中国医学伦理学2012，Vol.25Issue(1)：83-84,2.
乙型肝炎临床科研中的伦理问题及措施
Ethical Issues and Countermeasures in the Clinical Scientific Research on Hepatitis B
关鑫 1纪文利 1朱抗美 1樊民胜2
作者信息
- 1. 上海曙光医院伦理委员会,上海200021
- 2. 上海中医药大学社会科学部,上海201203
- 折叠
摘要
Abstract
National Ministry of Public Health issued "The notice of protection of rights of admission and employment among the carriers of Hepatitis B Surface Antigen" in 2010. Since then, the test of Hepatitis was canceled before admission and employment. Consequently we are going to take another consideration for people with this specific kind of disease. There are some special ethical issues when we take this group of people into clinical scientific researches, such as vulnerable problem, qualification of PI, ratio of risk and benefic, SAE, etc. Ethical committee should take some related measures to protect the subjects. Suggestions raised in this paper include further perfecting the procedure of informed consent in order to improve the research subjects'understanding towards the experiment, enhancing the ratio of tracking review, especially for the risk management of SAE, strengthening the handling of adverse reaction, and promoting on - spot review by incorporating ethical ward round in hospitals.关键词
乙型肝炎/临床科研/伦理委员会/知情同意/伦理审查/伦理查房Key words
Hepatitis B/ Clinical Scientific Research/ Ethical Committee/ Informed Consent/ Ethics Review/ Ethical Ward Round分类
医药卫生引用本文复制引用
关鑫,纪文利,朱抗美,樊民胜..乙型肝炎临床科研中的伦理问题及措施[J].中国医学伦理学,2012,25(1):83-84,2.
