Center for Bioethics, Children's Hospital Los Angeles, Los Angeles, CA, United States; Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.
School of Global Health Management & Informatics, University of Central Florida, Orlando, FL, United States.
Dev Cogn Neurosci. 2024 Dec;70:101460. doi: 10.1016/j.dcn.2024.101460. Epub 2024 Oct 21.
The HEALthy Brain and Child Development (HBCD) Study, a multi-site prospective longitudinal cohort study, will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. The HBCD study has faced several ethical and legal challenges due to its goal of enrolling pregnant people (including those with substance use disorder) and their newborns. Challenges not fully anticipated at the outset emerged from the rapidly changing legal landscape around reproductive rights in the United States. By embedding scholars in bioethics and law within research teams and engaging them in conversation with each other and other study personnel, we were able to address many challenges proactively and respond promptly to unanticipated challenges. In this paper, we highlight several important ethical and legal challenges that arose from the first phase of funding through the beginning of participant enrollment. We explain the methods used to address these challenges, the ethical and legal tradeoffs that arose, and the resolution of challenges through the design of the study. Based on this experience, we provide recommendations for research teams, sponsors, and reviewers to address legal risks and promote the ethical conduct of studies with pregnant people and caregivers. We highlight the importance of collaboration with bioethics and legal scholars in studies involving complex and evolving legal risks, as well as the necessity of designing robust approaches to informed consent and maintaining participant trust while navigating ethical challenges in research.
HEALthy 大脑与儿童发育（HBCD）研究是一项多地点前瞻性纵向队列研究，将从产前开始并计划持续到儿童早期，研究人类大脑、认知、行为、社会和情感发育。由于该研究旨在招募孕妇（包括患有物质使用障碍的孕妇）及其新生儿，因此 HBCD 研究面临着一些伦理和法律挑战。由于美国生殖权利的法律环境迅速变化，在研究开始时并未完全预料到的挑战出现了。通过在研究团队中嵌入生物伦理学和法律学者，并使他们相互交流以及与其他研究人员交流，我们能够主动解决许多挑战，并迅速应对意料之外的挑战。在本文中，我们重点介绍了在第一阶段资助结束和参与者入组开始时出现的几个重要的伦理和法律挑战。我们解释了用于解决这些挑战的方法、出现的伦理和法律权衡以及通过研究设计解决挑战的方法。基于这一经验，我们为研究团队、赞助商和评审员提供了建议，以解决涉及复杂和不断变化的法律风险的研究中的法律风险，并促进对涉及孕妇和照顾者的研究的伦理行为。我们强调了在涉及复杂和不断变化的法律风险的研究中与生物伦理学和法律学者合作的重要性，以及在研究中应对伦理挑战时设计强大的知情同意方法和维护参与者信任的必要性。
