临床医学研究中的伦理学问题及对策探讨  

Discuss on Ethics Problem and Countermeasure in Clinical Medical Research

作　　者：孙成春[1] 徐建江[1] 黄伦论[2] 薛源[2] 李朝武[3] 

机构地区：[1]济南军区总医院药剂科,250031 [2]济南军区总医院医务部,250031 [3]山东大学齐鲁医院药物临床试验机构办公室

出　　处：《中华医学科研管理杂志》2016年第4期244-247,共4页Chinese Journal of Medical Science Research Management

摘　　要：对临床医学研究中的伦理问题进行探讨，提出解决对策。伦理委员会和知情同意书是保护医学研究中受试者的主要措施。但是在实际操作中存在许多的问题，有研究者对科研伦理认识的问题，也有研究者为了避免“麻烦”而不愿签署知情同意书，或者流于形式。对于免除知情同意的情况应慎重。应加强医学伦理学的宣传教育，加强医疗机构伦理委员会的建设，提高科研人员对伦理学问题的认识，提升医学科学研究的质量，保护受试者的权益。To discuss the ethics problem in clinical medical research and propose t^e countermeasures. Ethics committee and informed consent are the main measures to safeguard the rights and interests of participants. But there are many problems on practical operation. Some are from the cognition of investigator to ethics on scientific research. Some investigators aren＇t willing to sign the informed consents due to the troublesome, or the informed consents become a mere formality. We also should take exempting informed consent prudently. We should enhance medical ethical education and the construction of ethics committee in medical institutions, improve cognitive level of ethical issues, increase the quality of medical research, and ensure the interests of participants.

关 键 词：临床研究 伦理学 知情同意 伦理委员会 

分 类 号：R-052[医药卫生]