National Institute of Child Health and Human Development: National Children’s Study
Transcript of National Children's Study Media Briefing
October 4, 2007
10:30 a.m. EDT

I would now like to turn the conference over to our host, Dr. John McGrath. Please go ahead, sir.

With that as background, I turn this over to Dr. Alexander, Director of the National Institute of Child Health and Human Development.

When fully implemented, we anticipate a total of approximately 35 to 40 centers in 105 locations being selected to carry out the study that will provide a representative sample of the diverse population of children in the United States.

Today's announcement represents a milestone for the National Children's Study. The Study's staff will now engage a broader cross section of families and communities and take another step towards its full operation.

Many of you are already familiar with the National Children's Study and others may be just starting to follow. For those new to the study, I will provide just a bit of background information. The National Children's Study is the largest and longest research study ever to look at the ways in which environment and genetics interact to influence child health and human development. It will look at how behavioral and social factors also interact with genetics in the physical environment.

Over the next quarter century, the study will involve more than 100,000 children from before they're born to age 21. Study researchers will search for environmental and genetic influences on the health conditions of children that are of concern to all of us: parents, educators, healthcare providers, and researchers. These conditions include pregnancy related problems, such as birth defects and prematurity, autism, asthma, diabetes, heart disease, obesity, mental health problems, and learning disorders, among others.

In large part the study will focus on diseases and conditions of increasing prevalence in the United States. For example, autism appears to be increasing. According to the Center for Disease Control and Prevention, its presence has risen from about 1 in 1,000 to 1 in 150 children. Asthma is also increasing. In 2005 about 9% of children ages 0 to 17 were recorded to currently have asthma and about 5% of children had one or more asthma attacks than in previous years. Environmental exposures are thought by many people to be responsible for these increases.

Study researchers will examine not only what children are eating and drinking, but what's in the air they breathe, what's in the dust in their homes, and their possible exposures to chemicals from material used to construct or furnish their homes and schools. The researchers also will analyze blood and other biological samples from study participants to test for exposure to environmental factors and whether these factors might influence their health. They've also looked at the neighborhood structure, the family, the community, and the school to assess the social and behavioral environments in which children grow.

There are many reasons why we're conducting the National Children's Study now. Among them, there's mounting evidence that the health habits and exposures of early childhood, perhaps starting before birth, affect the health and well being of adults, as well as children. The recent completion of the Human Genome Project provides scientists for the first time with an extraordinary opportunity to analyze the interactions between genetic and environmental factors that affect health, research that will one day enable scientists to target specific genes for more effective treatments. In addition to the genome, new tools for micro-assay of chemical exposures and new computer capability for storage and analysis of huge amounts of data are available for the first time.

Health disparities in many disease areas are on the rise among underserved populations. This study will help uncover these population specific differences in health, healthcare access, and disease rates. Special efforts will be made to enroll and retain minority populations in this study.

The study scientists will share what they find with children's families, who, in turn can share it with their children's physicians and other caregivers. Families and children who participate in the National Children's Study will directly contribute to the health and well being of not only their own children, but future generations of children as well.

The study findings will benefit all Americans by providing researchers, healthcare providers, and public health officials with information to revise or develop new health and safety guidelines, disease-prevention strategies, and new treatments.

With that background, I'm pleased now to announce the names and locations of the 22 new study centers, who have received a contract award from NICHD and the communities they will serve. The list of newly awarded centers is also listed in the press release.

The new centers are, in alphabetical order: Brown University, covering Providence County, Rhode Island; Children's Hospital of Philadelphia, covering Schuylkill County, Pennsylvania and Newcastle County, Delaware; Emory University covering Dekalb County, Georgia and Fayette County, Georgia; Johns Hopkins University covering Baltimore County, Maryland; Michigan State University, covering Wayne County, Michigan; The Mount Sinai School of Medicine, covering Nassau County, New York; Northwestern University covering Cook County, Illinois; St. Louis University, covering Macoupin County, Illinois and St. Louis, Missouri; The University of California, Davis will cover Sacramento, California; The University of California at Irvine will cover San Diego County; The University of Hawaii at Manoa will cover Honolulu County, Hawaii; The University of Massachusetts will cover Worcester County in Massachusetts; The University of Minnesota is responsible for Ramsey County, Minnesota; The University of Mississippi will cover Hinds County, Mississippi.

The University of New Mexico has been chosen to cover Valencia County, New Mexico; The University of North Carolina at Chapel Hill will cover Rockingham County, North Carolina; The University of Pittsburgh will cover two communities, Marion County in West Virginia and Westmoreland County, Pennsylvania; The University of Texas Health Science Center in San Antonia is responsible for Bexar County, Texas; The University of Utah will cover Cache County, Utah; The University of California, Los Angeles will do Los Angeles County, California; The University of Washington will cover King County, Washington; and Yale University will cover New Haven County, Connecticut.

We selected these new study centers competitively, based on rigorous criteria, including their ability to collect data for the study, the ability to build extensive community networks for recruiting and retaining eligible women and newborns, and a demonstrated capability to protect the privacy of information collected on participants.

Finally, let me add that the National Children's Study represents an invaluable investment in the future of our children and the future of this nation. This investment will not only help prevent illness and save lives, but will result in significant cost savings as well. We anticipate that the health information we gain will significantly reduce the societal burden of illness and disability.

Currently the financial burden of just five of the study's major health outcome theme areas, injury, obesity, diabetes, asthma, and neural behavioral disorders totals over $750 billion per year. A one percent reduction in just these five areas from knowledge gained from this study would save annually twice as much as the entire 25-year cost of the study.

Now I would like to introduce the Deputy Director of the National Institute of Child Health and Human Development, Dr. Yvonne Maddox, who is going to describe in more detail, the significant community engagement activities the new study centers will conduct to recruit and retain a diverse cohort of participants. Dr. Maddox.

A major challenge, as we all know, of the NCS will be reaching out to the 105 communities to identify and to engage 100,000 participants. But in fact, each of the new centers that we will be launching today have already identified and have already demonstrated success in reaching out to diverse populations. The awarding of these new centers really affirms the federal government's commitment to scientific research, to scientific research that will lead to the improvement of the health and well being of all of America's children.

The NCS is led by the U.S. Department of Health and Human Services, including the National Institute of Child Health and Human Development and the National Institute of Environmental Health Sciences of the NIH and the Centers for Disease Control and Prevention and the U.S. Environmental Protection Agency. In fact, more than 40 other federal agencies and departments have also provided input.

The 105 study locations, which are counted across the United States, represent a cross section of America, a cross-section of America in terms of ethnic, racial, economic, religious, geographic, and social groups. This is required if the study is to be a national sample of the country and a national sample of counties were selected for the study because this will ensure representation of the entire nation. The criteria for county selection included factors such as race, ethnicity, income, education level, number of births, and number of babies born with low birth weights.

How would this recruitment take place with all of these challenges before us? In these study locations teams with the help of healthcare professionals, help from community leaders will begin to recruit women who are pregnant or who are likely to become pregnant. We also recognize that some women will join the study through their local physician's offices, local clinics, and hospitals.

The study planners early on acknowledged that recruitment of such a diverse group of American women and their infants would indeed be a complex undertaking. But we all realize that we can build on the trusting relationships that have already been established. Particularly with these new centers that we are launching today, these investigators have already shown that they can recruit and they can retain individuals from various racial and ethnic groups. Working with community leaders this will again be a critical aspect of the study to ensure that recruitment takes place and that retention is maintained. This will require working with grass roots organizations, working to develop campaigns to explain the benefits of the study, to build relationships with the various area healthcare providers, and to reach out to parenting groups and to other organizations that offer health and information to families throughout the world. Evidence shows that many Americans have misconceptions about health and the research process, but we realize that we can build on our already trusting relationships to ensure that these misconceptions are clarified.

Retention of participants in this study will be a challenge. We all know this, but these strong relationships that our study participants will be able to put in place with each other and with the staff of the NCS I think, and we believe, will ensure continuity and retention. This will be done by engaging local community groups and advocates. It will be done by getting participants much more engaged with the community. This will be done through newsletters, interactive Web sites for children, and periodic get-togethers in order to maintain this continued relationship between the staff of the NCS and the participants.

There will be public presentations going on throughout the study. Everything that we can do and that the leadership of this study can do to maintain, to enroll, and maintain this diverse population will be done to ensure that this study is a representation of our nation.

Now I'd like to turn the session over to Dr. Peter Scheidt. It's my great pleasure to introduce him as the Director of the National Children's Study.

Thank you, Dr. Maddox. We are especially enthusiastic about today's announcement because it means that the 22 new study centers will begin preparations to recruit participants in the communities that they will serve. It is incredibly exciting to hear Dr. Alexander read the list of these new partners in moving this landmark research forward this morning. Allow me to briefly present a chronology of the study up to this point and to offer a look into the next phases of its development and implementation.
The National Children's Study officially began in the year 2000 when Congress directed NICHD and other federal agencies to lead a national, long-term study of children's health and development. This directive from Congress was issued through The Children's Health Act of 2000.

In 2004 after four years of extensive planning and input from the many scientists across the country, we identified 105 U.S. communities from which we would recruit and study participating families. We selected the 105 locations, using a probability based method to ensure that children and families from diverse ethnic, racial, economic, religious, geographic, and social groups are fairly included in a way that will be representative of the children in the United States and the experiences that they have, and to assure that we include in those experiences the critical exposures all of our children experience.

In 2005 the study officially got underway when we announced the selection of the first seven study centers. These centers called Vanguard Centers will be the first to recruit participants and will pilot test the study's different components for incorporation into the full study. We awarded the contract also for a large coordinating center that will manage information from the study centers and support the other aspects of the study and integrate all of the diverse components of this study into a coordinated enterprise. All Vanguard centers are actively engaged in the pre-recruitment activities today and recruitment in the Vanguards for the pilot will begin in 2008.

Funding for these new study centers and the study's initial phase comes from the $69 million appropriated from Congress in fiscal year '07; that's this past fiscal year. This funding allowed NICHD to issue the request for proposals in the RFP that is, for new study centers earlier this year, and to make these contract awards today.

With this large group of study centers funded, we are now well underway and will prepare for recruitment in earnest. The centers will begin hiring and training staff, meeting with local community groups and healthcare professionals to inform them about the study, and forming community-advisory boards to provide ongoing guidance on a range of study related issues.

When enrollment begins for the pilot next year and the full study the following year, women who are pregnant or are likely to have a child in the near future and their families during the four-year recruitment will be recruited. All study centers will aim to enroll at least 250 women every year who are either pregnant or likely to have a child from each location.

Initially researchers will collect information on women's pregnancies, including their diets, environments, chemical exposures, emotional stress, and many other widely varied exposures. When the children are born and periodically thereafter, researchers will collect biologic samples and environmental samples, like air, water, and dust from the children's environments. Researchers will meet with families, both in their homes and in clinical settings and the data will be collected remotely by telephone, computer, mail-in questionnaires and other technologies, as they become available over the life of the study.

These newly awarded study centers announced today will begin study start of activities in the 26 locations this year. We anticipate additional competitions next year and the year after for the 16 waves, wave one and wave two, in order to complete the full sample of the 105 locations.

With that, I think we can begin to move on to questions.

Does that answer your question?

There will be some samples analyzed initially, but most of the samples and specimens will not be analyzed until later when the children experience the kinds of conditions and diseases of concern for the study: asthma, learning problems, autism, diabetes. The samples, both environmental and biological samples, can then be analyzed for those children who experience these various conditions in comparison to the many children who do not experience those conditions. That is called embedded case control studies is how the majority of analyses and research analysis will be conducted to inform us about the causes and factors that contribute to these conditions.

Secondly, are you going to provide any incentives to the families that participate?

The study does require a fairly significant level of participation. There are planned to be three face-to-face visits during pregnancy, data information, and specimens collected at delivery and same face-to-face visits at 6 months and 12 months of age and then approximately every 3 years after. This is a not insignificant burden, but it is not so much that women will not be willing to participate and to undergo these visits and to provide this information.

They will be offered compensation in the way of incentives. There are many. First is the importance of participating in such landmark research for the benefit of all of our children and the country. There will be some inconvenience and the individuals will be compensated in an appropriate level for that inconvenience guided by the institutional review boards at the local communities and the ethics boards for the study, so that it is appropriate and expresses appreciation, but is not coercive.

In addition, they will be recognized for participating from the centers and provided with thank you's and small gifts of appreciation. But for the most part, we think that the most important value in participating will be what the mothers and the families can learn about their children, their children's health and the children's environment as a result of participating in this study. Other large studies have informed us that, in fact, that aspect is what participants most value about this kind of research.

The funding for contracts like this is also provided a year at a time. They have negotiated a budget for funding for the first year. That first year funding is provided. Funding for future years will be determined by the availability of funds, which depends on appropriations.

In addition to the federal effort, our plan is to make the data sets available to investigators in the field, so that they will be able to propose their own studies to test their own hypothesis that go beyond the hypothesis central to the study that are part of the federal effort and that are being funded by the federal government's funds.

They will be able to have the datasets available to them, the same datasets that the federal investigators will use. They will also have the opportunity to request access to the stored biological samples from the center to test their hypotheses. They can make application to the NIH, to other federal agencies, or to private sector for funding to test their hypothesis and use the dataset and the biological samples from the study to do that. So there is the combination of the federal data analysis effort that will involve federal scientists and the principal investigators at each of the sites working to do those central analyses, testing the core hypotheses, and the availability of the data set to investigators with all identifiers removed, so that they can test their own hypotheses and expand the value of the study far beyond just the data analysis capacity of the federal effort.

I'll take advantage of this to comment about the value of this National Children's Study as a platform for other kinds of more in-depth studies that we anticipate being able to do throughout the study on portions of the entire sample and the in-depth examination of media exposure is one of those categories.

Does that answer your question?

This study goes well beyond that and we'll have extensive evaluations, measures ...quantization will allow of the kinds of social and behavioral environment the child grows up in: the neighborhood, the community, the school, the church, any other exposures that the child has of this kind of a nature. So that we will have not just physical and chemical environments to look at, but the social and behavioral and neighborhood features as well.

We anticipate that the data from this study will be used extensively in terms of policy making. That extends not just to chemical exposures, but guidance for, as one of the questions related to earlier, media exposures and guidance of social and behavioral experiences that children may benefit from or may be harmful.

So we anticipate that there will be lots of that kind of use of the data. Whether the data will be sufficient from just this study to provide definitive answers or whether they will point to things that need more intensive study, we just have to wait and see.

If we're going to test about what kinds of exposures might have occurred to the 600 children who develop autism in the study, when that happens, after they're three to four years of age, we will only need to do the analyses for the necessary chemicals for that 600 and maybe another 1,200 controls or 1,800 analyses, rather than the entire 100,000. We cannot afford to do many, many chemical analyses on the full 100,000. For that reason, most of those types of test results will not be available for all of the participants. Where there are results available from the tests that will be done routinely and where those results are clearly of benefit or what we call actionable and of some importance to the participants, we do plan to share those results with the participants.

Does that answer the question?

You are correct in saying that the budget request sent to Congress in 2008 did not request funds for this study. The House Appropriations Committee provides $110 million, which is the target number needed in study projections to continue funding in 2008. That figure passed the entire House.

The Senate Appropriations Committee also provided $110 million, but no Senate action has yet been taken on the appropriation by the full Senate. We are waiting to see what happens. If the appropriation of the $110 million for the study passes and the bill is signed by the president, we will proceed with solicitation for the next wave of the study centers and expanded activities on the part of those already funded. If the appropriation is not provided, as was stated in the appropriations request sent to Congress, we will shut down the study and close the contracts, release the staff, and the study would come to an end.

So it depends on the appropriations process. Congress has to make a choice on this, as does the president when he receives a bill in terms of whether this is a go or no go. That will be true for 2008 and that will be true for the ensuing 25 years of the study.

As Dr. Scheidt mentioned earlier, to get more information about the National Children's Study, please visit the Web site at www.nationalchildrensstudy.gov.

Thank you for participating. We appreciate your interest. This concludes the telebriefing.