药物研发实验中的伦理问题及应对措施  

Ethical Issues and Suggestions in the Experiments of Drug Research and Development

作　　者：项荣武[1] 赵迎欢[1] 

机构地区：[1]沈阳药科大学社会科学部,辽宁沈阳110016

出　　处：《医学与哲学（A）》2015年第5期25-27,31,共4页Medicine & Philosophy:Humanistic & Social Medicine Edition

基　　金：2012年度国家社会科学基金项目"设计伦理视角下纳米制药技术风险及责任控制问题研究";项目编号:12BZX030

摘　　要：采用数理统计方法,对药物研发中可能产生的伦理问题进行实证分析,发现药物研发实验中的伦理问题表现为误用统计方法进行数据的合理性分析,致使数据失真;人为操作失误导致异常数据,发表不实数据资料;实验设计不科学导致数据不可靠,致使数据产生偏差。药物研发实验中实验数据和实验设计的伦理问题极为重要。建议将伦理学研究前移至药物研发的设计过程之中,通过电子化管理实验数据、改进和优化实验设计方法、采用虚拟实验和计算机模拟等现代化手段,以及确保实验数据完整性等措施,有效防范伦理问题的发生。To analyze the ethical issues in the experiments of drug research and development, an empirical study was conducted with the mathematical statistics method. Ethical issues in the experiments of drug research and development embody mainly in three aspects： data distortion by misuse of statistical methods; unrealistic data by human errors in operation and bias data by unscientific design of the experiments. Ethical issues related to experimental data and design in drug research and development are of vital significance. Therefore, it suggested that ethical research should be shifted forward into the design of drug research and development. Some measures, such as digital management of experimental data, optimized experimental design, virtual experiments, computer simulation and experimental data integrity should be taken into consideration.

关 键 词：设计伦理 药物研发 数据规范 

分 类 号：R-052[医药卫生]