Navigating ethical and legal challenges in the HEALthy Brain and Child Development Study: Lessons learned from the ethics, law, policy working group

• Published in: Developmental cognitive neuroscience Vol. 70; p. 101460
• Main Authors: Kingsley, Jenny, Andraka-Christou, Barbara, Shah, Seema K., Spicer, Paul, Newman, Sharlene, Ossorio, Pilar N.
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier Ltd 01.12.2024; Elsevier
• Subjects: Brain; Child; Child Development; Female; Humans; Infant, Newborn; Law; Longitudinal Studies; Original Research; Pediatrics; Pregnancy; Prospective Studies; Reproductive rights; Research ethics; Research regulation; Substance use; United States; United States; Pregnancy; Substance use; Research regulation; Pediatrics; Law; Reproductive rights; Research ethics
• ISSN: 1878-9293; 1878-9307; 1878-9307
• DOI: 10.1016/j.dcn.2024.101460

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. •Complex, longitudinal, observational studies often face unique ethical and legal challenges.•Ethical and legal trade-offs may be necessary in research involving pregnant people.•Embedding ethics scholars into research can help navigate these tensions.