COMPARATIVE STUDY ON ETHICAL AND LEGAL PROBLEMS OF CLINICAL RESEARCH

临床研究伦理与法律问题的比较研究

基本信息

批准号：
09620008
负责人：
MARUYAMA Eiji
金额：
$ 1.54万
依托单位：
KOBE UNIVERSITY
依托单位国家：
日本
项目类别：
Grant-in-Aid for Scientific Research (C)
财政年份：
1997
资助国家：
日本
起止时间：
1997 至 1999
项目状态：
已结题

项目摘要

In this research, I studied the legal and ethical problems of clinical research.After obtaining a rough sketch of Japanese practice, I studied the historical developments in and the present framework of the regulation of the clinical research in the United States. There are two kinds of regulation by the federal govemment. First is the regulation of the research conducted or funded by the federal departments or agencies. Second is the regulation by the Food and Drug Administration of the clinical trial of new drugs. I focused my attention on the first, because it has been more influential. The Department of Health, Education and Welfare, and later, the Department of Health and Human Services has taken the lead in the field. In 1991, the so-called "Common Rule" which was modeled on the DHEW's regulations was promulgated. The features of the Common Rule are : (1) the requirement of submission by the institutions of assurance of the protection of human research subjects ; (2) the requirement of the establishment of institutional review board (IRB), (3) the requirement of informed consent as the comerstone of the subject's protection.In the fall of 1999, the burst of ethical guidelines began in Japan. The Ministry of Health and Welfare's "Guidelines on Ethical Issues Surrounding Genetic Analysis Research (2000), " the Council for Science and Technology's "Fundamental Principles of Research on the Human Genome (2000)" and "Ethics Guidelines on Human Genome and Genetic Research (2001)" of three responsible ministries are prominent among them. The issues of stored samples and general consent and the problem of the permissibility and obligation of disclosing the subject's genetic information to his relatives are common to most sets of guidelines. It is suggested that understanding among people is prerequisite to the concept of general consent to the participation in research.

在这项研究中，我研究了临床研究的法律和伦理问题。在粗略了解了日本的实践之后，我研究了美国临床研究监管的历史发展和目前的框架。联邦政府有两种监管。首先是对联邦部门或机构进行或资助的研究的监管。二是食品药品监管总局对新药临床试验的监管。我把注意力集中在第一个上，因为它的影响力更大。卫生、教育和福利部以及后来的卫生和公共服务部在该领域发挥了主导作用。 1991年，颁布了仿照DHEW法规的所谓“共同规则”。共同规则的特点是：（1）要求机构提交保证保护人类研究对象的文件； (2)设立机构审查委员会(IRB)的要求,(3)作为受试者保护基石的知情同意的要求。 1999年秋天,日本开始出现伦理准则的爆发。卫生福利部的《基因分析研究伦理问题指南（2000 年）》、科学技术委员会的《人类基因组研究基本原则（2000 年）》和《人类基因组和基因研究伦理指南（2000 年）》三个主管部委的《2001》》就是其中突出的。储存样本和普遍同意的问题以及向其亲属披露受试者遗传信息的允许性和义务问题是大多数指南的共同点。有人建议，人们之间的理解是普遍同意参与研究这一概念的先决条件。