At the NICHD, we are awaiting the analysis from a review panel of the National Research Council and Institute of Medicine, of our plans for a bold effort to identify the myriad connections between environment, genes, and human health: the National Children’s Study.
The National Children’s Study is the most ambitious effort ever to determine how the environment influences health, both at the beginning of life and well beyond. We’ve long known that environmental factors play an important role in childhood diseases and disorders. For example, exposure to air pollutants like sulphur dioxide and ozone increases risk for asthma and respiratory disease. Contaminants in drinking water can lead to learning disorders and certain cancers. Obesity, too, has a strong environmental component, and, in turn, increases the risk for heart disease and diabetes.
Current plans are for the National Children’s Study to enroll, at or before birth, 100,000 U.S. children, representative of the U.S. population as a whole. Study participants would provide blood and tissue samples periodically, for storage and later analysis. Samples from their homes and communities—like house dust and tap water—would also be collected, catalogued, and stored for later analysis. Careful evaluations would be made of the children’s physical growth, development, and health, from birth until they reached 21 years of age. The data and collected materials would be available to any researcher to analyze, to help determine the links between environmental exposures, biology, and health. Such information would provide the raw material to devise interventions to identify those most at risk of many diseases and conditions, and, eventually, the means to prevent and treat them.
Preparation for the National Children’s Study has been under way since Congress authorized it in 2000. I know that seems like a long time to prepare. But perhaps not, when you consider the size, scope, and complexity of the National Children’s Study. Think of the United States Census, the survey of the United States population that takes place every ten years. The long interval between Censuses is important—Census Bureau staff uses that time to make plans and prepare. The NICHD, along with its partners in the federal government and many outside groups, have been steadfastly working to develop the means to identify and recruit the study’s volunteers and collect the appropriate data and samples, within a budget determined each year by the U.S. Congress. Although the decennial Census surveys the entire population, it collects the data only once every 10 years. The National Children’s Study, on the other hand, will be collecting a vast amount of data daily for over 21 years.
Scientific progress is often like an iceberg— what’s below the surface dwarfing that which we see. Today’s “scientific breakthrough” has often been decades in the making. Like any prototype designed to undertake something never done before, the National Children’s Study has had its fits and starts. Beginning in 2009, with the appointment of its second director, Dr. Steven Hirschfeld, the study was revamped, to recruit and follow the required participants most effectively and efficiently within a reasonable time and at a reasonable cost. In the November 14, 2013 New England Journal of Medicine, Dr. Hirschfeld, NIH Director Francis Collins, and I provided a brief history of the study and its proposed design . As requested by the Congress, the review panel of the National Research Council and Institute of Medicine is now assessing the soundness of this proposed design of the National Children’s Study’s Main Study to help us refine it further. Before we undertake such a monumental effort, we want to take extra care to ensure that our methods are optimal. If all goes as planned, National Children’s Study staff will issue contracts in the next year to begin the main study in 2015.
We will keep you posted on further developments.
Alan E. Guttmacher, M.D.
Originally Posted: November 20, 2013