摘要
《医师宣言》和药物临床试验质量管理规范(GCP)均要求医疗服务将患者/受试者的利益放在首位。在临床试验的科学性、社会性与受试者权益的冲突中,研究人员往往忽略受试者的权益而选择前者。文中通过对临床试验中一些问题的分析,认为不但要强调研究人员的职业精神的教育,重视职业精神的监督,也要重视创造一种能够使受试者安全、研究人员受益的共赢的文化环境。
According to both of the Physicians＇ Charter and the Good Clinical Practice,the subject＇s rights and benefits should be considered first.In practices,between the conflicts of scientific and social benefits and subject＇s rights and benefits,researchers sometimes neglect the latter one.After analyzed problems in clinical trials,it is realized that not only monitoring researchers＇ behaviors should be emphasized in terms of professional ethics,but also attention to developing a win-win culture environment for subjects and researchers should be paid attention to.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2010年第8期650-653,共4页
Chinese Journal of New Drugs
关键词
药物临床试验
研究人员
职业精神
受试者权益
clinical trial
researchers
professionalism
subject＇s rights and benefits
