Weill Medical College of Cornell University, New York, NY 10065, USA.
Am J Bioeth. 2011 May;11(5):39-49. doi: 10.1080/15265161.2011.562595.
Research to improve the health of pregnant and fetal patients presents ethical challenges to clinical investigators, institutional review boards, funding agencies, and data safety and monitoring boards. The Common Rule sets out requirements that such research must satisfy but no ethical framework to guide their application. We provide such an ethical framework, based on the ethical concept of the fetus as a patient. We offer criteria for innovation and for Phase I and II and then for Phase III clinical trials to improve the health of pregnant patients and of fetal patients and also criteria to responsibly manage the transition from investigation to clinical practice. Basing ethical criteria for research involving pregnant women on the ethical concept of the fetus as a patient insulates the proposed ethical framework and therefore research on pregnant women from the divisive and politicized concepts and discourses of personhood, fetal rights, and unborn child.
研究如何改善孕妇和胎儿患者的健康状况，给临床研究人员、机构审查委员会、资助机构以及数据安全和监测委员会带来了伦理挑战。《普遍规则》规定了此类研究必须满足的要求，但没有指导其应用的伦理框架。我们提供了这样一个伦理框架，其基础是将胎儿视为患者的伦理概念。我们为创新以及 I 期和 II 期临床试验，然后是 III 期临床试验，提出了改善孕妇和胎儿患者健康的标准，以及负责任地管理从研究向临床实践过渡的标准。将涉及孕妇的研究的伦理标准建立在将胎儿视为患者的伦理概念的基础上，可以保护所提出的伦理框架，从而使关于孕妇的研究免受人格、胎儿权利和未出生儿童等具有分歧和政治化概念和论述的影响。
