关键词: 伦理委员会, 伦理审查, 妇女, 孕妇, 临床试验

Abstract: Ethics Committee need to have special consideration when reviewing clinical research involving pregnant women or women of reproductive age by the fact that it may present risks and potential benefits to the woman herself, the pregnancy, the fetus as well as to the person the fetus is destined to become.Special ethical concerns regarding clinical research involving women are as follow:The potential for becoming pregnant during a study should not, in itself, be used as a reason for precluding or limiting participation.However, a thorough discussion of risks to the pregnant woman and to her fetus is a prerequisite for the woman' s ability to make a rational decision to enroll in a clinical research.Special ethical concerns regarding clinical research involving pregnant women are as follow:Evaluation of risk-benefit ratio should be considered from two aspects (i.e., pregnant woman, the fetus), taking into account the categories of research as well.Research in this population should be performed only if it is relevant to the particular health needs of a pregnant woman or her fetus, or to the health needs of pregnant women in general, and, when appropriate, if it is supported by reliable evidence from animal experiments, particularly as to risks of teratogenicity and mutagenicity.

Key words: institutional review board, ethic review, women, pregnant women, clinical trial