A major challenge in designing large-scale, multi-site studies is developing a core, scalable protocol that retains the innovation of scientific advances while also lending itself to the variability in experience and resources across sites. In the development of a common Healthy Brain and Child Development (HBCD) protocol, one of the chief questions is “is fetal MRI ready for prime-time?” While there is agreement about the value of prenatal data obtained non-invasively through MRI, questions about practicality abound. There has been rapid progress over the past years in fetal and placental MRI methodology but there is uncertainty about whether the gains afforded outweigh the challenges in supporting fetal MRI protocols at scale. Here, we will define challenges inherent in building a common protocol across sites with variable expertise and will propose a tentative framework for evaluation of design decisions. We will compare and contrast various design considerations for both normative and high-risk populations, in the setting of the post-COVID era. We will conclude with articulation of the benefits of overcoming these challenges and would lend to the primary questions articulated in the HBCD initiative.

设计大规模、多中心研究的一个主要挑战是开发一个核心的、可扩展的方案，该方案既要保留科学进步的创新性，又要适应不同中心的经验和资源的变化。在制定通用的健康大脑和儿童发育 (HBCD) 方案时，主要问题之一是“胎儿 MRI 准备好迎接黄金时段了吗？”虽然人们对通过 MRI 无创获得的产前数据的价值达成了一致，但实用性方面的问题仍然存在。过去几年，胎儿和胎盘 MRI 方法取得了快速进展，但所带来的收益是否超过了大规模支持胎儿 MRI 协议所面临的挑战，尚不确定。在这里，我们将定义跨具有不同专业知识的站点构建通用协议所固有的挑战，并将提出一个用于评估设计决策的暂定框架。我们将在后新冠时代的背景下，比较和对比正常人群和高风险人群的各种设计考虑因素。最后，我们将阐述克服这些挑战的好处，并解答六溴环十二烷倡议中阐述的主要问题。