Risk Prevention and Control of Pregnant Women in Drug Clinical Trials / 中国医学伦理学

ABSTRACT

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.