E-Update Newsletters 

This issue describes the Information Management System (IMS) used to integrate massive amounts of data from the Study Centers to answer vital questions for the National Children’s Study. It provides details about the IMS technology strategies, the criticality of a standardized system, and the need for multiple security layers within the IMS. This issue also highlights innovative solutions that have been proposed for the Study as well as technology opportunities that will benefit the Study in the future.

This issue examines the daily roles of three community liaisons for the National Children’s Study at the Waukesha County Vanguard Center in Wisconsin, the Queens Vanguard Center in New York, and the University of Utah Study Center. It highlights the challenges they face and their vital role to the Study and their communities.

This issue profiles three new Study Centers, University of Arizona, Tulane University, and Maine Medical Center, and the four locations they are managing. These are 4 of the 105 Study locations from across the country that have been selected to ensure a representative sample of children is followed throughout the length of the Study.

The search for Study participants has begun at five additional Study Centers of the National Children’s Study. All seven Vanguard Centers will recruit participants and gather information during an 18-month pilot phase.

After 8 years of intensive research and planning, the National Children’s Study selected 2 Vanguard Centers to launch the recruitment and Vanguard cohort phase of the Study. The University of North Carolina at Chapel Hill and the Mount Sinai School of Medicine in New York will begin recruiting volunteer Study participants this week.

The National Children's Study announced the 2008 Study Centers that will manage operations in 39 additional locations, entering the next phase of operations to examine the effect of genes and the environment on children’s health. The 2008 Study Centers will manage the Study in 25 states.

The National Children’s Study will follow children in 105 Study locations across the country, capturing daily life in farms, desert regions, mountains, inner cities, suburbs, and other kinds of communities. Recruiting a representative sample of children from diverse groups will ensure that Study findings reflect the experiences of many different American families and not just those of one particular race, ethnicity, socioeconomic class, or region.

The Study presents the lead agency partners—the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the Centers for Disease Control and Prevention, the Environmental Protection Agency, and the National Institute of Environmental Health Sciences—an opportunity and need for an unprecedented level of planning and interagency collaboration where contributions of all the lead agencies are seen as equally important.

The National Children’s Study awarded contracts to 22 new Study Centers to manage participant recruitment and data collection in 26 additional communities across the United States. The newly awarded Study Centers cover 20 states and include both urban and rural areas.

To ensure that every participant is as fully informed as possible, and to ensure that potential participants receive consistent information, the Study has developed an innovative informed consent process involving the use of a new video tool featuring questions at the end of each section to assure information is presented clearly and is understood.

During 2006, Vanguard Center leaders met with local community groups and health care professionals to inform them about the Study, formed Community Advisory Boards composed of representatives from the local community who will provide ongoing guidance on a range of Study-related issues, and conducted needs assessments in their communities.

The National Institute of Child Health and Human Development will post a Request for Proposals (RFP) in the coming weeks to award contracts to 15 to 20 new Study Centers. These Centers will manage operations in up to 30 additional Study locations.

The National Children’s Study will be the largest longitudinal child health study ever conducted in the United States, following 100,000 children from before birth to 21 years of age to understand how a variety of factors in one’s genes and one's environment influence health. Several landmark studies helped pave the way for this research effort.

The International Childhood Cancer Cohort Consortium, an international alliance of organizations conducting child health cohort studies—including the National Children’s Study—may be able to answer questions about rare childhood diseases, particularly about the etiology of childhood leukemia, the most common form of childhood cancer. It will pool information from 11 environmental health studies representing approximately 700,000 children.

2005 marked a significant milestone in the life of the Study with the announcement of the seven Vanguard Centers that will launch and carry out the Study across the country. Study planners are developing the Study Protocol, a roadmap to guide researchers’ sampling, recruitment, and data collection activities and pilot studies are field-testing procedures and technologies to be used in the Study.

The National Children’s Study today awarded contracts to six Study Centers and one Coordinating Center, signifying a major step in implementing the largest long-term study of children’s health and development ever conducted in the United States. The Study Centers awarded today will be the first to recruit participants and collect data in local communities as part of this decades-long research effort.

The National Children’s Study Federal Advisory Committee (NCSAC) met on April 27–28 to discuss the progress of the Study, focusing on the roles of NCSAC members, the importance of community engagement and partnerships, and next steps in the Study implementation.

The National Children’s Study staff held conference calls with county executives and health officials from among the designated Study Locations to discuss the goals of the Study and the role county governments can play in its implementation such as acting as an information resource within the community and helping engage the local media to reach the public with information about the Study.

The National Children’s Study continues to lay the groundwork for Study implementation, the first step of which involves a review of proposals from organizations and institutions applying to become one of the Vanguard Centers or the Coordinating Center for the Study.

The National Children’s Study Federal Advisory Committee (NCSAC) will continue to provide important advice and recommendations as the Study moves into the implementation phase. Dr. Duane Alexander, director, NICHD, nominated Dr. Alan Fleischman to become acting chair of the NCSAC and Dr. Marion Balsam to take on the role of executive secretary.

The National Children’s Study enters the implementation phase today with the release of a Study Plan, outlining objectives, methodologies, and measures related to the first years of the 21-year Study; the announcement of the locations across the United States where the Study will be conducted; and the posting of requests for proposals for institutions to manage initial Study sites and for a coordinating center.

Since its inception, many organizations have become involved in activities to raise awareness about the need for the National Children’s Study. These groups—from a range of children’s health, environment, national, and community organizations—have worked on their own to gain support and to ensure that the needs of their communities and constituents are represented in the Study.

The approach to select locations and participants for the National Children’s Study will employ a national probability sample. The sample will be a multistage design with clusters designed to enhance both efficiency and the ability to measure chemical, physical, and social characteristics of communities as well as of Study participants.

The Sampling Design Workshop was held on March 21–22, 2004 with the goal of furthering the process of identifying a promising and efficient sampling design for the National Children’s Study. To this end, an expert panel of nine distinguished researchers, with disciplines covering a broad range of scientific areas of importance in the Study, was asked to deliberate on issues and trade-offs involved in selecting the sampling design.

The fourth Study Assembly meeting reached an audience of more than 300 participants from state and local communities, advocacy organizations, the science and medical communities, and industry groups. The goal of the meeting was to engage a broad spectrum of partners from the nation’s communities in planning for the National Children’s Study.

The National Children’s Study Ethics Working Group, which addresses a range of ethical issues related to the design and conduct of the Study, issued a paper examining how pediatric research regulations would be applied to the Study and is developing a statement on the ethical complexity of recruiting and enrolling pregnant adolescents — one population that may participate in the Study.

After more than two years of careful planning and research, the National Children’s Study has entered Phase II, the pilot phase. Before the Study begins enrolling participants in late 2005, it will focus on key projects such as identifying Study sites, developing protocols, and creating a repository for Study samples.

With advice and support from the federally chartered National Children’s Study Advisory Committee and the 20 Working Groups of scientific experts, we produced more than 50 candidate hypotheses, pilot studies, and a corresponding number of proposed measures. From these products, the Interagency Coordinating Committee proposed an initial set of core hypotheses and began framing the core protocol.

The purpose of establishing core hypotheses is to build a framework for the Study design to create the Study protocol that will determine the sampling strategies, the frequency of follow-up activities, and the collection of data.