What is the National Children’s Study?
What will we learn from the Study?
How will the Study be conducted?
Where in North Carolina will the Study be conducted?
What is the Study timeline?
What is UNC’s role in the Study? What is the difference between a Study Center and a Study location?
Why was Durham County selected?
Who can join the Study?
What will women get for participating in the Study?
How will informed consent and medical records release authorization be handled?
What safeguards are in place for the protection of each participant’s privacy?
Who is conducting the study in North Carolina?
What is the National Children’s Study?
The National Children’s Study is the largest long-term study of environmental and genetic effects on children’s health ever conducted in the United States. By following 100,000 children from before birth to age 21, Study researchers hope to better understand how children’s genes and their environments interact to affect their health and development. In the Study, “environment” includes factors such as: air, water, and house dust; what children eat; how they are cared for; the safety of their neighborhoods; how often they see a doctor; and other factors.
What will we learn from the Study?
The Study will examine important health issues, including: birth defects and pregnancy-related problems; injuries; asthma; obesity; diabetes; and behavior, learning, and mental health disorders to establish links between children’s environments and their health. By tracking children’s development through infancy, childhood, and early adulthood, the Study hopes to better understand the root causes of harmful, harmless, and helpful factors that influence children’s health. Findings from the Study will benefit all Americans by providing researchers, health care providers, and public health officials with information from which to develop prevention strategies, health and safety guidelines, and possibly new treatments and cures for disease.
How will the Study be conducted?
The Study will be conducted in 105 locations (counties or groups of counties) across the United States. In these locations, Study teams will work with health care professionals and community leaders to recruit women who are pregnant or are likely to become pregnant in the near future for participation in the Study. Most families will be recruited through contact at their home. Others will join through their local physicians’ offices, health clinics, and hospitals. Initially, researchers will collect information on women’s pregnancies, including their diets, environments, chemical exposures, and emotional stress. When their children are born, and periodically thereafter, researchers will conduct interviews with mothers, assess the child’s development, and collect biologic and environmental samples. Researchers will collect data in person from families during home and clinic visits, and also remotely via telephone, computer, or mail-in questionnaires.
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Where in North Carolina will the Study be conducted?
Recruitment began in Duplin County in January, 2009. The Study team in Durham County has begun recruiting women this year (2011).
What is the Study timeline?
Recruitment began in seven Vanguard Locations in early 2009. Durham County (along with 29 other counties) will begin recruiting women in 2011. Other counties will begin enrolling families over the next couple of years. Each child will be followed from birth to age 21.
What is UNC’s role in the Study? What is the difference between a Study Center and a Study location?
UNC is one of the existing NCS Study Centers. Study Centers consist of research teams from nearby universities, hospitals, or other organizations that carry out the research at Study Locations. Most Centers will manage operations at more than one Study location. They will work within their designated Study Location(s). There will eventually be 30–50 Study Centers overall. Study Location(s) consist of counties (or groups of counties) where participants will be recruited and data collection will occur; there are 105 different study locations.
Why was Durham County selected?
Like all Study Locations, Durham was selected at random using a probability-based method to ensure that children and families across the nation — from diverse ethnic, racial, economic, religious, geographic, and social groups — are proportionately represented in the Study. The Study Locations selected include 79 metropolitan areas (urban, suburban, and small cities), and 26 rural communities.
Who can join the Study?
Women who live in parts of Durham County and become pregnant within a 4- to 5-year enrollment period may volunteer to be in the Study. Our goal is to have 1,000 children (250 children per year) born in Durham County participate in the study.
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What will women get for participating in the Study?
Families enrolled in the study will be compensated for their time and energies with monetary and nonmonetary incentives.
How will informed consent and medical records release authorization be handled?
All study protocols and consent materials have been reviewed by multiple Institutional Review Boards at the national and local levels. Each woman enrolling in the National Children’s Study will be informed about participation and asked to consent to it. Prior to her child’s birth, she will also be asked for permission for Study staff to obtain her medical information. Assent will be sought from the children themselves as they get older, and when they reach the age of legal consent, they will be asked to provide informed consent.
What safeguards are in place for the protection of each participant’s privacy?
Confidentiality for all National Children's Study participants is critical for the Study to be successful. Privacy protection and confidentiality training for all Study staff, use of unique identification numbers, and the design of computer management systems that protect personal identifying information will be implemented. Institutional Review Board approvals will be secured prior to Study initiation and information gathered for the Study will be used for research purposes only. The National Children's Study has also acquired a Certificate of Confidentiality from the National Institutes of Health to protect identifiable research data from forced disclosure.
Who is conducting the study in North Carolina?
A team of researchers from the University of North Carolina at Chapel Hill (UNC), Duke University, and Battelle Memorial Institute are working together to plan and implement the study in multiple counties in North Carolina. This team is made up of researchers, clinicians, and data collection experts who have an interest in improving the health of families and their children. The project is coordinated at the Carolina Population Center at UNC-Chapel Hill.
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For More Information
Website: http://centers.nationalchildrensstudy.gov/unc
Email: ncs_unc@unc.edu