孕妇药物研究非常必要、紧迫,人体试验是孕妇药物研究的重要环节.孕妇受试者是脆弱群体受试者,但不能因孕妇受试者可能面对特殊风险而将孕妇群体排除在孕妇用药临床试验之外.政府相关部门应细化相关法规,规范孕妇用药研究临床人体试验,维护孕妇受试者权益.为防控孕妇药物研究人体试验风险,建议将受试者限定为患病孕妇,开展孕妇药物研究0期临床试验.孕妇药物研究伦理审查,应坚持风险最小化、知情同意、合理补偿原则,应重视对孕妇药物研究的跟踪审查.同时,防控孕妇药物临床试验孕妇受试者风险,应形成合力.%Pregnant women drug research is quite necessary and urgent,of which human trail is an important link.Pregnant women are vulnerable subjects,but they should not be excluded from drug clinical trials because of possible special risks.The governments should refine the relevant laws and regulations to standardize the clinical trials of pregnant women and safeguard their rights and interests.In order to prevent and control the risks of human trail in pregnant women drug research,it is suggested that the subjects should be limited to the pregnant women who are ill and carry out the 0 phase clinical trial of pregnant women drug research.The ethical review of pregnant women drug research should adhere to the principle of risk minimization,informed consent and reasonable compensation.Meanwhile,the ethical review should emphasize the tracing review.Risk prevention and control of pregnant women in clinical trials should form a joint force.
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