E7-14514. National Institute for Child Health and Human Development; National Children's Study 2007 Research Plan

ACTION:

Notice; opportunity for review and comment.

SUMMARY:

Attached is the proposed Research Plan for the National Children's Study (NCS). The purpose of this notice is to inform scientific reviewers, professional colleagues, contributors, and all who are interested in this ground-breaking initiative, of the opportunity for review and comment. The Research Plan describes the Study's background, design, measures, and the rationale for their selections in sufficient detail so that readers can understand the basis of the Study and how it will be carried out. This plan was developed with input from scientists and other professionals across the country and from multiple federal agencies, especially the National Institute of Child Health and Human Development (NICHD) and the National Institute of Environmental Health Sciences (NIEHS) at the National Institutes of Health (NIH), the Centers for Disease Control and Prevention, and the U.S. Environmental Protection Agency (EPA). We welcome constructive comments and proposals for how the National Children's Study might address the pressing health concerns of our nation's children even more effectively. Procedures for commenting and communicating about the Research Plan are found on the NCS Web site at: http://www.nationalchildrensstudy.gov/​research/​research_​plan/​index.cfm.

DATES:

Submit responses to the National Children's Study (see below) on or before September 25, 2007.

FOR FURTHER INFORMATION CONTACT:

The National Children's Study, NICHD, NIH, 6100 Executive Blvd., Room 5C01, Bethesda, MD 20892. Telephone: [phone], Fax: [phone], e-mail: [e-mail], Internet at: http://www.nationalchildrensstudy.gov.

SUPPLEMENTARY INFORMATION:

The National Children's Study is a long-term study of child health 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; and how often they see a doctor.

The goal of the National Children's Study is to provide information that will ultimately lead to improvements in the health, development, and well-being of children. The primary aim of the Study is to investigate the separate and combined effects of environmental exposures (chemical, biological, physical, psychosocial) as well as gene-environment interactions on pregnancy outcomes, child health and development, and precursors of adult disease.

The Study will examine important health issues, including: birth defects and pregnancy-related problems, injuries, asthma, obesity and diabetes, and behavior, learning, and mental health disorders. By establishing links between children's environments and their health, and charting their development through infancy, childhood, and early adulthood, the Study hopes to determine the root causes of many childhood and adult diseases. 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.

The Study will employ a national probability sampling approach to select locations for conduct of the study. The sampling design utilizes a multistage clustered approach. In the first stage, 105 locations (generally corresponding to single counties) were randomly selected from all U.S. counties. Seven of the locations will serve as the Vanguard Locations and will participate in the pilot phase of the Study. Because the focus of the study includes assessment of the impact of exposures that occur early in pregnancy, both pregnant women and their partners, and women of childbearing age, comprise the initial target population for enrollment in each of the Study Locations. At the time of enrollment, participants will be asked to provide written informed consent for participation in the study. Three distinct groups will be enrolled and followed: Pregnant women and their partners, couples planning pregnancy, and women not currently planning pregnancy but with some probability of becoming pregnant during the four year enrollment timeframe.

The National Children's Study is in a unique position to answer many questions regarding the effects of environmental exposures on the long-term health of children. The focus on exposures prior to and early in pregnancy is a unique feature of this study, as is the breadth of planned exposure and outcome measurements. As technology continues to evolve, stored data specimens (biologic and environmental) will provide a valuable resource to answer important questions for future generations.

The prospective longitudinal design of the study will permit an in-depth examination of the effects of environmental exposures as they unfold over the course of development. This will include an unprecedented, process-oriented understanding of how exposures at particular points in development lead to both immediate and long-term consequences for children, and what circumstances, characteristics, or genetic predispositions mediate or moderate the relation between exposure and outcome. The size and representative nature of the sample will permit both valid inferences about the U.S. population as a whole, and exploration of subgroup-specific patterns of adaptation and maladapation.

Additionally, the data collected for the Study will provide a platform for future research. Data, biological samples, and environmental samples will be available for future studies as science evolves and new questions arise. The Study will serve as an exceptional resource both for science and for society.

Duane Alexander,

Director, National Institutes of Child Health and Human Development, National Institutes of Health.