A comprehensive ethical framework for fetal research and its application to fetal surgery for spina bifida.

Abstract

The transition from innovation to standard of care for fetal surgery should be guided by ethical considerations. We provide an ethical framework that identifies criteria for the investigation of fetal surgery. This framework addresses the initiation and assessment of clinical trials to determine whether they establish a standard of care, describes an appropriate informed consent process, considers whether selection criteria should include the abortion preferences of the pregnant woman, and considers whether physicians have an obligation to offer referral to such investigation. This ethical framework, in a clinically comprehensive fashion, takes account of the physician's obligations to the fetal patient, the pregnant woman, and future fetal and pregnant patients. We apply this framework to clinical investigations of fetal surgery for spina bifida.