Risk Prevention and Control of Pregnant Women in Drug Clinical Trials
10.12026/j.issn.1001-8565.2017.03.01
- VernacularTitle:药物临床试验孕妇受试者风险防控
- Author:
Hong TANG
;
Jinzhong ZHANG
- Keywords:
Pregnant Women Subjects;
Clinical Trial;
Ethical Review;
Risk Minimization;
Informed Consent
- From:
Chinese Medical Ethics
2017;30(3):267-272
- CountryChina
- Language:Chinese
-
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.
