A Report from The National Children's Study Ethics Working Group
The National Children's Study Ethics Working Group has been working over the last two years to address a range of ethical issues related to the design and conduct of the Study.
In its work, the Ethics Working Group has issued a paper examining how pediatric research regulations would be applied to the National Children's Study. The group is also developing a statement on the ethical complexity of recruiting and enrolling pregnant adolescents — one population that may participate in the Study.
Last June, the National Children's Study convened a workshop, Ethical Issues in Longitudinal Pediatric Studies: Looking Back, Thinking Forward, that focused on recruitment, retention, consent, confidentiality, information sharing, interventions, and interactions with communities.
Other Similar Studies
According to Ben Wilfond, M.D., co-chair of the Ethics Working Group, the purpose of the workshop was to have other researchers, who have conducted similar longitudinal studies, "discuss the good and the bad [experiences] and to identify questions that would be helpful to National Children's Study designers." Among the presentations, the group heard from researchers of studies that shared some similarities with the National Children's Study such as: Project Viva, a Boston-based study of over 2,000 pregnant women and their infants recruited in utero to assess pregnancy outcomes; The Tucson Children's Respiratory Study of 1,246 newborns followed from birth to age 20 to assess acute lower respiratory tract illnesses in early childhood and chronic obstructive airways disease in later life; and the Wisconsin Cystic Fibrosis Neonatal Screening Study Group that screened 650,341 newborn infants for cystic fibrosis.
Several broad themes emerged from the workshop including the central role of community involvement in all steps of the process, the importance of relationship building between participants and research staff to ensure participation, the challenge of communicating ethical issues to diverse communities, and how to relay study information and data to study participants.
Dr. Wilfond reported that, "It is clear that other studies have confronted and addressed issues similar to those faced by the National Children's Study. What was presented in the workshop reinforces our view that the ethical issues in the National Children's Study are not that different from those faced in previous studies. What is different is that the size and scope of the National Children's Study are broader. We are at the beginning of a process to try and address these issues, which are not, 'Study stoppers,' but are fully resolvable. But, because of the Study's size and scope, we need to work out the details carefully and fully."
Workshop participants also discussed new approaches to the informed consent process that might include interactive computer-based approaches, as well as the challenges of Institutional Review Board (IRB) review in a multisite study of this scope. Future plans for the Working Group include a workshop at the annual IRB meeting next fall to assess the IRB willingness to consider different review approaches.
Expansion of the National Children's Study Being Explored
The National Human Genome Research Institute, along with other interested federal agencies, is exploring the possibility of launching a large, adult longitudinal cohort to study relationships between genes, environment, and chronic disease. Consideration of the benefits and possible alternatives of expanding the National Children's Study to include grandparents and parents for this purpose is under discussion.
Warren Galke Joins the National Children's Study Program Office
Warren Galke, Ph.D., recently joined the National Children's Study Program Office as a Health Science Administrator. Dr. Galke is an accomplished epidemiologist with more than 30 years of environmental and occupational health experience. The primary focus of his career has been the study of childhood lead poisoning. Prior to joining the Program Office, Dr. Galke was the Director of Research and Evaluation at the National Center for Healthy Housing (NCHH), formerly the National Center for Lead-Safe Housing. While at NCHH, he was the principal investigator of the largest study ever conducted on implementing lead hazard control treatments in housing that presented a high risk of lead poisoning to children.
Dr. Galke will participate in the Study protocol development and help implement pilot studies and workshops. His early focus will be on the chemical and physical environment, including: serving on the Fertility and Early Pregnancy Working Group planning committee for a workshop concerning day-specific probability of pregnancy, responsibility for the creation of a white paper concerning the measurement of housing quality and conditions as proposed by the Social Environment Working Group, and plans for the development of the repository for biological environmental samples that will be collected for the Study.
National Children's Study in the News
The National Children's Study continues to gain attention in the media. Following are two recent mentions:
U.S. News & World Report—September 15, 2003
"Ills From The Womb"
Washington Fax—September 29, 2003
"National Children's Study Funding"
Comments or Questions?
Visit our Web site at http://nationalchildrensstudy.gov
The National Children's Study is led by a
consortium of federal agency partners:
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Centers for Disease Control and Prevention
U.S. ENVIRONMENTAL PROTECTION AGENCY