Department of Bioethics, Clinical Center, National Institutes of Health, Bethesda, Maryland, USA.
Section on Prenatal Genomics and Fetal Therapy, Center for Precision Health Research, National Human Genome Research Institute, National Institutes of Health, Bethesda, Maryland, USA.
Prenat Diagn. 2022 Jul;42(8):962-969. doi: 10.1002/pd.6163. Epub 2022 May 6.
Fetal therapy trials pose complex ethical challenges because risks and benefits to both fetuses and pregnant persons must be considered. Existing regulatory guidance is limited and many proposed ethical frameworks have unnecessarily restrictive criteria that would block the development and implementation of important new fetal therapies. We aimed to develop a new ethical framework for assessing the risks and benefits of fetal therapy trials.
We reviewed existing regulatory and ethical guidance on fetal therapy trials. We used conceptual analysis to design a new ethical framework, which is grounded in general ethical principles for clinical research.
We propose a new framework for assessing the risks and benefits of fetal therapy trials. We suggest that the potential benefits of a fetal therapy trial - for the fetus, the pregnant person, and society - should outweigh the risks for the fetus and the pregnant person. Furthermore, the risk-benefit profile for just the fetus and the risk-benefit profile for just the pregnant person should be appropriate.
We hope that this new framework will permit important studies while protecting pregnant persons and fetuses from disproportionate harms.
胎儿治疗试验带来了复杂的伦理挑战，因为必须考虑到胎儿和孕妇双方的风险和获益。现有的监管指导有限，许多拟议的伦理框架有不必要的限制性标准，这将阻碍重要的新胎儿治疗方法的开发和实施。我们旨在为评估胎儿治疗试验的风险和获益制定一个新的伦理框架。
我们回顾了现有的胎儿治疗试验的监管和伦理指南。我们使用概念分析来设计一个新的伦理框架，该框架以临床研究的一般伦理原则为基础。
我们提出了一个新的框架来评估胎儿治疗试验的风险和获益。我们建议胎儿治疗试验的潜在获益——对胎儿、孕妇和社会而言——应超过对胎儿和孕妇的风险。此外，仅针对胎儿的风险-获益特征和仅针对孕妇的风险-获益特征应是适当的。
我们希望这个新框架能够允许进行重要的研究，同时保护孕妇和胎儿免受不成比例的伤害。
