Researchers Face Many Ethical Challenges with HEALthy Brain and Child Development Study
March 1, 2025
By Stacey Kusterbeck
The HEALthy Brain and Child Development study is looking at the effect of various prenatal and postnatal exposures on pediatric brain and behavioral development. To answer important questions about early life influences on developmental trajectories (particularly in populations affected by socioeconomic disparities, substance exposure, and other adversities), researchers are recruiting a large cohort of pregnant individuals. Some participants have substance use disorders.
The study will follow participants and their children through early childhood. “Researchers anticipated, and encountered, numerous challenges in designing the study and enrolling participants,” reports Jenny Kingsley, MD, MA, pediatric critical care medicine attending and faculty in the Center for Bioethics at Children’s Hospital Los Angeles.
Kingsley and colleagues chronicled the challenges faced by the research team to better inform the broader research community and, hopefully, pave the way for future research to be conducted ethically with vulnerable populations.1 Researchers in the HEALthy Brain and Child Development study faced these ethical challenges:
- Determining how to include participants engaged in potentially illegal behaviors (such as substance use) without risking harm or stigmatization. Researchers had to navigate reporting requirements for substance use during pregnancy. Researchers were particularly worried about soliciting information about substance use from participants who live in states where substance use during pregnancy is considered child abuse. Ultimately, researchers designed a study protocol that allowed questionnaire and toxicology data to be sent to a central site. That way, no identifiable data were accessible at the local study site. This entailed asking participants to fill out electronic surveys, which were sent immediately to a central processing site without review by local study staff. “That solution attempted to mitigate the risk to the pregnant person, by blinding local researchers to results and protecting data integrity,” explains Kingsley.
- Avoiding exploitation or undue burden on vulnerable populations. During a pilot study phase, researchers discovered some unexpected risks to participants. Some participants worried about risks such as incurring an additional tax burden because of compensation or losing benefits. Other participants worried that they would create a paper trail (through the requirement to pay taxes) that would risk alerting authorities to their immigration status. “Both outcomes would pose substantial legal and financial risks to participants that needed to be thoughtfully addressed,” says Kingsley.
Researchers paid particular attention to the informed consent process. “While we all endeavor to early communicate study risks, benefits, and data use to participants, therefore ensuring informed consent, assuring that the informed consent process attains those goals may be challenging,” acknowledges Kingsley.
The informed consent process needed to be revisited throughout the study, to ensure that participants’ needs were being met. Researchers sought input from community advisory board members, study navigators, and participants. “This remains an ongoing process,” says Kingsley.
Some participants were unable to complete all study measures for a variety of reasons. Researchers outlined the minimum amount of data required to ensure the integrity of the study. “Researchers took seriously the risk of jeopardizing trust built with participants, and the risk of the withdrawal being seen as punitive,” says Kingsley. Researchers amended the informed consent document, taking care to explain the rationale for administrative withdrawal, and conveyed respect for the participants’ efforts. The authors suggest that Institutional Review Boards address the following ethical concerns when reviewing study protocols:
- Legal and ethical risks: How does the study protect participants engaged in potentially illegal activities (such as substance use) from legal repercussions? Are there adequate confidentiality safeguards to shield participants from external risks (such as interaction with law enforcement or child welfare agencies)?
- Stigma and discrimination: Does the protocol mitigate the risks of stigmatizing populations that already may face marginalization, particularly those affected by substance use or socioeconomic disadvantage?
- Informed consent: Are the consent procedures comprehensive and transparent, especially when dealing with vulnerable populations? Are participants fully aware of the potential risks and benefits?
- Equity in recruitment: Are recruitment strategies designed to ensure diversity and inclusion without exploiting underserved communities? Do recruitment practices balance the need for scientific rigor with ethical obligations to minimize participant burden?
- Community engagement: Has the research team engaged with community stakeholders to address ethical, cultural, and social concerns effectively?
- Data security and use: Does the protocol outline robust procedures for data storage, sharing, and use?
When vulnerable populations are being studied, “striking the right balance between ensuring human subjects’ protections, satisfying regulatory requirements, and supporting research among vulnerable populations to answer pressing questions about substance use and pediatric development may prove challenging,” concludes Kingsley.
Reference
- Kingsley J, Andraka-Christou B, Shah SK, et al. Navigating ethical and legal challenges in the HEALthy Brain and Child Development Study: Lessons learned from the ethics, law, policy working group. Dev Cogn Neurosci. 2024;70:101460.
The HEALthy Brain and Child Development study is looking at the effect of various prenatal and postnatal exposures on pediatric brain and behavioral development. To answer important questions about early life influences on developmental trajectories, researchers are recruiting a large cohort of pregnant individuals. Some participants have substance use disorders.
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