Open-uterine surgery to repair spina bifida, or ‘fetal surgery of open neural tube defects,’ has generated questions throughout its history—and continues to do so in a variety of contexts. As clinical ethics consultants who worked (Mark J. Bliton) and trained (Virginia L. Bartlett) at Vanderbilt University—where the first successful cases of open-uterine repair of spina bifida were carried out—we lived with these questions for nearly two decades. We worked with clinicians as they were developing and offering the procedure, with researchers (...) in refining and studying the procedure, and with pregnant women and their partners as they considered whether to undergo the procedure. From this experience in the early studies at Vanderbilt, we learned that pregnant women and their partners approach the clinical uncertainty of such a risky procedure with a curious and unique combination of practicality, self-reflection, fear, and overwhelming hope. These early experiences were a major contributing factor to the inclusion of an ethics-focused interview in the informed consent process for the Management of Myelomeningocele Study (MOMS) trial study design. (shrink)

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. (shrink)

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. (shrink)

The so-called genetics revolution rests on a history which at its least can be described as controversial. Modern genetics needs to bear this history in mind. In particular, as with the past, the area of reproductive choice seems particularly vulnerable to potential abuse. Courts in the UK and elsewhere have already shown themselves willing to interfere with the choices of women in the management of their pregnancies. Medical advance, perhaps particularly the capacity to visualise the developing foetus, has added complexity (...) to the question of whether the health care provider has one patient or two patients . Additionally, pregnancy is thoroughly monitored in modern medical practice and genetics may provide a further impetus or incentive to mandate increased policing of pregnancy. Gene therapy, once offered, will add further to the desire to ensure that women make the ‘right’ choice, especially when the invasion required is relatively minimal. Further, genetic information is at best predictive, but may, because of its scientific nature, appear to those receiving it to be certain. Thus, the provision of genetic information may reduce rather than enhance choice, unless carefully and sensitively provided. A mature and sophisticated debate about the role of genetics in reproduction is required—engaging rather than bypassing the public—if the real potential of genetics is to be vindicated. (shrink)