Chervenak Frank A, McCullough Laurence B
Department of Obstetrics and Gynecology, New York Weill Cornell Medical Center, New York Presbyterian Hospital, New York, NY 10065, USA.
Clin Perinatol. 2009 Jun;36(2):237-46, vii-viii. doi: 10.1016/j.clp.2009.03.002.
This article provides a comprehensive approach to the ethics of clinical investigation of fetal surgery. Investigators should address the initiation and assessment of clinical trials to determine whether they establish a standard of care and use an appropriate informed consent process to recruit and enroll subjects, consider whether selection criteria should include the abortion preferences of the pregnant woman, and consider whether physicians have an obligation to offer referral to such investigation. This approach is comprehensive because it takes account of the physician's obligations to the fetal patient, the pregnant woman, and future fetal and pregnant patients. The comprehensive approach to the ethics of fetal surgery is applied to the example of in utero surgical management of spina bifida.
本文提供了一种全面探讨胎儿手术临床研究伦理问题的方法。研究人员应着手开展并评估临床试验,以确定其是否确立了医疗护理标准,并采用适当的知情同意程序来招募和登记受试者,考虑选择标准是否应包括孕妇的堕胎偏好,以及医生是否有义务为这类研究提供转诊。这种方法是全面的,因为它考虑到了医生对胎儿患者、孕妇以及未来胎儿和孕妇患者的义务。胎儿手术伦理的全面方法应用于脊柱裂宫内手术管理的实例。