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

作　　者：关鑫 纪文利 朱抗美 樊民胜[2] 

机构地区：[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

出　　处：《中国医学伦理学》2012年第1期83-84,共2页Chinese Medical Ethics

摘　　要：为了更好地保护乙型肝炎临床科研中的受试者,通过探讨受试者为弱势人群的伦理问题、研究人员和伦理审查人员资质的伦理问题、受试者招募的伦理问题、对照选择的伦理问题和风险与受益比的伦理问题等,提出伦理委员会加强伦理过程管理的相关措施:完善知情同意的过程,提高受试者的理解度;提高跟踪审查频率,尤其加强SAE的风险管理;加强不良反应的处理;结合开展医院"伦理查房",推进现场检查。National Ministry of Public Health issued ＂The notice oi protection oi rights ot aclmlsslon anct em- ployment 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 spe cific 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 

分 类 号：R-052[医药卫生]