新藥臨床研究階段需要患者或志愿者簽定知情同意書。為了更好地發(fā)揮知情同意書對(duì)受試者的保護(hù)作用，體現(xiàn)科研項(xiàng)目的科學(xué)倫理性，研究者有必要精心設(shè)計(jì)知情同意書。針對(duì)目前知情同意書設(shè)計(jì)中存在的告知不全面、設(shè)計(jì)欠合理等問(wèn)題進(jìn)行簡(jiǎn)要分析，并介紹如何正確地設(shè)計(jì)與應(yīng)用知情同意書。

Vietnam is the one of developing countries in Sout heast Asia. In Vietnam, traditional Chinese medicines (TCMs) is widely accepted in the mainstream of local pharmaceutical market, and also covered by government reimbursement. As a result, Vietnam is one of the target countries for TCM to l aunch in the market. Supported by the National Eleventh “Fiveyear” Program, Tasly has carried out studies on the application of Yangxue Qingnao Granule in V ietnam. The article has given a brief review on technical requirements of the eva luation of Chinese Proprietary Medicine and indicated relevant ideas and views o f the application as an example of prescription drug application in Vietnam. The article has provided good experience for Chinese Proprietary Medicine manufactu rers in our country to enter Vietnamese medical market, and also established the foundation for the development of Chinese Proprietary Medicine in Vietnamese ma rket.

國(guó)家“十一五”科技支撐計(jì)劃資助項(xiàng)目(2006BAI11B00)