伦理审查中知情同意书主审表使用研究  

Research of ICF Assessment Form in Ethical Review

作　　者：李晓[1] 吕晓东[1] 于萍[1] 

机构地区：[1]辽宁中医药大学附属医院,沈阳110032

出　　处：《世界科学技术-中医药现代化》2013年第5期1157-1160,共4页Modernization of Traditional Chinese Medicine and Materia Medica-World Science and Technology

基　　金：国家中医药管理局国家中医临床研究基地业务建设科研专项(2012L02014):基于"以络论治"理论中药穴位贴敷对小儿肺炎易感体质的临床研究;负责人:吕晓东

摘　　要：为维护受试者的合法权益和整个社会的利益,创建宽松和谐的科研、医患环境,保证临床科研试验正常进行,确保临床试验研究符合伦理道德规范,伦理审查中的方案审查与知情同意审查是保护受试者的2大基石。好的知情同意书主审工作表是帮助伦理委员会提高方案审查质量的必要手段。In order to safeguard the legitimate rights and interests of the subjects and the interests of the whole society, a relaxed and harmonious environment was created to ensure the normal medical research, clini- cal research trials which fit in trial of ethical review. The protocol assessment form and ICF assessment form to review are two cornerstones of protecting subjects. A good ICF assessment form is a necessary means to help improve the quality of the Ethics Committee for review.

关 键 词：伦理审查 知情同意书主审工作表 临床试验 审查质量 

分 类 号：R052[医药卫生]