摘要
孕妇以及育龄期妇女参加临床试验,涉及她们本人、妊娠、胎儿和由胎儿长成的人、以及她们生育力的风险和受益,伦理委员会审查时需要有一些特殊的考虑。涉及妇女临床研究的特殊伦理审查问题主要包括:研究期间有怀孕的可能,其本身不能作为排除或限制育龄期妇女参加生物医学研究的理由;详尽讨论研究对孕妇和胎儿的风险,是妇女做出参加临床研究理性决定的先决条件;涉及孕妇临床研究的特殊伦理审查问题主要包括:风险和受益的判断应同时考虑研究对孕妇及胎儿两方面的风险与受益,并结合研究的类别进行考虑;只有当研究是针对孕妇或胎儿特有的健康需要,或针对孕妇总体的健康需要,并且如果合适,有来自动物实验、尤其是关于致畸和致突变风险的可靠证据予以支持,才能在孕妇群体中实施研究。
Ethics Committee need to have special consideration when reviewing clinical researeh 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 teratogonicity and mutagenicity.
出处
《中国临床药理学与治疗学》
CAS
CSCD
2006年第4期477-480,共4页
Chinese Journal of Clinical Pharmacology and Therapeutics
基金
国家科学技术部"临床试验关键技术及平台研究"资助项目(№2004AA2Z3766)
关键词
伦理委员会
伦理审查
妇女
孕妇
临床试验
institutional review board
ethic review
women
pregnant women
clinical trial
