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 Study Questions and Answers


What is the National Children’s Study?

The National Children’s Study will examine the effects of the environment and genetics on child health and development. Environment is broadly defined to include the physical, chemical, biological, and social and cultural environments. The Study will follow children from across the United States, from before or at birth through age 21. The goal of the Study is to improve the health and well-being of children by increasing our understanding of the role various factors have on health and disease. Findings from the Study will be made available as the research progresses, making potential benefits known to the public as soon as possible.

The National Children’s Study is:
  • Data-driven – meaning that data gathered from the Study is used to make decisions about the Study
  • Evidence-based – meaning that decisions about the Study are based on objective evidence.
  • Community and participant-informed – meaning that input from stakeholders, experts, local and regional communities, and the Study participants is actively sought. 

What will we learn from the Study?

The Study intends to learn more about how children can grow up healthy and how being a healthy child can lead to a being a healthy adult. Analyzing links between children’s environmental exposures and their health will facilitate research into such conditions as birth defects, pregnancy-related problems, injuries, asthma, obesity, diabetes, behavior, learning, and mental health disorders. Findings from the Study will benefit all Americans by providing researchers, health care providers, and public health officials with the information they need to develop prevention strategies, health and safety guidelines, and guide future research.

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How will the Study be conducted?

The National Children’s Study is an observational research study meaning no treatments or medical procedures will be performed. Participants will be asked to answer questions about their daily living, including their health, diet, and activities.  They may be asked to provide biological specimens such as blood and urine, and environmental samples like air, water, and dust. The Study staff may visit with families at home, at other places where children spend time, and also collect information from participants by telephone, Internet, or mail-in questionnaires.

What is the general timeline for the National Children’s Study?

The Vanguard Study, (pilot study), began enrollment in 2009 and will follow each child through age 21. The purpose of the Vanguard Study is to identify the most efficient and cost-effective ways to conduct the Main Study.

The Main Study is in the planning phase. Data collection will begin when a review of the proposed methodologies by the National Academies of Science is completed and new contracts for Main Study implementation are awarded. The Main Study will run for 21 years after the last participant is enrolled.

How does the National Children’s Study differ from other environmental health studies?

The National Children’s Study includes many factors that make it a unique study:
  • Scientific Scope – The scale and scope of the Study is larger than previous studies addressing similar questions that have been undertaken in the U.S. It will collect more samples, specimens, measurements, and health history than any other study to date. This information will include environmental samples, genetic information, health history, and information about learning and behavior.
  • Size – The Study intends to enroll enough families to ensure that information about most common conditions, and many uncommon conditions, can be recorded. The current estimate is that at least 100,000 families will be enrolled in the Study.
  • Duration – The Study intends to identify women prior to or around the time of conception or around the time of the birth of their child, and follow their children through age 21.

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Why is the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) conducting the Study?

The NICHD is directed, together with other federal agencies, to conduct the Study by the Children’s Health Act of 2000. For more information see the Funding and Legislation page.

What is the source of funding for the National Children’s Study?

The Study is funded by a designated appropriation from the United States Congress. For additional information, you can view the Funding and Legislation page.


How much funding has the Study received to date?

The Study’s funding history can be found on the Funding and Legislation page.


What can influence the way the Study is conducted?

The factors that influence Study conduct are

  • Data from the pilot or Vanguard Study
  • Data from other similar studies 
  • Input from scientists and other individuals within and outside the federal government
  • Input from Community and regional advisory boards 
  • Legal and policy changes
  • Scientific and technological developments
  • Available Funding and other resources
  • Advisory Committees  

​What is the National Children’s Study Federal Advisory Committee?

The National Children’s Study Federal Advisory Committee is a committee of experts constituted under the Federal Advisory Committee Act intended to provide scientific input and advice to the National Children’s Study at regular intervals in a public forum. More information can be found on the National Children’s Study Federal Advisory Committee (NCSAC) page.

How can I get involved in the National Children’s Study?

There are multiple ways to become involved in the National Children’s Study.
  • As a participant (when enrollment is open)
  • Researcher
  • Member of the public 

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How can I become involved as a participant?

The National Children’s Vanguard Study completed recruitment in July 2013.   Recruitment will begin again after the launch of the Main Study.

How can I become involved as a researcher? 

The National Children’s Study awards contracts for primary data collection and support of data collection, data and specimen archiving, and analysis. Individuals and organizations can compete directly for a contract or can partner with an organization that already has a contract.

Announcements for contracting opportunities related to the National Children’s Study are published on the Federal Business Opportunities website, FedBizOpps. These announcements are also posted on the Study website on the Business Opportunities page.

The Study infrastructure is available for collaboration with other studies that have complementary scientific goals. A specific program for Ancillary Studies (that is, scientific studies that have independent funding but utilize the Study’s infrastructure) is active, further details and applications are available on the Study website under Supplemental Methodological Studies.

How can I become involved as a member of the public? 

Members of the public are invited to provide input during open meetings of the NCS Advisory Committee and/or through formal requests for information, published in the Federal Register.  Suggestions can also be made by contacting the National Children’s Study Program Office directly using the contact information just below.

How do I communicate questions, comments, or concerns about the National Children’s Study?

Call us at: 877-865-2619
Write to us at: The National Children’s Study, 6100 Executive Boulevard, Suite 3A01, Bethesda, MD 20892-7510

How does the Study ensure participants’ privacy? 

Privacy and confidentiality are of utmost importance to the National Children’s Study. The privacy and confidentiality of all National Children’s Study participants is protected according to federal regulatory requirements for human research protection and protection of health information. The confidentiality of Study participants is also protected by a Certificate of Confidentiality issued by the NICHD, which prevents legally enforced disclosure of the identity of Study participants.

How can researchers access Study data?

The NCS is committed to making data available as soon as feasible.  Some data will be available in a restricted use format to qualified scientists. The NCS Data Access and Confidentiality Concept of Operations outline the National Children’s Study’s current approach to data access and confidentiality including the underlying principles as they pertain to the NCS. 

Have any research articles resulted from the Study?

Yes. A list of Study publications can be found on the Research Publications page.

What is the Vanguard Study?

The National Children’s Study (NCS) consists of two related phases: the Vanguard Study and the Main Study. The NCS Vanguard Study is a pilot, or preliminary, study and is being conducted in 40 locations across the United States. The NCS Vanguard Study began prior to the Main Study, yet after the Main Study begins both studies will run in parallel and follow children from birth to age 21.

The Vanguard Study is designed to help provide the detailed preparation needed to implement a study of the scope and complexity of the NCS Main Study. A Vanguard Study evaluates the feasibility, acceptability, and cost of recruitment strategies, Study procedures and outcome assessments. Feasibility evaluations assess technical performance and reliability; acceptability evaluations examine the influence of different components the Study design, specifically on Study participants and Study infrastructure; and evaluations regarding cost examine the level of effort, personnel, resources, and money required to adopt different strategies.

What is the National Children’s Study Main Study?

The Main Study is planned to be a study of approximately 100,000 children that will run parallel to the Vanguard Study. The overall goal of the National Children’s Study Main Study is to advance understanding and knowledge of the impact of environmental and genetic influences on child health and development. Environment is broadly defined to include the physical, chemical, biological, and psycho-social cultural environments. The Main Study will provide a rich source of information and material for researchers to investigate many questions related to the environment and child health, including areas of inquiry that have not even yet  been identified.

What is a Vanguard Study location?

Families who participate in the Vanguard phase of the National Children’s Study come from selected geographic locations across the United States. The National Children’s Study works within a designated Study location to recruit participants and to collect and process data.
Maps and a list of all Vanguard Study locations can be found on the Study Locations page.

Has recruitment ended in the Vanguard Study?

Vanguard Study recruitment ended effective July 2013. 

Who is enrolled in the Vanguard Study?

Women who meet Study enrollment criteria are enrolled in the Vanguard Study. These enrollment criteria depended on location of residence or care provider. Children of these women become Study participants once they are born. Mothers, fathers, and other adults who are legal representatives of these children are also eligible to be enrolled as participants in the Vanguard Study.

What role do fathers have in the Study? 

Fathers are participants in the Study, like mothers and children. They are encouraged to contribute information and samples to the Study. 

Is the Vanguard Study considered a generalizable sample of the U.S. population? 

No.  While the NCS Main Study proposed design is a national probability sample intended to be generalizable, the Vanguard Study (pilot phase) was designed to answer questions about study methods and implementation thereby maximizing the effectiveness and efficiency of the Main Study. Although the Vanguard Study includes participants from 40 locations around the United States, the selection of the sites or participants were not probability based so the population is considered from a statistical perspective a convenience sample.

Have all the Vanguard Study locations been identified?

Yes, all locations have been identified and a list can be found on the Study Locations page. 

Is data collection continuing in the Vanguard Study?

Yes, the Vanguard Study will follow and collect information from children enrolled in the Study through age 21.

What samples are the National Children’s Study collecting in the Vanguard Study?

The Vanguard Study has collected and will continue to collect a wide variety of biological and environmental samples. Examples of the type of samples collected include blood, urine, hair, saliva, cord blood, placenta, nails, meconium, breast milk, air, dust, and water.

What is the visit schedule for the Vanguard Study?

The visit schedule for the Vanguard Study currently includes visits during pregnancy for women and for children at birth, infancy, and through childhood. These visits may take place in-person or by telephone, internet or mail. The current schedule involves two pregnancy visits, a birth visit, and two in-person contacts and two remote contacts, typically by telephone, during a child’s first year, and then one in-person and one remote visit during the subsequent four years. Although they can be shorter, in-person visits typically last up to two hours, includes interviews, exams, and sample collection. The visit schedule after age five has not yet been finalized but will probably be a blend of in-person and remote visits every two to three years through age 21.

How have plans for the Study changed as a result of Vanguard Study findings?

One important example is how participants are recruited into the Study. The Vanguard Study began with a model of recruiting participants by National Children’s Study staff going door-to-door in selected neighborhoods to identify eligible women and encourage them to enroll in the Study. The initial recruitment effort yielded fewer women and was more costly than expected. Subsequently, after testing and evaluating alternate recruitment methods, the Study decided to utilize health care providers as the basis for future recruitment. The most recent recruitment effort in the Vanguard Study used a combination of hospitals and other community-based health care providers. This is known as the Provider-Based Sampling Feasibility Substudy (PBS) (further explained below).

How have the overall operations of the Vanguard Study changed over time?

Initially, the Vanguard Study enlisted locally based contractors to screen, enroll, and collect data from Study participants. This recruitment model proved to be less efficient and more costly than anticipated. For the first five years of Vanguard Study operations, the federal Government spent about $450 million for the services of the local field contractors.
In 2012, in an effort to reduce costs and streamline operations, the National Children’s Study revised the operations model to consolidate data collection services into four Regional Operations Centers. All of the initial local Study Center contractors, whose contracts began to expire in 2012, were directly invited to apply for the new contracts. The contracts for the Regional Operations Centers were awarded after a rigorous and open competition. The National Children’s Study completed the transition to the Regional Operations Centers in September 2013. 

What are the Regional Operations Centers?

Regional Operations Centers are research institutions under contract to conduct ongoing Study operations across the 40 Vanguard Study locations. There are four Regional Operations Centers and each is responsible for ten Study locations. Each Regional Operations Center is assigned one region of the U.S.—Central, East, South, and West.

When will Vanguard Study data be available, and to whom?

Currently, Vanguard Study data are available to our contractors for preparing reports and scientific publications. The data are not available to the general public or research institutions at this time, but policies and procedures are currently under development to provide broader access in the future.  

What is the PBS, or Provider-Based Sampling Feasibility Substudy?

The Provider-Based Sampling Feasibility Substudy is one of the recruitment methods tested in the Vanguard Study. It compared the efficiency and effectiveness of enrolling women two ways:
  1. At their first doctor’s visit at an office or clinic during pregnancy
  2. At the time of birth in a hospital or birthing center

What is the National Children’s Study Main Study design?

The Main Study will use a national probability sampling design. 

Will the National Children’s Study Main Study be a statistically valid generalizable sample of the U.S. population?

Yes, the Main Study is intended to be a statistically valid generalizable sample of the U.S. population.

Where are the National Children’s Study hypotheses for the Main Study?

The National Children’s Study has defined a set of sample hypotheses for the Main Study. These hypotheses are intended to demonstrate the capabilities and limitations of the Study design and sample size. The National Children’s Study is hypothesis informed, but not hypothesis driven; that is, hypotheses guide the design and data collection strategies, therefore ensuring the NCS has the flexibility to adjust to changing science and health information.
The Study will not be limited by a list of specific hypotheses, but will rather collect data based on general areas of interest and function to generate hypotheses. The Study will serve as a high quality data resource allowing it to address an unlimited number of future scientific questions and hypotheses including many that may not even be imaginable now.

Will the National Children’s Study Main Study collect preconception data?

The proposed study design includes enrolling some women before they become pregnant. However, the number of women enrolled during a preconception state has not yet been determined.

From where will the National Children’s Study Main Study recruit participants?

Specific locations have not yet been selected.