Iijima Yoshihiko
Department of Ethics Review Committee, Nagoya University Graduate School of Medicine.
Rinsho Shinkeigaku. 2011 Nov;51(11):830-3. doi: 10.5692/clinicalneurol.51.830.
Clinical research is guided by ethical principles promulgated in several statements, principally the Nuremberg Code, the Helsinki Declaration of the World Medical Association etc. In Japan, clinical research of medical products, principally trial of new pharmaceutical products is regulated by GCP (good clinical practice). Other types of clinical research are regulated by some ethical guidelines for clinical researches. The result is a regulatory position that is a complex combination of legislation and ethical guidelines. In the Ethical Guideline for Clinical Studies revised in 2008, clinical research is classified into intervention research and observational research. When researchers plan clinical research, they must determine the type of clinical research and appropriate ethical guideline for the type of clinical research. Advances in health informatics and genetic research have produced a new and very rich body of raw material for clinical research in the form of gene banks and genome-wide association study etc. The use of human tissue and medical information in the course of clinical research raises issues under the ethical regulations for research with human subjects.
临床研究遵循多项声明中颁布的伦理原则，主要是《纽伦堡法典》、世界医学协会《赫尔辛基宣言》等。在日本，医疗产品的临床研究，主要是新药品试验，受药品临床试验质量管理规范（GCP）监管。其他类型的临床研究则受一些临床研究伦理准则的监管。其结果是一种由立法和伦理准则复杂组合而成的监管状况。在2008年修订的《临床研究伦理准则》中，临床研究被分为干预性研究和观察性研究。当研究人员计划进行临床研究时，他们必须确定临床研究的类型以及适用于该类型临床研究的伦理准则。健康信息学和基因研究的进展产生了以基因库和全基因组关联研究等形式存在的、用于临床研究的全新且非常丰富的原始资料。在临床研究过程中使用人体组织和医疗信息引发了人体研究伦理规范方面的问题。
