【摘要】 药物临床试验既要符合伦理学原则、法规原则,又要具备科学原则。伦理学原则要求受试者最大程度受益和尽可能避免伤害。文盲患者属于临床试验中的弱势人群。全文结合伦理审查与药物临床试验监管工作中发现的问题,分析文盲患者参与抗肿瘤药物临床试验的若干伦理问题。更多还原

【Abstract】 The clinical drug trails should accord to ethics,legislation and scientific principles. The ethical principle requires that the rights and benefits of the subjects be maximized while risks should be minimized.Vulnerable groups include illiterate patients in clinical trials. According to the findings from the ethics committee and clinical research institution,the ethics issues of illiterate patients in clinical trails of anti-cancer drug were discussed in this paper.更多还原