 43,47（补充）。

前田達明: "医療水準"医療の基本ABC. 123・12(特別). 126-129 (2000)

前田龙明：《医疗标准》ABC 123・12（特别）126-129（2000）。

上田國寛: "遺伝子診断から予防医学への応用"第25回日本医学学会総会会誌. 第II巻. 251 (1999)

Kunihiro Ueda：“从基因诊断到预防医学的应用”，日本医学学会第 25 届大会杂志，第 2 卷（1999 年）。

IDA, Ryuichi: "Ethical Norm Setting and Ethical Review System in the Human Genomic Medical Sciences"Experimental Medicine. Vol.18, No.12. 192-195 (2000)

IDA，Ryuichi：“人类基因组医学科学中的伦理规范设定和伦理审查系统”实验医学。

IDA, Ryuichi: "Law and Ethics relating to the Human Genome Research"Hogaku Ronso (Kyoto U.). Vol.148 : 5-6. 121-142 (2001)

IDA，Ryuichi：“与人类基因组研究相关的法律和伦理”Hogaku Ronso（京都大学）。